Pfizer
Flu-like symptom reports
Female, 40 - 59 years
| Age | Reported | Symptoms | Notes |
|---|---|---|---|
| 40 | 2020-12-31 | dizziness, fever, shortness of breath |
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITC...
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CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST. TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS. SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES. TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
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| 40 | 2020-12-31 | fever, fatigue |
No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, ache...
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No adverse event, just side effects: Sore arm on day 1, within 24 hours low grade fever 100.2F, aches, neck lymph node soreness/slight swelling, fatigue
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| 40 | 2020-12-31 | fatigue |
Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with a...
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Sore arm at the site x 3 days. that evening fatigue, myalgias. at 4 am the next morning awoke with abdominal pain, nausea, then an episode of liquid stool. These continued throughout the next day until the evening of day 2. By morning of day 3 they were gone
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| 40 | 2020-12-31 | throat pain, headache, fatigue |
Swollen lymph nodes in neck, arm, and chest. Sore Throat, fatigue, headache. Lymph nodes swollen on ...
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Swollen lymph nodes in neck, arm, and chest. Sore Throat, fatigue, headache. Lymph nodes swollen on right side after one week of injection. Bilateral swelling of lymph nodes by day nine.
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| 40 | 2021-01-01 | throat irritation |
Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benad...
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Rash throughout scalp, face, neck, ears,torso,thighs,legs, arms, back, itchy throat and ears. Benadryl 50 mg Pepcid 40 mg Prednisone 60 mg The rash started after 1 hour. Took 25 mg benadryl then by 9 pm it got worse, took another 25 mg benadryl without improvement. Continue taking benadryl next day and took pepcid by 12 noon the next day. Following day 22nd December the patient went to hospital ER at 1200 noon. There got prescribed 60 mg prednisone PO with benadryl 50 mg and pepcid 20 mg. Received instructions to continue taking same dose for another 4 days.
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| 40 | 2021-01-01 | headache, fatigue |
Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Sev...
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Severe headache same day lasting for 36 hrs. Severe fatigue starting next day lasting 24 hrs. Severe headache starting again on day 4 lasting through day 5. Unable to focus, eat because of headache. Sore arm for 24 hrs post vaccine.
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| 40 | 2021-01-03 | dizziness |
Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ...
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Approx. 3 hours after being vaccinated. Developed confusion, dizziness, and blurred vision. Went to ER. BP noted to be 163/100. After one hour and a half, BP in the 120's systolic and 90's diastolic. Continued to have blurred vision. Blood pressure became labile and continued to be in the range of 160's over 100's to 130/90's. After 48 hours, vision no longer blurred, Blood pressure returned to normal baseline and maintained. Took BP for over one week after, morning, noon, and night on the Left arm and Right arm. My BP stayed in the 117/70-120/80 range. Wanted to make sure I had no underlying hypertension. No other adverse issues.
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| 40 | 2021-01-03 | dizziness |
Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as thoug...
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Chest started tightening then started having a hard time swallowing. Felt dizzy, faint, and as though I was going to pass out. Epi pen was administered when I wasn't able to swallow. Was taken to ER on a stretcher, however they said on the way, I wasn't responding and couldn't open my eyes. Muscles began cramping and loss sensation in limbs. Hands wouldn't open up as they cramped. Blood pressure kept going up and down.
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| 40 | 2021-01-03 | runny nose, headache, fatigue, throat irritation |
Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximate...
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Fatigue, myalgias, arthralgias, headache, rhinorrhea, scratchy throat, chest tightness - approximately 72 hours duration
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| 40 | 2021-01-03 | fatigue, dizziness, fever, headache |
Headache; fatigue; muscles aches; Fever/ 103.6/100.8/"102 something"; Dizziness; This is a spontaneo...
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Headache; fatigue; muscles aches; Fever/ 103.6/100.8/"102 something"; Dizziness; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, expiry date: Mar2021, via an unspecified route of administration from 20Dec2020 at a single dose (dose unknown, by injection once) for covid-19 immunization. Medical history included multiple sclerosis (MS) from 2015 and ongoing. The patient's concomitant medications were not reported. The patient previously took ocrevus for multiple sclerosis. She had COVID in August, and got antibody testing, as the medication she was on (ocrevus) for MS knocked out antibodies, so she received the vaccine. The patient spiked a fever of 103.6. She couldn't get out of bed all day and she started having dizziness and headache yesterday, which got progressively worse, and last night she had fever of like 100.8, muscles aches and fatigue, and she woke up this morning and her temperature was "102 something", and she took ibuprofen. She stated that she then got out of bed, as she could hardly get out of bed before or she would pass out, and now her temperature is 103.6, and she has never had it that high before. The dizziness started soon after vaccine. It is all over the place, when she stands, she is incredibly dizzy, but is ok now that she is sitting. She added that she has MS, so dizziness was not abnormal for her. The headache started soon after vaccine; it comes and goes, it goes away and comes back. For the muscle aches and fatigue, they got a lot worse, but was ok now, the Ibuprofen is kicking in. She had stayed in bed all day, then her temperature was 103.6, she had finally got out of bed and took her temperature and ibuprofen. Outcome of events fever, fatigue, myalgia was not recovered whereas the outcome of other events was unknown. No follow-up attempts are possible. No further information is expected. The information on the batch/lot number was obtained.
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| 40 | 2021-01-03 | chills |
I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; ...
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I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case. A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case
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| 40 | 2021-01-03 | headache, weakness, shortness of breath, fever |
I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shak...
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I had seizure like 3 times; Vasovagal reaction; Fever; Headache; Weakness; It's just little bit shaky and breathless; It's just little bit shaky and breathless; allergic reaction; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 vaccination. There were no relevant medical history and concomitant medications. The patient reported that on an unspecified date, she had an allergic reaction. She had vasovagal reaction and seizures. Vasovagal was an allergic reaction that happened, and added that basically it's an allergic reaction. The patient experienced fever, headache, and weakness like right now. It was just little bit shaky, ever since yesterday and she had been way off like she take it as instruction yesterday, weakness, headache and breathless did not stopped from yesterday. The patient had been taking Tylenol for fever and headache. The patient reported that the events persisted. On 24Dec2020, lab work was done at the hospital, and she was told that the lab work was okay and they did CT scan of head because she developed seizure. She had seizure like 3 times so they scanned her brain. The outcome of the events was not recovered.
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| 40 | 2021-01-04 | fatigue, fever, chills, shortness of breath |
12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm...
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12/19 - Elevated heart rate, trouble breathing. No med attn needed. 12/23 - 7pm Chills (2hrs), 9pm low grade fever, 11pm 101.2 fever, body aches, fatigue (2 days). Took Ibuprofen. Fever did not go over 99 after Ibuprofen. 2-3 episodes of diarrhea. Seen by PCP on 12/24 via after hours clinic. Recovered in 4 days.
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| 40 | 2021-01-04 | dizziness, throat swelling, respiratory tract congestion |
About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense...
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About 30 minutes after the vaccine, I was driving and suddenly felt congestion, flushing and a sense of fullness/swelling in my throat. I pulled over and called my husband. I could breathe fine, but the sensation of swelling in my throat was frightening and I felt like I couldnt swallow my saliva. I also had the feeling like I might faint (hot and flushed). This all passed pretty quickly (5 minutes), and I took a benadryl when I got home and rested.
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| 40 | 2021-01-04 | headache | Developed headache and backpain within 5 minutes from vaccination |
| 40 | 2021-01-04 | fever, chills | Fever and chills 12 hours after injection |
| 40 | 2021-01-04 | chills, fever, sweating | Fever, body aches, chills and sweats |
| 40 | 2021-01-04 | headache, throat irritation, dizziness, throat pain, fever |
Following vaccination, patient reported throat scratchiness in the right side. She has had previous ...
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Following vaccination, patient reported throat scratchiness in the right side. She has had previous allergic reactions to allergy shot and stated that this is how she felt before. VS: 0740- HR 127, O2 100%, BP 127/75. 0752- HR 100, O2 100%, BP 134/82. 0805- HR 103,O2 100%, BP 159/80. Patient evaluated by physician and monitored in clinic for additional 30 minutes. 0841 HR 104 O2 98 BP 135/77; 0847 HR 100 O2 100 BP 136/73. Discharged from clinic. On 1/4/21 patient presented to urgent care reporting that over the course of the evening and next day she developed intermittent fevers with a T-max of 103 degrees as well as headache and lightheadedness. She has had intermittent symptoms ongoing since her vaccination prompting her to come for evaluation at urgent care. She denies difficulty swallowing. She had been intermittently taking antihistamines. Positive for sore throat. COVID antigen testing was negative, patient discharged.
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| 40 | 2021-01-04 | headache, respiratory tract congestion, throat pain | Headache congestion clear nasal discharge throat pain and inflamation no smell no taste |
| 40 | 2021-01-04 | headache, malaise | Headache, nausea, metalic taste, general malaise, low back pain |
| 40 | 2021-01-04 | fatigue, headache |
Headache; Fatigue; Muscle/ joint pain; Muscle/ joint pain; This is a spontaneous report from a conta...
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Headache; Fatigue; Muscle/ joint pain; Muscle/ joint pain; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) Intramuscularly on 26Dec2020 10:30 AM (Anatomical Location: Arm Left) at single dose (first dose) for COVID-19 immunization. Medical history and concomitant medications were reported none. Patient did not have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Headache, Fatigue, Muscle/ joint pain on 26Dec2020 12:30 PM. Patient did not receive any treatment. The outcome of the events was recovered in unknown date. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
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| 40 | 2021-01-04 | shortness of breath, fever, headache |
Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and join...
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Hives, wheezing,SOB,itching, Tingling in tongue initially. 01/05/2021 Fever 100.8, headache and joint pain Treated with Albuterol inhaler and Benadryl 25mg x2
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| 40 | 2021-01-04 | weakness, headache, migraine |
One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in s...
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One week post Injection, on 12/28, I noticed a hard lump on my left clavicle (about 1.5 inches in size)-same side as injection. It was painful and partially mobile. No other symptoms other than those of headache a few days prior mentioned below. I went to urgent care on 12/29 where CXR and soft tissue ultrasound were ordered. CXR normal. US 12/30 showed cluster of lymph nodes in that area. Lump appears to be smaller this week and not painful. Also, I developed a severe migraine on 12/26 (5d post vaccine). So severe that it was debilitating which is unusual for me. It lasted approximately 36 hours.
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| 40 | 2021-01-04 | chills |
Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills ...
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Patient experienced aching, fever, diarrhea that started 12/30/20. Symptoms continued adding chills , body aches, and vomiting over the next several days leading to an Emergency Room visit on 1/4/20.
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| 40 | 2021-01-04 | dizziness, fatigue, headache, chills | Severe headache, bilateral ear pressure, intense vomiting, chills, dizziness, fatigue, nausea |
| 40 | 2021-01-04 | headache |
eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report fr...
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eye pain; sensitivity to light; headache/Headache worsened/migraine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old female patient received BNT162B2 on 29Dec2020 12:30 at left arm at single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included labetalol, lisinopril, tolvaptan (JYNARQUE), calcium, and ascorbic acid/ferrous fumarate (VITRON C). Patient experienced headache the night on 29Dec2020 21:00 after took the vaccine. Slept the night without much trouble. Headache worsened in the morning, almost felt like a migraine attack with sensitivity to light and eye pain etc. on 30Dec2020. Treatment was not received for these events. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-05 | dizziness |
After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling...
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After vaccine administration, c/o of dizziness, "woozy", after 30 minutes c/o bilateral leg tingling/weakness, difficulty ambulating.
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| 40 | 2021-01-05 | fatigue | Arm soreness, mild fatigue but she is overall okay |
| 40 | 2021-01-05 | throat pain, fever, headache, nasal congestion, fatigue |
Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times t...
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Chest heaviness and pressure about 10 minutes afterwards, got better then came back multiple times that same day. I also had sore throat and funny taste in my mouth. That night is when I mainly definite effects, chills, fatigue, body aches, low grade fever and head ache. Wednesday and Thursday I was in bed with fever, nasal congestion, body aches. Friday I started to feel better and function. By Saturday I was fine. Was in communication with my PCP. My daughter, 3 years old tested positive for Covid on 1/4/2021 and now I'm starting to feel bad.
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| 40 | 2021-01-05 | fever | Fevers started 12 hours post vaccine. Severe arm pain. Out of proportion to previous IM vaccines. |
| 40 | 2021-01-05 | chills |
Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and de...
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Had arm soreness last night. Woke up with body aches, despite taking tylenol. Have had chills and developed a fever of 101.
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| 40 | 2021-01-05 | fatigue, body temperature increased |
I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience...
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I received the vaccine at 1050hrs on 12/16/20. At around 0900hrs on 12/18/20, I began to experience severe fatigue. At ~1330 on the same day, I had a mildly elevated temperature - normal baseline for me is 97.6, with that reading at 99.4. Due to the fatigue, I slept from 1400 hrs until 0500 on the following day, 12/19/20. No other symptoms to report besides a tender injection site for the first 48 hours.
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| 40 | 2021-01-05 | headache |
I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circl...
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I started seeing a squiggly bright circle. It started as a spot then grew to a bright outlined circle. I also started to get a headache. I took 3- 200mg ibprofen. About 10 minutes later, the vision problem went away.
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| 40 | 2021-01-05 | dizziness, weakness | Lightheadedness, dizziness - "felt like the room is spinning," weakness and tingling all extremities |
| 40 | 2021-01-05 | dizziness |
Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling d...
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Pfizer-BioNTech COVID-19 Vaccine. Patient received COVID vaccination on 1/5/2021 and began feeling dizzy, light-headed and then had a witnessed syncopal episode with seizure-like activity, vomiting and loss of consciousness. Onset of symptoms were almost immediately following receipt of the vaccine. Patient demonstrated seizure-like activity again while in the ED. Patient received lorazepam 1 mg IV, diphenhydramine 50 mg IV, Lactated Ringers 500 ml IV bolus, NS 1000 ml bolus, potassium bicarbonate 25 mEq. Patient ED visit 0852 until 1404. Patient responded well to treatment and was discharged in stable condition.
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| 40 | 2021-01-05 | headache, fatigue |
Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day o...
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Second dose of vaccine. Unable to sleep post vaccine evening zero. Severe fatigue post vaccine day one. Headache. Arm pain out of proportion to previous IM vaccinations.
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| 40 | 2021-01-05 | shortness of breath |
Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing,...
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Started with tingling in arms and hands within 5 minutes, then tingling in tongue, and heart racing, lead to difficulty breathing and turning pale. Staff stuck me with an EpiPen in my right thigh and EMT was called and Benadryl was administered.
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| 40 | 2021-01-05 | fatigue |
Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and starte...
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Very fatigue the next day after vaccine. I had whole body tiredness. My arm was very sore and started about 3am . The site was fine but the deltoid and tricep muscles were very sore.
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| 40 | 2021-01-05 | weakness, chills, fever |
Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), ...
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Weak, nausea, hives, high fever 102.9 for 16 hours, chills, joint pain (arms, hips, legs and back), symptoms improved after 32 hours. Loss of voice at 42 hours but has since came back.
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| 40 | 2021-01-05 | fatigue |
Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep wa...
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Whole body fatigue the next day. Arm was very Sore. The site was fine but the deltoid and tricep was very sore. I have regular yearly flu shots with no issues.
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| 40 | 2021-01-05 | dizziness, fatigue, headache |
dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; diz...
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dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: ej1685) for the first dose via an unspecified route of administration in the right arm on 29Dec2020 09:00 for covid-19 immunization. Medical history included diabetes, anxiety/depression, obesity and allergies to penicillin (PCN). Concomitant medications included metformin hydrochloride (MEFORMIN), glipizide, insulin glargine (TOUJEO), dulaglutide (TRULICITY), gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced dizziness headache fatigue day 1, headache fatigue day 2, headache fatigue nausea flushed day 3, event onset date reported as 29Dec2020 09:15. The events were reported as non-serious. No treatment was received for the event. The outcome of the events was not recovered.
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| 40 | 2021-01-06 | headache, somnolence |
After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flash...
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After 10 mins of shot had hot flash, nagging headache, nausea in waves. Driving home more hot flashes and nausea, pain in left hip. Got really sleepy. Had problems with left hip, problem getting out of car very stiff. Couldn't stand on the left leg. Had stinging with every step. Burning sensation in the hip. Right arm started having nagging pain with tingling, took Tylenol. Tried to get out of bed, left hip felt like something was poking with fire. Saw bumps on hip, left back. Upper arm was still having tinge. Took Benadryl. Next morning woke up with lesions on left hip, some ruptured that felt like acid and then form a scab. The right arm started with the lesions. Went to urgent care. Dr. diagnosed patient with shingles. Patient questions the Shingles at her age. Pt was given Valtrex for the shingles.
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| 40 | 2021-01-06 | headache, chills, fever |
Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had co...
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Developed chills, fever (102), headache, body aches, back pain, sore arm at injection site. I had covid March 2020.
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| 40 | 2021-01-06 | headache, discomfort | EE reports facial swelling with pressure and HA at 3:00 pm went to the ER at 6:00 pm |
| 40 | 2021-01-06 | headache, fever, weakness, chills | HEADACHE FEVER CHILLS NAUSEA VOMITING WEAKNESS BODY ACHE |
| 40 | 2021-01-06 | headache | Headache and severe stomach pain lasting 2 days |
| 40 | 2021-01-06 | weakness, chills, headache, influenza like illness, fever |
Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and...
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Headache began 5 minutes after shot. Took 500 mg Tylenol. About 4 hours later began feeling weak and muscle aches. Took 600mg ibuprofen. At 1am had massive headache body aches chills to the core. Took more Tylenol. At 5:30am fever of 100.4 and flu like symptoms. Called into work.
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| 40 | 2021-01-06 | weakness, fever, headache, chills | Headache, chills, body-ache, fever, nausea, vomiting, and weakness. |
| 40 | 2021-01-06 | fatigue, somnolence, fever, throat pain, sweating, headache, chills |
I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a s...
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I received the vaccine at 0930 am 1/6, about 6 hours later I started feeling extreme fatigue and a slight sore throat. I left work early at that time. When I got home I couldn't stay awake and fell asleep around 6pm. Then starting having GI distress cramping, pain and diarrhea around 9pm-11pm. At 2 am I woke up with chills and fever, I took a Tylenol around 3-4 m and then broke out if huge sweat, then finally fell asleep. 1/7/21 I mostly have soreness, headache and fatigue now.
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| 40 | 2021-01-06 | fatigue, influenza like illness, fever, chills |
I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really cou...
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I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am. After that I felt tired and felt like when I had Covid back in November. I started feeling better about Sunday, still a little tired but felt more back to normal. My heart rate is still getting back to normal so my Dr is following me on that.
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| 40 | 2021-01-06 | skin warm |
Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was j...
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Localized swelling/redness/warmth/soreness that started on the day after vaccine. I thought it was just a normal vaccine reaction because I have had those in the past. It seemed to get a little smaller and less red/warm in the next few days but then started to get more red and swollen in the past 24-48 hours. It has been a week since the vaccine. It is itching some now for the past 2 days as well.
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| 40 | 2021-01-06 | fever, headache |
On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful...
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On Monday January 4th I received my Covid-19 vaccine at work, at 410pm. That evening went uneventful. The following day, Tuesday January 5th I woke up with a sore right arm and a slight headache. The headache increased in intensity throughout the day, developing also body aches and a fever of 100.4. The symptoms seemed to improve slightly after taking Tylenol. The next day, Wednesday January 6th I felt much better, the body aches were almost gone, I had no fever and no headache. When I got home from work I noticed hives all over my arms, anterior and posterior neck - going into the hairline, face, especially around my mouth, chest, abdomen, upper and lower back. The affected areas were itchy and I also felt a slight burning/stinging sensation on my neck. Even though I did not notice any hives on my legs, my right ankle was itchy, as well. I took Claritin 10 mg and I did not notice much difference. When I woke up today, Wednesday January 7th the hives were still present on my arms, chest, abdomen and back and they looked like dissipating. It is currently 6:12 pm on January 7th and my hives are almost gone
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| 40 | 2021-01-06 | chills, fatigue |
Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative: Employee notes approximately ...
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Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative: Employee notes approximately 48 hours of COVID like symptoms, similar but milder than what they experienced with the infection. Noted extreme fatigue, pain, diarrhea, chills and muscle aches with resolved after approximately 48 hours.
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| 40 | 2021-01-06 | fever, headache, sweating, chills |
Sensitive to temperature, chills , fever, sweats, headache, tx with tylenol, with no relief, 01/07...
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Sensitive to temperature, chills , fever, sweats, headache, tx with tylenol, with no relief, 01/07/2021 faint headache only
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| 40 | 2021-01-06 | headache |
Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at i...
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Severe muscle pain, that went into back, and all the way down to fingers of left hand. Swelling at injection site, and then swelling and tingling in left hand. and head ache. Symptoms didn't subside until day 3. Still have pain in left arm that radiates down to elbow. All other symptoms subsided.
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| 40 | 2021-01-06 | shortness of breath | rash on arms and torso; shortness of breath, and body aches |
| 40 | 2021-01-07 | nasal congestion, chills, body temperature increased, headache, fatigue |
12 hours from vaccine #2, I started with rigors, myalgias/arthralgias, severe headache, temperature ...
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12 hours from vaccine #2, I started with rigors, myalgias/arthralgias, severe headache, temperature 100-101, nasal congestion, and profound fatigue. Symptoms resolved after 36 hours with Tylenol/Advil and supportive care. Sent for COVID Rapid PCR which was negative; missed 1 day of work.
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| 40 | 2021-01-07 | sweating, throat swelling |
Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Re...
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Acute allergic reaction Tongue swelling Facial swelling Throat swelling Rash on throat and chest Redness in throat Diaphoresis Momentary loss of consciousness
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| 40 | 2021-01-07 | headache, shortness of breath |
After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Ra...
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After receiving injection, patient reported SOB, chest tightness, hand tremor, and seeing stars. Rapid response called , patient observed for 30 minutes and walked to car. Patient then presented to emergency department at 12:06pm with concern for reaction and h/o heart mumur as a child. Patient referred to Urgent Care Clinic and presented at 12:30, endorsed headache and anxiety. Patient received acetaminophen 1,000mg PO x 1 dose, diphenhydramine 25mg PO x 1 dose, and ibuprofen 600mg PO x 1 dose in Urgent Care. Crackers and water given. Patient provided education on managing anxiety and discharged.
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| 40 | 2021-01-07 | dizziness, headache, fever, chills, fatigue, malaise |
Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is alread...
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Around at 7AM when I arrived at work I started feeling chills, took temperature 99.5F that is already elevated for me. About 9:30 my temp was 101.8F and they sent me home. I just had the chills and fever. I got home and developed a headache and around 1PM I started feeling really dizzy. The temperature did not subside and the next day I woke up and I couldn't function, I felt really dizzy I kept laying down and drinking water, I could not keep anything down my stomach did not feel well. I felt like I had to vomit. When I sat down in the toilet then my ears started ringing pretty bad all of a sudden I could not hear anything and I passed out in the toilet. My husband found me and tried to wake me up. After that I still feel dizzy. I did not have any appetite either. I could barely hold water. The next day I was not as dizzy but my stomach was still upset but I could hold some soup down but then started with diarrhea. Employee health kept calling me everyday and I did the the telehealth appt and I also had a little bit of a rash in my chest that appeared all of a sudden red like a streak. The dizziness I had for the first 4 days, diarrhea did not come until the 3rd day and I had it for 2 days and my temperature was back to normal on the 4th day. Everything started to get better (my stomach stopped feeling queezy) around the 4th day but still felt fatigued until about 12/29/2020.
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| 40 | 2021-01-07 | dizziness |
At about 10 minutes after administration, patient felt a bit lightheaded. She was given apple juice ...
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At about 10 minutes after administration, patient felt a bit lightheaded. She was given apple juice and was able to bring her mask down from her face and lightheaded feeling quickly resolved. BP 148/83 p 74.
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| 40 | 2021-01-07 | dizziness | Dizziness Tingling Left arm to finger tips. |
| 40 | 2021-01-07 | dizziness, chills, fatigue, headache |
Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a conta...
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Dizziness; Diarrhea; Sore Arm; Headache; Fatigued; Chills; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular at the left arm on 31Dec2020 13:00 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness, diarrhea, sore arm, headache, fatigued, and chills on 01Jan2021. The patient did not received any treatment for the evets. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19 via a blood test in Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks. The patient recovered from the events on an unknown date in Jan2021.
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| 40 | 2021-01-07 | chills, fever, fatigue, headache |
Fatigue; fever; chills; body aches; headache; This is spontaneous report from a contactable other hc...
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Fatigue; fever; chills; body aches; headache; This is spontaneous report from a contactable other hcp (patient). A 40-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscularly at right arm on 29Dec2020 11:45 at single dose for COVID-19 immunization. Medical history included anxiety/depression-mild, known allergies to penicillin (PCN), patient was diagnosis (dx) with Covid 19 on 20Nov2020. Concomitant medication included duloxetine, hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZID), colecalciferol (VITAMIN D), paracetamol (TYLENOL) and MV, all received within 2 weeks of vaccination. The patient experienced fatigue, fever, chills, body aches, headache that lasted about 24 hours, all started from 29Dec2020 11:45. Then continued fatigue and mild body aches since then. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.
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| 40 | 2021-01-07 | cold sweat, fever |
Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold s...
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Fever, muscle/body aches. Stiff neck Arm VERY sore. Woke up the night after receiving with cold sweats and arm throbbing (like someone punching repeatedly in the arm) and sensitive to tje touch. Arm painful for 3-4 days
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| 40 | 2021-01-07 | headache, head discomfort | Headache pressure around head for 2 days |
| 40 | 2021-01-07 | fatigue, headache |
Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started a...
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Headache started at 1pm and was gone by 7:30pm Very sore arm Then the nausea and diarrhea started and lasted until 5am Then chills started from 3:00am until 7:00am Then fatigue continued throughout the day- I slept for 15hours
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| 40 | 2021-01-07 | fatigue, weakness, somnolence |
I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time wa...
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I had arm soreness that I needed to take Tylenol and I was exhausted no energy I had a hard time walking around the hospital I almost fell asleep on my desk. I fell asleep that night and felt fine the next day! Advanced maternal age because I'm 40 so I'm high risk, Low on Vitamin D3 early in my pregnancy, beginning of Dec I was lightly anemic, due date Feb 9th
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| 40 | 2021-01-07 | throat irritation, shortness of breath |
Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later wit...
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Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.
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| 40 | 2021-01-07 | shortness of breath |
Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with r...
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Patient received dose #2 at 2:35 pm, at 2:45 pm onset of severe pruritis, shortness of breath with rapid onset of dyspnea. Epinephrine Injection, USP Auto-Injector 0.3 mg administered. Code blue called. This occured in hospital setting, emergency department responded to vaccination clinic. Oxygen therapy, Methlyprednisolone 125 mg IV push, Diphenhydramine 50 mg IV push.
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| 40 | 2021-01-07 | headache |
Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and righ...
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Patient report tingling of the tongue and pain with swallowing. Right side tongue swelling and right side facial tingling with difficulty to swallow occurred 45 minutes after receiving the vaccine. Patient took 50 mg of Benadryl after 10 minutes there was improvement and after 30 minutes it completely resolved. She woke up the next morning with HA and diarrhea she took Tylenol and will monitor.
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| 40 | 2021-01-07 | discomfort, shortness of breath |
Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal...
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Pfizer-BioNTech COVID-19 Vaccine Approximately 24 hours after injection I felt dyspnea with minimal exertion and at rest while wearing my hospital mask, which I attributed to the cheap quality of the mask. Breathlessness was relieved after I took it off. I shoveled snow with no problem over the weekend, and was off work. Three days later, on 1/3 around 7 pm, I experience the same feeling while wearing the same type of mask, and it was relieve when I took it off. The following day, 1/4 around 2pm, while wearing a different disposable mask in the grocery store, felt extremely overheated and realized I was having difficulty breathing with minimal exertion. This time the feeling did not pass when I left the store/removed my mask, and residual effects of not being able to easily take a deep breath stayed with me the entire day. The feeling was gone in the morning, but did eventually re-occur the next day (tightness in my lungs not allowing for easy deep breaths) on 1/5 near the end of a shift where I had been wearing yet a different type of disposable mask. The symptoms starting around 4:30 pm and lasted throughout the rest of the evening. At this point I notified employee heath and scheduled a covid test. The next two days, on 1/6 and 1/7, the same type of dyspnea persisted throughout the day; while at rest, not relieved, and with no other symptoms (no cough, fever, etc.) Ibuprofen appears to relieve the discomfort, and I have returned to work, however the symptoms are still present if I am not taking Ibuprofen. Possibly some kind of pleurisy. My lung sounds are clear.
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| 40 | 2021-01-07 | cough, fatigue, shortness of breath |
Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and ...
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Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped. I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.
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| 40 | 2021-01-07 | headache, fatigue | Severe Headaches Body aches Fatigue Chest pain allergies worsened |
| 40 | 2021-01-07 | headache, chills, fever, fatigue |
Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, los...
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Severe body aches, chills, headache, fever, joint pain, back pain, fatigue, brain fog, diarrhea, loss of appetite
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| 40 | 2021-01-07 | headache | Severe headache about 12 hours , severe nausea 18 hours |
| 40 | 2021-01-07 | headache | The next day had headache and right axillary swelling and tender right axillary lymph nodes. |
| 40 | 2021-01-07 | dizziness, lethargy, headache |
Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right ...
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Tingling and numb face and lips mostly on right side of face, right ear pain, right jaw pain, right side headache, sore arm at site, nausea, dizziness, lethargic
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| 40 | 2021-01-07 | migraine, malaise, chills |
bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; ...
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bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue. She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
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| 40 | 2021-01-07 | dizziness, headache, fatigue |
fatigue, headache, nausea, dizziness, body aches which started on 01/08/2021 at 0730 am, took advil ...
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fatigue, headache, nausea, dizziness, body aches which started on 01/08/2021 at 0730 am, took advil at 230 pm and tylenol at 330 pm on 01/08/2021. Pt. states that she is feeling much better after tylenol.
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| 40 | 2021-01-07 | headache, chills, fever |
fever 103, chills, achy body. Fever broke 2nd of January. Headache beginning on the 5th ended on th...
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fever 103, chills, achy body. Fever broke 2nd of January. Headache beginning on the 5th ended on the 7th that may or may not be related.
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| 40 | 2021-01-07 | headache, fatigue |
low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hour...
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low-level headache (was able to go to work, but a bit miserable), tired/run down-lasted several hours (no more than 10) arm pain (at injection site)-it is a bit warm to the touch and a small bruise- still occuring (approximately 12 hours after it started this morning)
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| 40 | 2021-01-07 | fatigue, chills, headache | sore arm, headache, chills, fatigue |
| 40 | 2021-01-08 | fever, chills, headache |
1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pa...
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1/6/21: left arm soreness and decreased range of motion around 5pm. lower extremity weakness and pain, skin sensitivity (feeling like a sunburn when touched) chills and fever (100.4) around 8pm. 1/7/21: fever (101.1), headache, dental/jaw pain around 2am. Nausea started around 6am. Fever lasted all night till around 10am. Blood pressure 138/85 and resting HR 125 and fever started again around 12pm. Chest tightness during exhalation around 2pm. Went to the Emergency Room around 2:30pm. Fever and headache returned around 8pm and gone by 10pm.
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| 40 | 2021-01-08 | headache |
11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE...
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11:30 SHOT GIVEN, BY 11:40 FELT TINGLING IN LIPS AND THROAT AND HEART RATE 125 (MY RESTING HEARTRATE IS 68), BY 11:45 TIGHTNESS IN CHEST AND NECK, HEARTRATE STILL 125 RANGE, NOON: BP 154/75 (MY NORMAL IS 96/58) AND HIVES 12:10 BENADRYL (25MG) GIVEN 12:25: BP 163/78 AND ALL OTHER SYMPTOMS STILL PRESENT 1:00 SECOND BENADRYL (25MG) GIVEN 1:11: BP 158/78 1:45 HEARING TURNED MUFFLED MOVED DOWNSTAIRS TO ER SECTION AT HOSPITAL GIVEN STEROIDS, PEPCID AND WATCHED FOR ADDITIONAL TIME ON 1/9/21: STILL ON BENADRYL AND STEROIDS: WOKE UP AT 8:00 AM SORE ARM AND SLIGHT HEADACHE, 9:00 RED SPLOTCHES ON FACE, NECK AND CHEST, 11:30AM ON 1/9/21: TIGHTNESS IN CHEST AND NECK CONTINUING STEROIDS AND BENADRYL
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| 40 | 2021-01-08 | headache |
Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Bod...
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Headache (4/10) and body aches (5/10) pain respectively began at about 18 hours after injection. Body and head aches, particularly joints and back, continue and have worsened at 30 hours out. Mild-mod soreness at injection site (4/10)
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| 40 | 2021-01-08 | headache | Nausea, headache and arm pain |
| 40 | 2021-01-08 | headache, chills | Shaking chills, nausea/vomiting, headache, palpitations. No symptoms with initial vaccine. |
| 40 | 2021-01-08 | throat pain | Swollen left tonsillar lymph node and left sore throat |
| 40 | 2021-01-08 | fever, dizziness, chills | dizziness, fever, chills, tachycardia > 90 bpm |
| 40 | 2021-01-09 | fatigue, throat pain, headache, dizziness |
11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, sev...
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11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain and kidney pain
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| 40 | 2021-01-09 | headache, fever |
12 hr after injection: headache myalgia, arthralgia, fever, abdominal pain, severe nausea started an...
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12 hr after injection: headache myalgia, arthralgia, fever, abdominal pain, severe nausea started and lasted for 12 more hours. Conservative management at home with oral fluid hydration, acetaminophen and ibuprofen helped improved symptoms. Headache is still present on 1/10 at 0200 am, over 24 hr after injection.
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| 40 | 2021-01-09 | headache, fever, chills, fatigue |
Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fa...
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Approx 12 hours after injection fever (t-max 101.3), chills, body ache, head ache, skin ache, and fatigue lasting approx 24 hours. Severe fatigue lasted 48 total hours. Fully back to normal 4 days after vaccine. These were severe symptoms, but those that were expected. I only report here because I didnt know how else to make side effects known, in case this is still being followed.
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| 40 | 2021-01-09 | fatigue | Fatigue |
| 40 | 2021-01-09 | chills, fever, headache | Fever, chills, body aches, nausea, headache |
| 40 | 2021-01-09 | headache, fatigue, chills |
I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I ...
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I received my 2nd dose around 11:15am on Wednesday. Approximately 6 hours after getting the shot I started feeling tired and a couple hours after that I felt crummy and the chills started. Mine weren't nearly as bad as some others have experienced. I didn't sleep well that night and woke up with a mild headache and body aches. Approximately 10AM on Thursday I noticed I had swelling in my upper lip and later my jawline with slight numbness. My eyes started feeling puffy that evening, approximately 6:30pm, and the symptoms began to improve after taking a Benadryl around 7:15pm. The swelling and numbness didn't seem to move down towards my throat nor did I experience any difficulty breathing or swallowing. I sl
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| 40 | 2021-01-09 | cough, throat irritation |
Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ...
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Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.
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| 40 | 2021-01-09 | headache |
headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, ...
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headache and jaw/tooth pain on left side only evaluated by EMTs Vital signs stable , neuros intact, lungs CTA
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| 40 | 2021-01-10 | somnolence, throat irritation, headache, fatigue, malaise |
0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started ...
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0808- shot 0812- face got extremely red and hot- burning from inside out 0816- nausea 0829- started to feel chest get tight and began wheezing 0850- went home - itchy on chest stomach, back, and chin/throat. Still very red. 0915- took Benadryl did breathing treatment- cold pack to face 1015- itchy- less- headache, no wheezing no nausea- fell asleep 1215- woke up- chest tight- did breathing treatment- headache 1515- took another 25mg Benadryl Slept most of day til next morning. Went to work 12/29/21 at 6am by 12 feeling really under the weather and tired. Went home took Motrin600mg and went to bed . 12/30 went to work back to normal
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| 40 | 2021-01-10 | dizziness |
24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous rep...
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24 hours later sever dizziness; Injection site soreness; Internal itching; This is a spontaneous report from a contactable Other HCP. A 40-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), intramuscular on 04Jan2021 10:00 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date. Anatomical location was left arm. The patient experienced internal itching on 04Jan2021 10:15, 24 hours later severe dizziness on 05Jan2021, injection site soreness on 04Jan2021 10:15. The patient underwent lab tests and procedures which included covid-19 test on 05Jan2021 (unknown result). The events outcome was unknown. Information on the Batch/Lot number has been requested.
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| 40 | 2021-01-10 | headache, skin warm, fatigue, chills |
About 12 hours post vaccine I experienced headache, fatigue, muscle aches, and chills. About 48 hour...
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About 12 hours post vaccine I experienced headache, fatigue, muscle aches, and chills. About 48 hours post vaccine developed rash - raised red swollen area around where the vaccine was given. The area was hot to the touch and very itchy. Currently great than 72 hours post vaccine and rash is still there and still hot and itchy.
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| 40 | 2021-01-10 | headache, chills, fever |
Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; conf...
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Auditory & visual hallucinations; Auditory & visual hallucinations; tachycardia; extreme panic; confusion; felt like skin was on fire/pulsating; felt like skin was on fire/pulsating; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; severe pain especially at knees/hips/base of head and neck; uncontrollable vomiting; bad chills and fever; bad chills and fever; insomnia; felt as if she had been given drugs; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 14:30 at single dose on right arm for COVID-19 immunization. Medical history included COVID prior vaccination and latex allergy. There were no concomitant medications. No other vaccine in four weeks. The patient previously had allergic to diazepam (VALIUM), clonazepam (KLONOPIN), ondansetron (ZOFRAN) and lorazepam (ATIVAN). The patient experienced auditory & visual hallucinations, tachycardia, extreme panic, confusion, felt like skin was on fire/pulsating, severe pain especially at knees/hips/base of head and neck, uncontrollable vomiting, bad chills and fever, insomnia. She felt as if she had been given drugs. All of the events happened on 05Jan2021 01:30 and resulted in Doctor or other healthcare Recovering professional office/clinic visit. No treatment received for the events. No COVID tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Auditory hallucinations and Visual hallucinations cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-10 | headache, chills |
C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 d...
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C/o headaches onset 12/26 x4 days; Nausea chills onset 12/30 x 2 days; Body aches onset 1/1/21 x 4 days. Visited urgent care 1/2/21 - labs done & released w/ return to work 2-5 days.
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| 40 | 2021-01-10 | weakness, headache, sweating, dizziness |
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain unde...
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Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine, weak ,lightheaded, sweating, headache,
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| 40 | 2021-01-10 | discomfort |
Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . ...
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Patient states on 01/09/2021 had soreness to the injection site. Felt " discomfort but not pain" . Described discomfort as constant. The next day on 01/10/2021 at about 8am, the discomfort started to radiate down to her left armpit area and left lateral breast area. Denied redness or fever but did state area was " swollen" . Stated affected areas felt " hard but it was probably because there was swelling". Patient states she had full range of motion to left arm, no numbness or tingling to left arm or hand. No complaints of shortness of breath , chest pain, or rash.
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| 40 | 2021-01-10 | fever, headache |
Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for ano...
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Significant arm pain starting one after injection lasting 48 hours. Mild arm pain afterwards for another 24 hours. Joint pain, headache and low grade fever for 48 hours.
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| 40 | 2021-01-10 | headache, body temperature increased |
Started out with my shoulder blades being sore that night. I woke up the next morning and was sore a...
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Started out with my shoulder blades being sore that night. I woke up the next morning and was sore all over, my head hurt, and my temperature was anywhere from 100.3-101. I checked it various times thru out the day. By the time I was ready for bed I felt a little better, but not up to normal standards. I slept thru the night and woke up fine. I wasn't sore anymore and my twmp was 98.2.
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| 40 | 2021-01-10 | chills, headache |
The day after the injection she noticed swelling in her right axilla that is painful but no redness....
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The day after the injection she noticed swelling in her right axilla that is painful but no redness. She also had one day of headache, chills and joint pain.
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| 40 | 2021-01-10 | headache |
This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient r...
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This is the 2nd vaccine for the patient. She was not given another lot# for this vaccine. Patient reports nausea, feels like throat is closing, change in her voice (hoarse), patient reports a metal taste in her mouth. Flushed cheeks, facial swelling and whole body was red and flushed, reddish spotting. Also reporting headache. She is still reporting the abnormal taste and headache.
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| 40 | 2021-01-10 | fatigue | Tiredness Gastrointestinal effects |
| 40 | 2021-01-10 | headache | Tongue swelling, headache, tachycardia, elevated BP |
| 40 | 2021-01-10 | dizziness, sweating |
Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasova...
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Vaccine recipient received vaccine on 1/8/2021. At the end of her 15 minute observation had a vasovagal episode with diaphoresis, lightheadedness and dizziness. She was sent to the ED for further observation and had experienced nausea and vomiting. She was given Zofran. She was stable and discharged from the ED.
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| 40 | 2021-01-10 | migraine, chills | chills, body aches and migraine beginning on 1/4/21 and lasting until 1/6/21. |
| 40 | 2021-01-10 | headache, chills, fatigue |
fatigue was about 6 hours post vaccination, 12 hours after vaccination + fatigue, Headache, muscle a...
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fatigue was about 6 hours post vaccination, 12 hours after vaccination + fatigue, Headache, muscle and joint pain/aches and chills, ibuprofen taken and resolved HA. 24-30 hours post vaccination + severe body aches (bone pain) and chills. All symptoms resolved at 30 hours post vaccination
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| 40 | 2021-01-10 | headache, fatigue | fatigue, headaches, muscle aches |
| 40 | 2021-01-10 | cold sweat, sweating | itchy, clammy, sweaty |
| 40 | 2021-01-10 | dizziness |
lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine ...
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lightheaded ness and near syncope bradycardia as hypotension started about 10 minutes after vaccine administered. about 1 hour later had wheezing and chest tightness lasting about 4 hours
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| 40 | 2021-01-10 | weakness |
shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours af...
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shoulder injury following vaccination. suspect SIRVA. Extreme shoulder pain started a few hours after vaccination and developed loss of range of motion, weakness, inability to lift arm, tingling and numbness down the length of arm. Severe pain prohibiting ADLs; needing assistance with every day functions. Pain is incrementally improving but after 4 days still without recovery. Suspect nurse placed too high, injecting into bursa instead of deltoid muscle. RN seemed concerned after injection. She also was not sitting during injection, increasing the likelihood of injecting too high.
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| 40 | 2021-01-11 | lethargy, fever, chills |
Employee immediately felt flushed. States that by 0400 the next day she awoke to fever of 102.1'F, ...
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Employee immediately felt flushed. States that by 0400 the next day she awoke to fever of 102.1'F, severe body aches, chills, and lethargy
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| 40 | 2021-01-11 | body temperature increased |
Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on K...
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Employee's arm is red/sore (big/hive) with a black/ bluish bruise, evolving cellulitis. Started on Keflex 500 mg PO Q8hr x 10 days. Had a temp of 103 on 1/4/21 but resolved by 1/8/21.
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| 40 | 2021-01-11 | body temperature increased |
Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evo...
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Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.
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| 40 | 2021-01-11 | chills, weakness, nasal congestion, fever, headache |
Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontane...
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Fever; chills; head ache; severe joint pain; nausea; congestion; severe weakness; This is a spontaneous report from a contactable nurse (patient herself). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 05Jan2021 07:45AM at a single dose for COVID-19 immunization. The patient's medical history included hypothyroid and ADD (Attention Deficit Hyperactivity Disorder), both from an unknown date and unknown if ongoing. The patient had known allergies to PCN. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included unspecified/ other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Jan2021 09:00 AM, the patient experienced fever, chills head ache, severe joint pain, nausea, congestion, and severe weakness. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. Outcome of the events was unknown. The report was assessed as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect. Information about lot/batch number is requested.
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| 40 | 2021-01-11 | dizziness, headache |
Had a headache prior to vaccine. 20 minutes after vaccine started feel numbness on left side of face...
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Had a headache prior to vaccine. 20 minutes after vaccine started feel numbness on left side of face and it was affecting vision a little. Called them and they told me to come back. I felt light headed and they put me in the wheelchair and took me to ER. ER: assessed by Dr: heart monitor for 30 minutes. Sent me home to watch my symptoms. Numbness in my face lasted into next day but then went away after that. Still having dizziness on and off since I've received the shot. Headaches - having them, too, off and on. TeleMed appt with DR on 7th. She recommended a MRI of brain - normal.
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| 40 | 2021-01-11 | fever, headache |
Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, wa...
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Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, warmth, pain at injection site.
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| 40 | 2021-01-11 | malaise, headache | Headache, and Feeling unwell. Still present on 1/6/21 |
| 40 | 2021-01-11 | headache, fever | Headache, fever, body pain |
| 40 | 2021-01-11 | fever, headache |
Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia...
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Headache- severe x 4 days High Fever (103) (6 hours post injection begain, lasted 1. 5 days) Myalgia Pain - bone, and muscle Vomiting Nausea Agitation Diarrhea Inflammation, edema, heat firm induration at injection site
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| 40 | 2021-01-11 | chills | Left eye feels full, swollen, chills. |
| 40 | 2021-01-11 | head discomfort | PAIN BEHIND EYES, HEAD TO EXPLODE DOWN BAck OF HEAD |
| 40 | 2021-01-11 | headache, fatigue, chills, shortness of breath |
Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expec...
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Patient had her second dose of the Pfizer vaccine Friday, 1/8/2021 at 10:30am. She has had the expected fatigue, muscle aches, headache, chills. however, she had also developed significant swelling in her left armpit and the swelling has spread into her left chest wall and down into her left ribs. It has also become painful. It?s very painful to lower her arm against her body, to raise her arm above her shoulder, to lift anything, even a bottle of water. It?s also painful to take a deep breathe right in the area on the left chest where the swelling is and into her ribs under her armpit. The area doesn?t seem to be significant red or warm. It is very tender to touch and the swollen area is firm. It has not responded to ice or NSAIDS. Her shoulder and arm do not seem to have any swelling."
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| 40 | 2021-01-11 | shortness of breath |
Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in num...
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Prior to 1st Covid vaccination the patient reported a history of mast cell syndrome resulting in numerous anaphylactic events. The patient had been consulted by her immunologist to proceed with vaccination and due to her history she was observed for a period of 30 minutes. Upon returning for her 2nd vaccination she reported that she experienced some skin manifestations (hives) but no anaphylactic reaction resulting in difficulty breathing. She stated that she had discussed this again with her immunologist and she wished to proceed with the 2nd dose and she was prepared to receive EpiPen if necessary if reaction develops. Within 10 minutes of the vaccination she felt flushing sensation and then itching all over and her "throat closing up". She was quickly administered 0.3 mg IM epinephrine and IM diphenyhydramine with some improvement in her symptoms. While being transported to the ED an additional 0.3 mg dose of epinephrine was administered. The emergency department also administered the following treatments: famotidine 40 IV x 1 dose, methylprednisolone 125 mg IV x 1 dose, racepinephrine nebulized x 1 dose. The patient was ultimately discharged approximately 2 hours later with return to her baseline condition.
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| 40 | 2021-01-11 | chills, shortness of breath | Shortness of breath, chills and Burning sensation on face. I took some Benadryl to help |
| 40 | 2021-01-11 | headache, chills, fever |
about 12 hours after receiving the 2nd dose of vaccine patient started with Chills, Body Aches, Feve...
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about 12 hours after receiving the 2nd dose of vaccine patient started with Chills, Body Aches, Fever, Headache. Stated that a few hours later she started with diarrhea
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| 40 | 2021-01-11 | cough | cough |
| 40 | 2021-01-11 | shortness of breath |
lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021...
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lymphedema in armpit, pain in armpit, lymphedema in left chest, pain in left chest; started 1/9/2021 in the morning, worsened over the next 48 hours; swelling progressed to level that made resting arm against body too painful, lifting arm above level of shoulder too painful, lifting objects in left hand too painful, deep breathe caused pain in left chest and rib/flank area, swelling in chest area progressed across chest toward neck and covering clavicle. swelling continued to increase until 1/12/2021, the first day which swelling and pain has decreased.
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| 40 | 2021-01-11 | headache, chills, weakness, fever |
severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant w...
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severe shaking chills; fever; muscle/bone aches; muscle/bone aches; headaches; nausea; significant weakness; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 40-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via unspecified route on left arm at single dose for COVID-19 immunization on 04Jan2021, 07:45 AM, at 40-year-old. No relevant medical history. No allergies to medications, food, or other products. No concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. On 04Jan2021, 08:00 PM, 12 hours after vaccine, the patient developed severe shaking chills, fever, muscle/bone aches, headaches, nausea, and significant weakness (this lasted about 8 hours). No treatment was received. Since the vaccination, the patient did not have been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving. It was reported as non-serious per the reporter.
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| 40 | 2021-01-11 | shortness of breath |
shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (...
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shortness of breath; tightness in her chest; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number: EL0140, expiry date: 19 Vaccine: Mar2021, via an unspecified route of administration in the left arm from 29Dec2020 16:00 to 29Dec2020 16:00 as SINGLE DOSE for COVID-19 immunisation. Medical history included blood pressure abnormal (She has been on blood pressure med for 3 years). Concomitant medication included labetalol oral 200 mg, 2x/day for Blood pressure. The patient reports since Sunday night, 03Jan2021, she noticed feeling a little tightness in her chest and shortness of breath but her O2 saturation is fine. Reports she tested it at 98% to 97%. Asking is this a side effect of the vaccine, has it been reported? Does it have anything to do with the expected effectiveness after a week of getting the first dose? She is scheduled for the second dose 18Jan2021. The outcome of the events was not recovered.
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| 40 | 2021-01-11 | headache |
swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours...
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swelling to left arm with lymph nodes swelling; mild headaches, body ache lasting more than 48 hours left arm cellulitis on steroid and antibiotic
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| 40 | 2021-01-12 | headache, fever, chills | Chills, fever, muscle aches, headache |
| 40 | 2021-01-12 | fever, chills | Fever Body aches Headache Chills Shaking Nausea |
| 40 | 2021-01-12 | chills, fever |
Following day patient developed fever 103, chills, vomiting, 48 hours after vaccine patient develope...
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Following day patient developed fever 103, chills, vomiting, 48 hours after vaccine patient developed diarrhea which lasted 2 days. She was covid tested 1/9/2021 which was negative.
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| 40 | 2021-01-12 | dizziness, fatigue |
I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was init...
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I began feeling lightheaded and dizzy almost immediately followed by extreme fatigue. There was initially some mild tingling in extremities. After an hour later, my legs were almost numb and I had difficulty moving them. The fatigue got increasingly worse
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| 40 | 2021-01-12 | skin warm |
I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painf...
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I noticed a rash on both arms at the antecubital fossa on 1/10/21. The rash is red, tender to painful and warm to the touch., slightly itchy but painful when itched. I did not notice the rash anywhere else that day. I feel warm in the face and ears but temperature has stayed between 98.3-98.9 since vaccination was administered. I noticed raised red bumps from my olecranon to mid forearm on the ulnar side of both arms but moreso on the right arm.
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| 40 | 2021-01-12 | chills, headache | Left arm pain, headache, chills. Resolved. |
| 40 | 2021-01-12 | headache, fatigue | Left axillary lymphadenopathy, headache, muscle ache, fatigue. |
| 40 | 2021-01-12 | lethargy | Nausea, Vomiting, lethargy, pain, loose stools. |
| 40 | 2021-01-12 | chills, headache, dizziness |
Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flus...
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Patient experiencing moderate-severe body aches, chills, feeling of burning all over skin, skin flushing, nausea, headache, dizziness, near syncope, and bouts of being tachycardia. acetaminophen 1gm q6 hours x 4 doses for 2 days ondansetron 4mg x 1 dose
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| 40 | 2021-01-12 | sweating | Systemic: Sweating |
| 40 | 2021-01-12 | sweating |
This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablat...
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This is a 40 y/o woman with a past history of re-entry supraventricular tachycardia who is s/p ablation in October, 2020 who presented to our Emergency Room on 1/12/21 due to the abrupt onset of left sided chest discomfort and diaphoresis. The patient awoke from sleep with this sensation. Chest pain was sharp, unchanged since onset, without ameliorating/exacerbating factor or activity. Participated in physical fitness training on day prior to presentation without unusual exertion or activity. Mild nausea on day of presentation. Obtained COVID-19 vaccine the day prior. No history of adverse reaction to vaccines in past. Normal labs/troponin and patient was sent home. Normal ECG. Following ablation in October, Following ablation in Oct, 2020, the patient reports no return of symptoms.
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| 40 | 2021-01-12 | chills, body temperature increased |
about 12 hours out had severe body aches, shaking chills, headache and temp of 100. those symptoms ...
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about 12 hours out had severe body aches, shaking chills, headache and temp of 100. those symptoms resolved 48 hours post injection but had upset stomach and loose stool which persisted. 1st injection just had soreness at site and a mild headache
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| 40 | 2021-01-12 | body temperature increased, somnolence |
drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vacc...
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drowsiness within 1 hour swelling on upper lip (lasted about 15 minutes) occurred 4 hours after vaccine administered increased temp and bodyaches occurred approx. 6 hours after vaccination
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| 40 | 2021-01-12 | fever, cough, fatigue, headache | headache, soreness, fever, cough and sore muscles |
| 40 | 2021-01-12 | discomfort |
heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that we...
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heaviness on the one/left side of her body; left ear pain; left side of tongue is sore; pain that went down from her neck to her abdomen; pain that went down from her neck to her abdomen; injection pain on left arm.; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1686, expiration date not reported), intramuscular on the left arm on 05Jan2021 at 15:00 to 05Jan2021 15:00 at SINGLE DOSE for Covid-19 vaccine. Medical history included allergies, gallbladder problems, and had a little diarrhea. Concomitant medications included famotidine (PEPCID) for any potential allergic reaction, and diphenhydramine hydrochloride (BENADRYL) for allergies, all are ongoing. On 05Jan2021, the patient experienced left ear pain, left side of tongue is sore, pain that went down from her neck to her abdomen, injection pain on left arm, and on 06Jan2021, heaviness in one/left side of the body. The patient is most concerned with the pain she is experiencing. The patient was calling about Covid vaccine and got her first shot yesterday, on 05Jan2021, around 3pm. The patient stated that they had her stay about 30 minutes to make sure no major side effects. She had gone home and noticed that her tongue on left side was swollen and persisted into the evening and had a little diarrhea. She was experiencing left ear pain and decided to lay down. She stated that when she laid down noticed that she had pain that went down from her neck to abdomen, that when she woke up this morning that she had pressure on left side of her body and everything else had gotten better. She clarified that it was not swollen but sore. She stated that the diarrhea is not related to the Covid vaccine but is because she had gallbladder problems, her gallbladder was taken out before the vaccine. She stated not pressure just heavy and that the arm was regular injection pain. She stated that the shooting pain in ears is continuous like she was getting an ear infection. She stated that the symptoms are all on her left side, she clarified pressure on left side as heaviness. Stated that the allergies were diagnosed way before Covid vaccine. The patient wanted to know if other people have experienced these side effects. She stated that left side of tongue swollen resolved overnight because she did not wake up with it. Later she clarified that her left tongue was sore. Resolved completely. She stated left ear pain started last evening, that it comes and goes. Stated that the pain that went from neck to her abdomen started yesterday evening and stopped yesterday evening. Stated her left arm is sore. Stated it is sore if she touches it and is okay if she is just sitting there. She stated that she took diphenhydramine hydrochloride 25mg in case her tongue was swollen and she was having a reaction. Stated that she took two acetaminophen (TYLENOL) before she went to bed. The outcome of the events of left ear pain and injection pain in left arm was not recovered, while pain that went down from her neck to abdomen recovered on 05Jan2021, heaviness in one side of the body recovered on 06Jan2021, the rest of the events recovered on an unspecified date. The seriousness of left arm injection pain was not provided, reporter assessed other events as non-serious. The causality for the event of injection pain to left arm was related to the suspect drug, causality for other events was unknown.
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| 40 | 2021-01-12 | dizziness, fatigue, fever |
lightheadedness, fatigue, fever and pain & stiffness in the arm were the vaccine was administered. T...
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lightheadedness, fatigue, fever and pain & stiffness in the arm were the vaccine was administered. These symptoms lingered into the next day causing me to stay home from work the following day.
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| 40 | 2021-01-13 | fatigue, chills |
Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm sore...
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Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; Body chills, extreme fatigue, arm soreness at injection site; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female Nurse reported for herself received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Elt9899/expiration date: unknown), via unknown route of administration, on 17Dec2020 at 07:45 PM (at the age of 40 years old) as a single dose in the left arm and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: Eh9899/expiration date: unknown), via unknown route of administration, on 07Jan2021at 06:30 AM (at the age of 40 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included asthma. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Albuterol inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 03:00 PM, the patient experienced body chills, extreme fatigue, arm soreness at injection site. No treatment was received for the events body chills, extreme fatigue, arm soreness at injection site. The outcome of the events body chills, extreme fatigue, arm soreness at injection site was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 40 | 2021-01-13 | fatigue |
Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that...
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Currently 32 weeks pregnant, delivery date of March 14,2021. The next morning I had a sore arm that lasted 2 days. A couple days of fatigue. I had on episode of vomiting, I believe it was the 12/31 or 1/1/.
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| 40 | 2021-01-13 | shortness of breath |
EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-11...
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EKG which showed some abnormal activity; resting heart rate rose to 113, and remained between 110-113 for 48 hours/her resting heart rate was elevated around 110-115; she felt slightly short of breath; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date Mar2021), intramuscular (top of her right arm) first dose on 29Dec2020 11:00 at single dose for Covid-19 immunization. The patient's medical history included ongoing allergic to contrast dye, allergic to dust, and covid from Apr2020. There were no concomitant medications. The patient had the first dose of the Pfizer covid vaccine and she had an uncommon reaction. She received the first dose of the covid vaccine on 29Dec2020 around 11am. 24 hours after receiving the vaccine on 30Dec2020 around 11am she felt slightly short of breath and her resting heart rate was rose to 113, and remained between 110-113, elevated around 110-115. Her heart rate stayed elevated for about 2 hours. She called her doctor and she was instructed to go to urgent care where they did an EKG which showed some abnormal activity. Reports she has no history of cardiac issues in the past. The doctor at urgent care recommended for her to be transported by ambulance to emergency room to rule out a pulmonary embolism. Her heart rate remained elevated and while she was in the ER she had an EKG, lab test, chest x-ray, and nuclear cat scan since she is allergic to iv contrast dye. Her cardiac enzymes were negative. She did not have a pulmonary embolism. Her d-dimer was 1,131. She confirms she was not admitted. She has an apple watch and was told to monitor her heart rate. She was instructed to call # if she experienced shortness of breath. The patient heart rate remained elevated for the next 48 hours and she did not start to feel normal and recovered completely around noon on 01Jan2021. She just had a follow up with her primary doctor. She asked if she should get the second dose of the vaccine. Her doctor consulted with the allergist and stated she should call Pfizer to ask if she should receive the second dose. Vaccination Facility Type was Nursing home where she works. No additional vaccines administered. No prior vaccinations within 4 weeks. The outcome of the events heart rate increased and dyspnoea was recovered on 01Jan2021 and unknown for the remaining event.
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| 40 | 2021-01-13 | fever, chills |
Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen...
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Fever, chills, body aches, headache, redness, swelling and hot to touch at injection site. Ibuprofen after vaccine given. No problem until following day, late morning. Ibuprofen and tylenol alternating. Swelling and redness at injection site have increased daily.
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| 40 | 2021-01-13 | dizziness, headache |
Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would po...
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Hives, red swollen itchy bumps on left ankle foot and mid leg. Various hives and pumps that would pop up on hands and elbows, and right foot that would itch and come and go, but the bumps on the left leg wont go away. I have taken benadryl (2 adult tablets each night), hydrocortisone cream, alcohol rub, and still hasn't gone away a week later. Headache for 7 days. A little dizziness.
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| 40 | 2021-01-13 | headache, fever, fatigue | Low grade fever (99.8-100.2), headache, fatigue, and soreness at injection site |
| 40 | 2021-01-13 | weakness, chills |
Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting....
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Memory loss, severe chills, sever muscle/joint pain, tingling throughout body, intractable vomiting. Unable to walk due to pain and weakness for 24 hrs
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| 40 | 2021-01-13 | headache |
Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight naus...
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Patient describes gastro problems, body aches and headache, lymph nodes are swollen and slight nausea
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| 40 | 2021-01-13 | dizziness, fatigue |
Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observatio...
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Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.
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| 40 | 2021-01-13 | headache, dizziness, chills |
Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hand...
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Systemic: Chills, Systemic: Headache, Systemic: dizziness, bitterness in taste in mouth, shaky, hands cold to touch, high heart rate - 120, BP 154/89
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| 40 | 2021-01-13 | headache |
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/visio...
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Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: blurred/vision changes, tachycardia-Medium
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| 40 | 2021-01-13 | headache |
developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved up...
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developed severe headache and tongue tingling 10' after injection: transferred to ED. sx resolved upon arrival to ED. no further intervention. - observed for 4 hrs, d/c to home
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| 40 | 2021-01-13 | fatigue |
fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old femal...
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fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient experienced fatigue with outcome of recovering. The patient did not receive any treatment for the event. The event was assessed as non-serious. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 40 | 2021-01-13 | fatigue, fever, chills |
onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling w...
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onset 01/12/21 at approximately 1:00pm began with report of aching, muscle aches, feverish feeling with chills. Went home at that time. Later that day around 4:00pm developed worsening fever/chills, body aches, nausea. Temp reported 101.8 oral. 01/12/21 around 6:00pm developed vomiting, muscle weakness, fatigue, joint aches, knee pain. During the night reported night sweats. AM 01/13/21 reported temp of 102.5 and new onset of skin sensitivity with touch to include clothing, water with bathing and continued symptoms of all symtpoms reported above. 01/14/21 continues with muscle weakness, body aches, fatigue, chills without temp, new onset of axillary pain right arm and reported chest tightness that began on 01/13/21. Denies difficultly with breathing, just chest tightness. Symptoms are improving each day, just reports lingering today, 01/14/21.
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| 40 | 2021-01-13 | chills |
uncontrolled chills that lasted for an hour; This is a spontaneous report from a contactable healthc...
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uncontrolled chills that lasted for an hour; This is a spontaneous report from a contactable healthcare professional. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number E5168/expiration date unknown), dose number 2 intramuscularly on 07Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The vaccine was administered in a Public Health Clinic facility. No other vaccine was received within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination, and was not tested for COVID-19 since the vaccination. Medical history included diabetic and high blood pressure. Historical vaccine included dose 1 of BNT162B2 (lot number EK5730) on 17Dec2020 for immunisation. Concomitant medications included unspecified routine diabetic care meds. On 08Jan2021 03:50, the patient experienced uncontrolled chills that lasted for an hour. She received 2 Advil liquid gels for the event. The outcome of the event was Recovered/Resolved With Sequel. The event was assessed as non-serious.
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| 40 | 2021-01-14 | headache, dizziness |
1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/...
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1330-Patient relates her mouth went dry and she became dizzy. Also c/o nausea and HA .HR 72 BP 151/104 O2-84-94%RA. Patient c/o tingling in fingers and toes 1340-Patient to ED room 18. 1545-Patient discharged from ED with dx of Vasovagal response
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| 40 | 2021-01-14 | shortness of breath, dizziness |
15 minutes after receiving the second dose of vaccine, she felt light-headed and short of breath. Sh...
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15 minutes after receiving the second dose of vaccine, she felt light-headed and short of breath. She received Epinephrine 0.3 mg IM, solumedrol, and Benadryl. She remained hemodynamically stable.
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| 40 | 2021-01-14 | headache, shortness of breath |
Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report fro...
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Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Clare Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
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| 40 | 2021-01-14 | fatigue, chills | Body aches, fatigue, chills |
| 40 | 2021-01-14 | throat irritation, shortness of breath | Chest tightness, Difficulty in breathing, Tachycardia, Throat tingling and burning. |
| 40 | 2021-01-14 | fever, headache |
Fever to 99.8; muscle aches; Headache; sore arm for days; This is a spontaneous report from a non-co...
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Fever to 99.8; muscle aches; Headache; sore arm for days; This is a spontaneous report from a non-contactable nurse. A 40-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 28Dec2020 12:00 to 28Dec2020 12:00 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took chlorhexidine and experienced allergies. The patient experienced Fever to 99.8 body, muscle aches, Headache and sore arm for days, felt like being punched repeatedly in the arm; all on 28Dec2020. The outcome of the event was recovered on unspecified dates. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 40 | 2021-01-14 | fatigue, headache |
HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums ...
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HA, fatigue, pain at the injection site and nausea. Treatment include: Tylenol, hydration and tums the next day. Outcome complete resolution of symptoms on day 3.
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| 40 | 2021-01-14 | fatigue, headache, chills |
Headache, Acetaminophen and rest, 24+ hours Nausea, no treatment, 24+ hours Fatigue, rest, 24+ hours...
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Headache, Acetaminophen and rest, 24+ hours Nausea, no treatment, 24+ hours Fatigue, rest, 24+ hours Chills, blanket, intermittent over 24+ hours
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| 40 | 2021-01-14 | fatigue |
Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach c...
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Heart palp. started about hour after inj. BP was up and down. Pulse was very high. Tired, stomach cramps.
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| 40 | 2021-01-14 | throat irritation, throat pain, fatigue, dizziness |
I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing...
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I received my shot at 12:15 at around 12:30 I started feeling more aware of my throat. My swallowing felt slightly off however, I was not aspirated secretions. My throat felt slightly thick and I had the sensation of wanting to clear my throat. I took a deep breath and I could breath. It started to feel like my throat was getting sore or irritated. I felt slightly warmer. I decided to wait the full 30 minutes. When I went to stand had a moment of dizziness that passed but then I felt lightheadedness for about 2 hours after the injection. My ear felt like it was warm and there was slight pressure there. My throat continued to feel irritated and still feels lightly irritated after 4 days. After about 3 hours it felt like something lifted and I felt better. That night I was really fatigued and tired. Maybe slightly cold. The next day felt fine except for the throat irritation that still persists today. The side where I received the injection my arm, shoulder, and chest area felt affected for two days after receiving injection.
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| 40 | 2021-01-14 | fatigue, chills, fever |
Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine....
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Patient had regular soreness, redness of injection site. Fever, chills, fatigue hours after vaccine. Patient experienced syncope the morning after vaccination for about 15 minutes. Having bruised head and left eye.
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| 40 | 2021-01-14 | throat irritation | Rash on left forearm/itching/throat itching/ heart rate fast/left hand itching |
| 40 | 2021-01-14 | nasopharyngitis, fever | fever, body aches, cold symptoms |
| 40 | 2021-01-14 | fever |
muscle aches; fever; nausea; Vomiting; This is a spontaneous report from a contactable other healthc...
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muscle aches; fever; nausea; Vomiting; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, intramuscular right arm from 08Jan2021 to 08Jan2021 as single dose for COVID-19 immunisation. Historical vaccine includes first dose of BNT162B2 via intramuscular from 18Dec2020 to 18Dec2020 with lot number: EJ1685 on right arm. Medical history included allergies to sulfa drugs. Concomitant medication included metronidazole. The patient previously took Ciprofloxacin and Codeine and experienced allergies. On Saturday, 09Jan2021 at 07:00 AM, the patient developed fever, muscle aches, nausea, and vomiting. The outcome of the events was recovered on Jan2021. No treatment was given for the events. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-14 | migraine, chills |
within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nause...
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within 1 hour of the injection I started to get a migraine headache with photo sensitivity and nausea. within 12 hours i had body aches and chills which resolved. after five days i have still been experiencing migraine headaches
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| 40 | 2021-01-15 | cough, headache, fatigue, fever, chills |
1/13/20 fever, cough, chills, headache, fatigue lasted only a few hours. 1/14/20 approximately 36 h...
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1/13/20 fever, cough, chills, headache, fatigue lasted only a few hours. 1/14/20 approximately 36 hours (8pm) I developed pain and swelling in my left armpit. I went to bed and woke up with the same swelling and pain. Checked in at Urgent Care 1/15/20 swelling started in glands in neck around mid day.
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| 40 | 2021-01-15 | headache |
My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless ...
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My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless I touch it, but if I do bump it or make contact with it, it hurt like the area was very bruised or recently injured. The pain has improved but it is still very sensitive. I didn?t think it was related to the shot, but I could not recall any injury. I can function like normal. My dr suggested I do a round of steroids, but to contact her immediately or go to ER if it worsened. I am to follow up with her in 2 weeks.
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| 40 | 2021-01-15 | fatigue |
Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I ...
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Received the COVID-19 Pfizer-BioNTech vaccination at 8:40pm at a stadium location. Around 8:57, I had a metallic taste in my mouth and the left side of my tongue went numb. A little later the left side of my face felt weird and the inside of my ear felt numb. It wasn't tingling, but it felt like I had a Novacaine shot (like when you get a filling at the dentist). My neck got stiff and I was really tired. The symptoms lasted about 4 hours. When I woke up this morning the left side of my face and jaw still do not feel 100%. My left eye is watery. I'm very tired.
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| 40 | 2021-01-15 | fatigue, sweating, malaise, body temperature increased, chills, headache |
Started with a headache approx 16 hours after injection. Felt fatigued so went to bed and slept for ...
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Started with a headache approx 16 hours after injection. Felt fatigued so went to bed and slept for a little bit. Woke up to eat around 6pm on 1/13/21 and started to get chills and not feeling well along with the headache and fatigue so decided to lie back down. Woke up 1:30am on 1/14/2021 soaked in sweat and nauseous still having all the other symptoms. Took oral temp and was 101.4 shortly after vomited and started having some body aches and went back to bed. Woke back up 5am on 1/14/2021 fever had broke, still had headache, fatigue, and some chills and went to work, took imitrex to help with headache. 1/15/2021 woke up at 4:30am with slight headache feeling much better and by 1/16/21 most symptoms have subsided or gotten extremely better.
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| 40 | 2021-01-16 | chills, dizziness, fatigue, headache, weakness | Dizziness, weakness, injection site pain, tiredness, headache, chills, joint pain, nausea. |
| 40 | 2021-01-16 | migraine |
Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post in...
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Migraine the day after initial injection (12/24/20). Lasted in to the morning of the 2nd day post injection (12/25/20). Mild to minimal nausea off and on the day after injection. Extreme left arm pain from that injection day through the 4th day post injection (12/27/20). After 2nd dose - bruised arm at injection site. Left arm pain not as severe as 1st injection. Headache more mild.najsea a bit more noticeable off and on. Wheezing and nasally. Muscle aches.
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| 40 | 2021-01-17 | chills, fatigue, headache, influenza like illness |
Received dose 1 of vaccine and on day of and day after of vaccine administration experienced headach...
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Received dose 1 of vaccine and on day of and day after of vaccine administration experienced headache, chills, fatigue. and body aches--all flu like symptoms pregnancy info not avl from report filed.
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| 40 | 2021-01-17 | fever |
severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5...
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severe aching hands/severe arm pain; feet like arthritis bad day after vaccine; Low grade fever 99.5 c; This is a spontaneous report from a contactable Physician .This Physician reported different events for 2 doses. This case is for 2nd dose. The 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on 08Jan2021 at SINGLE DOSE for COVID-19 immunization. She received the first dose on 17Dec2020 8:00 AM at right arm at single dose Lot number#Ej1685 and she had flare a week after first vaccine with mild foot swelling but severe leg and foot pain.Medical history included Possible asthma and left foot post traumatic arthritis with multiple surgeries including precious allograph, meralgia parasthetica left side. The patient is not pregnant. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. None Concomitant medications (received within 2 weeks of vaccination) .No known allergies. . After second vaccine severe aching hands, feet like arthritis bad day after vaccine. Low grade fever 99.5 c. No treatment received for the events. The events were assessed as non-serious. The patient had not been tested for COVID post vaccination. The outcome of the events was recovering on unspecified date. Information on lot/batch number has been requested.
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| 40 | 2021-01-18 | malaise, body temperature increased, chills |
I had two am Jan 9, chills, aches, low grade temperature. That lasted about 24 hours. Malaise - ext...
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I had two am Jan 9, chills, aches, low grade temperature. That lasted about 24 hours. Malaise - extreme -lasted the same amount of time. I took Tylenol twice.
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| 40 | 2021-01-19 | throat swelling, throat pain |
1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen p...
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1/1/21 sore throat lung pain in back . F/U with Dr antibiotic Amoxicillin Strep diagnosis, swollen pressure in lungs, antibiotic has provided some relief to lungs but pain continues, feels lungs are fatigue and worked. 20 days swollen throat has continued, and small rashes with no itch come and go on eyelid, chin, shoulder.
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| 40 | 2021-01-19 | fever |
1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smel...
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1day after my vaccine I had fever, body aches, headache. 13 days after this vaccine my sense of smell and taste are almost gone. I also had this happen also 12 days after my 1st vaccine and both my COVID swabs were negative then.
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| 40 | 2021-01-19 | headache, fever |
Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Mi...
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Dose Number:1/ Date of start of drug: 21Dec2020/ Dose Number:2/ Date of start of drug: 08Jan2021; Mild fever; Nausea; Headache; Pain in the muscles and joints; Pain in the muscles and joints; This is a spontaneous report from a contactable consumer reporting for her sister. A 40-years-old female patient received the second dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Jan2021 at single dose for COVID 19 immunization via an unspecified route of administration from 21Dec2020 to 21Dec2020 at SINGLE DOSE for an unspecified indication . The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 21Dec2020. On 08Jan2021 about 12 hours after the administration of the vaccine, the patient experienced mild fever, nausea, headache, pain in the muscles and joints. The outcome of all the reported events was recovering. The patient received the second dose before the day 21. Information on the lot/batch number has been requested.
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| 40 | 2021-01-19 | fatigue, headache, dizziness |
Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21...
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Employee received the 2nd dose of the COVID-19 vaccine at 2:30 PM on 1/11. The next morning (1/12/21), she began to have numbness and tingling in the right arm and right side of face and developed dizziness, headache, nausea, and fatigue. Advised by employee COVID hotline to report to the ED.
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| 40 | 2021-01-19 | throat pain, runny nose, fatigue, malaise | Fatigue, Sore Throat, Runny Nose, General Malaise, Body aches, Swollen Arm |
| 40 | 2021-01-19 | dizziness, fever, chills |
Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, ...
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Fever, rigors, body aches, extreme joint pain, dizziness, swollen lymph nodes in the right arm pit, clavicle and neck.
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| 40 | 2021-01-19 | chills, fever, lethargy, dizziness |
Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous repo...
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Fever; chills; lightheaded; muscle aches; joint pain; diarrhea; lethargy; This is a spontaneous report from a contactable nurse. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date not reported), intramuscular in the left arm on 08Jan2021 12:00 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EK5730, expiry date not reported), intramuscular in the left arm on 18Dec2020 12:00 at single dose for COVID-19 immunisation. The patient previously took cefalexin (KEFLEX), clindamycin and codeine and experienced drug allergies. On 09Jan2021 12:00, the patient experienced fever, chills, was lightheaded, muscle aches, joint pain, diarrhea and lethargy. No treatment was received for the adverse events. Clinical outcome of the events was recovered on an unspecified date.
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| 40 | 2021-01-19 | chills, fever, headache |
Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08J...
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Fevers; chills; body aches; headache; sore arm; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose; This is a spontaneous report from a Non-contactable nurse. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685) via intramuscular into left arm on 22Dec2020 12:00 at first single dose; then on 08Jan2021 at second single dose for covid-19 immunization. No covid prior vaccination. The patient known allergies included Cytotec, peanuts, lentils, peas, chick peas and other medical history included Asthma, migraines, kidney stone. There is no other vaccine administered in four weeks. Other medications in two weeks included multi vitamins, vit B2 and magnesium. On 09Jan2021, the patient experienced Fevers, chills, body aches, headache, sore arm and no treatment involved. No covid tested post vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-19 | sweating, fatigue, chills |
Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in undera...
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Initial symptoms on the evening of dose were just really sore arm, swelling of lymph nodes in underarm and body aches. Overnight I was restless and unable to sleep well, body aches and hot and then chilled and cold. By morning my arm was so sore and swollen it was difficult to move it, continued with all over body aches, fatigue to the point of unable to sit up, no fever but alternated chills/cold and hot/sweat. I did take ibuprofen every 4-6 hours throughout the day. This is the same type of reaction I had to tetanus when a teen.
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| 40 | 2021-01-19 | chills, fever | Ongoing treatment for vertigo |
| 40 | 2021-01-19 | chills, fever, headache | Rash, swelling, nausea, headache, diarrhea, muscle pain, fever, chills |
| 40 | 2021-01-19 | chills, headache |
Received vaccine at 1100. Patient woke up at 0151 with headache, chills and body aches. Symptoms ...
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Received vaccine at 1100. Patient woke up at 0151 with headache, chills and body aches. Symptoms the same this afternoon at 1200.
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| 40 | 2021-01-19 | nerve pain |
Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit wi...
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Swollen lymph node in left armpit with pain radiating down arm; Swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched; Swollen lymph node in left armpit with pain radiating down arm; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 08Jan2021 08:45 at single dose at left arm for COVID-19 immunization. Medical history included osteopenia, vitiligo, known allergies: Demerol and Vicodin. The patient's concomitant medication received in two weeks included Vitamins. The patient previously took the first dose of bnt162b2 intramuscularly on 18Dec2020 20:45 (lot number: EH9899) at single dose at right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine received in four weeks. The patient experienced swollen lymph node in left armpit with pain radiating down arm; nerve pain in tips of right index and middle fingers intermittently and when touched on 09Jan2021 07:00. No treatment received for the events. No COVID prior vaccination. COVID test post vaccination: Nasal Swab Negative on 05Jan2021. The outcome of the events was not recovered.
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| 40 | 2021-01-19 | chills, headache, fatigue | headaches, chills, mild fatigue. didn't take temp. |
| 40 | 2021-01-20 | dizziness, fatigue, headache, throat pain |
Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upp...
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Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional. A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room. The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.
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| 40 | 2021-01-20 | body temperature increased |
temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experien...
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temperature elevated (99.8, 101.8, 101); at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain; She is very achy; shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand; This is a spontaneous report from a contactable nurse (patient). This 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686) intramuscular, in left deltoid, on 11Jan2021 at 10 AM, COVID-19 immunization. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing asthma diagnosed at childhood, ongoing diabetes diagnosed in her twenties, she was overweight, about 7 or 8 years ago she ended up having cellulitis due to the nurse not using aseptic technique but not due to a vaccine, she was diagnosed with COVID on 18Dec2020 (she was off quarantine as of 28Dec2020, going back to work on 31Dec2020). When she was diagnosed with COVID, it caused an asthma exacerbation and she needed a 5-day oral burst of 40 mg prednisone. Concomitant medications were none. On 11Jan2021 the patient experienced temperature elevated, at the injection site (upper left deltoid) she was experiencing very small redness and a sharp shooting pain and she was very achy. Her temperature started last night (11Jan2021), temperature was 99.8. She tried to hydrate. She also had a temperature at 6 AM on 12Jan2021 morning. On 12Jan2021 she had temperature of 101.8 and this was after taking antipyretics 6 hours before. Then, on 12Jan2021, her temperature was 101. She was on the phone with her primary care provider and she was told to take more antipyretics. She just took more antipyretics. She stated it felt almost like they hit a nerve when administering the vaccine since she was experiencing shooting pain all the way down from her left upper deltoid to her middle and ring finger on left hand. She believed, based on anatomy, that there were nerves going right there. She knew she was overweight but her upper arms were not that bad. She tried to take a shower to cool herself down. She received the vaccine through pharmacy since she was working at a long term care facility around COVID. Pharmacist came to the long term care facility where she works to administer the vaccine. The events did not require ER visit. Relevant tests: none. Fever outcome was unknown. The other events had not yet resolved. Sharp shooting pain came and went. The reporter considered all the events serious as medically significant and related to BNT162B2 vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-01-21 | fever, fatigue |
101 fever and sever body aches 12 hours after second dose. Extreme fatigue for another 24 hours. 36...
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101 fever and sever body aches 12 hours after second dose. Extreme fatigue for another 24 hours. 36 hours after vaccine felt perfectly normal again.
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| 40 | 2021-01-21 | body temperature increased, chills | 5PM - SORE ARM (UNABLE TO LIFT) 4AM - CHILLS 2PM - FEVER 101.2 TOOK TYLENOL |
| 40 | 2021-01-21 | dizziness |
After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart ...
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After her 15 minute post-vaccination waiting period, noticed her smart watch indicated a high heart rate (approximately 180). She sat back down for a few minutes and her heart rate slowly decreased. However, when she collected her belongings and began to walk , she noticed that her heart rate increased again and she felt dizzy. She stopped by a clinic within the hospital to have her heart rate checked on a pulse oximeter. It was reading about 130, but varied from 109 up to 140's/150's. She then called her doctor who encouraged her to contact the clinic. She does not feel unwell while at rest but did have dizziness when walking. After visiting with Dr she was escorted to the Emergency Department for evaluation.
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| 40 | 2021-01-21 | headache | Body ache headache stiff neck stomach pain nausea vomiting arm swelling |
| 40 | 2021-01-21 | dizziness, weakness |
I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm...
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I begin to lose consciousness; I felt lightheaded; My face and ears got red and I begin to feel warm; My face and ears got red and I begin to feel warm; Then My whole body felt really weird; my lips went numb; Afterwards for approximately 4 hours I could barely talk or open my eyes; Afterwards for approximately 4 hours I could barely talk or open my eyes; I got red rash on my neck and chest; I felt so weak, I could not move my body!; This is a spontaneous report from a contactable Other HCP reporting for herself. A 40-years-old female patient received the second dose bnt162b2 (BNT162B2) vaccine , intramuscular in the left arm on 18Dec2020 12:15 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of the vaccine. The patient experienced got red rash on my neck and chest on 18Dec2020 12:15 with outcome of recovering , felt lightheaded on 18Dec2020 12:15 with outcome of recovering , face and ears got red and begin to feel warm on 18Dec2020 12:15 with outcome of recovering , then whole body felt really weird on 18Dec2020 12:15 with outcome of recovering , lips went numb on 18Dec2020 12:15 with outcome of recovering , begin to lose consciousness on 18Dec2020 12:15 with outcome of recovering , afterwards for approximately 4 hours could barely talk or open my eyes on 18Dec2020 12:15 with outcome of recovering , felt so weak, could not move my body on 18Dec2020 12:15 with outcome of recovering. The patient was hospitalized for one day for all the reported events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Dec2020 . The patient received Epipen injection, steroids, saline & Benadryl as treatment for the reported events. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-01-21 | headache, migraine |
Injection 1-muscle soreness for about 8 hrs at site and headache for a couple days. Injection 2- m...
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Injection 1-muscle soreness for about 8 hrs at site and headache for a couple days. Injection 2- muscle soreness at site, migraine that evening, and severe neck pain. Muscle pain in neck and shoulders for a few days causing ha?s in the evenings.
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| 40 | 2021-01-21 | headache, fatigue, chills |
No symptoms or reactions immediately. Injection site was very sore the following day. Followed by b...
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No symptoms or reactions immediately. Injection site was very sore the following day. Followed by body aches, chills, headache, muscle and joint pain. Tired.
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| 40 | 2021-01-21 | somnolence |
Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and acr...
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Twelve minutes after receiving the vaccine injection, patient reported tingling in both arms and across her upper back. She had taken a dose of Benadryl, 50 mg p.o. prior to coming to the clinic, due to her prior history of allergies. Her blood pressure was checked in left arm, 134/94. She denied chest pain, SOB or feeling of swelling in tongue or face. After the tingling sensation, she began to experience pruritus of her arms, back and scalp. Visual inspection revealed no visible rash or hives. When she began rubbing on her left arm to relieve the itchy sensation, the area of rubbing became erythematous. She was observed for 45 minutes after the injection. Symptoms did not progress and she was discharged from the clinic. Phone follow-up 24 hours later: pruritus has resolved. She took 2 more doses of Benadryl 50 mg p.o. yesterday, at 2 p.m. and 11 p.m. Only symptom reported today is sleepiness.
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| 40 | 2021-01-21 | dizziness | dizziness and vertigo |
| 40 | 2021-01-24 | chills, fever, headache | Headache, fever, chills, body aches, joint pain on 1/24/21. Treating with Tylenol. |
| 40 | 2021-01-24 | dizziness, headache |
Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nyst...
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Itching; headache and body aches; headache and body aches; chest tightness; had hives; Vertigo; Nystagmus in her eyes; passing out; vomiting/puke when vertical; Dizziness; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; tingling and numbness in throat and lips; heart rate 125; BP of 170/100; throat tightness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=El1283) via an unspecified route of administration at left arm on 08Jan2021 11:30 at single dose for covid-19 immunization. Vaccine was administered at hospital. Medical history included ongoing autoimmune disorder. The patient had known allergies to Amoxicillin and wasps. No family medical history relevant to events. Ongoing concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE) for autoimmune disorder, celecoxib (CELEBREX) for autoimmune disorder, oral dimenhydrinate (DRAMAMINE), oral fexofenadine hydrochloride (ALLEGRA) and oral famotidine (PEPCID). No other vaccine in four weeks. The patient previously took flu vaccine (Expiry Date: Nov2020), tetanus vaccines for immunization. At 11:40 on 08Jan2021, the patient had tingling and numbness in throat and lips, heart rate was 125. By noon had hives and blood pressure (BP) of 170/100 (normal BP was 96/58 and heart rate was 65), chest tightness and throat tightness, the patient was given Benadryl (50mg) and monitored. No change so walked to emergency room. Given intravenous Benadryl and steroids then released the same day on 08Jan2021. The patient woke up on Saturday and shortly after hives came back, itching, chest tightness, headache and body aches. Saturday night on 09Jan2021 she went back to hospital due to continued reaction from 09Jan2021 06:00 pm until 10Jan2021 04:30 PM. The patient was admitted for heart testing then released on Sunday afternoon simply due because each doctor said they didn't know what to do. The patient slept from late Saturday night to Monday (except testing and eating at hospital), on 11Jan2021 around noon the patient took a shower and hives, itching and tingling all came back. Completely started over with reaction and started dizziness. On Tuesday 12Jan2021, primary care physician (PCP) for tests. Chest tightness started subsiding but very dizzy, puke when vertical. Wednesday: rheumatoid doctor. The patient had extreme vertigo. Other reported events: passing out, vomiting. Nystagmus in her eyes was very strong so that she got very dizzy. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care or Hospitalization. Adverse event start time also reported as 11:45 am. The patient underwent lab tests and procedures which included blood pressure 170/100 on 08Jan2021, blood test and electrocardiogram (EKG) with unknown results, heart rate: 125 on 08Jan2021. Normal BP was 96/58 and heart rate was 65. Heart and lungs examination with clear result. The patient had no Covid prior vaccination. Nasal Swab of Covid tested post vaccination on 05Jan2021 with a result of negative. Heart rate 125 recovered on 12Jan2021. BP of 170/100 recovered on 12Jan2021. Chest tightness sometimes she has episodes. She cannot walk without assistance. She stated she currently was 100% dependent on someone else. Throat tightness recovered on 11Jan2021. Outcome of other events was not recovered. She was treated at hospital with Oral and IV Benadryl and IV Steroids on 08Jan2021. On 09Jan2021 she was administered Oral Prednisone, Oral Diphenhydramine HCl (BENADRYL) and Oral Acetaminophen(Tylenol). Steroids switched from prednisone Oral to dexamethasone Oral twice daily. On 13Jan2021 she started on ondansetron (ZOFRAN) 4mg 3xday Promethazine (Fenagrin) 25 mg once at night. Information on Lot/Batch has been requested.
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| 40 | 2021-01-24 | fever, headache, chills, dizziness |
Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the e...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emegency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, light headedness, headache, and myalgias. In the emergency department vitals stable and within normal ranges including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted or reported. Patient adminsitered fluids with symptom improvement. Discharged to home stable.
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| 40 | 2021-01-24 | dizziness, headache, chills, fever |
Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the e...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Two days after receiving vaccination patient presents to the emergency department for a near syncopal episode. Since vaccination patient reports fever (up to 101 degrees Fahrenheit), chills, hight headedness, headhache, and myalgias. In the emergency department vitals stable and within normal ranges, including temperature 36.5 degrees Celsius. No rash, hives, or shortness of breath noted. Patient administered intravenous fluids with symptom improvement. Discharged home stable.
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| 40 | 2021-01-24 | malaise, chills, fever, fatigue, headache |
Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injecte...
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Right arm injection site pain/swelling/red circle. Right Axillary lymph node swelling in arm injected. Headache, tiredness, muscle pain, chills, fever- T max. 101.8, feeling unwell.
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| 40 | 2021-01-24 | body temperature increased, chills |
beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea,...
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beginning around 8pm on 1/20/21 (day of vaccine), chills. woke up around 2am on 1/21/21 with nausea, feeling warm -- temp of 100.7; chills, fever, and nausea all morning of 1/21/21; fever and chills continued through 1/22/21 around 11am. Treated with Tylenol and Zofran. On 1/22/21 noticed lymph node swelling on arm where vaccine given. Neuropathy 1/22/21. Treated wtih ibuprofen 600mg TID. Lymph node remains swollen as of 1/25/21. Lymph node is hard.
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| 40 | 2021-01-25 | headache, fever | 15 hours post vaccination, I am experiencing headache, nausea, fever, and body aches |
| 40 | 2021-01-25 | fatigue, headache |
Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; Thi...
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Face numbness; Headache; Fatigue; Legs aching; Muscle soreness in the left arm; Rapid heartbeat; This is a spontaneous report from a contactable health care patient. This 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 11Jan2021 at single dose for COVID-19 immunisation. Vaccine location was left arm. Medical history included frequent migraines, anxiety and anemia. Historical vaccine included first dose of BNT162B2 (Lot # 1), intramuscular left arm, on 21Dec2020 at 07:30 AM for COVID-19 immunisation. Age at vaccination was 40-years-old for both doses. Concomitant medications included topiramate (TOPAMAX), ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE DAY VITAMINS), phentermine, phendimetrazine tartrate (BONTRIL), naproxen sodium (ALEVE), escitalopram. On 11Jan2021 at 12:00 PM, the patient experienced face numbness, headache, fatigue, legs aching, muscle soreness in the left arm, and rapid heartbeat. No treatment was received for the event. Outcome was recovering. Information on the lot/batch number has been requested.
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| 40 | 2021-01-25 | fever, shortness of breath, chills |
Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; T...
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Left axillary swelling; tachycardia; shortness of breath; fever; chills; muscle aches; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 10Jan2021 18:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 20Dec2020 (04:00 PM) for Covid-19 immunization. Medical history included known allergies to latex, cinnamon, and nickel. Concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced left axillary swelling, tachycardia, shortness of breath, fever, chills, muscle aches, and joint pain on 10Jan2021 (19:00). The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 post vaccination.
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| 40 | 2021-01-25 | headache, fever, chills |
Severe body aches; Chills; Headache; Temp 100; GI upset; diarrhea; This is a spontaneous report from...
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Severe body aches; Chills; Headache; Temp 100; GI upset; diarrhea; This is a spontaneous report from a contactable physician (patient) reported that a 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the right arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL), ibuprofen and biotin, cyanocobalamin, folic acid (MVI 3). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020 07:15 on the right arm for COVID-19 immunization. On 11Jan2021 21:30 (reported as 'after 12 hours'), the patient experienced severe body aches, chills, headache and temp 100, then after 48 hours (Jan2021) those symptoms resolved, but had GI upset and diarrhea. The patient underwent lab tests and procedures which included body temperature: 100 (no unit reported) on 11Jan2021. The outcome the events severe body aches, chills, headache and temp 100 was recovered on Jan2021 (reported as after 48 hours those symptoms resolved) while GI upset and diarrhea was recovering. The patient did not received any treatment for the reported events.
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| 40 | 2021-01-25 | dizziness |
a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super di...
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a flood of heat throughout my body; pain in my calf muscle; tingling; Woke me up all night; super dizzy; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 12Jan2021 10:00 at a single dose for COVID-19 immunization. There were no medical history. The patient is not pregnant. Concomitant medication included amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced super dizzy on 12Jan2021 10:06, a flood of heat throughout her body, pain in her calf muscle, tingling, and it woke her up all night on 12Jan2021 12:00. Outcome of the events was recovering.
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| 40 | 2021-01-25 | dizziness |
difficulty falling asleep; Lightheaded; This is a spontaneous report from a contactable other health...
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difficulty falling asleep; Lightheaded; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249), via an unspecified route of administration on the left arm on 06Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included Hashimoto, seasonal allergies, ripe food, allergies to weed, grass, trees. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), fexofenadine hydrochloride (ALLEGRA) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient previously took erythromycin, Bactrim and experienced allergies. Patient did not have COVID and did not receive other vaccines four weeks prior to vaccination and was not pregnant. The vaccine was received at a workplace clinic. On 06Jan2021 10:45, the patient experienced difficulty falling asleep and was lightheaded. No treatment was received for the events. The patient has not tested for COVID post vaccination. Outcome of the events was recovered with lasting effects. No follow-up attempts are possible. No further information is expected.
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| 40 | 2021-01-25 | fever, headache |
fever 101; moderate headache; tachycardia at rest; This is a spontaneous report from a contactable n...
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fever 101; moderate headache; tachycardia at rest; This is a spontaneous report from a contactable nurse reporting for herself. A 40-year-old female patient received the second dose of bnt162b2 (BNT162B2, lot number: EL1287, expiry date: not reported), via an unspecified route of administration, on 12Jan2021 04:15 PM at a single dose on the left arm for COVID-19 immunization. The patient was not pregnant. She received the vaccine at a workplace clinic. She had not received any other vaccines in four weeks. Medical history included arthritis. The patient had no known allergies. Concomitant medications included paracetamol (TYLENOL), multivitamin, and airborne immune supplement; these are the other medications she took in two weeks. The patient previously received the first dose of bnt162b2 (BNT162B2, lot number: EL1284, expiry date: not reported), via an unspecified route of administration, on 23Dec2020 04:45 PM at a single dose on the left arm for COVID-19 immunization. On 13Jan2021 03:00 AM, within 12 hours of 2nd vaccine dose, the patient experienced fever 101, moderate headache, tachycardia at rest. The patient was not diagnosed with COVID prior to vaccination and had not tested for COVID post vaccination. The patient received no treatment for the reported adverse events. Outcome of the events was recovering.
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| 40 | 2021-01-25 | malaise, chills, fatigue, headache |
headache; chills; tiredness; nausea; feeling unwell; This is a spontaneous report received from a co...
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headache; chills; tiredness; nausea; feeling unwell; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 40-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), intramuscular in left arm, on 11Jan2021 00:00 (reported as 12:00AM), at single dose, for COVID-19 immunization, in workplace clinic. There was no medical history. Concomitant medication was not reported. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination. The patient did not receive other vaccines in four weeks. The patient is not pregnant. The patient experienced headache, chills, tiredness, nausea and was feeling unwell all on 11Jan2021 14:30. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The outcome of the events was recovering.
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| 40 | 2021-01-25 | migraine, productive cough, nasal congestion, chills, respiratory tract congestion |
nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigo...
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nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigors; nasal stuffiness; chest congestion; wet cough; This is a spontaneous report from a contactable physician. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on 08Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose last 18Dec2020 (lot number=EJ1685). The patient experienced nuchal rigidity, migraine, photosensitivity, auditory sensitivity, arthralgia, lethargy chills, rigors, nasal stuffiness, chest congestion, wet cough on 09Jan2021 05:00. The outcome of the event nuchal rigidity was not recovered while other events were recovered with sequelae.
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| 40 | 2021-01-25 | skin warm | pain, redness, and warm to touch, progressively has gotten worse |
| 40 | 2021-01-26 | chills, fever |
36 hours after the injection I developed large red, warm and painful area at the injection site. 24 ...
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36 hours after the injection I developed large red, warm and painful area at the injection site. 24 hours after that I was experiencing fever and chills again. I also started to vomit
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| 40 | 2021-01-26 | skin warm |
About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no ap...
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About 20 minutes after receiving her 2nd dose of vaccine, the patient developed tingling lips (no apparent angioedema), itching and warmth of the face and chest. Her face and upper chest did appear flushed. She was administered Benadryl, and her symptoms resolved after half an hour.
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| 40 | 2021-01-26 | dizziness, headache |
After my 1st vaccine I felt dizzy and experienced headaches. I tested positive for Covid 19 on 12-30...
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After my 1st vaccine I felt dizzy and experienced headaches. I tested positive for Covid 19 on 12-30-2020.
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| 40 | 2021-01-26 | throat irritation, dizziness |
After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EP...
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After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.
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| 40 | 2021-01-26 | fever, fatigue, chills |
After second dose about 16 hours after experienced chills bodyaches sore joints muscles and low grad...
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After second dose about 16 hours after experienced chills bodyaches sore joints muscles and low grade fever and fatigue
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| 40 | 2021-01-26 | fatigue, weakness, dizziness |
Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and sync...
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Around 10 minutes after injection, she developed symptoms that included nausea, dizziness, and syncope. Symptoms progressed over time until she seemed almost catatonic at times including delayed responses, staring straight ahead (later she closed her eyes), slurred speech. She kept repeating, "I feel like jelly" and that she was very tired. Pharmacist gave her 25 mg diphenhydramine at 10:55 am. Around 11:10 the facilities administer called 911 at the request of (PharmD).
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| 40 | 2021-01-26 | fatigue | Fatigue Pain at injection site |
| 40 | 2021-01-26 | headache, fatigue |
I experienced fatigued and headaches after my 2nd dose injection. I tested positive for Covid 12-30...
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I experienced fatigued and headaches after my 2nd dose injection. I tested positive for Covid 12-30-2020.
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| 40 | 2021-01-26 | fever, fatigue, headache |
I received the second dose of the vaccine on 1/4/21 and experienced fatigue, muscle aches, headache,...
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I received the second dose of the vaccine on 1/4/21 and experienced fatigue, muscle aches, headache, and a fever of 99.6 beginning 36 hours after the vaccine was administered extending to about 60 hours after administration. I missed work on 1/6/21 due to symptoms.
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| 40 | 2021-01-26 | shortness of breath, chills, fever |
Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, ...
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Myalgias, rigors and chills starting at 2:00am on 1/24/2021 Fever (101.5), rigors, severe myalgias, tachycardia, dyspnea at 12:00pm 1/24/2020 Improvement with ibuprofen and acetaminophen. Resolved by 1/25/2021
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| 40 | 2021-01-26 | shortness of breath, dizziness |
Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a co...
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Pulse started racing; I felt dizzy; Short of breath; Anxious; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 31Dec2020 11:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with Covid prior to vaccination. The patient has no known allergies. Concomitant medication includes vitamins NOS (MULTIVITAMIN). The patient did not receive other vaccines in the last four weeks. The patient received the vaccine in a facility. About 5 minutes after (31Dec2020 11:35 AM) the patient received the vaccine, the patient's pulse started racing, and she felt dizzy, short of breath and anxious. The adverse events result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The patient has not been Covid tested post vaccination. The outcome of the events was recovered on an unspecified date. The following information on the batch/lot number has been requested.
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| 40 | 2021-01-26 | headache, fever, fatigue |
RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AR...
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RECEIVED VACCINE IN THE AM. IN THE EVENING I STARTED TO FEEL FATIGUED AND BEGAN TO HAVE CHILLS. AROUND 2AM I WOKE UP WITH A FEVER (99F), CHILLS, BODY ACHES, SORENESS IN LEFT ARM AND LEFT SIDE OF NECK, HEADACHE, NAUSEA & VOMITTING. I TOOK 4 X 200MG IBUPROFEN. I FINALLY WAS ABLE TO SLEEP AGAIN AROUND 7AM. I HAD A HEADACHE, BODY ACHES, NAUSEA AND FATIGUE THROUGH THE REST OF THE DAY. I SLEPT MOST OF THE DAY. AFTER 48 HOURS MOST SIDE EFFECTS WERE GONE, EXCEPT FATIGUE AND SORENESS IN LEFT ARM AND SIDE OF NECK.
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| 40 | 2021-01-26 | headache, fever, chills | The main symptoms was fever 101 for up to 10 hours, chills, and headache. |
| 40 | 2021-01-26 | respiratory tract congestion | Tightness in chest, chest congestion without cough , or fever. Need not seek medical attention . |
| 40 | 2021-01-26 | fatigue, headache, chills |
body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels li...
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body aches; chills; severe headache/Extreme headache; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; chest discomfort/chest pain/heaviness/Feels like something is heavy on my chest; extremely tired; not able to carry out daily activities; This is a spontaneous report from a contactable other health care professional. A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Jan2021 07:45 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history reported as none. The patient has no known allergies. The patient received first dose of COVID19 vaccine BNT162B2 on 24Dec2020 11:45PM at left arm. There were no concomitant medications. The patient stated, On 11Jan2021 16:00, "I'm having body aches, chills, severe headache/extreme headache and chest discomfort/chest pain. I understand that the body is trying to build an immune response and I understand that body aches and chills are part of that but I don't get headaches, ever, and I have never had chest discomfort or heaviness like this so how is that an immune response. I want you to tell me why I feel this way." It was also reported that the patient was extremely tired, and not able to carry out daily activities. The patient did not receive treatment for the events. The outcome of the events was not recovered. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Information about batch/lot number has been requested.
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| 40 | 2021-01-26 | headache, throat pain, weakness, fatigue |
heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs cr...
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heart palpitations; Stated that it felt like nerves on inside of her body were reacting like bugs crawling on the inside of her skin; bad headache; Sore throat; tongue swollen; tired; weak; This is a spontaneous report from a contactable consumer reported for self. This 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Jan2021 on Arm Left at single dose (lot: EK9231) for covid-19 immunisation. Med history and concomitant medications were none. The patient had injection done yesterday (12Jan2021) and wanted to report symptoms. Stated that it felt like nerves on inside of her body were reacting like bugs crawling on inside of her skin 12Jan2021 at 6:30pm which calmed down at 10:00pm, bad headache 12Jan2021 at 6:30pm, sore throat, tongue felt swollen happened on 12Jan2021 after the injection, both resolved at 10:30pm. Stated that she did do Benadryl. Stated that she took another Benadryl this morning and it feels like it is wearing off and the sensation is coming back. Stated felt tired and weak on 12Jan2021. Stated felt like having palpitations and heart going too fast on 13Jan2021. Stated that she called her primary healthcare provider and was told to call Pfizer. Wanted to know if she needed to go to her doctor. Outcome of the events sore throat, tongue felt swollen was recovered 12Jan2021 10:30pm. Outcome of other events was not recovered.
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| 40 | 2021-01-26 | fatigue |
woke up during the night after her second dose (dose given on Friday) with joint pain (around midnig...
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woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after); joint pain; intense fatigue; muscle aches; arm was sore at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration (left arm) on 08Jan2021 (11:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EH9899) on 18Dec2020 (02:45 PM) via an unspecified route (right arm) for Covid-19 immunization. The patient's medical history included drug allergy (reported as known allergies: Cephalosporin (mild reaction of hives one time after having taken it with no issues for years-pending clarification)). There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that she woke up during the night after her second dose (dose given on Friday) with joint pain (around midnight or shortly after [09Jan2021, 12:15AM]). The entire day after her 2nd dose (during the day Saturday) every joint in her body ached and she experienced intense fatigue. There were also some muscle aches in her shoulders and her arm was sore at the injection site as it usually is after a tetanus shot (she stated she had soreness in her arm the day after the first injection but no other adverse events after the first injection). She did not seek medical treatment and did not take any over the counter medications to alleviate the symptoms as she does not typically take medications unless absolutely necessary. By the next day (Sunday), she was much better and had only slight joint pain remaining in her neck. By the following day (Monday;11Jan2021), all symptoms had resolved. She further stated that the symptoms experienced for one day did not make her regret getting the vaccine and she continue to strongly recommend the vaccine. The outcome of events was recovered on 11Jan2021. The patient has not been tested for COVID-19 since the vaccination.
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| 40 | 2021-01-28 | fatigue, fever, dizziness, headache | Fatigue, fever, myalgia, headache and dizziness. |
| 40 | 2021-01-28 | chills, fever, headache |
I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injectio...
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I received 2 dose on 1/26 at 8:40 a.m. About 4:30 p.m. I start feeling a throbbing pain at injection site. I around home about 6:00 p.m. immediately I start having chills, fever, muscle ache , nausea , and headaches. I could not sleep all night I was back and forth with chills and fever up to 102 for two days. On third day I felt better but headache and nausea linger still.
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| 40 | 2021-01-28 | fever, chills, fatigue |
I woke up at about 1am, feeling achy and with the chills. I had a fever of 102. I took Tylenol and ...
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I woke up at about 1am, feeling achy and with the chills. I had a fever of 102. I took Tylenol and went back to bed. I woke up about 8 feeling exhausted and achy. I took more Tylenol and started to feel better for a few hours. About 12pm I started to feel worse again and took a nap until about 3pm. When I got up at 3pm I had the chills and could barely get out of bed. I had a fever that alternated between 104 - 105 until 6pm. The fever broke around 6pm and I was still a bit achy and exhausted, but started progressively feeling better. I felt totally fine the next morning.
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| 40 | 2021-01-28 | shortness of breath, chills |
approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also ha...
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approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy. She also had intermittent itching and chills. Rapid Response team notified and she was observed for an additional 30 minutes with improvement in symptoms. She was dismissed at 1000 to home
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| 40 | 2021-01-31 | shortness of breath |
Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient de...
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Patient administered 2nd dose of Pfizer COVID vaccine on 1/25/2020. Six days later the patient developed generalized hives treated with over the counter antihistamine (benadryl). The next day patient again had hives, trouble swallowing, and difficulty breathing. She presented to an Emergency Department and was treated with epi IM and oral antihistamines (H1 and H2). Discharged to home on prednisone 40 mg PO QD x 3 days and then 20 mg PO QD x 2 days. Patient again had trouble breathing 2/1/2020 and returned to the ED. Patient 10 weeks pregnant.
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| 40 | 2021-02-01 | headache, fever, fatigue |
Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left ...
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Around 6 am,( day after vaccine- approximately18 hrs after vaccine) achy legs, fever, sore arm(left arm), fatigue, headache. Lasted approximately 12 hours
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| 40 | 2021-02-01 | fatigue, fever | Vomiting, diarrhea, fever, generalized intense pain. Fatigue still experiencing at this time |
| 40 | 2021-02-02 | sweating, malaise, chills |
The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG c...
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The patient was admitted to the hospital on 24 January with chest pain, elevated troponin, and EKG changes in the setting of a couple days of chills, sweats and malaise after receiving the covid vaccine. Initially there was concern for acute MI and he was taken for a coronary angiogram. The angiogram was clean and showed no obstructive disease. He had a cardiac MRI which showed findings consistent with myocarditis. He was treated with supportive care and eventually was discharged. He was worked up for other causes of myocarditis with none to be found.
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| 40 | 2021-02-02 | cough |
tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles o...
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tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 40 | 2021-02-07 | headache, fever, sweating | 8 DAYS ONGOING, NAUSEA, BODY ACHES, NECK MUSCLE TIGHTNESS, LOW GRADE FEVER, DIAPHRESIS, HEADACHES |
| 40 | 2021-02-07 | fever, chills, headache, malaise |
CHILLS, FEVER 40 DEGREES CELSIUS, HEADACHE, ACUTE LEFT AXILLARY PAIN AND EDEMA, RIGHT AXILLARY PAIN...
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CHILLS, FEVER 40 DEGREES CELSIUS, HEADACHE, ACUTE LEFT AXILLARY PAIN AND EDEMA, RIGHT AXILLARY PAIN, GREY COMPLEXION, MALAISE, GENERALIZED JOINT PAIN. DIFFICULTY RAISING UPPER EXTREMITIES DUE TO PAIN AN MUSCLE WEAKNESS,
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| 40 | 2021-02-07 | body temperature increased, weakness, dizziness |
inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were ...
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inflammatory response; had heart rate in 150's; nauseated all day; temp was 102; Both my knees were swollen; both legs were tingly; dizzy; very weak; shaky; This is a spontaneous report from a non-contactable consumer (patient). A 40-years-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included asthma, mitral valve, Known allergies: Sulfa, Shellfish, sulfide. No other vaccine in four weeks. No covid prior vaccination. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR) and Asthma inhalers. 6 hrs after vaccinated I became dizzy, very weak and shaky. Next day was nauseated all day, felt shaky, by 3 pm temp was 102, had heart rate in 150's. Both my knees were swollen, both legs were tingly. I took Motrin and Tylenol and most symptoms resolved by morning. Friday morning, I still felt weak but other symptoms resolved. I was not expecting the inflammatory response which is why I am letting y'all know. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: negative on 21Jan2021. The outcome of the event Very weak not recovered, inflammatory response was unknown and of the rest events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
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| 40 | 2021-02-08 | shortness of breath, dizziness |
hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she f...
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hard time catching her breath; throat felt a little tight; her throat felt a little tight, and she found it hard to swallow; little nervous; very lightheaded; her husband told her she looked very pale; her heart rate jumped to over 150, according to her (company name) watch; she had pins and needles up and down her entire left arm; her left arm initially felt almost totally numb from her shoulder to her finger tips, and then she felt pins and needles down the entire length of her arm.; maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the first dose of bnt162b2 (Lot Number: EK4176), via an unspecified route of administration in left arm on 25Jan2021 12:50 at single dose for covid-19 immunization. Medical history included coeliac disease from Mar2013 and ongoing. There were no concomitant medications. She said initially she was OK after she received the COVID-19 Vaccine. She said after about 5 minutes in from receiving the COVID-19 Vaccine, she had a hard time catching her breath, and her throat felt a little tight, and she found it hard to swallow. She said she thought she was nuts at first, and was a little nervous for a minute. She said the staff at the vaccination center made people wait 15 minutes after receiving the COVID-19 Vaccine before being allowed to leave. She said she actually spoke to the vaccination center staff while she was waiting for the 15 minutes to go by. She said she didn't say anything to the staff because she thought she might be crazy. She said she scheduled her second COVID-19 Vaccine dose, and after the 15 minutes went by, she left. She said her husband had drove her to and from the COVID-19 Vaccine facility location. She said 5 minutes into her car trip after leaving the facility, she became very lightheaded. She said her throat began to feel tight again (saying the throat tightness was worse than what she first experienced at the convention center), and she kept trying to clear her throat. She said her husband told her she looked very pale. She said her heart rate jumped to over 150, according to her Apple watch. She said she had pins and needles up and down her entire left arm. She clarified her left arm initially felt almost completely numb from her shoulder to her finger tips. She said she thought that maybe a nerve was hit when the COVID-19 Vaccine was administered in her left arm. She clarified the numbness improved in her left arm, but she still has a pins and needle sensation down the length of her left arm. Patient asked if it is OK for her to received the second COVID-19 Vaccine based on what she experienced after the first COVID-19 Vaccine dose. Reported if she would have been driving the car after she received her first COVID-19 Vaccine dose, she would have had to pull over on the side of the road because of the side effects she was experiencing. Reported the side effects she experienced in the car after leaving the vaccination facility, resolved after a couple minutes, with the exception of the pins and needles and numbness in her left arm. She said the pins and needles, and numbness in her left arm improved, but was still present. Reported she had a well visit not too long ago, and her blood work was perfectly fine. The outcome of the events Peripheral nerve injury, Pins and needles, Numbness of upper extremities was recovering, other events was recovered on 25Jan2021.
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| 40 | 2021-02-10 | headache |
Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after ...
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Pain at site of injection upon waking the next morning and in shoulder area. About 15 hours after vaccine. Began to feel moderate body aches all over body with a headache. Began using restroom repeatedly with significant back pain and spasms. Muscle aches and pain continue. This reaction is after the 1st dose and I have had Covid July 2020.
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| 40 | 2021-02-11 | fever, headache |
About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red ra...
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About 12 hours after the vaccine I developed headache, fever 100.5, nausea and vomiting, and red rash across my chest up to my neck and under both breasts. All symptoms but the rash improved the following day. I went to have my 8 week pregnancy US 6 days after this second vaccine dose and there was no fetal heart rate. The baby measured 8.7mm and there should be a heart rate when the baby measures >7mm. I had all of my pregnancy symptoms up through the day of the vaccine and then they disappeared the day my vaccine symptoms improved. I do not have a history of miscarriage.
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| 40 | 2021-02-16 | headache |
mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her ...
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mild case of Bell's Palsy.; skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears; headache; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper left arm on 01Feb2021 at 04:30 PM at single dose for COVID-19 immunization. Medical history included asthma (exercise induced) and menstruating. Concomitant medications included Ibuprofen because she was menstruating. No other vaccine in four weeks. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: Apr2021) via intramuscular in the upper right arm on 11Jan2021 at 04:30 PM at single dose for COVID-19 immunization. The patient was not pregnant. The skin of the patient's jaw and chin started to feel numb about 20 minutes after receiving the vaccine, headache came and went rapidly on 01Feb2021 17: 00. The sensation progressed rapidly to include numbness of her cheeks, eyebrows, and ears. The symptoms appeared rapidly after leaving the clinic as the patient was driving away on her from work. Both sides of her face were impacted equally. She went to an urgent care facility to be evaluated. An Urgent Care Physician's Assistant evaluated the patient. They looked inside her throat to see if it was closing up (it wasn't). They used a swab to test her sensory ability on her face by pressing with either the fuzzy-side or the blunt (wooden) side. When the patient asked the PA how she did, she indicated that she failed the test. They gave her Benadryl. At home, the patient went to bed, woke up normally, and did a "frown test" in front of the mirror. Her left side of face wasn't working the same way as the right side. She may have a mild case of Bell's Palsy in the morning of 02Feb2021. The patient had no covid prior vaccination, no covid tested post vaccination. Benadryl was received as treatment for the events. Outcome of the event "skin of the patient's jaw and chin started to feel numb/numbness of her cheeks, eyebrows, and ears" and "mild case of Bell's Palsy" was recovering, of the event "headache" was recovered.
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| 40 | 2021-02-17 | headache, fatigue |
tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for...
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tired; headache; faint; vomit; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female received the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via intramuscular on 04Feb2021 18:00 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included sertraline hydrochloride (ZOLOFT). On 05Feb2021 5:30, the patient experienced faint and vomit and on 16: 00, more vomit, tired and headache all day. No treatment received for the events. Since the vaccination, the patient has not tested for COVID 19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 40 | 2021-02-18 | headache, nerve pain |
Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into lar...
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Sever joint pain, headache Hives on the backside of not of my legs with itching that turned into large welts a few hours later that then turned into 2 large welts on the side/back of my upper thighs. 2 days later and ever since I have severe nerve pain that is constant and is affecting my ADLs.
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| 40 | 2021-02-21 | dizziness, weakness |
A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went sti...
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A fast heartbeat- Dizziness, and weakness; Numbness and tingling; The muscles of my fingers went stiff, where my thumbs couldn?t move away from my inner palms and my other fingers would not bend. I also had difficulty speaking, as if my tongue was numb or hard to move. Â This lasted about an hour (15 hrs post-vaccine).
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| 40 | 2021-02-21 | cough, headache |
After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 da...
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After first dose on 1/11/2021 employee mentioned she had sinus congestion and a head ache for 2-3 days. She also experienced numbness of her left hip and swelling of her wrist. She was seen by her PCP and they did not associate the condition with the vaccine. After her 2nd dose on 1/28 she had a slight cough for 3 day and swelling of the arm and leg. She went to urgent care on 2/19 due to swelling and pain of her arms and legs. She was prescribed gabapentin, and pain medications. Employee developed left sided facial pain paralyses and went to the ED on 2/21 diagnosed with Bells Palsy and given acyclovir, norco and she is taking antibiotics for an ear infection. Currently still symptomatic.
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| 40 | 2021-02-21 | dizziness |
Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, ...
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Patient felt light headed 5 minutes after receiving the vaccine. Patient had an episode of syncope, which was attended by EMS. Patient regained consciousness within 30 seconds of episode. Patient has had previous episodes of syncope, but not with vaccinations. All vitals were normal when checked by EMS. Her BG was 121 mg/dl. Patient recommended to go to the hospital to get checked out but patient refused. Waited for husband to come pick her up - 5:45pm.
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| 40 | 2021-02-21 | chills, fever, fatigue | fatigue low grade fever 100.9 chills nausea lasted for 24 hours |
| 40 | 2021-02-21 | headache, fatigue, malaise, chills, dizziness |
malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to ...
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malaise, nausea, loose bowel movements a few times a day, headache- dizziness, chills, inability to focus, and fatigue - day 3-6 chills- day 7 tingling in legs and feet/hands - day 4 and continue off an off for past 2.5 weeks after vaccine headaches- continued off and off for past 2.5 weeks
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| 40 | 2021-02-22 | dizziness |
Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (pat...
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Chest tightness, after taste in mouth, palpitations, temp 98.4 degrees, BP - 122/82, Pulse - 80 (patient states vitals elevated from normal); shaking, dizzy, nausea
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| 40 | 2021-02-22 | fatigue, headache, fever |
Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I ha...
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Evening of vaccine starting around 3 pm I had Diarrhea, Nausea, Headache, & Fatigue. Over night I had chills so possible fever but I did not check it. Next morning woke up with Full Body Aches, Very Fatigued, Headache, Injection Site Pain and Swelling.
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| 40 | 2021-02-22 | throat pain, fever, headache, fatigue |
Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memor...
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Headache, muscle pain, sore throat, fever, sinus pressure, difficulty focusing eyes, fatigue. Memorable symptoms began on Feb. 19th, the worst day was Feb. 20th, when I was unable to complete my usual daily activities. My symptoms have begun to improve today, Feb 23rd. On Dec. 17th, 2020 I was diagnosed with COVID19.
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| 40 | 2021-02-22 | chills, dizziness, sweating |
Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminoph...
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Started with discomfort on arm where the vaccine was administered. When I got up to take acetaminophen, I felt very dizzy, nauseous, stay up, couldn't talk, after I drank cold water, I started with profuse sweating followed by chills, also had lower abdominal pain and pain on the left side of the chest. I went to the bathroom and did not have diarrhea. I was finally able to get up with help from my wife. Slow walking. The event lasted about 15 minutes. Since then I've take acetaminophen every 4 hrs.
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| 40 | 2021-02-22 | lethargy, fatigue | Systemic: Exhaustion / Lethargy-Medium |
| 40 | 2021-02-22 | headache, fatigue | generalized muscle ache fatigue injection site swelling, errythema and pain Headache |
| 40 | 2021-02-22 | headache, malaise |
mild headache 10 hrs after 2nd dose; malaise in the morning, the day after 2nd vaccine administratio...
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mild headache 10 hrs after 2nd dose; malaise in the morning, the day after 2nd vaccine administration; took tylenol and felt normal within an hour
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| 40 | 2021-02-23 | headache, fatigue |
Following the injection, after approximately four hours later I began to feel some slight disorienta...
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Following the injection, after approximately four hours later I began to feel some slight disorientation and tiredness. Later the same evening I experienced brain fog and confusion for the next several days as well as a terrible headache. Additionally my tongue felt tingly. All of these symptoms passed within several 3- 4 days following the vaccination. injection site discomfort was also a symptom.
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| 40 | 2021-02-24 | dizziness |
light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other H...
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light headed; woke up with hives on my neck; This is a spontaneous report from a contactable Other Health Professional (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PAA15 6651), via an unspecified route of administration in left arm on 03Feb2021 09:00 at single dose for Covid-19 immunization. Medical history included allergies to medications, food, or other products: Penicillin. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to vaccination, was the patient diagnosed with COVID-19: No. There were no concomitant medications. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: None. The patient previously took erythromycin and experienced Allergies: erythromycin. The patient experienced light headed and woke up with hives on her neck on 04Feb2021 06:00 with outcome of recovered in Feb2021. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient underwent lab tests and procedures which included BinaxNOW Covid-19 Ag Nasal Swab: negative on 05Feb2021 and negative on 08Feb2021. No treatment received for the adverse event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
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| 40 | 2021-02-28 | headache |
After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting head...
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After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; After the first vaccine I had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so; This is a spontaneous report from a contactable other healthcare professional (HCP). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration in the right arm, on 06Jan2021 at a single dose, for Covid-19 immunization. Patient had no relevant medical history and no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Facility type where vaccine was administered was reported as other . On an unspecified date in Jan2021, after the first vaccine the patient had arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. The patient did not receive treatment for the events. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination. Information about batch/lot number has been requested.
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| 40 | 2021-02-28 | headache |
Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient)...
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Headache; pain at injection site; This is a spontaneous report from a contactable consumer (Patient). A 40-year-old female non-pregnant patient received first dose of bnt162b2 (formulation: Solution for injection, Brand: Pfizer, Lot number: unknown) via unspecified route of administration at 12:15 on 27Jan2021, on left arm at single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medication included CELEXA (celecoxib), NEXIUM (esomeprazole sodium) and ZYRTEC (cetirizine hydrochloride). It was reported that on an unknown date in Jan2021 at 07:00, the patient experienced headache and pain at injection site. The events were reported as non-serious by the reporter. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 40 | 2021-02-28 | chills, headache, fever |
arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contact...
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arm pain; fever; chills; headache; muscle aches; nausea; This is a spontaneous report from a contactable other HCP. A 40-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in right arm on 26Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history was not reported. there were no known allergies.Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose ofbnt162b2 on 06Jan2021 in right arm and experienced arm, shoulder and neck pain on my right side along with a lasting headache for a week or so. After the 2nd vaccine, the patient experienced arm pain, fever, chills, headache, muscle aches and nausea on an unspecified date. there outcome of the events was recovering. There was no treatment for the events. The patient was not tested for COVID-19 prior and after the vaccination. Information on the lot/batch number has been requested.
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| 40 | 2021-02-28 | dizziness |
felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood press...
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felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76. Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.
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| 40 | 2021-02-28 | somnolence, chills, headache, fever, dizziness |
felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Fri...
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felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; dizziness; chills; headache; weird hallucinations; sore arm; felt groggy and feverish (highest temp was 100.4) with dizziness and chills and headache all day Friday; This is a spontaneous report from a contactable nurse, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE solution for injection, Lot unknown, second dose) intramuscular in left arm on 28Jan2021 at 09:15 (at the age of 40-years-old) at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Past drug history included allergies: cefazolin sodium (ANCEF). Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on 05Jan2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had a sore arm and felt groggy on Thursday night (28Jan2021). The patient was feverish (highest temp was 100.4 F) with dizziness and chills and headache all day Friday, on 29Jan2021. On Friday night (29Jan2021) the patient had weird hallucinations (I hallucinated?, I guess, I was awake and talking to my husband and he said I seemed awake? but that my bed was breaking in half and sinking into the floor, and I kept telling him I couldn't breathe but he said I was breathing normally). No treatment was provided for the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache. The outcome of the events weird hallucinations, sore arm, felt groggy, feverish, dizziness, chills, and headache was recovered on 31Jan2021. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The reported event hallucination was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 40 | 2021-03-02 | dizziness, discomfort |
Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in lef...
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Person received an injection of covid-19 vaccine. She sat down for 15 minutes. Tingling began in left arm, and person felt slight lightheadedness during observation. As person arose from chair, tingling in left arm began to increase and she asked healthcare worker if the tingling was normal. Worker stated "I think so". Friend then aided person as she began to fall to floor - person then placed on stretcher and became unconscious. EMTs times two were summoned to stretcher and they placed heart monitor and blood pressure cuff on person. Person was transferred to the Health Center - upon transfer, person became conscious and felt a heaviness on left side of body. Able to ambulate to BR and felt heaviness of left side of body. Bloodwork and CT scan were performed at FCHC and person reported as normal. It was decided by ER Doctor to transfer person to Hosp. Blood was drawn every so often and MRI was performed which person stated was all normal. Hosp. staff kept person overnight for observation. At approximately 2000 on 2/27/2021, person states that she felt back to normal with tingling of left arm subsided. Person was released early afternoon on Sunday, February 28th, 2021 after Doctor assessed person.
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| 40 | 2021-03-02 | dizziness, chills, migraine, fatigue |
chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue seve...
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chills; fatigue; migraine-like headaches; dizziness; nausea; migraine-like headache and fatigue severe enough to prevent normal activity; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), intramuscularly into the left arm on 28Jan2021 14:15 at a single dose for COVID-19 immunisation. Medical history included Polycystic ovarian syndrome (PCOS), depression, obesity and allergies to latex. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN), colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B12). The patient previously took tetracycline and experienced drug allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly into the right arm on 06Jan2021 03:15 PM at a single dose for COVID-19 immunisation. On 28Jan2021 20:00, patient experienced chills, fatigue, migraine-like headaches, dizziness, nausea and migraine-like headache and fatigue severe enough to prevent normal activity. The events were reported as non-serious. The patient did not receive any treatment for the events reported. Outcome of events was unknown.
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| 40 | 2021-03-03 | headache, fever |
2/25/2021- Admitted to hospital following severe high-grade fevers and headaches. Received her seco...
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2/25/2021- Admitted to hospital following severe high-grade fevers and headaches. Received her second dose of Pfizer COVID vaccine on 2/24/2021. Reported fevers as high as 105 at home. Admitted for IV hydration. Her fever persisted 24 hours after admission and headaches got worse. Patient started on Topamax with better control of headaches. Fever subsided 24 hours prior to discharge. Discharge home on 2/28/2021.
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| 40 | 2021-03-03 | chills, headache |
Chills; Body aches lasting a while; Joint pain everywhere; Head ache; This is a spontaneous report f...
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Chills; Body aches lasting a while; Joint pain everywhere; Head ache; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 16Feb2021 10:00 AM (age at vaccination was 40 years old, vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 26Jan2021 11:15 AM (vaccine location: Right arm) at single dose for COVID-19 immunisation. The patient's medical history included environmental allergies. The concomitant medications were reported none.Patient experienced chills, body aches lasting a while, joint pain everywhere and headache, all starting 14 hours and 30 mins after second dose on 17Feb2021.The outcome of events was recovering without treatment given. Information on the batch/Lot number has been requested.
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| 40 | 2021-03-07 | fatigue, headache |
Severe Fatigue; moderate nausea; severe headache; moderate muscle aches; mild diarrhea; This is a sp...
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Severe Fatigue; moderate nausea; severe headache; moderate muscle aches; mild diarrhea; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 03Feb2021 08:30 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension), depression, anxiety, RLS (Restless leg syndrome) and insomnia. Patient was not pregnant at the time of vaccination. Concomitant medication included lisinopril, trazodone, clozapine, pramipexole dihydrochloride (MIRAPEX), duloxetine hydrochloride (DULOXEE). The patient experienced severe fatigue, moderate nausea, mild diarrhea, severe headache, moderate muscle aches on 03Feb2021 10:00 with outcome of recovering. No treatment was received. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 40 | 2021-03-07 | headache |
Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pre...
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Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG, cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.
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| 40 | 2021-03-07 | fever, headache |
chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous...
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chest pain; loss of smell; fever; headaches; vomiting/nausea; vomiting/nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL9264), via an unspecified route of administration in the left arm on 30Jan2021 15:45 at a single dose for covid-19 immunization. Medical history included heart problems, migraine, anemia, asthma and unspecified allergies. The patient is not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 19:00, the patient experienced chest pain, loss of smell, fever, headaches, vomiting and nausea. The patient did not receive treatment for the events. The outcome of the events was not recovered.
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| 41 | 2020-12-31 | migraine, fatigue | Migraine x 4 days, nausea off and on x 3 days, itching arms and stomach x 2 hours, fatigue x 2days |
| 41 | 2020-12-31 | dizziness, chills |
Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followe...
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Tachycardia approximately 10mins after receiving vaccine, lasting several minutes, trembling followed, observed by hospital staff for approximately 45mins then taken to ER, discharged with 90mins. Body aches and chills for 1-2days. dizziness, nausea, lightheaded for 4-5 days to follow.
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| 41 | 2021-01-01 | somnolence, fatigue, chills, weakness, headache, fever |
Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and b...
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Day after vaccine experienced weakness, chills fatigue. Day four felt better went snowboarding and balance was off and fell several times. Body aches and pain continued. 12/29/2020 at 8 pm had fever of 100. 12/30 fever 103f chills, slept almost all day loss of appetite. 12/31 no fever in the morning but acting different than normal. In after non could not tell my husband child?s name went to the ED where I was admitted for altered mental status. Discharge today with altered mental status, unspecified. Wife still has headache but normal level of consciousness.
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| 41 | 2021-01-01 | fatigue |
Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five da...
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Random heart palpitations, tachycardia, mild chest tightness and occasional fatigue. Started five days post COVID Pfizer vaccine. Symptoms strikes at random times. No prior health issues.
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| 41 | 2021-01-02 | dizziness, throat irritation |
A few minutes after receiving her vaccine she reported dizziness and an itchy throat. She was observ...
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A few minutes after receiving her vaccine she reported dizziness and an itchy throat. She was observed for a few minutes and she stated that the dizziness was worse and that she felt flushed so she was given 0.3mg of IM epinephrine after which she began to immediately improve. She was also given 50mg PO diphenhydramine. She was observed for 60 minutes after the epinephrine dosing without any recurrence of her symptoms and she was discharged home with strict ER return precautions.
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| 41 | 2021-01-02 | headache, fatigue, shortness of breath, body temperature increased |
Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, ba...
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Headache, back pain 8 days after vaccine Shortness of breath, burning in chest, extreme fatigue, back pain, intermittent headache on days 9-13 after vaccine Temperature 100.0 on day 11 after vaccine COVID tests on days 9, 10, and 13 all negative
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| 41 | 2021-01-02 | fatigue, headache | Injection Site pain, Tiredness, And Headache using Tylenol. |
| 41 | 2021-01-02 | fever | Sore arm, diarrhea, low grade fever. No treatment. |
| 41 | 2021-01-03 | throat pain, influenza like illness, headache, shortness of breath, dizziness, cough, weakness |
12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, ...
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12/24/20- tenderness, swelling at injection site for 1 week; 12/30- flu like symptoms, dizzy, weak, headache, muscle pain, nausea, vomiting. Seen in ED on 1/3/21 with reports of all over body numbness, shortness of breath, cough, sore throat, unable to eat/drink. EMS reports patient went unresponsive at home, but was doing purposeful movements. Respiratory panel which included COVID, Flu, was resulted as not detected. CXR, CBC, Comprehensive metabolic panel, Urinalysis. Patient diagnosed with COVID-19; Cough; Shortness of Breath; Nausea and Vomiting; generalized body aches. Discharged home with prescription for Tessalon 10mg capsule - Take one every 8 hours and Zofran 4mg PRN every 8 hours and follow-up with primary And follow up with primary care MD.
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| 41 | 2021-01-03 | sweating |
Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and ...
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Approximately 5 minutes after her Pfizer vaccine, she felt like her throat was closing, flushed and became diaphoretic.
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| 41 | 2021-01-03 | fever, headache | Fever, Headache, Nausea, stomach cramping, vivid dreams |
| 41 | 2021-01-03 | throat swelling |
Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint ...
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Taste buds went numb, metallic taste, slight swelling of throat, itchiness all to upper body, joint pain, and pain at injection site. Lasting about 12 to 24hours. Antihistamines treated at home.
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| 41 | 2021-01-04 | fever | 4 days the vaccine I got a high fever, body aches and tonsils were severly swollen and couldnt work |
| 41 | 2021-01-04 | headache, chills, fatigue, malaise, fever | Chills, fever, general malaise, headache, fatigue, ?electric-like? shots all over head |
| 41 | 2021-01-04 | fatigue, chills, fever, headache |
Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Na...
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Fatigue; Myalgia; Injection site pain; Headache (frontal)/Worsening headache; Joint pain; Chills; Nausea; Vomiting; Worsening headache w/ photophobia; Subjective fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=59267-1000-1 /EH9899), via intramuscular on 28Dec2020 09:45 at single dose on her right arm for Covid-19 immunization. Medical history included psoriasis. The patient had no known allergies. Allergies to medications, food, or other products was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. It was reported that 6h after administration on 28Dec2020 16:00, the patient experienced fatigue, myalgia, injection site pain; 10h after (in addition to above) on 28Dec2020, the patient experienced headache (frontal), joint pain, chills and 12-28h after (in addition to above) in Dec2020, the patient experienced nausea, vomiting, worsening headache w/ photophobia, subjective fever, joint pain. The patient was not received any treatment for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 41 | 2021-01-04 | chills, fever, headache, weakness, fatigue |
I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on t...
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I received the 1st Covid vaccine on December 23rd, 2020, then I was exposed to the coronavirus on the 25th of December, then I started having symptoms at 3:30 am on December 29th I went and got tested that morning and the test was positive for covid-19. I then went home to quarantine. I have experienced fever, body aches, headaches, nausea, diarrhea, sinus pressure, chills, loss of taste and smell, weakness and fatigue. But have been able to continue to recover at home.
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| 41 | 2021-01-04 | skin warm |
Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash ...
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Immediately post-vaccine, face felt hot and tingling, lasted 45 minutes. Nausea 12/26-12/27. Rash on flexural of both arms, started with just left then progressed to both arms 12/27; achy feeling still; "gross feeling;" swollen lip with blister, started 1/3; left supraclavicular lymph node swollen
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| 41 | 2021-01-04 | fever, chills, malaise |
On the 21st in the morning I had alternating chills and subjective fever. I did not really have feve...
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On the 21st in the morning I had alternating chills and subjective fever. I did not really have fever and kept monitoring it during the day. The next day I kept with the subjective fever and the chills, went to the urgent care the next day and was tested for covid, flu and strep and it came positive for strep. I was prescribed an antibiotic and stayed home the next day since I still did not feel well.
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| 41 | 2021-01-04 | headache |
On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and...
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On the morning at 6:00 am of the de after the vaccination, patient woke up with pain in her body and headaches, with nausea and vomiting and a tight chest sensation. The doctor gave the order of solumedrol 80mg IV, TORADOL 30MG IV, TORADOL 30MG Im, Zofran 4 IV and .9 NSS 500mL IV. Afterwards the patient was discharged from the emergency room.
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| 41 | 2021-01-04 | throat swelling |
Patient reported having a swollen epiglottis on the date of the vaccination that did not resolve unt...
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Patient reported having a swollen epiglottis on the date of the vaccination that did not resolve until the following date.
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| 41 | 2021-01-04 | fatigue, chills, headache, throat pain |
Severe fatigue; chills; headache; sore throat; muscle aches; This is a spontaneous report from a con...
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Severe fatigue; chills; headache; sore throat; muscle aches; This is a spontaneous report from a contactable Other HCP (patient). A 41-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number not provided), via an unspecified route of administration in left arm on 23Dec2020 16:45 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced severe fatigue, chills, headache, sore throat, muscle aches on 24Dec2020. Case was non-serious. The patient underwent lab tests and procedures which included covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test date=26Dec2020, covid test result=Negative. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 41 | 2021-01-04 | fever |
after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to m...
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after the vaccination i had a high fever, body aches and and my tonsils were swollen causing me to miss work
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| 41 | 2021-01-04 | fever, chills |
very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other ...
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very sick; chills; fever; diarrhea; vomiting; This is a spontaneous report from a contactable other hcp. A 41-year-old female patient received bnt162b2 (lot number: EH9899), intramuscularly at arm left, first dose on 22Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got the vaccination yesterday (22Dec2020) and she has been very sick, chills, fever, diarrhea and vomiting. Didn't come to work today and she claims is getting worse. The event was unwitnessed by staff and the reported by client employer. Age at vaccination is 41 years old. Adverse event started on 23Dec2020. The event was reported as non-serious. The outcome of the events was unknown.
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| 41 | 2021-01-05 | skin warm |
I received the vaccine on 12/23/20, and the reaction popped up around new years. On 1/1/21 an area o...
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I received the vaccine on 12/23/20, and the reaction popped up around new years. On 1/1/21 an area on the skin became bright pink, medium hard to the touch and very warm compared to the skin around it. The area got larger and continued to spread over about two more days. Today is 1/6/21 and the skin is back to normal. I did not get a fever, chills, or any other symptom of note.
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| 41 | 2021-01-05 | fatigue | Injection site pain 1.5 days, extreme fatigue days 2&3 |
| 41 | 2021-01-05 | dizziness, sweating, headache |
approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1...
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approximately 40 minutes after receiving the vaccine she became flushed, sweaty, dizzy. Then about 1 hour after vaccine she had a headache. I took her blood pressure, it was 158/83, Pulse 92, Respirations 20, not shortness of breath or respiratory difficulty noted. She laid down and continued to feel the same way after 2 hours post vaccination. Her husband picked her up and she went home to rest for the day. She was given instructions on when to seek medical attention and to call me later today to let me know how she is feeling.
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| 41 | 2021-01-05 | fatigue |
got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a conta...
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got a very metallic taste in my mouth; sleep a lot; tired; This is a spontaneous report from a contactable healthcare professional. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140/ELO140), via an unspecified route of administration, at the left arm on 30Dec2020 06:30 at a single dose for COVID-19 immunization at a hospital. Medical history included seasonal allergies and doesn't take medications. On the same day of 30Dec2020, about an hour after vaccination, patient got a very metallic taste in mouth, which lasted for about 12-18 hours and did sleep a lot, which she expected, but woke up about 11 at night and still had it and it was gone. Patient knew she slept longer than she normally does, went to bed at 1PM and slept until 11PM, which is not usually normal. Was up for about an hour or two and then went back to bed until 8AM of 31Dec2020. Patient was concern was if it was some type of reaction that it would mean she was going to have a stronger reaction to the second one and stated it was irritating but not a huge deal. Patient also felt tired and expected it as she worked five 12-hour shifts in a row. Patient was not sure if the metallic taste was connected to the COVID-19 vaccine. No prior vaccinations within 4 weeks. Outcome of the events was unknown.
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| 41 | 2021-01-05 | headache |
hives; intense itching; headache; injection site is red and raised and itches intensely.; injection ...
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hives; intense itching; headache; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; injection site is red and raised and itches intensely.; This is a spontaneous report from a contactable nurse. A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular in the right arm, on 28Dec2020 at 08:45 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccine wad administered at a hospital. There were no other vaccinations given within 4 weeks and no other medications were taken within 2 weeks. Medical history included allergies to penicillin and shrimp. There were no concomitant medications. The patient previously took codeine and experienced an allergy. On 28Dec2020, the patient experienced hives, intense itching coupled with a headache, injection site is red, raised and itched intensely. The clinical course was as follows: Within 3 hours of receiving the vaccine she developed hives and intense itching coupled with a headache. She reported that the hives come and go and have covered pretty much her entire body in waves of occurrences. The injection site was red and raised and itched intensely. It has been 48 hours since and still there are hives. The patient was not hospitalized for the events. Treatment included diphenhydramine (BENADRYL) however she stated that it does not seem to affect the hives or address the itching. The clinical outcome of the events: hives, intense itching coupled with a headache, injection site is red, raised and itched intensely, was not recovered. The patient was not tested for COVID-19 after receiving the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 41 | 2021-01-05 | shortness of breath, fatigue, chills |
slight shortness of breath all lasting over 1 week; Extreme chills; extreme fatigue and tiredness; w...
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slight shortness of breath all lasting over 1 week; Extreme chills; extreme fatigue and tiredness; whole body muscle aches; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (batch/lot number and expiration date not provided, not available/provided to reporter at the time of report completion), via an unspecified route of administration, at arm left, first dose on 23Dec2020 09:15, at single dose, for COVID-19 immunization. No relevant medical history. No known allergies to medications, food, or other products. There were no concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced extreme chills, extreme fatigue and tiredness, whole body muscle aches, slight shortness of breath all lasting over 1 week, all from 23Dec2020 16:15. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (test type: Nasal Swab, test name: rapid test): negative, on both 27Dec2020 and 30Dec2020. The outcome of the events was not recovered. Information about Batch/Lot number has been requested.
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| 41 | 2021-01-05 | throat pain, headache, fever |
vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated...
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vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site was pink, warm, indurated (size of tennis ball); vaccine site rt deltoid began to itch and had red blotches; vaccine site rt deltoid began to itch and had red blotches; Headache; low grade fever; sore throat; This is a spontaneous report from contactable healthcare professional . A 41-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at a right deltoid on 16Dec2020 11:00 at a single dose for COVID-19 immunization, at a hospital. Medical history included seasonal allergy. No known allergies to medication, food or other products. The patient's concomitant medications were not reported. On 19Dec2020 16:00, day 3 post vaccine, the patient experienced headache, low grade fever, and sore throat. On 27Dec2020, day 11, patient experienced vaccine site right (rt) deltoid began to itch and had red blotches. On 28Dec2020, day 12, the patient experienced vaccine site was pink, warm, indurated (size of tennis ball). Treated with paracetamol (TYLENOL), topical/oral diphenhydramine (BENADRYL) and topical 1% hydrocortisone. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any medications within 2 weeks of vaccination. The patient was tested for COVID-19 with via rapid test and PCR with nasal swab, both negative on 22Dec2020. The patient recovered from the events, headache, low grade fever, and sore throat on 24Dec2020, day 8 post vaccine and the rest of the events on 30Dec2020, day 14. Information about lot/batch number has been requested.
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| 41 | 2021-01-06 | dizziness, fatigue, fever |
24 hours post-vax woke with severe dizziness severe, fatigue, and muscle aches. Fever from 12/21 -12...
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24 hours post-vax woke with severe dizziness severe, fatigue, and muscle aches. Fever from 12/21 -12/22 21, peak temp 102.9. However, I am breastfeeding and suspect I may have had mastitus. Took measures to hydrate and express milk to ensure that was treated. Spoke to NP in the ER unit, did not take prescribed meds since fever broke.
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| 41 | 2021-01-06 | migraine, fatigue |
24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site...
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24-48 hrs site red, swelling, pain, sore arm, severe fatigue, hive to arm and neck of injection site, 48-96 nausea and diarrhea X24hrs, severe migraine, improving fatigue and hives. treated with rest, advil , and Benadryl
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| 41 | 2021-01-06 | fever, chills |
Approximately 36 hours post 2nd dose of vaccine I experienced intermittent fever and severe chills ...
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Approximately 36 hours post 2nd dose of vaccine I experienced intermittent fever and severe chills (rigors) over a 6 hour period not relieved by ibuprofen; tmax 103. All symptoms resolved by the 48 hour post vaccine mark
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| 41 | 2021-01-06 | cough, shortness of breath |
Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination....
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Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.
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| 41 | 2021-01-06 | dizziness, skin warm |
Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narra...
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Dizziness light headed, itchiness on head, ears felt hot and red, elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.
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| 41 | 2021-01-06 | chills, fever, headache | Fever 104, chills, nauseas, swollen lymph's armpits, severe headaches |
| 41 | 2021-01-06 | fever, chills |
Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vo...
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Fever, chills, body aches, ( muscle and joint pain), pain at injection site, nausea, 1 episode of vomiting, abdominal pain
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| 41 | 2021-01-06 | headache, fever | Headache, Myalgia & Fever Narrative: |
| 41 | 2021-01-06 | fatigue, fever | Hives, fatigue, and fever |
| 41 | 2021-01-06 | respiratory tract congestion, throat swelling, headache, throat irritation |
Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then i...
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Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction
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| 41 | 2021-01-06 | dizziness | Light headedness, skin flushing, syncope |
| 41 | 2021-01-06 | nasal congestion, fatigue |
Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine unt...
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Pfizer vaccine administered to associate 12/21 at 9:46am. Felt healthy and well prior. Felt fine until about 3pm. Just typical arm pain. Moderate/Severe Fatigue set in around 3-6pm. Needed to nap from 4-5pm (extremely unsusual). Felt fine the next day. Moderate congestion in ears starting around the same time (6 hours after) and is persisting 30 hrs later. Feel like my ears will not pop and trying to yawn a lot. Also felt pretty bad sinus congestion starting at 7pm 12/21 (10 hrs after vaccine). Could not breathe through nostrils. Treated with sinus rinse and sudafed.
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| 41 | 2021-01-06 | fatigue |
Sedation, Myalgia, Immediate post vaccine, employee reported feeling "funny" almost like she was int...
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Sedation, Myalgia, Immediate post vaccine, employee reported feeling "funny" almost like she was intoxicated. this passed after a few hours. Narrative: Employee missed greater than >1 days of work second to symptoms (aches and extreme fatigue)
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| 41 | 2021-01-06 | sweating | Vomiting, diaphoresis |
| 41 | 2021-01-06 | headache, somnolence, fatigue |
fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - on...
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fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - onset about 1230, lasted the rest of the day and intermittently the next few days injection site pain x 3 days - moderate, pain would wake me in my sleep if I rolled onto affected side
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| 41 | 2021-01-06 | migraine, fatigue |
site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and...
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site red, swelling, pain, hives, nausea, diarrhea, severe fatigue, severe migraine, hives to arm and neck side of injection 24-96hrs. Treated with rest, advil, Benadryl
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| 41 | 2021-01-06 | sweating |
tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. ...
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tingling in right hand progressing up arm, patient felt like heart was racing, felt hot and sweaty. Heart rate was normal and skin felt normal to touch per medical staff. Patient denied shortness of breath, itching, no rash noted. Medical Authority, assessed patient, ordered Benadryl 25mg po. Patient intially denied need to take Benadryl, advised patient will need to be observed in emergency department. Patient did not want to go to the ED and instead took Benadryl 25mg po. Patient was monitored for 1 hour and 10 minutes, 55 minutes after Benadryl given. Patient felt ready to leave at this time.
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| 41 | 2021-01-06 | fever, headache, chills |
woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F...
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woke up 1/6/21 @ 4am with chills and nausea. Took a Zofran. Awoke again at 5am with fever of 100.6 F. Fever did not respond to 600 mg ibuprofen. Later that day developed headache and body aches. Pain at injection site present as well.
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| 41 | 2021-01-07 | fatigue |
Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General ache...
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Abdominal cramping; Diarrhea on 30Dec pm over night; Injection site soreness; Arm pain; General aches; fatigue; This is a spontaneous report from a contactable healthcare profess. A 41-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), intramuscular on 29Dec2020 14:45 at a single dose for Covid-19 immunization. Medical history included colitis ulcerative. Concomitant medications included infliximab (REMICADE), calcium D, sertraline hydrochloride (ZOLOFT), and probiotics. The patient previously took ampicillin sodium (OMNIPEN) and BACTRIM DS and experienced allergies. On 30Dec2020, at 04:45 PM, the patient experienced abdominal cramping and diarrhea on pm overnight, injection site soreness/arm pain, general aches and fatigue. The patient did not receive any treatment for the events. The patient has no Covid prior to vaccination and did not take Covid test post vaccination. The outcome of the events was recovering.
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| 41 | 2021-01-07 | malaise |
About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling li...
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About 5minutes after vaccination had syncope episode, in and out for about 5-10, malaise, feeling like ? under anesthesia since then.
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| 41 | 2021-01-07 | headache, chills, body temperature increased | Achy body, headache, ear ringing, chills and a temperature. |
| 41 | 2021-01-07 | fatigue | Diarrhea, nausea, and fatigue |
| 41 | 2021-01-07 | dizziness | Dizziness, unable to walk but she is okay now |
| 41 | 2021-01-07 | fever, fatigue, weakness, chills, shortness of breath |
Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, b...
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Extremely Sore arm that evening, Into shoulder joint, down arm to elbow. The following day chills, body aches and 102.0 fever. Fever lasted until day 3. Day 3-5 weakness, SOB with any exertion, fatigue. Had to call off work on day 3.
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| 41 | 2021-01-07 | fever, chills |
Fever; Chills; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare ...
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Fever; Chills; Vomiting; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 02Jan2021 08:00 to 02Jan2021 08:00 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jan2021 03:30, the patient experienced fever, chills, vomiting, and diarrhea. The patient underwent lab tests and procedures which included Sars-cov-2 (Nasal Swab) test on Jan2021: with negative result post vaccination. The outcome of the events was recovering. No treatment was given for the events. No follow-up attempts are possible, information about batch number cannot be obtained.
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| 41 | 2021-01-07 | headache | Headache after 1st dose, reported receiving 2nd dose on 01/08/2021 |
| 41 | 2021-01-07 | headache | Headache and vomiting nausea and gastro problems |
| 41 | 2021-01-07 | headache, fatigue | Headache, Myalgia, extreme fatigue, joint pain unable to complete household work. Narrative: |
| 41 | 2021-01-07 | shortness of breath, lethargy |
Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy ...
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Lethargy onset approximately 4 hours after dose. SOB while supine. 1 day later continued lethargy and orthopnea, plus imms site soreness.
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| 41 | 2021-01-07 | chills, dizziness |
Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained o...
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Patient felt chilled and light headed. She was brought to a room and laid in a bed. She complained of nausea and dizziness with standing. Vital signs were monitored. Oxygen saturation remained at 100%. BP 120s-130s/80s. She did not complain of any shortness of breath or wheezing. She did not complain of any itching. No skin or mucocutaneous findings. She was monitored for 4 hours and given 1L of IV fluids, zofran and ativan. She returned to baseline over the monitoring period.
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| 41 | 2021-01-07 | chills, dizziness |
Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and ...
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Patient reported feeling "woozy", got the chills and HR became elevated. She appeared shaky. HR and BP elevated. She was given water and juice. Provider walked in and spoke with her regarding an adrenaline release causing some of her symptoms. Over the 5 minutes, patient became less shaky, BP and HR dropping. She stated she felt much better. She discharged with instructions to follow up with her PCP if needed. Provider felt she could discharge home. Several days later, patient reported continued "woozy" feeling, chills, and elevated HR. She was seen in the ED at that time, with no remarkable findings.
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| 41 | 2021-01-07 | chills, cold sweat, discomfort, fatigue |
Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, local...
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Pfizer COVID-19 vaccine 1 (12/16/20) and 2 (1/5/21): Body aches, chills, fatigue, cold sweats, localized discomfort
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| 41 | 2021-01-07 | fatigue |
Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontane...
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Random heart palpitations; tachycardia; mild chest tightness; occasional fatigue; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), via an unspecified route of administration on 23Dec2020 07:00 at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies from an unknown date. The patient previously took oxycontin and experienced allergies. Concomitant medications included women multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced random heart palpitations, tachycardia, mild chest tightness and occasional fatigue five days after receiving the vaccine on 28Dec2020 12:00. No known underlying health issues before the vaccine. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events resulted in Emergency room/department or urgent care.
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| 41 | 2021-01-07 | body temperature increased | Recipient reported a temp of 101.2 |
| 41 | 2021-01-07 | chills, fatigue |
Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and la...
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Right forearm pain, slight swelling, and neuropathy (burning pain) began 12/22 in the evening and lasted until Saturday 12/26 - responded and improved with acetaminophen and ibuprofen; slight fatigue x 2 day and some slight chills
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| 41 | 2021-01-07 | fatigue, sweating, headache, weakness |
Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatig...
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Sore arm Headache- all over pain like a sinus infection body sweats nausea weakness dry heaves fatigue
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| 41 | 2021-01-07 | malaise, chills |
Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? kno...
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Symptoms - ? EE reports pain at injection immediately after injection. EE reports ?nickel size? knot on her arm almost immediately after, worsening to 2x2 size this morning (1/8). 1/7 morning: body aches, chills, feelings of unwell. Unsure of fever as she has been rotating Tylenol and motrin. EE reports she saw RN at campus this morning for inspection of injection site. Home remedies? - ice pack to injection site and rotating Tylenol (last dose 20:30 1/7) and motrin (last dose 23:00 1/8) Any improvement? ? mild improvement Recommendation? EE encouraged to continue to ice injection site and to rotate Tylenol and motrin. EE encouraged to continue to monitor symptoms and to call vaccine support with further questions and/or concerns. EE denied history of COVID-19 exposure without proper PPE and denied recent travel. EE educated to manange per Illness in the Workplace Policy. EE encouraged to fill out V-safe. EE verbalized back understanding and denied further questions at this time.
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| 41 | 2021-01-07 | fever | body aches, fever, nausea, sore arm, up all night |
| 41 | 2021-01-07 | fatigue | chest tightness arm pain nausea diarrhea body aches fatigue lost work two days |
| 41 | 2021-01-07 | dizziness, fever, throat pain, chills, dehydration, headache, fatigue |
chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest...
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chills & shivering; high fevers (peaked 102.7); tachycardia (noted to be 148 standing, 120's at rest in supine); headaches; nasal/sinus congestion; fatigue; dehydration; dizziness; sore throat; GI issues; Sore arm; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old female patient received first dose of BNT162B2 (COVID-19 vaccine, lot number EK5730), via an unspecified route of administration on 28Dec2020 11:00 at single dose on left arm for COVID-19 immunization. Medical history included COVID-19, hyperthyroidism, Grave's Disease, benign PVCs (Premature ventricular contractions), PACs (Premature atrial contraction) from an unknown date and unknown if ongoing, allergies, Penicillin allergy, allergy to pineapple, kiwi and pomegranate, and NUMEROUS environmental allergies (dust, weed, pollen, trees, animals. it's a long list) from an unknown date and ongoing. Concomitant medication included cetirizine, fluticasone, propylthiouracil. The patient previously took clindamycin and methimazole and experienced drug allergy. On 28Dec2020 the patient experienced sore arm (like flu vaccine) the day of the vaccination. Early the following morning (on 29Dec2020 04:00) developed chills & shivering. Progressed to high fevers (peaked 102.7), tachycardia (noted to be 148 standing, 120's at rest in supine), headaches, nasal/sinus congestion, fatigue, associated dehydration & dizziness. Subsequent sore throat & GI issues. Symptoms lasted 4-5 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included covid test type post vaccination (nasal swab): negative on 02Jan2021, body temperature: high fevers (peaked 102.7) on 29Dec2020, tachycardia: noted to be 148 standing, 120's at rest in supine on 29Dec2020. No treatment received for the adverse events. The outcome of the events was resolved on an unspecified date.
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| 41 | 2021-01-07 | malaise, head discomfort, headache |
felt a strange feeling in the right-side of the neck that ended around the base of the head/Since th...
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felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; felt a strange feeling in the right-side of the neck that ended around the base of the head/Since then, it just doesn't feel right; nausea; Since then, it just doesn't feel right; since the vaccine have stiffness when turning my neck; a few headaches; This is a spontaneous report from a contactable nurse (patient) A 41-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, intramuscularly on 21-DEC-2020 09:30 (at the age of 41-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Soon after receiving the vaccine in my right arm, she felt a strange feeling in the right-side of the neck that ended around the base of the head and nausea on 21Dec2020. Since then, it just doesn't feel right and still have the nausea and since the vaccine have stiffness when turning my neck on 21Dec2020. "I can't really describe it much more than it feels strange and hasn't gotten better". The patient had a few headaches on 21Dec2020 but am unsure if that's related to the vaccine as they didn't occur immediately after receiving it. The events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events felt a strange feeling in the right-side of the neck that ended around the base of the head, nausea, Since then, it just doesn't feel right, since the vaccine have stiffness when turning my neck and a few headaches was recovering. Since the vaccination, the patient has not been tested for COVID-19.
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| 41 | 2021-01-07 | fatigue, dizziness, throat pain, nasopharyngitis, sweating, headache | headache, sore throat, light headed, nauseous, fatigue, cold and sweaty-no fever |
| 41 | 2021-01-08 | headache, fatigue, chills |
2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expecte...
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2nd Pfizer vaccine was given on Thursday Jan. 7th around 1240pm. That evening I experienced expected muscle aches, chills, headache, fatigue. The next evening, Jan 8th I experienced chest pain which felt like heartburn or gastritis (which I do not typically have) in addition to the muscle aches, chills and headache returning. The morning of Jan 9th I woke up with a swollen face in addition to ongoing body aches, fatigue and headache and took 50mg of Benadryl and went to urgent care for evaluation.
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| 41 | 2021-01-08 | dizziness, shortness of breath |
About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lig...
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About 5-10 minutes after receiving the vaccine experienced spontaneously elevated heart rate and lightheartedness while sitting in a chair in the observation room. After a few minutes pulse returned to normal and lightheartedness abated. At no point did I experience shortness of breath, no facial or airway edema. Just a brief period of tachycardia and feeling of impending doom.
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| 41 | 2021-01-08 | fever, fatigue, chills, headache |
Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-...
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Arm soreness (start: ~8 hrs post-vaccination, duration: 4 days) Fever & Chills (start: ~14 hrs post-vac, duration: 1.5 days) Fatigue (start: ~24 hrs post-vac, duration: 1 day) Joint & Muscle pain (start : ~24 hrs post-vac, duration: 1 day) Headache (start ~24 hrs post-vac, duration: 8-12 hrs) Armpit/upper breast pain (start ~48 hrs post-vac, duration: 2 days)
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| 41 | 2021-01-08 | dizziness, malaise, headache |
Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue...
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Depression, Dizziness, Headache, Myalgia, Diarrhea & NauseaVomiting Narrative: On 12/28/20 continue with headache, abdominal malaise, Dizziness. But referred is improving.
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| 41 | 2021-01-08 | fever, weakness, chills | Fever, chills, weakness, myalgias, near syncope, increased heart rate. |
| 41 | 2021-01-08 | chills |
Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay ...
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Had chill soon after the injection and about 5 minutes later had slight nausea, I was told to stay 15 more minutes for observation . About 30 minutes or so after the injection, I had sever nausea. The person at the observation sent me to ER for close monitoring . After couple hours of sever nausea My body started itchy for few hours without hives. In ER, prescribed zofran but didn?t take it. Stayed ER for few hours and I was released
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| 41 | 2021-01-08 | chills, fatigue | Nausea, chills, fatigue for 12 hours. Treated with Advil at home, resolved. |
| 41 | 2021-01-08 | nerve pain | Nerve pain L face/head 9/10 pain gradual improvement over 7 days |
| 41 | 2021-01-08 | fatigue, headache |
Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and pro...
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Oral dysaesthesia - scratchy throat morning after vaccination, then developed tongue burning and progresses to full mouth Fatigue, headache, body aches
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| 41 | 2021-01-08 | fever, headache, chills |
Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. To...
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Pfizer-BioNTech COVID-19 Vaccine- Woke up at 01:30 with extreme chills, body aches & fever 101.8. Took 2 Tylenol & woke up at 0400 with a fever of 102.6, chills, body aches & horrible headache. I also had no appetite, nausea & developed fever blisters on lower lip. Lasted until Tuesday 12/29 & ended up going to the ER because the headache was so horrible & would not go away.
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| 41 | 2021-01-08 | lethargy, dizziness |
employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of h...
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employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.
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| 41 | 2021-01-09 | fatigue, chills, cold sweat, fever | 1/9 0230 bodyaches, chills, fatigue, fever, tightness in chest 1/10 2139-feels clammy and bodyaches |
| 41 | 2021-01-09 | headache, chills, fatigue | Chills, headache, body aches, fatigue |
| 41 | 2021-01-09 | fatigue, fever | Fatigue. Severe axillary lad and supraclavicular lad. Myalgia. Fever |
| 41 | 2021-01-09 | chills, fever | Fever(low grade) , body aches, headaches, dirrhea, chills |
| 41 | 2021-01-09 | dizziness, headache |
HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55P...
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HEADACHE, LIGHTHEADED, BODYACHES, LITTLE NUMBNESS IN THE RIGHT CHEEK B/P 152/93 PULSE 96 @ 12:55PM PATIENT STATED SHE IS NOT GETTING WORSE @1:26PM PATIENT REFUSED EMERGENCY SERVICES AND/ OR CALLING MD
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| 41 | 2021-01-09 | dizziness |
I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I ...
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I had an adverse reaction 10 minutes after my injection. My heart rate went up as well as my BP, I felt hot and faint. Ems was on site and monitored until ambulance arrived. I was given Benadryl immediately.
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| 41 | 2021-01-09 | headache, chills, malaise, respiratory tract congestion, runny nose |
I was exposed to a covid positive person on 12/15/2020, 13 days before receiving my first dose on 12...
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I was exposed to a covid positive person on 12/15/2020, 13 days before receiving my first dose on 12/29/2020. I started feeling unwell on 12/31/20. On 1/1/2021, chills and body aches started for two days. I continue to have daily headaches and off and on chills and body aches. Other symptoms are congestion, running nose and diarrhea.
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| 41 | 2021-01-09 | fever, headache, fatigue |
Nausea, body aches, fever (100.1 max), headache, extreme fatigue. Fever one day, body aches, extreme...
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Nausea, body aches, fever (100.1 max), headache, extreme fatigue. Fever one day, body aches, extreme fatigue and headaches 2 days, normal fatigue and nausea about a week.
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| 41 | 2021-01-09 | headache, fatigue, fever |
Nausea, headache, fatigue, muscle aches, fever (100.3) fever day one and 3. Headache muscle ache ...
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Nausea, headache, fatigue, muscle aches, fever (100.3) fever day one and 3. Headache muscle ache nausea and fatigue everyday so far.
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| 41 | 2021-01-09 | chills, fatigue, fever | Severe muscle aches (all throughout body), chills, feverish, fatigue |
| 41 | 2021-01-09 | shortness of breath |
Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days aft...
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Wheezy, chest tightness, SOB within 45 minutes of vaccination. Took antihistamines daily x3 days after vaccine
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| 41 | 2021-01-09 | dizziness |
Within one minute of receiving the vaccine patient became very shaky and heated. Felt like she was g...
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Within one minute of receiving the vaccine patient became very shaky and heated. Felt like she was going to pass out. I gave the patient one 25mg Benadryl at 11:18 and orange juice. Within a few minutes of taking the Benadryl and also being able to take in air outside the mask her symptoms improved and felt herself.
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| 41 | 2021-01-09 | fever |
fever of 101F that began approximately 12 hours after vaccine administration and lasted less than 24...
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fever of 101F that began approximately 12 hours after vaccine administration and lasted less than 24 hours.
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| 41 | 2021-01-10 | fever, headache, chills |
12 hours after the inj had chills, myalgia, headache low grade fever and nausea. Developed pain in e...
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12 hours after the inj had chills, myalgia, headache low grade fever and nausea. Developed pain in external genitalia, Had ulcerations with bruising on 1/9/21. (Lesions)
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| 41 | 2021-01-10 | dizziness | Develops dizziness on 1/7/2021, intermittent that lasted till 1/8/2021. |
| 41 | 2021-01-10 | fatigue, fever, headache | HA, fatigue, low grade fever, body aches treatment include Tylenol with improvement. |
| 41 | 2021-01-10 | fatigue, fever, chills |
I started with low-grade fever and chills about 12h after receiving my second dose of the Pfizer cov...
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I started with low-grade fever and chills about 12h after receiving my second dose of the Pfizer covid19 vaccine. Chills lasted for about 15min, they were of moderate intensity. Then I had low grade fever, body ache and tiredness for the entire next day (01/08/2021); it was bad enough to interfere with my regular activities of work and childcare. I ended up taking the day off. On the following day (01/09/2021), I woke up fully restored.
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| 41 | 2021-01-10 | fever, malaise, nasopharyngitis, headache |
Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following mor...
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Jan 8, 2021 around 8pm, I felt cold and unwell but no fever. My left arm was sore. The following morning, I had fever of 101.4F. I also had bad headache and muscle aches. I tool 500 mg of Tylenol, had lots of fluids and rest for 2 days. Sunday when I woke up I felt better and I feel well now.
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| 41 | 2021-01-10 | fever, fatigue, weakness |
Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and bo...
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Left arm pain at 11pm on 1/8/21, fever 102.0 body aches head ache began at 5am 1/9/21 , fever and body aches , tachycardia continued throughout 1/9/21, 1/10/21 tired weakness but no fever 1/11/21 all resolved except for slight left arm pain
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| 41 | 2021-01-10 | fatigue, shortness of breath, headache |
On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/2...
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On 1/6/20 one hour after vaccine, had a headache and mild shortness of breath and fatigue. On 1/7/20, the shortness of breath worsened, developed muscle aches, headache and fatigue continues, blood pressure became elevated. Was seen in the Emergency Room. On 1/11/20 was evaluated by Primary Care Provider. Blood pressure medications were increased and taken off work until stable.
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| 41 | 2021-01-10 | fatigue, throat pain, chills, dizziness, fever, headache |
Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-...
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Pfizer BioNTech Covid 19 vaccine EUA- Symptoms started at 2100 on 1/5/21 and ended 0800 01/07/2021-- fever 101.3, body aches, chills, extreme fatigue, sore throat, dizziness, sinus congestion , abdominal pain, tender lymph nodes in neck HA and pain at injection site.
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| 41 | 2021-01-10 | cough, fever, throat pain, headache, fatigue | Sever headache, fever, dry cough, sore throat, fatigue, muscle pain |
| 41 | 2021-01-10 | malaise, headache | Severe headache with photosensitivity, soreness at injection site, malaise |
| 41 | 2021-01-10 | dizziness |
Staff of facility experiences light headiness and extreme dizziness. Patient explained that her leg...
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Staff of facility experiences light headiness and extreme dizziness. Patient explained that her legs felt heavy and were very tingly. Monitored BP and remained within normal rages. Gave Benadryl at 11:35am. Patient also drank water and ate some food. After sitting for 45 minutes patient felt better
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| 41 | 2021-01-10 | dizziness | c/o palpitations, dizziness |
| 41 | 2021-01-10 | fatigue |
cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and ...
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cheeks were swollen; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; when I brushed my teeth, i felt a severe burning sensation inside my mouth and the inside of my mouth started to swell; so tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the left arm on 26Dec2020 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included allergic reaction with known allergies to sulfa, seafood. Concomitant medications included acetylsalicylic acid/caffeine/salicylamide (EXCEDRIN) and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I just finished a night shift from work and got home on 02Jan2021 around 07:45 when I brushed my teeth, I felt a severe burning sensation inside my mouth and the inside of my mouth started to swell. I didn't think much of it since I was so tired but then woke to get ready to work then my mouth and cheeks were swollen (02Jan2021 at 16:00) and barely could open my mouth." No treatment was provided for the events burning mouth, mouth swelling, cheeks were swollen and so tired. The outcome of the events burning mouth, mouth swelling, cheeks were swollen and so tired was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 41 | 2021-01-10 | chills, headache, fever | fever chills HA body aches |
| 41 | 2021-01-10 | malaise, chills | malaise, chills |
| 41 | 2021-01-10 | sweating |
palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to thro...
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palms of hands started to swell and itch. diaphoretic, then neck started to itch. extended to throat leading to difficulty swallowing
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| 41 | 2021-01-11 | cough |
2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little wo...
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2 weeks of cough superimposed a chronic cough with mild wheeze & chest tightness. Seemed a little worse after shot. Patient noted walk in cold air on way to vaccine apt seemed to trigger it.
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| 41 | 2021-01-11 | sweating, runny nose, headache, fatigue, chills, nasal congestion, fever |
41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes a...
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41-year-old woman who presents to the office on 1/12/2021 for fatigue, congestion of nose and eyes and lack of taste and smell. Patient's initial symptoms started on 1/8/2021 with some rhinorrhea. The following day on 1/9/2021 she went to the gym feeling fine. That evening she felt fatigued and attributed to her workout earlier in the day. The next day she developed a severe headache with fever, sweats, chills and body aches. Yesterday on 1/10/2021 she developed nasal congestion and eye symptoms. Patient presented to the office today on 1/12/2021 for testing and was Covid positive. Patient had a positive Covid test on 11/11/2020 with mild symptoms of headache, fatigue without congestion or loss of taste and smell. At that time the duration of her symptoms was 3 days. She had the first Pfizer Covid vaccine on 12/18/2020 with minimal muscle soreness. She had the second Pfizer Covid vaccine on 1/8/2021. Patient works in administration of a medical facility. She has minimal contact with clinical staff and patients. No one in her office has had Covid symptoms or infection. Patient's other contacts are at home and the gym. She does attend a gym class with 10 other participants. She does not know whether anyone in the gym class has had symptoms.
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| 41 | 2021-01-11 | headache, fever | Body aches, fever 103, headaches, abdominal pain for 28 hours |
| 41 | 2021-01-11 | shortness of breath, headache, fatigue, chills |
Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but...
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Chest pain and SOB with onset about 40 min after vaccine and slowly getting worse (never severe, but definitely uncomfortable) over next few hours. Finally tried 2 puffs of my son?s albuterol about 5 hrs post vaccine and felt relief within 20?30 minutes. The next day I had more expected side effects: headache, myalgias, chills and fatigue. No recurrence of the chest symptoms.
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| 41 | 2021-01-11 | fever, chills, fatigue | Developed fever, chills, aches and fatigue within 24hour of vaccine administration |
| 41 | 2021-01-11 | dizziness, fatigue, headache |
Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue...
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Dose 1 -Headache for 4 days, and fatigue Given 12/21/2020 @ 0900am Dose 2-headache, shaky, fatigue, light headed, blurred vision, high blood pressure and mental fogginess Given 01/11/2021 @ 1430pm
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| 41 | 2021-01-11 | headache, fever, malaise, fatigue, chills |
Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot fla...
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Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; Experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days; This is a spontaneous report from a contactable Nurse (patient). This 41-Year-old female Nurse (no pregnant) received first dose of BNT162B2 (Lot number: EJ1685) on 04Jan2021 09:00 AM on Left arm for COVID-19 immunization. Medical history was migraines. Concomitant drug was not reported. Known allergies: amoxicillin, cefaclor (CECLOR), ciprofloxacin hydrochloride (CIPRO), erythromycin, Zithromax. Patient experienced extreme nausea, moderate diarrhea, moderate fatigue, mild headache, fever of 38, hot flashes/chills, body aches, general malaise and very mild injection site soreness in the hours and days following injection on 05Jan2021 00:30 (reported as 04Jan2021 12:30 PM) with outcome was recovering. Treatment: Medication for nausea (zofran). Covid test post vaccination on 06Jan2021, result unknown. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Follow-up attempt are not possible. No expected further information.
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| 41 | 2021-01-11 | dizziness | FLUSHING, LIGHT HEADED, AND TINGLING |
| 41 | 2021-01-11 | headache |
Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; h...
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Five min after shot. Tingling in whole arm - mostly above the elbow (left arm). Felt palpitations; heart was racing. Felt warm - no sweating but getting hot. At the site - the nurse called the EMT's - they Gave me 50 mg of benydryl syrup - in 20 min. checked heartrate first in 90's and then they rechecked and it was in 80's. Blood Pressure - 130/90. Half an hour later I was home - bad headache of two days. Left arm was very sore for those two days, not swollen, though. By third day those resolved.
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| 41 | 2021-01-11 | dizziness, chills |
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with rednes...
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Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became back of hands and face became flushed red again and took more benydrol and next day face and cheeks was still blouchey and red. Hot flashes and chills .
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| 41 | 2021-01-11 | headache |
Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and dif...
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Onset of "kaleidoscope vision" at 10:50 AM, followed by headache, nausea, light sensitivity, and difficulty focusing eyes (symptoms of ocular migraine). Severe symptoms lasted 5 hours, mild symptoms lasted through the evening and next day (today I still have a mild headache and nausea). I have previously had 1 migraine (~5 yrs prior) in the setting of repeated fume exposure during a renovation at my workplace, no other history of migraine.
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| 41 | 2021-01-11 | shortness of breath |
Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her th...
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Patient is mildly tachycardic, flushed, complaining of shortness of breath and sensation that her throat is closing. Patient has some inspiratory stridor. She was moved to a room and given intramuscular epinephrine, diphenhydramine, famotidine, and methylprednisolone.
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| 41 | 2021-01-11 | dizziness |
Patient reported to observation area for monitoring post-Injection. Â No prior history of adverse ...
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Patient reported to observation area for monitoring post-Injection.  No prior history of adverse reactions or allergic reactions to any medications, vaccines or injections.  She reported to myself (Dr.) at 4:05 pm with feeling of lightheadedness, flushing and racing heart beat.  Initial Exam: Vitals: 143/87, HR 114, O2 sat 100% CV: Tachycardia, regular. No m/r/g Respiratory: CTAB. No w/r/r Skin: Facial flushing but otherwise no rash or hives. Oral: no tongue or lip swelling  Patient placed in supine position on stretcher, received water hard candy.  Repeat vitals @ 4:30: 151/84, HR 107, Sp O2 100% Exam: Unchanged.  After an additional 15 minutes of rest patient was able to ambulate without assistance and ultimately return to home via uber. Boyfriend was alerted.
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| 41 | 2021-01-11 | fatigue | Recipient reported heartburn sensation, and fatigue. |
| 41 | 2021-01-11 | chills, fatigue | Some fatigue and chills |
| 41 | 2021-01-11 | cough, throat irritation |
Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Be...
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Started coughing at 8:20 thought just a dry throat. By 8:25 throat became itchy. Assessed by EMT. Benadryl 25 mg po given at 8:40 and manager called to take her from work due to Benadryl
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| 41 | 2021-01-11 | weakness, headache |
Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial nu...
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Upon resting in waiting area after administration of vaccine, I began to notice left-sided facial numbness, extending to left shoulder / pectoris area. The symptom was mild throughout, did not get any worse. However, the symptoms have not subsided and I have continued to experience mild facial numbness (left). Yesterday, 01/07/21, I had an intermittent episode of tingling and left sided weakness which lasted a several hours in the afternoon. In addition to facial numbness, I also experienced left upper arm soreness, especially at site of injection. I also had a mild headache which lasted a three days.
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| 41 | 2021-01-11 | throat irritation |
a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin;...
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a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration at Left arm on 04Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included irritable bowel syndrome. Concomitant medication included amoxicillin, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), colecalciferol (VITAMIN D), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). No other vaccine in four weeks. The patient had allergies to ciprofloxacin(CIPRO). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.Since the patient got the vaccine, she had been experiencing a huge amount of gas and bloating as well acid and burning sensation in her throat and neck and chin on 04Jan2021 15:00. The outcome of the events was not recovered. No treatment received for the events. Information about Lot/Batch number is requested.
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| 41 | 2021-01-12 | sweating, headache, fever | 103 Fever 24 hrs chills 48 hrs tired 48 hrs nausea 72 hrs sweating 72 hrs headache 72 hrs |
| 41 | 2021-01-12 | headache |
24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the ...
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24 hours after the injection I had a sore arm, developed slight body aches and headache. Since the injection I had been getting headaches almost daily, mostly on my right side of my head. On Dec. 5, 2021 I noticed I was getting a sore eyebrow. Later that evening ok noticed swollen lymph nodes throughout my scalp, face, ear, jaw, neck and chest. My eyebrow also started to swell and was slightly pink. When the swelling was worse the next day - I went to urgent care and saw A doctor that diagnosed me with facial cellulitis. After a couple days my eye was not getting any better and started to itch severely. Called to urgent care over the weekend and takes to one of the providers who said to use cold compresses and elevate my head as much as I could. On Dec. 11, 2021 I called back to the provider I had seen on Dec. 6 - he told me he believed I had developed shingles and to go to the eye doctor that day. I saw a doctor on Dec. 11 & was diagnosed with shingles. They started me on antivirals along with the antibiotics they had prescribed on Dec. 6.
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| 41 | 2021-01-12 | weakness, malaise, fatigue | Arm Sore, fatigue, weak, body aches, not feeling well |
| 41 | 2021-01-12 | headache |
Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Bena...
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Employee received first vaccine 12/22/21. Developed hives on neck and face later that day. Took Benadryl routinely and Prednisone 10mg daily for three days with resolution of symptoms. Patient has a history of hives after flu vaccine, antibiotics, and childhood vaccines. Had second COVID vaccine 1/12/21. Developed hives on neck, arms, chest, and back. Also had a mild headache and nausea on 1/12/21 which have resolved. Is again taking Prednisone and Benadryl. Patient did not seek medical help. She has Prednisone on hand for these reactions since they are common for her.
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| 41 | 2021-01-12 | headache | Excruciating headache, dry mouth and eyes, Nausea and vomiting |
| 41 | 2021-01-12 | fatigue | Injection site pain, fatigue. Resolved. |
| 41 | 2021-01-12 | fatigue, headache |
Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swellin...
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Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder. Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend. By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.
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| 41 | 2021-01-12 | headache |
Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progre...
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Received the vaccine on a Wednesday afternoon. That evening I developed body aches, which got progressively worse over the course of the following day. I developed a persistent headache on Thursday that stuck around until Sunday. On Saturday morning I woke up feeling ok, still had the dull headache, but was ok enough to be up and around. At approximately 10:30 Saturday morning I was hit with stroke symptoms. I had weakness in my left hand, tunnel vision, couldn?t understand words that were spoke to me and was aphasic with garbled speech. Went to local ER and was worked up for stroke. Symptoms resolved Within approximately 45 minutes. All tests, lab results ok.
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| 41 | 2021-01-12 | fatigue, headache |
So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 ...
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So within a few minutes I had numbness and coldness in the entire arm and a headache. Then maybe 10 hrs later, nausea, numbness, body aches, joint pain, headache and fatigue.
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| 41 | 2021-01-12 | fever |
Sunday I had al little ache and pain. On the 21st I had to leave work with a fever 101.4 also had bo...
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Sunday I had al little ache and pain. On the 21st I had to leave work with a fever 101.4 also had body ache. It progressed from there then I tested positive for Covid. I went to a clinic to get tested was given Zpac, Zythrimac, steroids' .
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| 41 | 2021-01-12 | throat swelling, throat irritation |
developed a scratchy throat at 2100 and by 2130 felt like throat was tightening. Went to ER and rec...
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developed a scratchy throat at 2100 and by 2130 felt like throat was tightening. Went to ER and received Benedryl 50 mg IV, Solu medrol IV and protonix IVPB.
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| 41 | 2021-01-12 | headache, fever, migraine | fever loss of appetite headache/migraine body aches muscle cramps, rash |
| 41 | 2021-01-12 | fatigue, throat pain, throat swelling, headache |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have he...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; After the shot i have headache, sorethroat, cough and cold till this date; A 48-years-old non-pregnant female patient, receivedBNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in left arm, on 18Dec2020 (at the age of 41 years-old) as a single dose for COVID-19 immunization. The vaccination was administered at a pharmacy/drug store. Medical history was not reported. Concomitant medication included sertraline hydrochloride (SERTRALINE HYDROCHLORIDE). The patient had not received any other vaccines within four weeks prior to the vaccination nor received any other medications withing 2 weeks prior. It was reported that the patient had been tested for COVID-19 prior to vaccination and was negative. On 18Dec2020, the patient experienced itchy sore eyes one hour after vaccination, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after. The patient was not hospitalized nor received treatment for the events. The clinical outcome of the events of Itchy, sore eyes 1 hour after, sore and itchy arm for 5 days, headache, swollen sore throat, tiredness all 5 days after, was not recovered., the outcome of the COVID-19 positive was unknown. It was reported that the patient tested positive for COVID-19 via nasal swab, post vaccination on 31Dec2020. No follow-up attempts possible. No further information expected. Lot/batch number was not provided and unable to obtain
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| 41 | 2021-01-13 | fatigue, weakness, chills, headache |
10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days....
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10 hours after injection of 2nd vaccine I experienced body aches, chills, nausea that lasted 2 days. 3rd day post injection nausea continued and started experiencing back/flank pain. 4 and 5th day post injection still have nausea/back pain and chest pain, headache. Overall tiredness and weakness. I was also tested for Covid and it was negative.
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| 41 | 2021-01-13 | throat irritation |
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm...
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1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm. Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90. Benadryl 25 mg given PO. Sitting in chair, able to answer all questions with no apparent distress in speaking. Continued symptoms above at 1630 administered an additional 25mg benadryl PO . Alert and oriented, able to call spouse for a ride home. Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
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| 41 | 2021-01-13 | headache |
Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache...
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Approximately 10 hours post injection, she started to feel left sided weakness/slight pain, headache, dull neck pain that extended all the way down to my left foot and left arm soreness. She noticed facial droop on the left side at which case, she decided to sleep it off. When she woke up the following morning, She still had a slight droop but not as noticeable. Symptoms disappeared approximately 24 -30 hours post injection.
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| 41 | 2021-01-13 | dizziness |
Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and no...
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Approximately 20 minutes after the shot I became dizzy and nauseous. Followed my my upper lip and nose tingling and then the whole face tingling and numb feeling as if I had gotten a novacaine shot. This has continued all night but is currently more on my left side of face and down left forearm tingling/numb.
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| 41 | 2021-01-13 | dizziness |
Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensatio...
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Approximately 5 minutes after receiving the vaccine, pt reported feeling light-headed and a sensation that her heart was racing . Slightly elevated BP returned to baseline by 1436.
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| 41 | 2021-01-13 | nasal congestion, fever, chills | Chills, fever of 100, nasal congestion |
| 41 | 2021-01-13 | dizziness |
Dizziness and nausea within 2 mins of the vaccine. Dizziness went away after 10 mins but nausea has ...
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Dizziness and nausea within 2 mins of the vaccine. Dizziness went away after 10 mins but nausea has remained for over 24hours.
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| 41 | 2021-01-13 | fatigue |
Employee stated that she experienced a panic attack while on duty the same day she received the vacc...
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Employee stated that she experienced a panic attack while on duty the same day she received the vaccine - approximately 12 hours after administration. She has a history of panic attacks, especially when she is fatigued - which she states she was that day. She also reported that her friends brought her a double expreso coffee approximately 1 1/2 hours before attack. She went to the ED where she was released home.
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| 41 | 2021-01-13 | dizziness, headache |
Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips...
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Extreme hot flash that felt like needles all over the body, knees felt like they were on fire, lips and tounge were tingling, bad taste in mouth, elevated blood pressure and heart rate, and dizzy. Dissipated after about 30 minutes, and left a headache.
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| 41 | 2021-01-13 | fatigue |
Extremely enlarged lymph nodes along axillary and clavicle. Elevated CBC counts. Appeared 8 days pos...
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Extremely enlarged lymph nodes along axillary and clavicle. Elevated CBC counts. Appeared 8 days post injection. Remaining enlarged still a week later. Fatigue as well.
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| 41 | 2021-01-13 | fatigue, chills | Fatigued, nausea, chills |
| 41 | 2021-01-13 | headache, fatigue |
Headache, Fatigue -30 min after (gone at 37 hours) Muscle Aches - 27 hrs after (gone at 37 hours) ...
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Headache, Fatigue -30 min after (gone at 37 hours) Muscle Aches - 27 hrs after (gone at 37 hours) Eyelid edema & swelling in fingers - 37 hours (gone 72 hours)
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| 41 | 2021-01-13 | malaise, headache, dizziness |
I was approached by a person in the center at approx 1000 stating she had an employee that received...
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I was approached by a person in the center at approx 1000 stating she had an employee that received their first COVID vaccine and was not feeling well. I went over to find the employee sitting in the person's office in a chair. She was able to tell me she received her first COVID vaccine approx 30 mins ago. She stated she stayed there for the 15 mins after the vaccine with no reaction. She is now having ringing in her ears, feeling lightheaded, hot, nauseaus, and "I feel like I am in a cloud." She denies allergies or past hx of vaccine reactions. Denies hx of anaphylaxis. She denied any sob or chest pain. Employee was holding her head. She stated she had only had some coffee and juice today and was feeling hot. BP was taken and was 112/90 and she is not tachy and no resp distress observed. Patient was able to speak to me in full complete sentences initially. Another person came over and the employee was asked if she could stand and walk. Employee stated she felt she could stand and walk and when she did this she had to hold onto something to avoid falling and she was sat back down. Emergency services was called and employees speech was slow and almost slurred at times. Emergency services arrived and transported employee.
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| 41 | 2021-01-13 | fatigue, headache |
My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches...
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My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches. Consulted with my PCP who suggested a mammogram and an ultrasound. Both done at Hospital. It shows lymph nodes are swollen and a follow up appointment has been schedule for 3 months. If they are still swollen a biopsy will be made.
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| 41 | 2021-01-13 | chills, fever, weakness |
Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours a...
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Patient developed loss of taste, fever 100.1, shivering , muscle ache and weakness within 24 hours after second dose.
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| 41 | 2021-01-13 | runny nose, cough, fatigue, headache | Persistent Nausea Cough, post nasal drip Mild Headache, Neck and body ache, fatigue |
| 41 | 2021-01-13 | nasopharyngitis |
Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL324...
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Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this". Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot". Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction". Pt is drinking water with honey. Gave her some fresh water and monitored. Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold". When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes". I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18: BP= 116/68, HR=80 Resp rate 16-18. Pt is alert, oriented and states "feeling a little better". Tingling sensation is "leaving". Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC. Determined this is most likely symptoms caused by her anxiety. Pt left ambulatory with her co-worker and symptoms were resolved.
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| 41 | 2021-01-13 | chills, fever, headache |
Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I...
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Same night that I got the vaccine I got a headache and on the second day I started getting nauseas I was aching I had a fever 102.8 I had chills, body aches, my muscles where hurting, I also felt the pins & needles on my feet everything lasted about 36hrs. The headache lasted about 3 days.
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| 41 | 2021-01-13 | chills, headache, sweating, fatigue |
Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigu...
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Severe aches, chills, headache, stomach cramps, nausea, vomiting, diarrhea, sweats, eye pain, fatigue, skin sensitivity. Treated with Tylenol and CBD lotion. Mostly resolved within 36 hours of onset.
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| 41 | 2021-01-13 | shortness of breath |
Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharm...
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Shortness of breath; Anxious; Chest Heaviness; This is a Spontaneous report from a contactable pharmacist. A 41-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284) via intramuscular route of administration on left arm at a single dose for COVID-19 immunization at a nursing home. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced shortness of breath, anxious, and chest heaviness on 07Jan2021 11:00. The events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Treatment and outcome of the events were unknown. The patient had not been tested for COVID-19 since the vaccination.
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| 41 | 2021-01-13 | fever |
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all ...
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Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted for 1 day
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| 41 | 2021-01-13 | chills, malaise |
not feeling well overall; nausea; diarrhea; chills; This is a spontaneous report from a contactable ...
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not feeling well overall; nausea; diarrhea; chills; This is a spontaneous report from a contactable Pharmacist (patient). This 41-Year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140), via an unspecified route of administration, on 06Jan2021 at 01:30 PM at single dose for COVID-19 immunisation. Vaccine location was Left arm. The patient was vaccinated at hospital, age at vaccination was 41-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included sambucus nigra (ELDERBERRY), colecalciferol (VITAMIN D), camellia sinensis (GREEN TEA). On 08Jan2021 at 12:00 AM, the patient experienced nausea, diarrhea, chills, not feeling well overall. The events were reported as non-serious. The patient was tested for Covid post vaccination however it was also reported that she was not tested (to be clarified). Outcome was recovering. No treatment was received for the events.
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| 41 | 2021-01-13 | fatigue |
right side between neck and clavicle appears to be swollen lymph node, tender to palpate, fatigue w...
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right side between neck and clavicle appears to be swollen lymph node, tender to palpate, fatigue will monitor and report to PCP if needed
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| 41 | 2021-01-13 | shortness of breath |
severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of brea...
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severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself). A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization. Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening. The patient went to the Emergency room due to the events. Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg. The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-01-13 | fatigue, headache |
sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same p...
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sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same place where injection was given , still sore and pain full to touch and headaches .
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| 41 | 2021-01-13 | cough, fever |
took a rapid test and it came up positive; took a rapid test and it came up positive; fever 100.8; c...
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took a rapid test and it came up positive; took a rapid test and it came up positive; fever 100.8; coughing; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, reported as Pfizer covid19 el1284), via an unspecified route of administration on 30Dec2020 14:30 in left arm at single dose for covid-19 immunisation. Medical history included asthma and arthritis. Concomitant medication included ibuprofen and paracetamol (TYLENOL). The most recent COVID-19 vaccine was administered in public health clinic/ veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient got the vaccine on Wednesday 30Dec2020, and by Saturday (02Jan2021 22:30) she started with a little coughing that increase on Monday (04Jan2021), Monday afternoon she had fever 100.8. She thought she was experiencing side effects and reported to her supervisor and didn't work the 2 next days. She when back to work on Thursday (07Jan2021), she was sent to a covid clinic and took a rapid test and it came up positive. The patient underwent lab tests and procedures which included nasal swab (rapid antigen testing - SARS-CoV-2): positive on 07Jan2021. The events were reported as non-serious. No treatment was received for the events. Outcome of events were recovering. Information on the lot/batch number has been requested.
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| 41 | 2021-01-13 | weakness |
within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over for...
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within 10 minutes of vaccination, patient c/o feeling warm and nausea. symptoms progressed over forty minutes to include hypertension, nape of neck "fullness", weakness, and tingling hands. HR in '70's initially then progressed to tachycardia in 130's. EMS called for ED transport.
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| 41 | 2021-01-14 | migraine |
13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (pat...
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13-hour migraine; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: El3246, via an unspecified route of administration on Left arm from 07Jan2021 10:00 to 07Jan2021 10:00 as SINGLE DOSE (first dose) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication includes prenatal vitamins. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient experienced 13-hour migraine the day after the vaccine on 08Jan2021. The outcome of the event was recovered.
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| 41 | 2021-01-14 | throat irritation, throat swelling |
About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongu...
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About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.
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| 41 | 2021-01-14 | shortness of breath, headache, fever |
Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out ...
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Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out of bed for the entire day, severe headaches through the entire day Day 2: fever of 101, shortness of breath, severe headache, entire left arm in pain
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| 41 | 2021-01-14 | chills, malaise, fatigue, sweating |
Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over,...
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Day of vaccine, patient started feeling fatigue, malaise, site pain & swelling, joint pain all over, profuse sweating w/no fever, chills, all over inflammation & swelling, hives upper extremity, petechial rash, and the next day after the vaccine, the patient started experiencing swelling in R-axilla (lemon size). 3 days after vaccine all symptoms have resolved except swelling in right axilla.
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| 41 | 2021-01-14 | dizziness, head discomfort |
Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sic...
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Dizzy at work around 4pm. Tightness in chest worked its way down to stomach - felling queasy and sick to the stomach. When driving home from work, she instantly felt really hot and had a lot of flushing that felt like a hot flash. Hot all over. Had to pull over and take off layers of clothes. Sat with the air on in the car. Burning sensation when she got home felt like brillo pad was used on face. Burning sensation on cheek all the way down to chin. Face was really on fire. Today, the burning sensation have gotten better, but her cheeks still have prickly, tight sensation. Headache at 8pm yesterday when she was trying to go to bed at the back of the head. Felt like a lot of pressure.
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| 41 | 2021-01-14 | headache, chills, throat pain, fever |
Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, ext...
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Extreme chills with body shaking for 6 hours, fever, sore throat, nausea, excruciating headache, extremely high resting heart rate (over 100-usually under 60)
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| 41 | 2021-01-14 | fatigue, chills, headache, fever |
Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at i...
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Fatigue; Dry mouth; Low grade fever; Chills; Headache; Itchy rash at injection site; Itchy rash at injection site; Soreness at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 31Dec2020 12:45 at left arm, at single dose for covid-19 immunization. Medical history known allergies: penicillin, chocolate from an unknown date. Concomitant medication included acetylsalicylic acid (ASPIRIN) and Birth control pills. The patient previously took erythromycin and known allergies: Erythromycin. The patient was not pregnant at the time of vaccination. The patient experienced fatigue, dry mouth, low grade fever, chills, headache, itchy rash at injection site, soreness at injection site on 31Dec2020 15:00. No treatment was received for all events. The outcome of the events was recovered on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. No follow up attempts are possible. No further information is expected.
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| 41 | 2021-01-14 | headache, fever |
Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, join...
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Headache, Myalgia, Fever, HYPERtension, employee stated after receiving vaccine had body aches, joint aches, photophobia, headaches, fever, hypertension Narrative: Employee stated H/A, body aches, joint aches, photopobia, fever, hypertension BP 170/100, employee sent to to ER due to elevated b/p. denies any other symptoms.
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| 41 | 2021-01-14 | cough |
I had common side effects of cough/sneezing for 24-48 hours. I was 20 days post-op double mastectomy...
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I had common side effects of cough/sneezing for 24-48 hours. I was 20 days post-op double mastectomy with DIEP reconstruction. Although we knew I?d have side effects that would out weigh me getting the virus, we didn?t think ahead of that. My adverse event is that I ended up with a hernia in my lower left stomach. I have a bulge and some pain. My surgeon will be able to fix it after 3 months post-op.
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| 41 | 2021-01-14 | fever, chills, fatigue, headache |
I vomited several times; Severe headache; Muscle aches; Chills; Joint pain; Tiredness; Fever; This i...
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I vomited several times; Severe headache; Muscle aches; Chills; Joint pain; Tiredness; Fever; This is a spontaneous report from a contactable physician (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration from 07Jan2021 10:00 at left arm, at single dose for covid-19 immunization. Medical history included COVID 19 positive 12Dec2020, the patient was diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products was reported no. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient received vaccine at 07Han2021 10:00PM (as reported). 4 hours after receiving the vaccine 07Jan2021 14:00 the patient vomited several times, the patient had and still have severe headache, muscle aches, chills, joint pain, tiredness and fever. The patient realized that these are side effects and not adverse reactions but she felt that they were quite severe and she thought it was due to the fact that she so recently had COVID 19. OTC meds were received for all events. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 41 | 2021-01-14 | headache, fever |
Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units un...
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Inject site pain; muscle/joint pain; muscle/joint pain; fever with temperature of 99-100.6 [units unspecified]; under arm lymph node pain; headache; This is a spontaneous report from a contactable healthcare professional. A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EL1284; expiration date: unknown), intramuscular left arm on 08Jan2021 08:45 AM at a single dose for covid-19 vaccination. Medical history included asthma, allergies, high blood pressure and gastric sleeve. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), beclometasone dipropionate (QVAR), mometasone furoate (FLONASE), aminobenzoic acid, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (B-COMPLEX), cyanocobalamin (B-12), colecalciferol (D) and macrogol 3350 (MIRALAX). The patient previously took vancomycin but had allergies. The patient received the first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EK5730; expiration date: unknown) intramuscular left arm on 18Dec2020 07:45 AM at a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced inject site pain, muscle/joint pain, fever with temperature of 99-100.6 [units unspecified], under arm lymph node pain and headache on 09Jan2021 23:30. The events were considered as non-serious. The treatment the patient received for the adverse event were acetaminophen (TYLENOL), fluids, ice packs and magnesium. The patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included temperature was 99-100.6 [units unspecified] on 09Jan2021. The outcome of the events was recovering.
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| 41 | 2021-01-14 | dizziness, fever |
Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professio...
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Nausea; dizziness; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283), via an unspecified route of administration in the left arm on 08Jan2021 08:00 at a single dose for COVID-19 immunization. The patient's medical history included migraine and seasonal allergies. The patient was not pregnant at the time of vaccination. The patient have no known allergies to medications, food, or other products. Concomitant medications included melatonin and levocetirizine dihydrochloride (XYZAL). The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899), intramuscular in the left arm on 18Dec2020 at the age of 41-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 08Jan2021 09:30, the patient experienced nausea, dizziness, fever. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
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| 41 | 2021-01-14 | headache, productive cough, fever, somnolence, fatigue |
On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was...
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On 1/12 at about 6:30 AM, I felt muscle tightness on the left side. The whole right ring finger was numb and lock. Within minutes, I felt tingling sensations along all my fingers and thumbs. Then numbness at the tips. Then, both my hands were very cold. At about 2- 3, I fell groggy, tired. Then came the chill and fever, also light headaches. The numbness was gone. 1/13 I hit my right funny bone and my pinky, ring, and middle fingers were locked up tight. I tried to uncurl them. But they stayed locked. It lasted about 1-2 minutes. I got stomach pain around 5. 1/14 I have excessive phlegm at around 3pm and currently still have excessive phlegm. Then at around 10 pm, I had bad warped vertigo.
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| 41 | 2021-01-14 | fatigue, headache |
Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. A...
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Received second Pfizer vaccine on 1/13 at 7pm. Woke with headache and injection site pain on 1/14. As day progressed, fatigue, joint pain, mm aches increased. Fatigue, headache, injection site pain and swelling, new or worsened joint and muscle pain
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| 41 | 2021-01-14 | chills, fever | Severe chills, fever tmax 101.2, body aches |
| 41 | 2021-01-14 | chills, fever |
Staff had 2nd vaccine yesterday 01/13/2021 at 11:20. At night 3 am woke up with bodyache, lower bac...
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Staff had 2nd vaccine yesterday 01/13/2021 at 11:20. At night 3 am woke up with bodyache, lower back pain, fever 103, could not sleep. Took Tylenol. Today at 12 noon staff feels chill, fever 102. Now ok. W
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| 41 | 2021-01-14 | malaise, fatigue, chills, fever, headache |
Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At app...
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Symptoms - ? Patient reports she woke up on 1/14 with pain to injection site and sore L arm. At approximately 0400 + chills, HA, body aches, and nausea without emesis. + fever (Tmax 100.3), Patient reports yesterday took motrin/tylenol around the clock. Today (1/15), Patient reports no fever today but ?brain fog? and feelings of fatigue. Patient reports last dose of motrin 600 mg at 08:00. Patient reports she called off work yesterday due to not feeling well. Last day of work and shift - ?Tuesday, January 12th Home remedies? - Tylenol, motrin, rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the TCH Medical Directive. Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. Patient reports she called out of work yesterday, next scheduled shift Monday (1/18). Patient educated to manage her RTW according to the TCH Illness in the Workplace policy. Patient verbalized back understanding and denied further questions at this time.
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| 41 | 2021-01-14 | chills, fever, headache |
Within 12 hours of receiving second dose of Pfizer COVID-19 vaccine, patient developed fever 39.5, c...
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Within 12 hours of receiving second dose of Pfizer COVID-19 vaccine, patient developed fever 39.5, chills, body aches and headache. Tylenol and ibuprofen did not help with fever much. No notes on further escalation of care or resolution.
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| 41 | 2021-01-14 | headache |
Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I ...
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Within ten minutes, I had a massive headache and the roof of my mouth went numb. Within one hour, I had severe bruising, dark purple, the size of a half dollar, that JUST went away and I am due on 1/17/2021 for my next vaccine. I had no pain, only dark purple bruising and swelling. The headache and mouth issue went away after three days.
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| 41 | 2021-01-14 | dizziness, shortness of breath |
became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED...
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became anxious. c/o SOB, palpitations, dizziness, felt she was going to faint. Was evaluated in ED, discharged home
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| 41 | 2021-01-14 | dizziness, lethargy | lethargy, body aches, dizziness, numbness in arms, dizziness, nausea, high pulse rate |
| 41 | 2021-01-14 | throat irritation, throat swelling |
~15 minutes post vaccination, reported feeling sensation on right side of throat. Tightness, burning...
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~15 minutes post vaccination, reported feeling sensation on right side of throat. Tightness, burning, swollen ("like strep throat, raw") 1515: Dose of 50mg capsule of diphenhydramine PO Can swallow without difficulties Denies troubles breathing 15:25: Notes some improvement in symptoms, denies worsening VS: 148/98
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| 41 | 2021-01-15 | chills, fever, sweating, headache, fatigue |
Fever (max 102.5), chills, sweats, headache, muscle pain, fatigue. Fever started 13 hours after inje...
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Fever (max 102.5), chills, sweats, headache, muscle pain, fatigue. Fever started 13 hours after injection. I am now 29 hours post-injection, and fever (as well as all other symposiums) persists.
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| 41 | 2021-01-15 | throat irritation |
I started itching while being monitored post vaccine administration within the 5 minutes of the vacc...
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I started itching while being monitored post vaccine administration within the 5 minutes of the vaccine being administered. The itching was everywhere including my tongue and throat, since this is my workplace and I was working I had to go home and was given Benadryl to take upon arrival, the Benadryl did not help so I did a virtual visit with a physician who recommended that I increase the dose of benadryl at the same time I called my PCP to inform them of the issue they ordered, Atarax 25 mg every 6 hours plus taking an over the counter antihistamine.
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| 41 | 2021-01-15 | nerve pain |
I was exposed to Covid in November. I tested negative twice but had nerve pain along the right side ...
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I was exposed to Covid in November. I tested negative twice but had nerve pain along the right side of my face when my son had tested positive. Both times I got the vaccination the nerve pain in my face came back. It was fairly painful the second time. The concern is that I had an inflammatory response similar to when I actually may have had Covid both times. It went away within 48 hours and I have been done since.
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| 41 | 2021-01-15 | fatigue |
Numbness to central part of my face one hour after vaccination. Went home and took 800 mg of ibuprof...
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Numbness to central part of my face one hour after vaccination. Went home and took 800 mg of ibuprofen and 25 mg of benedryl then went to bed (after working night shift). Upon waking around 4pm the numbness was gone
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| 41 | 2021-01-15 | headache, fever, chills, sweating | febrile 102.5, achy, chills, sweaty, headache |
| 41 | 2021-01-15 | fatigue, runny nose, headache | headache, fatigue, runny nose |
| 41 | 2021-01-16 | throat irritation |
1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted fo...
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1/17/2021 2:42 pm gave vaccine 1/17/21 2:54 pm itchy throat on outside was upset and we opted for 25mg Benadryl as a precaution. BP 112/72. Reported itchy back. Checked back, unremarkable. 3:30, no issue ? she went home. F/u 4:30 - no issues
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| 41 | 2021-01-16 | skin warm |
I received my second dose of Pfizer's Covid vaccine on 1/9/21. The person who gave the vaccine admi...
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I received my second dose of Pfizer's Covid vaccine on 1/9/21. The person who gave the vaccine administered it SQ, not IM. I did develop a cellulitis like reaction to the area. The redness began almost immediately following the vaccine, however, the following 2 days the area grew larger and hot to touch. The area currently is red and itchy, however, swelling and warmth is gone. My concern is the efficacy of the vaccine since it was not given IM.
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| 41 | 2021-01-16 | throat irritation |
Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tight...
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Vax injection at 4:05 pm, Symptoms started at 4:10 pm. burning throat, difficulty swallowing, tightness in chest. 25 mg benadryl given with a little improvement. Symptoms return and worsen- 25 mg benadryl given and rapid response called. Taken to ED and admitted. Given 125 mg of solu-medrol IV and albuterol inhaler. Symptoms eased and discharged to go home. 01-15-2021- 4:30am woke with burning in throat mild difficulty swallowing. Took 50 mg benadryl and inhaler. Symptoms eased. 01-16-2021- felt better 01-17-2021- 5:00 pm- noticed onset of tightness in throat, feeling of something caught at back of throat and start of mucus drainage. Continued clearing of throat. Took 25 mg of benadryl and inhaler.
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| 41 | 2021-01-16 | headache, throat irritation |
Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/n...
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Within 25 minutes of receiving the vaccine, my left arm became very heavy and there was a tingling/neuro sensation in left wrist/hand. A pressure began in the anterior of my throat which increased gradually. I sought treatment in our Urgent Care just after noon that same day. The Provider monitored my vitals which were good and administered liquid Pepcid. Said Provider chose not to give Benadryl as I had taken Zyrec that morning for my allergies. I was discharged from the Urgent Care and went back to work at 1245. At 1730 hours, I had a slight headache above my right eye and extreme right-sided jaw pain with tooth sensitivity. These lasted for only 10 minutes. At 1830, the anterior and bilateral portions of my throat began to feel "prickly" and I developed a wheeze. I used an albuterol inhaler to relieve the wheeze successfully. At this time I also developed an itchiness throughout my whole body, worse on left side than right side. I took 100mg of Benadryl with no relief. At 0300, I took another dose of 100mg of Benadryl with no relief. I also took an itch pill/antihistamine of my husband's which provided no relief. At 0800, I took 20 mg of Zyrtec. At 1030, I took 100mg of Benadryl. I continued to use Benadryl throughout the day, every 4-5 hours. At 1800, I had a fullness in my throat, a tightness in my chest and my left shoulder blade felt almost numb. I also had a hoarse voice which passed by the next morning. The chest tightness was intermittent over the next day or two. On Friday, the itchiness had improved some but was still prominent. I continued to use Zyrtec and Benadryl throughout the day. My Primary Doctor called in Prednisone if needed. By Saturday morning, I felt MUCH better. Today is Sunday and I am no longer itching and I feel so much better today.
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| 41 | 2021-01-16 | chills | severe shaking chills with onset at 10pm that lasted for 2 hours, no treatments used |
| 41 | 2021-01-17 | fatigue, headache, chills, sweating, fever | DOLOR MUSCULAR Y DE CABEZA FIEBRE ESCALOFRIOS SUDORACION CANSANCIO |
| 41 | 2021-01-17 | throat pain, fatigue, cough |
Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went t...
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Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold. The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-17 | throat irritation | PATIENT PRESENT THROAT ITCH AND SKIN RASH |
| 41 | 2021-01-17 | headache | headache, dry mouth, and arm pain |
| 41 | 2021-01-17 | headache, chills, shortness of breath, fatigue, dizziness |
tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloa...
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tightness in my chest; sob/shortness of breathe; headache; chills; body aches; extreme fatigue; bloating; shakes; blurred vision and couldn't focus on my cell phone; tachycardia/heart rate went up; dizziness/ felt dizzy; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: ER9231), via an unspecified route of administration in the right arm on 06Jan2021 at 10:00 AM at a single dose as COVID-19 vaccine. Medical history included anaemia and anaphylactic reaction to shellfish. The patient was not pregnant at the time of vaccination, did not receive any other vaccine within 4 weeks prior to the COVID vaccine, and had no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications. On 06Jan2021, within 2 hours (at 12:00 PM), the patient experienced blurred vision, within 4 hours tachycardia and dizziness, within 8 hours headache, chills, body aches, and extreme fatigue, and within 12 hours, tightness in her chest, SOB, extreme fatigue, and body aches. As treatment, the patient received ibuprofen. The patient stated that she had a pretty severe reaction. She also informed her employer but nobody helped. They observed her 15 mins. post-vaccination. She was fine within 15 minutes. It was also reported that within 2 hours, she had blurry vision, tachycardia, and felt dizzy. In the middle of the day, she felt chills, shivers, dizziness, bloating, and headache. The patient also stated that she experienced shakes and taking a shower hurt, also, chest was tight all day. It was further reported that when she was sent back home from work, she started having a severe body ache, fatigue, chills, and shivers. She experienced tightness in her chest , shortness of breath, and she could barely get out of bed. This lasted all day. She still had the blurred vision and couldn't focus on her cell phone. She felt a little bit better today but was still not 100%. She contacted her MD who advised her to report this to Pfizer. The patient wanted to know if it was safe to receive the second dose of COVID-19 vaccine. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the event 'Vision blurred' was not recovered, for the event 'Tremor' was unknown, while for the rest of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 41 | 2021-01-18 | fever, headache, fatigue |
muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong tha...
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muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong that I can't have my foot firmly on the floor; Fever; strong headache; muscle pain generalized; tiredness; This is a spontaneous report from a contactable other Health Professional. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, Cardiac arrhythmia, allergy to crustaceans. The patient's concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergies, and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 21Dec2020 09:30 AM at a single dose on left arm for COVID-19 immunization. The patient experienced fever, strong headache, muscle pain generalized, tiredness on 08Jan2021, and "muscle pain is so strong that I can't have my foot firmly on the floor" on 08Jan2021 07:00. No treatment was received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about Lot/Batch has been requested.
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| 41 | 2021-01-19 | shortness of breath |
5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observati...
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5 minutes after vaccination, recipient became flushed, red in face, felt hot. Reported to observation RN that she began feeling short of breath. RN administered Epinephrine in left thigh. Patient escorted to Emergency Department for further evaluation approximately 10 minutes later due to recurrence of symptoms.
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| 41 | 2021-01-19 | chills, throat pain, malaise, fatigue | Body aches, fatigue, sore throat, malaise, chills |
| 41 | 2021-01-19 | headache, fatigue, chills, fever, sweating |
Chills/sweats/fever/aches for about 5-6 hours. Then left with aches and mild headache. Occasional n...
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Chills/sweats/fever/aches for about 5-6 hours. Then left with aches and mild headache. Occasional nausea throughout the day and fatigue.
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| 41 | 2021-01-19 | fever | Fever day after vaccine was given along with reaction site pain |
| 41 | 2021-01-19 | fever, headache |
Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the s...
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Fever of 100.4, body aches, chest tightness and headache. Tylenol dosing for 24 hours remedied the side effects.
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| 41 | 2021-01-19 | fatigue, chills, headache, fever | Fever of 102.8, body aches, chills, fatigue, headache, injection site soreness |
| 41 | 2021-01-19 | dizziness, weakness, shortness of breath |
The patient self-reported this adverse reaction through the hospital electronic reporting system. I...
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The patient self-reported this adverse reaction through the hospital electronic reporting system. In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".
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| 41 | 2021-01-19 | fatigue |
sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a s...
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sore left deltoid; mild muscle aches; mild neck/joint pain; mild neck/joint pain; tired; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1283), via an unspecified route of administration in the left deltoid, on 09Jan2021 (at the age of 41-years-old) at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and COVID-19. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included amlodipine besilate (NORVASC), ascorbic acid (vitamin C; MANUFACTURER UNKNOWN), ergocalciferol (reported as: vitamin D; MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), and magnesium (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified daily multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in left arm, on 19Dec2020 at 07:00 (at the age of 41-years-old) for COVID-19 immunization and experienced sore left deltoid (Day 1), body aches (Day 1), headache (HA) (Day 1, 2, & 3), all over body aches (Day 2), fatigue (Day 2, 3, & 4), chills (Day 2), myalgia/muscle ache (Day 3), all over joint pain (Day 3), lower/upper extremity (LUE) pain (Day 4), and muscle and bone pain (Day 4). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced sore left deltoid, mild muscle aches, mild neck/joint pain, and tired on 09Jan2021. The events were reported as non-serious. The events occurred on day 1 after vaccination and by day 2, the patient felt great with no side effects. Therapeutic measures were taken as a result of all of the events, which included paracetamol (TYLENOL) and ibuprofen (MOTRIN). The clinical outcome of sore left deltoid, mild muscle aches, mild neck/joint pain, and tired was recovered on 10Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 41 | 2021-01-20 | headache |
Really bad headache; Really itchy/itching in her upper body and in legs, like a rash; Rash/itching ...
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Really bad headache; Really itchy/itching in her upper body and in legs, like a rash; Rash/itching in her upper body and in legs, like a rash; Mottled skin; This is a spontaneous report from a contactable nurse reporting for herself A 41-years-old female patient received bnt162b2 (BNT162B2; Lot #EL3249) vaccine , in the left arm on 11Jan2021 13:00 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient experienced really bad headache on 12Jan2021 with outcome of unknown , really itchy/itching in her upper body and in legs, like a rash on 12Jan2021 with outcome of unknown , mottled skin on 12Jan2021 with outcome of unknown. Unknown treatment was given for really bad headache The reported events were considered Important Medical Events.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events headache, pruritus, rash and livedo reticularis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-20 | migraine, fever |
general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spo...
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general body pain; migraine; nausea; a low grade fever of 99; it "hit her like a bus"; This is a spontaneous report from a contactable consumer (patient's sister). A 41-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration on Jan2021 at the age of 41-year-old at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had no covid prior vaccination. Patient previously received first dose BNT162B2 on Dec2020 at single dose for covid-19 immunisation. She had received her second dose of vaccine and it "hit her like a bus", she experienced general body pain, migraine, nausea, and a low grade fever of 99 on Jan2021. Outcome of events was unknown. Information on lot/batch number has been requested.
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| 41 | 2021-01-20 | fever, skin warm, weakness, chills |
hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakne...
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hand was hurting so bad/feeling more pain in her hands; hurting down into her breast; feeling weakness; joint hurting; fever; chills; whole body aches; restless; joints and muscles were hurting; She saw really bad redness and it was increasing in size; It was swollen and warm to touch; It was swollen and warm to touch; she has had horrible feelings; inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); inappropriate schedule of vaccine administered (first dose on 21Dec2020, second dose on 09Jan2021); Cellulitis; This is a spontaneous report from a contactable Nurse (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 09Jan2021 at 10:30 a.m. at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medication were not reported. The patient received first dose on 21Dec2020 (lot number: EJ1685) on left Arm. Patient received second dose of the Pfizer COVID19 Vaccine on 09Jan2021 at 10:30 a.m. and until 11 that night she had no symptoms. She started feeling weakness and joint hurting. After midnight she had fever, chills, and whole body aches. She was restless. All her joints and muscles were hurting. The chills were really bad. She was taking Motrin 200mg and she took three pills at the time, so she took high dose kind of. It didn't get better until Monday, 11Jan2021, at around 1:00PM. It was She stayed home. She has heard from so many people that the second dose gives this kind of symptoms. She was already prepared with the medication. She knew the symptoms would get better. She didn't just right away go to the doctor. For two days she was running all the symptoms. Patient commented also that the last two days she has had horrible feelings. She didn't pay attention to the arm. With any shot, pain is normal. She was getting better with the other symptoms, but was feeling more pain in her hands. She saw really bad redness and it was increasing in size. It was spreading. When moving her arm, it was radiating under the arm and to the side of her breast. Then she felt really bad and came to work. She showed it to her friend and it was spreading and hurting. It was swollen and warm to touch. She went to Urgent Care downstairs. On 12Jan2021 at 10:50AM she went to Urgent Care and was diagnosed with cellulitis in left upper arm. Antibiotics were prescribed as treatment. She informed took vitamins. At the time of the reporting event outcome was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162BB2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-01-20 | fatigue |
tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is ...
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tingling in her right arm; I woke up on Monday very tired; she had symptoms of bells palsy; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female (no pregnant) patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686) on 05Jan2021 10:15AM at Upper Left Arm for COVID-19 immunization. Medical history and concomitant drug were not reported. She said she got Botox injections in her forehead, as well as, a little bit by each eye, a little less than 3 weeks prior to receiving the COVID-19 Vaccine. She clarified she believes she was injected with only 50cc's of a Botox 100mg vial. She said she does not have the Botox NDC, Lot, and Expiration Date from the Botox that was injected into her forehead and eye areas approximately 3 weeks earlier. Patient got the 1st shot of covid vaccine on 05Jan2021. On Monday she had symptoms of bells palsy and wanted clinic trials result for it. Reported her Bell's Palsy symptoms started on Monday, 11Jan2021, and she was formally diagnosed with Bell's Palsy in the right side of her face in the Emergency Room on 12Jan2021 was reported as worsened. She said the doctor told her the Bells Palsy could worsen before it improves. She said the doctors ruled out a stroke and diagnosed her with Bells Palsy. Stated she has tingling in her right arm that comes and goes on 12Jan2021. She doesn't have the right arm tingling all the time. Event details: On Saturday, 09Jan and Sunday 10Jan my right eye began to twitch from time to time. I woke up on Monday very tired and my eyes were swollen and I had bags under my eyes. I felt a little off but went to work. In the middle of the day my right eye began hurting with a burning sensation. I thought I needed to change my contact lenses. The following day, Tuesday 12Jan. I woke up and noticed that I can't fully close my right eye. I felt tired again and my eyes had bags under them. I went to work and felt like not myself. Around 10am, I ate cereal and noticed that I was chewing funny. At 1:30 pm I felt tingling around my right lip and at 4pm I noticed that smile is off and that I was not able to smile fully with my right side. That was when I went to the Emergency Room. She said she was given 3 Prednisone 20mg pills while she was at the hospital yesterday, as well as, a prescription for Prednisone 20mg tablets. She said she is to take 3 Prednisone 20mg tablets per day for 6 days. She clarified once she finishes the Prednisone 20mg prescription, she will have taken 7 days of Prednisone 20mg tablets. She stated the Prednisone 20mg tablets were dispensed in a pharmacy vial, and she does not have the NDC, Lot and Expiration Date. She said she also received a prescription for Valacyclovir 1gm tablets. She said she is to take 1 Valacyclovir 1gm tablet, three times a day, for 7 days. She said the Valacyclovir 1gm tablets are dispensed in a pharmacy bottle, and she doesn't have the Valacyclovir 1gm NDC, Lot and Expiration Date. She said she doesn't want to get the second COVID-19 Vaccine dose now. No Covid prior vaccination. Covid tested post vaccination (Nasal Swab): Yes- Negative. Outcome of reaction/event at the time of last observation was Not Recovered/Not Resolved. Follow-up attempts are completed. No further information is expected.
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| 41 | 2021-01-21 | headache, nasal congestion | Congestion, out of body experience (like a fog where you cannot think), headache, syncope |
| 41 | 2021-01-21 | fatigue, fever |
Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injectio...
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Fever, body aches, fatigue - all lasting 12 hours, then resolved. Also having cellulitis to injection site, started with adverse symptoms, still having & redness is getting larger now (55 hours after injection)
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| 41 | 2021-01-21 | shortness of breath |
Hives started on my chest, they were very sensitive, first noticed when my chest felt raw from my sh...
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Hives started on my chest, they were very sensitive, first noticed when my chest felt raw from my shirt. Hives went up from my chest to my neck and eventually to my face. About 30 mins after hives started, my breathing became labored. I took 3 Benadryl and was preparing to give my self an EpiPen injection. Benadryl was enough to slowly bring everything back to normal. This began around 6:00 pm, Benadryl was taken around 6:45, by 9:00pm I was completely normal for bed.
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| 41 | 2021-01-21 | headache, fatigue |
I experienced mild to moderate headaches. I felt very fatigued. I still have mild to moderate heada...
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I experienced mild to moderate headaches. I felt very fatigued. I still have mild to moderate headaches today.
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| 41 | 2021-01-21 | headache, fatigue |
I got my 2nd vaccine on 1-14-20 at 9am. About 6 hours later I had severe headaches, fatigue, muscle ...
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I got my 2nd vaccine on 1-14-20 at 9am. About 6 hours later I had severe headaches, fatigue, muscle pain, also pain at the injection site. i felt very tired. The next day I had severe headaches, muscle pain and fatigue and took Ibuprofen as pain medication. My headache went from a severe to moderate. All the rest of days continued with headaches.
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| 41 | 2021-01-21 | headache | I had eye pain and drainage, body aches, abdominal pain, headache and joint pain. |
| 41 | 2021-01-21 | dizziness |
Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to hav...
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Pfizer COVID-19 Vaccine EUA. At 1317 (18 minutes after vaccine administered) Patient observed to have rash to chest and neck. Patient stated she felt "warm in her neck and inner thighs". Rash progressed to ears and face. Patient stated she was having "tingling in the mouth w/progression to her face and eyes. Patient taken to triage area for observation, VS Q 5 mins. Patient noted to have tachycardia PR 103 and elevated BP 178/100 on initial VS. Pulse rate decrease after 5 minutes to 95. BP remained elevated. Patient placed on gurney in recumbent position and water given. Patient given a mirror to view face and patient stated " my face is swollen slightly". Absent selling to lips or tongue. EPI pen 0.3mg/0.3ml auto injector administered at 1339.patient transported to site ED for further evaluation. O2 applied enroute to ED at 4L/min via NC when patient stated she felt a little lightheaded. Patient care transferred to ED and report given.
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| 41 | 2021-01-21 | shortness of breath |
Pt received COVID vaccine (2nd dose) at 0857. Pt reported after twenty-five minutes that it was "dif...
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Pt received COVID vaccine (2nd dose) at 0857. Pt reported after twenty-five minutes that it was "difficult to take a deep breath". RN and EMT took VS. VSS. Clear lung sounds. RN told pt to remain for an additional 15 min of observation. Patient stable and able to leave on her own at the end of 15 min observation.
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| 41 | 2021-01-21 | fever, chills, headache |
Same symptoms as when I actually had covid mid December. Headache, back ache, fever, chills, body ac...
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Same symptoms as when I actually had covid mid December. Headache, back ache, fever, chills, body aches
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| 41 | 2021-01-21 | fatigue | Soreness at injection site with slight swelling. Fatigue on day 1 following administration. |
| 41 | 2021-01-24 | dizziness |
Employee became dizzy after vaccine administration. Employee was laid down with an ice pack at the b...
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Employee became dizzy after vaccine administration. Employee was laid down with an ice pack at the back of her neck and monitored. Her heart rate was 75 and her POX was 99%. She immediately felt better.
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| 41 | 2021-01-24 | weakness, migraine, influenza like illness, headache, dizziness |
Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right,...
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Following the 1st dose- arm soreness and pain at injection side. 2nd dose- axilla pain on the right, flu like symptoms, headache, joint pain followed by migraine headache on day 3 post second dose. On Saturday day 4 hives, itching all over the body. Treated with oTC Benadryl 50mg q 6hrs. On day 5 the rash was more severe. Contacted PCP and was prescribed prednisone 20mg daily. Day 6- today, rash slightly improved but still present and itchy. Feeling weak and dizzy.
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| 41 | 2021-01-24 | chills, throat irritation, throat pain, malaise, headache, fatigue, body temperature increased |
I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the inject...
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I began feeling a sore, scratchy throat, a headache and localized redness and swelling at the injection site about 6 hours after receiving my vaccine. The next morning, about 18 hours after receiving the vaccine the injection site redness had extended to about 2" and had become painful. At about 22 hours after injection I began having a significant headache, chills, elevated temperature of 100 degrees, body aches, exhaustion and overall unwell feeling. This feeling persisted through the remainder of the day. By 46 hours post vaccination the redness and swelling had grown to about 3" and now had a strong red center, was hot and hard to the touch. I was still having chills, temperature stayed around 99 degrees, still felt tired and had headache. At about 66 hours post injection I have sinus congestion and the swelling and redness at the injection site is about 3 1/2" and swelling without redness now extends about 2" past the redness down my arm.
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| 41 | 2021-01-24 | weakness |
Left arm numbness in thumb, wrist, and upper arm. Left arm weakness and achiness. Treated with ibup...
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Left arm numbness in thumb, wrist, and upper arm. Left arm weakness and achiness. Treated with ibuprofen; tylenol; ice to neck, shoulder and wrist; range of motion exercises; heat for muscle relaxation; rest. Decreased pain and ache with rest.
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| 41 | 2021-01-24 | shortness of breath |
This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immun...
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This is a 41 y/o woman with who received her second COVID-19 vaccination today. Following this immunization, she appropriately stayed in the waiting area for the 30 minutes. She then got in car and 15 minutes after, she noticed that her tongue was feeling full/swollen and that was experiencing neck swelling. These symptoms persisted and resembled a prior allergic response to Tetracycline and Aleve. Wheezing and breathing difficulty ensued and EMS was activated. On arrival to the emergency department she was found to have wheezing with stridor. A dose of epinephrine was administered and she was monitored in the emergency department with an initial improvement in symptoms. Approximately one hour and 30 minutes after initial epinephrine administration patient reported that she was having continued difficulty swallowing and she was starting to feel a little worse. At this point a second dose of IM epinephrine was administered. The patient was subsequently admitted to inpatient medicine team for further monitoring.
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| 41 | 2021-01-24 | runny nose |
Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a ...
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Throat, ears and nose itching; Nose running; Throat tightening; This is a spontaneous report from a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1 via an unspecified route of administration on 22Dec2020 17:00 at a single dose on the right arm for COVID-19 immunization. Medical history included allergy to NSAIDs. The patient previously took buproprion and experienced allergies. No other vaccine was received within 4 weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), and clarithromycin (CLARITIN). The patient experienced throat, ears and nose itching, nose running, and throat tightening on 23Dec2020 01:00. The patient received Benedryl and Prevacid taken at home for the events. The outcome of the events was recovered.
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| 41 | 2021-01-24 | migraine, weakness, dizziness, influenza like illness, headache |
following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose...
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following the 1st dose on 12/29/2020- soreness and swelling at injection site followinf the 2nd dose on 1/19/2021- swelling and pain at injection side, right axilla severe pain, flu like symptoms, nausea, headache. migrane developed on day 3, on day 4 hives and pruritus all over the body, swelling of hands and feet, on day 5 the symptoms worsened despite medicating with OTC benadryl 50mg every 6hrs. Contacted PCP and was prescribed prednisone 20mg daily with some improvement. day 6- today rash still present, pruritus present, weakness, dizziness, shaky. unable to work or drive.
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| 41 | 2021-01-25 | skin warm, shortness of breath, cough |
About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, an...
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About 45 minutes to an hour after the administration of the vaccine m, my cheeks became red, hot, and swollen. There were also hives. I took Benadryl which stopped the spreading but it did not go away. I had shortness of breath, and by about 6:00 it was hard to breath when lying down. I did an albuterol treatment with my nebulizer. It helped but it took much longer than usual. There were was about 30 minutes that I found my epipen and was going to the ED if it got worse. My breathing improved. The red changed to pink but was still swollen and tight 7 hours later. The second one of Benadryl helped get rid of most of the pinkness. When I woke up this morning, I had a little bit of a wheezy cough that I didn?t have yesterday. My daily Zyrtec and singular helped that a little. I have new hives along my jawline this morning that are very minor but they do itch. The redness and swelling was similar to reactions I?ve gotten when I drink a beer or have eaten soft shell crab, but typically Benadryl will clear that up and it doesn?t linger for so long. This was more aggressive. My side effects at this point are minor, but I have a call in to my allergist to see if I should be doing anything different and questions about the second dose.
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| 41 | 2021-01-25 | sweating, fever, throat irritation, chills, dizziness |
Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially ...
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Approximately 10 mins post injection I had intermittent abdominal cramping which I didn't initially associate with the injection, 30 mins post injection after obs period I felt dizziness. Chills within an hour, accompanied by sweating. Continued to work through it because otherwise felt okay. Dizziness subsided shortly after additional antihistamine and Pepcid. Approximatley around 7 pm my face start burning and itching, I had a diffuse red rash all over my face and my torso. I took 50 mg of Benadryl and rash resolved. It was not hives, almost appeared as flushing, Over the weekend I had fevers, chills but nothing that prevented me from my daily life. I however, have felt since my 2nd vaccine throat irritation, and itching, sweating. I am just continue my Zyrtec and regimen I took several years ago when I had this type of immune response. I didn't bother with MD, I left a message with nurse.
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| 41 | 2021-01-25 | chills | Chills, body aches, vomiting |
| 41 | 2021-01-25 | weakness, headache, fatigue, fever, dizziness |
Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had di...
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Developed fever 100.4-101 lasting 48 hours. Extreme dizziness for 2 days to the point where I had difficulty standing. This lingered for an additional 3 days, but not as severe. Muscle pain especially in hips and back, weakness, fatigue, headache and loss of appetite.
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| 41 | 2021-01-25 | fatigue, fever | Fatigue, muscle aches/body aches and fever |
| 41 | 2021-01-25 | malaise |
Initially a general ill feeling and then pain in the hip joint.; Initially a general ill feeling and...
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Initially a general ill feeling and then pain in the hip joint.; Initially a general ill feeling and then pain in the hip joint.; This is a spontaneous report from a contactable consumer. A 41-year-old female patient (NOT PREGNANT) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer) in Jan2021, via unknown route of administration at single dose (second dose); via unknown route of administration at single dose (first dose) in Jan2021 for unknown indication. Medical history and concomitant medications were unknown. There were unknown allergies. There was unknown if patient received other vaccine in four weeks and Other medications in two weeks. Patient experienced initially a general ill feeling and then pain in the hip joint in Jan2021. Patient did not receive any treatment. Patient did not have COVID prior vaccination and COVID tested was unknown post vaccination. The outcome of the events was recovered in Jan2021. Information on the Lot/Batch Number has been requested.
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| 41 | 2021-01-25 | headache | Severe headache, muscle and body aches |
| 41 | 2021-01-25 | fever |
aches; muscle pain; low grade fever; enlarged lymphnodes left supraclavicular region; This is a spon...
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aches; muscle pain; low grade fever; enlarged lymphnodes left supraclavicular region; This is a spontaneous report from a contactable other health care professional. A 41-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), intramuscular on 11Jan2021 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), fexofenadine hydrochloride (ALLEGRA). The patient had first dose of COVID-19 vaccine on 21Dec2020 intramuscular at right arm. On 12Jan2021, the patient experienced aches, muscle pain, low grade fever, and enlarged lymphnodes left supraclavicular region. The outcome of the events was recovering. The patient did not receive treatment for the events.
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| 41 | 2021-01-25 | malaise |
could not get up from the bed; she did not feel well; This is a spontaneous report from a contactabl...
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could not get up from the bed; she did not feel well; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm single dose for prevent COVID on 18Dec2020 at 07:00am, at 41-year-old. Medical history included: seizures from 2014. Concomitant medication included: ongoing topiramate oral 50mg one tablet in the morning and two tablets in the evening for seizures; levetiracetam (KEPPRA). No additional vaccines administered on same date of BNT162B2. She was okay on 19Dec2020. After mid-day around noon (19Dec2020) she did not feel well, and it was hard for her to work on the 19th. She missed two days of work. On 20Dec2020 she could not get up from the bed. Emergency Room or Physician Office not visited. No relevant tests done. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown. Information about lot/batch number has been requested.
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| 41 | 2021-01-25 | headache, malaise |
headache; feeling unwell; received the first dose on 18Dec2020 injection in left arm at 07:00am/ sec...
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headache; feeling unwell; received the first dose on 18Dec2020 injection in left arm at 07:00am/ second dose on 11Jan2021 at 15:30; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, in the left arm on 11Jan2021 at 15:30, at a single dose, for COVID-19 immunisation (prevent COVID). Relevant medical history included seizures diagnosed in 2014. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) injection on 18Dec2020 at 07:00 A.M. in the left arm for COVID-19 immunisation (prevent COVID). She was ok on 19Dec2020. After mid-day around noon she did not feel well, and it was hard for her to work on the 19th. She missed two days of work. On 20Dec2020, she could not get up from the bed. Concomitant medications included topiramate for seizures and levetiracetam (KEPPRA). The patient did not receive other vaccines within four weeks prior to and on the same day of COVID vaccination. The vaccine was administered in the hospital. The patient received the COVID vaccine yesterday (11Jan2021). She missed work today (12Jan2021) since she was feeling unwell and having a headache. She works in housekeeping. She started feeling unwell and her headache started after 3 in the morning. She wanted to stay home. Last night she was quite unwell, but she was better after taking second dose of Tylenol. She may need to take more medicine in 2 hours. The events did not require emergency room or physician visit. She does not have lot, NDC, or expiration date to provide for either dose. Outcome of the events headache and feeling unwell was recovering. Information about lot/batch number has been requested.
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| 41 | 2021-01-25 | chills, fever |
menstrual cycle started 4 days early with heavier than usual flow; Myalgias; Chills; Tmax 100.7; Thi...
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menstrual cycle started 4 days early with heavier than usual flow; Myalgias; Chills; Tmax 100.7; This is a spontaneous report from a contactable physician reported for herself. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142), intramuscular in the right arm on 08Jan2021, 15:00 at a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient did not have Covid prior to vaccination. Patient did not have other vaccine in four weeks. Concomitant medications included multivitamin. The patient previously took amoxicillin and experienced hypersensitivity (reported as known allergies to amoxicillin). The patient received the first dose of bnt162b2 (lot:EK5730), intramuscularly in the right arm on 18Dec2020 at 11:00AM at a single dose for covid-19 immunization. The patient experienced myalgias, chills, tmax 100.7 on 09Jan2021 09:00. It was also reported that patient's menstrual cycle started 4 days early with heavier than usual flow on 09Jan2021 11:00. Patient did not received treatment for the events. The outcome of the event myalgia, chills and pyrexia, was recovered on 09Jan2021, 21:00 and recovered on an unknown date for the event menstrual cycle abnormal. Patient was not tested positive for Covid-19 post vaccination.
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| 41 | 2021-01-26 | throat pain, headache, chills, runny nose, fatigue, fever |
After the first dose I began to shake uncontrollably and I had uncontrolled muscle movements in my w...
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After the first dose I began to shake uncontrollably and I had uncontrolled muscle movements in my whole body. I had the chills and a headache as well as muscle aches and a sore throat. After the second dose I had the chills again, headache, fever, sore throat, severe fatigue, muscle aches, runny nose that lasted over 24 hours.
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| 41 | 2021-01-26 | chills, headache, fatigue, sweating |
Chills; sweats; headache; myalgia; fatigue; This is a spontaneous report from a contactable other hc...
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Chills; sweats; headache; myalgia; fatigue; This is a spontaneous report from a contactable other hcp reported for herself. This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at right arm on 11Jan2021 09:00 AM at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No COVID prior vaccination, no COVID tested post vaccination. No other vaccine in four weeks. NO other medications in two weeks. Patient received first dose of BNT162B2 (lot number= EJ1685) at right arm on 20Dec2020 07:15 PM. On 11Jan2021 08:30 PM, the patient experienced Chills, sweats, headache, myalgia, fatigue. No treatment received. The event outcome was recovered.
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| 41 | 2021-01-26 | headache, chills, weakness, fever |
Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous rep...
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Fever; chills; body pains; headache; diarrhea; nausea; vomiting; weakness; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142, expiration date not reported) via an unspecified route of administration on the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies: Penicillin, shellfish, seafood. The patient's concomitant medications were not reported. The patient experienced fever, chills, body pains, headache followed by diarrhea, nausea, vomiting and weakness on 07Jan2021 10:00 pm. Treatment was received for the events (unspecified). The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included Nasal Swab on 09Jan2021: Negative. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-26 | dizziness | I had motion sickness , dizzy, and nausea. |
| 41 | 2021-01-26 | fever, weakness, chills, dizziness, headache, sweating, throat pain |
weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding...
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weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events. No follow-up attempts are possible. No further information is expected.
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| 41 | 2021-01-28 | dizziness |
1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states sh...
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1/27/2021 09:52:40 AM > Patient c/o dizziness and lightheadedness, BP 100/80, P 89, O2 99, states she is hypertensive with a normal BP of 130/80's , Juice and cookies given with additional observation time. 1000: BP 120/62 with patient still c/o dizziness, will continue to monitor. 1015: BP 130/82, patient states dizziness has improved slightly and that she has a ride and not driving, nurse encouraged patient to go to the nearest ER if symptoms persist. RN 1/28/2021 01:58:49 PM > contacted patient to f/u, message left
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| 41 | 2021-01-28 | dizziness |
Around 10 minutes after receiving vaccine, pt. c/o feeling flushed, hot and light headed. Pt. asses...
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Around 10 minutes after receiving vaccine, pt. c/o feeling flushed, hot and light headed. Pt. assessed by staff. BP: 100/68, HR: 68, RR: 16, O2 sats: 97%. No other symptoms noted. Pt. declines to go to emergency room. Will follow up with PCP if needed.
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| 41 | 2021-01-28 | shortness of breath, sweating, chills, throat pain |
It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches a...
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It started with painful ears and pressure, nausea, sore throat, chills, sweats, general body aches and pain and a little trouble breathing. They started to subside four days after vaccine was administered.
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| 41 | 2021-01-31 | throat swelling |
Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report f...
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Allergic reaction; Throat swelling; tightness; difficulty swallowing; This is a spontaneous report from a contactable Other Health Professional (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. The patient medical history reported no current heath issue like no "acute" (not clarified) current she got but she had got "bulging" (not clarified) disc and "effects" in the past, no "aplasia" (not clarified) nothing, no and she was "marina" (not clarified)." There were no concomitant medications. The reporter reported a patient that had an allergic reaction to the Pfizer Covid vaccine. Nurse stated that when she was "admitted" (not clarified) she was in the ER being monitored she got "admitted" (not clarified) first day today 7:45 not clarified (15Jan2021). The patient experienced allergic reaction, included "Throat swelling, tightness, difficulty swallowing." The reporter gave the patient "Api" (not clarified) 0.3 milligram and then also she had "Dimedrol" (not clarified) 125 and then she had CAPCID 20mg IV "piggy back" (not clarified). She had Benadryl 50 milligrams." The outcome of the events was unknown. Information on the batch number and lot number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reaction cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-01 | dizziness, throat swelling | 4 minutes- severe dizziness 6 minutes throat and tongue swelling 8 minutes - asthma attack |
| 41 | 2021-02-03 | weakness |
currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous repo...
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currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy; This is a spontaneous report from a contactable physician report for self. This 41-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), at left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included Breast cancer (remission, 15 years ago), GERD, Hyperlipidemia. Concomitant medication not reported. Patient previously received second dose of Gardasil vaccine on 16Dec2020 at left arm and first dose of BNT162B2 (lot number: EJ1685) on 30Dec2020 08:15 AM at left arm. Five days after 2nd covid vaccine (on 25Jan202021 01:00 PM), patient started experiencing excruciating pain along the plantar aspects of both feet. This, with numbness and tingling ascended upwards (in a matter of hours) to lower back and arms. Patient went to local emergency room and was later transferred to (Institute name) for higher level of care. She was currently receiving IVIG for Acute Inflammatory Demyelinating Neuropathy. This is a GBS-like illness. Very debilitating, due to pain. No motor deficits yet. Hoping the IVIG stops the Demyelinating process in its tracks. The events resulted in hospitalization for 6 days. Patient received Nasal Swab covid test date on 25Jan2021 with result of "Negative". The outcome of events was not recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported event acute inflammatory demyelinating neuropathy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-04 | throat pain, dizziness |
Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lighth...
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Had covid after 19 days got the vaccine; Had covid after 19 days got the vaccine; immediately lightheaded dizzy; body aches; severe sore throat; gums swollen and red; gums swollen and red; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 15Jan2021 15:15 at single dose for COVID-19 immunisation. Medical history included covid-19 (covid prior vaccination: Yes). No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). No other vaccine in four weeks. The patient experienced side effects immediately lightheaded dizzy , body aches, severe sore throat, gums swollen and red on 15Jan2021, had covid after 19 days (as reported) got the vaccine. The events resulted in emergency room/department or urgent care. Events treatment included steroids and fluids. The outcome of events was not recovered. No covid tested post vaccination. The patient was not pregnant. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported covid based on the known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-04 | malaise, respiratory tract congestion, throat pain |
resurgence of Covid-19 symptoms experienced the month prior; I still feel sick; congestion; sore thr...
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resurgence of Covid-19 symptoms experienced the month prior; I still feel sick; congestion; sore throat; This is a spontaneous report from a contactable other HCP (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EK9231) on 08Jan2021 17:00 at single dose in left arm for Covid 19. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included sleep, had Covid back in Dec, early Dec. Concomitant medication within 2 weeks of vaccination included zolpidem tartrate (AMBIEN) to sleep. The patient experienced resurgence of Covid-19 symptoms experienced the month prior on 11Jan2021 12:00 AM. She had her first dose on 08Jan2021 and all of her Covid symptoms return except this time little bit worse than the first. It says 13 days since her dose and she still feel sick on 11Jan2021 12:00 AM, congestion on 9Jan2021, sore throat on 9Jan2021. No treatment received for all the events. All the events result in Doctor or other healthcare professional office/clinic visit. The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet. The outcome was not recovered. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient stated, "Advil, probably 400 mg maybe like two times a day at most but it wasn't every day. I did not take it every day, I take it for couple of days."; Sender's Comments: The 41-year-old female patient had Covid in early Dec2020. On 08Jan2021, she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), and experienced resurgence of Covid-19 symptoms on 11Jan2021. The patient have Covid test (Nasal Swab covid test) on 15Jan2021 but have not received the result yet. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the resurgence of Covid-19 symptoms most likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 41 | 2021-02-05 | headache, nerve pain, chills, lethargy, fever |
After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, b...
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After receiving 2nd dose of vaccine on 1-25-2021 at 11:20, I had spiked a fever of 104.00, nausea, body chills, lethargy, vomiting, head ache and arm pain. Took 50 hours to get out of bed and feel half normal. Thought I was on the road to recovery when the arm pain started to increase. No rash or swelling occurred at the sight. It presents with pain more nerve like pain in my shoulder, elbow and radiated to fingers. On Feb 5th the pain was so bad I went to see a shoulder specialist and are trying to figure out what is going on. My right arm remains painful to move with nerve issues. The specialist advise I report. In the meantime, I will follow up Monday with another specialist and also undergo some nerve testing.
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| 41 | 2021-02-09 | nerve pain |
Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbnes...
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Horrible muscle and nerve pain in lower extremities. Burning sensation with shooting pain, numbness, and tingling in lower extremities. Feet contract and I am unable to walk on them if I do not keep them flat.
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| 41 | 2021-02-16 | fever, shortness of breath, headache, fatigue |
Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; ...
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Fatigue; fever; vomiting; pain and swelling at injection site; pain and swelling at injection site; bone and muscle aches throughout body; bone and muscle aches throughout body; headaches; nausea; painful lump on under arm of the arm that the shot was given; trouble breathing; chest heaviness; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old female patient (pregnant: unknown) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, , Formulation: Solution for injection, Lot number: unknown, expiration date unknown), via intramuscular on the left arm on 04Feb2021 at 11:30 at a single dose for COVID-19 immunization in the hospital. Medical history included diverticulosis and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient concomitant medications were not reported. The patient experienced fatigue, fever, vomiting, pain and swelling at injection site, bone and muscle aches throughout body, headaches, nausea, painful lump on under arm of the arm that the shot was given, trouble breathing, chest heaviness all on 04Feb2021 at 19:00 PM. Patient visited emergency room/department or urgent care in response to the events. Patient received Zofran, dexamethasone and espi. The reporter assessed the events as non-serious. The patient was recovering from the events. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 41 | 2021-02-21 | dizziness |
Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal ...
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Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.
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| 41 | 2021-02-21 | fatigue, runny nose |
Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary reg...
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Runny nose, Body aches, fatigue, joint pains (diffuse), lymph node swelling of neck and axillary region on same side as vaccination given, muscle soreness and pain of chest wall on same side as vaccination given, felt hot and prickly all over but not measuring fever, nausea. Symptoms started late Friday night after vaccination and are ongoing still as of Monday after receiving.
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| 41 | 2021-02-21 | fever |
deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following inj...
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deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following injection DVT persists and was diagnosed 6 days later; all other symptoms resolved within 24 hours
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| 41 | 2021-02-21 | throat swelling |
itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongu...
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itchiness along left side, pain in neck on left side, itchiness of the lips, minor swelling in tongue and throat
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| 41 | 2021-02-22 | skin warm, headache, fatigue, dizziness, chills |
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache....
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Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
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| 41 | 2021-02-22 | fever |
Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The followi...
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Pfizer shot #1: She received the 1st COVID vaccine Pfizer on January 24th at 7:00 p.m.. The following day she noted a low-grade fever. On January 26 she noted edema of her eyes and lips associated with facial redness and itching that she treated with Benadryl intermittently for the past 2.5 weeks. She was seen in follow-up by her dermatologist who suspected an inflammatory reaction and prescribed anti-itch facial cream. She was also seen by her primary care who suspected angioedema and prescribed her an EpiPen which she has not needed to use. Pfizer shot #2: 2nd shot delayed due to snow. Above sx resolved before shot #2. She had her 2nd COVID injection February 20 at 3:50 p.m. About 1.5-2 hours later she noted onset of itching to her eyes and nipples along with itching of the skin in the locations of her usual eczema. She noted that her lips and eyes were a little puffy but less severe swelling to the eyes and lips than the 1st injection. She took 2 Benadryl shortly after onset of these symptoms. This seemed to lessen symptoms about 50%. Later she noticed that her voice sounded raspy and hoarse and she had a sensation of swelling to her tongue and throat but she was able to swallow. Her throat felt scratchy. She denies having lightheadedness, urticaria or GI symptoms. She went to the ED and was treated with benadryl, solumedrol and pepcid, monitored for a few hours and then discharged on 60 mg prednisone X 3 days and advised to continue benadryl 50 mg Q6h. She takes zyrtec 10 mg BID for seasonal/perennial allergies. Allergy history: She has a history of both idiopathic urticaria in early childhood and idiopathic angioedema in her early 20's. States she had extensive testing but the cause was never exposed. Took high dose prednisone for 4-5 months, angioedema resolved spontaneously and then flared again a few months later. Finally resolved with n additional 3 months of prednisone. She has both seasonal (feb-may) and perennial allergies to cat and dust, asthma and allergy to ampicillin--rash in childhood, and humira--fevers.
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| 41 | 2021-02-22 | fever, headache, fatigue, chills, malaise |
Started with achiness just before midnight (after having sore arm all day, but not troubling), woke ...
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Started with achiness just before midnight (after having sore arm all day, but not troubling), woke with fever/chills/headache about 1am and unable to sleep well 1-6am, slight nausea 4-8am, still ongoing achiness all over body and just ill-feeling and fatigue (currently 11am day-after vaccine)
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| 41 | 2021-02-22 | fever | Vomiting fainting fever |
| 41 | 2021-02-22 | headache, fever |
Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted througho...
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Woke at 3am with severe body aches, headache, fever of 101.3 and nausea. Symptoms persisted throughout the day with max temp of 103. Also had swelling at injection site with redness the size of a baseball and extreme tenderness to upper arm.
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| 41 | 2021-02-28 | chills, headache |
MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in ...
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MRI showing inflammatory lesion of the Pons/Single lesion appearing inflammatory in nature found in the pons at origin of cranial nerve 6; single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6; Development of double vision/double vision with right gaze and head turning; mild chills; headache; significant diarrhea; vision noted to be off; This is a spontaneous report from a contactable other health care professional, the patient. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 14Jan2021 at 01:15 (at the age of 41-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included spontaneous coronary artery dissection with stenting (reported as "five years ago") and complex migraines from an unspecified date. The patient is allergic to Tramadol, Codeine and Novocaine. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899) on 23Dec2020 at 01:15 AM as a single dose in the left arm for COVID-19 immunization.The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN).The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported the development of double vision on 25Jan2021 at 06:00. She was hospitalized and remained hospitalized for three days. She reports having had an MRI (date not specified) which showed an inflammatory lesion of the Pons. She further described the events as follows: Initially mild chills and headache "the day after" developing into significant diarrhea for four days and on and off diarrhea for several weeks. One week after vaccine vision noted to be off but no official work up developing into double vision with right gaze and head turning three weeks after vaccine. She also stated that there was a single lesion appearing inflammatory in nature found in the Pons at origin of Cranial Nerve 6. Treatment received included Solumedrol and Pepcid infusion. Lab data included an MRI on an unspecified date which showed inflammatory lesion of the Pons and COVD-19 testing as follows: SARS-CoV-2 Nasal Swab PCR test on 20Jan2021 and on 11Feb2021 both of which were negative. The clinical outcomes of brain inflammation, double vision, chills, headache, diarrhea, vision decreased and cranial nerve disorder were reported as recovering. No follow-up attempts are possible. No further information expected.; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 41 | 2021-02-28 | headache |
the second dose; I have headache; I noticed the gums are swollen but not as big as the first time.; ...
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the second dose; I have headache; I noticed the gums are swollen but not as big as the first time.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on 26Jan2021 at single dose for COVID-19 immunization. Medical history included High Blood Pressure. Concomitant medication included amlodipine for High Blood Pressure. The patient previously took first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization and experienced "gum on my right face was swollen". It was reported that patient received the second dose and when she woke up, she had headache and then noticed the gums were swollen but not as big as the first time in Jan2021. No treatment received for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 41 | 2021-03-01 | shortness of breath, cough, dizziness |
Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vac...
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Pfizer-BioNTech COVID-19 Vaccine EUA: The patient reported to have received 2nd Pfizer COVID-19 vaccine on 2/19/21. Unknown where the patient got their vaccine administered. Immediately afterwards, the patient developed hives, cough, and lightheadedness and was sent to Hospital. They were treated with steroids and diphenhydramine. Their symptoms resolved and they were discharged. On 2/20/21 patient came to emergency room in the morning with allergic reaction. They woke up in the morning with hives, swelling in face, and feeling of thickness in throat and shortness of breath. They were given dexamethasone, diphenhydramine, and famotidine. Their symptoms resolved and they were discharged. While at home the patient developed hives and took diphenhydramine. They had tingling and a rash over their face. On 2/20/21 the patient returned to the emergency room in the evening with a rash. The symptoms were pain and burning. They also complained of abdominal cramping, mild nausea, and left sided chest pain. Their symptoms improved and they were discharged. On 2/22/1 the patient returned to the emergency and was subsequently hospitalized. They presented with face swelling, general pruritus, and hives. She reported chest tightness and paresthesia involving her lips. Admitted on 2/22/21 to 2/25/21. She was given diphenhydramine, famotidine, and hydrocortisone.
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| 41 | 2021-03-02 | fatigue, chills, fever |
Fever last night of 102.3; cold chills; aches; extreme fatigue; loss of appetite; This is a spontane...
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Fever last night of 102.3; cold chills; aches; extreme fatigue; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 24Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included asthma. Concomitant medication included valaciclovir hydrochloride (VALTREX). The patient previously took acetylsalicylic acid (ASPIRIN) and hydrocododone and experienced allergies. The patient experienced cold chills and aches, extreme fatigue, loss of appetite on 26Jan2021 10:00 AM. At days 5-7, my symptoms went from to strongly moderate. Fever last night (30Jan2021) of 102.3. No treatment was received for the events. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 41 | 2021-03-02 | fatigue |
Patient received her second covid 19 vaccine on the 18th of February - about four hours after she de...
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Patient received her second covid 19 vaccine on the 18th of February - about four hours after she developed some soreness, fatigue and had a hard time moving her arm. Continued for a couple of days. Sunday 2/21 patient woke up without taste and her tongue was numb. That evening she began having some neck pain, below her ear, she massaged and didn't help all that well. At around 3 am that night, the pain was entirely on the right side of her neck and face, she took ibuprofen which mildly helped at night it was the entire neck. Monday 2/22 patient massaged area and it helped a little. She continued to have pain Tuesday 2/23 - Around 9am that morning patient noticed right sided facial drooping and her tongue was not working properly. She also noticed that her eye would not respond like her left eye. It was sluggish. When she went to brush her teeth, she noticed that the water would not stay in her mouth and it came out. At around 7pm that evening she went to the emergency room
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| 41 | 2021-03-02 | headache, fatigue, shortness of breath |
face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really...
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face started to feel "hot and on fire"; face and neck turned bright red; face started to feel really tight; Heart Rate then was elevated to 115 bpm; shortness of breath; itchy eyes; headache; nausea; Arm still felt sore; fatigued; At site of injection there was a warm sensation; metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) solution for injection, intramuscular at left arm on 29Jan2021 at 10:30 AM at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. The patient's concomitant medications were not reported. The patient was not pregnant and has no other vaccines in four weeks. She will have a birth control in two weeks. It was unknown if the patient has COVID prior to vaccination. She was not tested with COVID post vaccination. The patient was given COVID-19 vaccine at a hospital. When she initially received the vaccine on 29Jan2021, the site of injection had a warm sensation which resolved within a minute. Then on the ride home, she had a metallic taste in her mouth. While at home around 4:00 PM, her face started to feel hot and on fire and then her face and neck turned bright red. Her face started to feel really tight and hot. Heart rate was then elevated to 115 bpm. She then started having shortness of breath, itchy eyes, headache and nausea. The patient sat down and took 10 mL of BENEDRYL (as reported) at 4:30 PM or 4:40 PM. Between 5:00 PM and 7:00 PM, her face and neck were still slightly red. Her arm felt sore and she was fatigued. She again took 10 mL of BENEDRYL at 7:30 PM. She woke up on 30Jan2021 and still felt fatigued and the back of arm (tricep area) was very sore. The patient also took paracetamol (TYLENOL) 600 mg. The outcome of the event vaccination site warmth was recovered with sequel on 29Jan2021 and recovered with sequel on Jan2021 for all other events.
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| 41 | 2021-03-02 | fatigue, night sweats, influenza like illness, headache, chills |
flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a sponta...
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flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included Seizure disorder, depression, anxiety, mild hyperthyroidism and Penicillin allergy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR), and omeprazole. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced flu-like symptoms, headache, aches, chills, night sweats, and more fatigue than normal on 17Dec2020 19:00. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The patient has not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.
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| 41 | 2021-03-03 | headache, fatigue |
headache was heavy; her body and bones felt tired; sinuses felt heavy; shoulders are heavy; her thig...
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headache was heavy; her body and bones felt tired; sinuses felt heavy; shoulders are heavy; her thigh on the back is heavy; stated that she cannot move but can walk; neck on side when she has hiccups that she feels pain and in her back; neck on side when she has hiccups that she feels pain and in her back; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 29Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On the second day (Jan2021), her body and bones felt tired when she stretched and her sinuses felt heavy. On 01Feb2021, her headache was heavy. She took Benadryl. Her shoulders, neck on side and her thigh on the back were heavy on 2021. She cannot move but can walk on 2021. When she walks that it feels likes electricity. Also on 2021, her neck on side when she has hiccups that she feels pain and in her back. Patient was worried about it and wanted to know if it was normal to feel like this after the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 41 | 2021-03-07 | sweating, dizziness, cold sweat |
Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; swea...
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Severe stomach cramping; diarrhea; dizzy; nausea; cold clammy pale skin; cold clammy pale skin; sweating profusely; very low body temp; rapid pulse; shaking; This is a spontaneous report from a contactable consumer who reported for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, via an unspecified route of administration in the left arm on 02Feb2021 04:00 PM at a single dose for covid-19 immunisation. Medical history included obesity. Patient was not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 02Feb2021 at 10:00 PM (6 hours after vaccine was given), the patient experienced severe stomach cramping, diarrhea, dizzy, nausea, cold clammy pale skin, sweating profusely, very low body temp, rapid pulse, and shaking. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 41 | 2021-03-09 | runny nose, dizziness, chills, weakness, fatigue, fever, shortness of breath |
Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection s...
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Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021
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| 41 | 2021-03-17 | headache, throat pain, cough, dizziness, fatigue |
sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough;...
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sore throat; nausea; palpitations; headaches; Dizziness; fatigue; faint; body aches; myalgia; cough; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 07Jan2021, 15:00 (lot number: EL3246), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in the hospital. The patient's medical history included Covid-19 prior to vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive other vaccines within four weeks. The patient was not pregnant at the time of vaccination. The patient experienced sore throat, nausea, palpitations, headaches, dizziness, fatigue, faint, cough, body aches and myalgia on 08Jan2021, 19:00. The adverse events required doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient received treatment including antibiotics (did not help); pain medications for myalgia. The patient was underwent COVID-19 (Nasal Swab) on 15Jan2021 which was negative, and PCR and Flu (nasal swab) test on 20Jan2021 which was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 42 | 2020-12-31 | sweating, dizziness |
Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, co...
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Dizziness, nausea, diaphoresis, syncope/fall. Totally blacked out and fell. Helped back to bed, covered in sweat. No fever. Layed in bed until next morning around 10am, still dizzy and nauseated.
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| 42 | 2020-12-31 | dizziness |
about an hour and a half after my shot Wednesday 12/30/20, I became extremely dizzy, it hit me sudd...
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about an hour and a half after my shot Wednesday 12/30/20, I became extremely dizzy, it hit me suddenly. Lasted for a few hours. 12/31/20 when I woke up, I was still light headed and slightly dizzy and I still feel the same 1/1/20 dizziness is not nearly as bad as the first day.
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| 42 | 2021-01-01 | throat irritation |
@ 1525 Pt stated to this nurse that her throat felt like it was "burning a little". Denies s/s of ...
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@ 1525 Pt stated to this nurse that her throat felt like it was "burning a little". Denies s/s of any breathing issues. Water was given to her by this nurse. @ 1528 she stated that it felt more like "an itchy feeling in her throat/chest". Expressed to this nurse around 1533 that the issues had slightly resolved, and that she felt anxious upon receiving the vaccine. This nurse gave Pt a Benadryl 25mg @ 1539. States that her s/s are better. Pt states she takes the following medications, Allegra po once daily, Flonase daily, and Flovent. Does voice that she has chronic allergies/asthma. Pt is still in observation @ present time 1552. Left observation @ 1554, states that her s/s had improved.
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| 42 | 2021-01-01 | nasopharyngitis, shortness of breath, fatigue, headache |
Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue s...
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Immediately: headache, feeling off/loopy, mild shortness of breath 45 min later: dry mouth, tongue swelling, mild fatigue, sinus pressure , shortness of breath 1 day later: redness injection site, moderate swelling or arm, mild head cold 2 days later: mild fatigue, sinus pressure, pain arm and redness of injection site
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| 42 | 2021-01-01 | influenza like illness, shortness of breath, nasal congestion, fatigue, fever, dizziness, chills, headache, malaise |
pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy n...
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pfizer-Biotech/Covid-19 vaccine flu like symptoms- nausea, light headed, trouble focusing, stuffy nose, body aches, fever and chills but no actual fever- body just felt really warm. problems breathing at times (like a panic attack), headache, stiff neck, fatigue-- I fell asleep in my car because I was so tired. sore arm, irritability, When trying to lie down, I could not get comfortable, I found myself lying on the floor since it was cold, this is not normal behavior. i felt super sick. I was crawling on the floor because of how dizzy and tired i felt. It felt like a really bad drunk or hangover. noises were too loud, it felt horrible. I don't know if it is done.
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| 42 | 2021-01-02 | dizziness |
11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patie...
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11:42 am patient felt dizzy and palpitations 10-12 minutes after receiving vaccine. 11:47 am patient evaluated by EMS BP 168/110, Pulse 120, EKG done. patient reporting feeling better but wishes to to seen in ED. 11:54 am patient transported to hospital by EMS
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| 42 | 2021-01-02 | throat irritation |
After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat,...
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After receiving vaccine, c/o heart racing, palpitations, pulse- 100-120, hot flash, scratchy throat, c/o "tonsil swelling"....
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| 42 | 2021-01-02 | fever, headache, chills |
Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive...
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Woke up with severe chills, shaking, fever of 100.8, generalized body aches, generalized sensitive skin, and mild headache. All symptoms resolved after 1 day.
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| 42 | 2021-01-03 | fever, chills |
After patient received an injection, patient developed fever, body aches, body chills, and injection...
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After patient received an injection, patient developed fever, body aches, body chills, and injection site is red and swollen. Patient also mentioned that her arm pit area is also swollen.
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| 42 | 2021-01-03 | headache |
Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50m...
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Developed wheezing/chest tightness. No stridor or rash or injection site symptoms. Took Benadryl 50mg q4 x 3 doses, took albuterol every 2 hrs for 8 hrs. Had EpiPen nearby (a family member's, not mine), but did not use. Felt fine the next morning, 24 hrs afterwards. Just mild headache for a few days (not unusual for me)
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| 42 | 2021-01-03 | headache, fatigue, shortness of breath |
Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 min...
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Few minutes after receiving the vaccine I have noticed slight shortness of breath, then after 45 minutes, I developed a headache. These symptoms worsen as the day progressed. The severe headache and increased shortness of breath lasted 14 days along with dangerously elevated blood pressure, fatigue, and nausea.
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| 42 | 2021-01-03 | chills, lethargy, fever |
Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. To...
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Nausea ,vomiting 48hrs fever 101 maxing out on Tylenol . Body aches Lethargy, Chills. Sore arm. Took anti nausea meds for 4 days.
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| 42 | 2021-01-03 | dizziness, fatigue | Nausea, Vomiting, extreme fatigue, dizzyness |
| 42 | 2021-01-03 | shortness of breath | Patient complained of shortness of breath, chest tightness, and throat closure |
| 42 | 2021-01-03 | shortness of breath |
Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for...
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Shortness of breath and tremors with Pfizer-BioNTech covid-19 vaccine 25 minutes after 0.3 mL IM for right deltoid after first dose. Hemodynamically stable and afebrile. Differential diagnosis includes but is not limited to allergic reaction, anxiety, panic attack, asthma attack, sequelae of hyperthyroidism. After resting comfortably in the room for approximately 15 minutes, she reported that her symptoms were starting to subside. She happily excepted diphenhydramine (dose not documented). She was observed for 2.5 hours and had no worsening of symptoms. Her vital signs were stable and she had appropriate SPO2 on room air throughout her stay in the emergency department. We discussed strict return precautions for evidence of allergic reaction, chest pain, worsening shortness of breath, altered mental status or fever. She will follow-up with her primary care doctor. Discharged in stable condition to the care of her husband.
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| 42 | 2021-01-04 | chills, fever, headache |
About 16 hours after receiving my second dose of the covid vaccine I began to have chills, muscle ac...
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About 16 hours after receiving my second dose of the covid vaccine I began to have chills, muscle aches, headache and fever of 100.8.
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| 42 | 2021-01-04 | chills |
About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt li...
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About 20-30 after injection it became a bit difficult to swallow. Throat felt thicker; heart felt like it was racing. Shivering and Blood pressure was up a little. 14:19 Benadryl 25 mg administered. 14:30 BP 164/92, P-76 R-16 O2 100% Discharged back to work at 16:15.
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| 42 | 2021-01-04 | fever |
About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI...
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About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 28Dec2020 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included the patient had allergies to medications, food, or other products, Bactrim and Sulfa based medications, & food sensitivities. Concomitant medication included birth control. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergies to medications: BACTRIM. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 About 45 minutes after injection, patient got a bloody nose out of nowhere (14:00), then at night at 22:00 (10:00PM) started having gastrointestinal (GI) symptoms & low grade fever. The events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever. Outcome of the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever were recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 42 | 2021-01-04 | dizziness, fatigue, headache |
Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizz...
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Approximately 6.5hrs after vaccination, patient developed severe fatigue, some palpitations and dizziness. The next the morning, she had headache, nausea and strange feeling on the tip of throat and nose. She also had pain and swelling in the injection side, no erythema.
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| 42 | 2021-01-04 | influenza like illness |
Flu like symptoms that began the day after vaccination, lasting for 1 day. Reported severe residual ...
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Flu like symptoms that began the day after vaccination, lasting for 1 day. Reported severe residual joint aches in shoulder, scapula, hips, wrists, ankles. Right sided pain persisted, left side lessened. Relieved by NSAIDS
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| 42 | 2021-01-04 | weakness, headache |
Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 4...
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Headache started 20 minutes after vaccine was administered Left arm feels very heavy, weak started 40 minutes after vaccine was administered
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| 42 | 2021-01-04 | fatigue |
I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node...
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I had fatigue and body aches for 4 days I woke up Sunday morning and I had a huge swollen lymph node the size of a golf ball at the base of the right side of my neck that lasted for 2 days, I was put on ogmentin for 5 days and it went away after that
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| 42 | 2021-01-04 | fever, chills, fatigue |
Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site ...
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Nausea; vomiting; pain at injection site with paresthesias in the lower arm; pain at injection site with paresthesias in the lower arm; neck pain on the injection side; severe fatigue; myalgia; Fever; chills; SOB on exertion; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old female patient received 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), via an unspecified route of administration at arm left, on 18Dec2020 at 02:30 PM, at single dose, for COVID-19 immunisation. Medical history included hypertension, obesity, mood disorder, latex allergy. Patient did not experience COVID-19 before vaccination. Concomitant medications included trazodone (unknown manufacturer), escitalopram (unknown manufacturer). On 18Dec2020 at 10:00 PM the patient experienced nausea with outcome of recovering, vomiting with outcome of recovering, pain at injection site with paresthesias with outcome of recovering, neck pain on the injection side with outcome of recovering, severe fatigue with outcome of recovering, myalgia with outcome of recovering, fever with outcome of recovering, chills with outcome of recovering, shortness of breath (SOB) on exertion with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 25Dec2020. No therapeutic measures were taken as a result of the events. The events were considered non serious.
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| 42 | 2021-01-04 | cough |
Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to spe...
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Pt received COVID Vaccine at 1055, 1120 pt began coughing severely and could not stop, unable to speak. 1120 25mg Benadryl liquid given, Pepcid 20 mg given PO, cough worsening. 1122 second dose of Benadryl given, called for MD. Brought pt to Private room via wheelchair. Upon arrival, audible stridor noted. Epinephrine 0.3 mg IM given at 1126. IV started, placed patient on monitor and O2 via 1L NC. MD at bedside along with RT and pharmacy. 1134 Solumedrol 125 mg IV given, 1 puff of Ventolin given. Lungs clear. 1140 Coughing stopped, pt able to speak now. Vital signs: 1130 SPO2 99% Pulse 142 1135 99% pulse 106 BP 168/102 1140 sats 100% HR 93 BP 157/105 1145 sats 100% HR 97 BP 159/93 1200 sats 99% HR 103 155/97 114
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| 42 | 2021-01-04 | fatigue |
Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of...
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Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
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| 42 | 2021-01-04 | night sweats, fatigue |
Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a...
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Sore arm; nocturnal diaphoresis; generalized mild pain; fatigue; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EJ1685), via an unspecified route of administration, on 18Dec2020 at 02:45 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 42-years-old. No other vaccine was received in four weeks. Medical history included prior to vaccination the patient diagnosed with COVID-19 and known allergies were Penicillin (PCN), ephedrine, calamine, calendula, pollen. Concomitant medications included escitalopram 10mh. On 19Dec2020 at 07:00 AM, the patient experienced sore arm, nocturnal diaphoresis, generalized mild pain, fatigue. The events were reported as non-serious. The patient recovered in Dec2020 form the events. No treatment was received.
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| 42 | 2021-01-04 | chills, fatigue, headache, dizziness, weakness |
arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills ...
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arm pain all the way down to fingers unable to lift arm past head dizzy weak headache nausea chills no fever exhausted no appetite arm pain is 60% better today no redness at injection site mild swelling at injection site mentally foggy weak vision
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| 42 | 2021-01-04 | throat irritation |
throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a sponta...
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throat feeling "hot"; tongue feeling numb and thick; tongue feeling numb and thick; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date unknown) intramuscular at left deltoid on 28Dec2020 10:00 at single dose for Covid-19 immunization. The COVID-19 vaccine was administered in the workplace clinic. Medical history included allergies to shellfish, allergies to strawberries, and environmental allergies. Concomitant medications were not reported. On 28Dec2020 10:30 am (approximately 30 min post vaccine), the patient experienced that her throat feeling "hot" and her tongue feeling numb and thick. The patient denied ever feeling short of breath. The patient's vital signs were recorded on 28Dec2020. The patient was not tested for COVID-19 since vaccination. The outcome of the events throat feeling "hot", tongue feeling numb and thick was unknown. The reporter considered the events non-serious; did not results in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating, not a congenital anomaly/birth defect.
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| 42 | 2021-01-05 | headache | Headache Injection site pain/soreness |
| 42 | 2021-01-05 | headache | Headache Narrative: |
| 42 | 2021-01-05 | chills, headache | Headache, Myalgia, NauseaVomiting, chills, pain at injection site Narrative: will report to work |
| 42 | 2021-01-05 | fatigue, headache | Headache, Myalgia, fatigue,golfball size reddness at injection site |
| 42 | 2021-01-05 | fatigue | Sore arm and fatigue lasting 24 hours. Ibuprofen. |
| 42 | 2021-01-05 | weakness, somnolence, fever, malaise, headache, fatigue |
she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from ...
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she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown. Information about lot/batch number has been requested.
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| 42 | 2021-01-05 | headache, night sweats, fatigue |
vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontan...
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vaccination site pain; Tiredness; Headache; Joint pain; Muscle pain; Night sweats; This is a spontaneous report from a contactable Pharmacist, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), intramuscularly in the right arm on 30Dec2020 at 16:30 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included Graves' disease from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing and anxiety from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE), duloxetine (DULOXETINE). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. On 31Dec2020 at 02:00, the patient experienced vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats. No therapeutic measures were taken as a result of the events. The clinical outcome of the vaccination site pain, tiredness, headache, joint pain, muscle pain and night sweats was resolving. It was also reported that since the vaccination, the patient had been tested on 31Dec2020 for COVID-19 with results pending.
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| 42 | 2021-01-06 | dizziness |
12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discha...
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12 minutes post vax felt warm, dizzy, hypotensive, syncope. Transferred to ED, monitored and discharged. On 12/24/2020 developed cyanosis to lips. Returned to ED and placed on 5 day steroid therapy and diphehydramine. Mildly improved.
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| 42 | 2021-01-06 | discomfort |
About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of m...
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About 5 minutes after the shot, I started to feel a tightness in my throat. It lasted a couple of minutes and then passed. Then about 45 minutes after I started to feel a heaviness/ache in my upper chest. This feeling continued for days. Around day four I began to have a feeling of great pressure in my throat, particularly when swallowing. I noticed that my heartrate was elevated, but that might have been because the feeling was very stressful. The feeling would increase when I turned my head to the side or put my chin down.This feeling persisted for 3 days. After three days the feeling changed slightly and started feeling more like the sensation one gets when you have food stuck in your throat. As I type this, it is 8 days after the vaccine and I still feel this sensation in my throat.
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| 42 | 2021-01-06 | malaise |
Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sor...
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Agitation, Depression, Myalgia, sore right arm Narrative: Employee states, "I did experience the sore arm, though mine lasted about a week. I received my vaccine the morning of the 21st and by the evening I was experiencing what I have been called "tantrum moodiness". Short fuse, unreasonably angry, felt like crying, yelling, arguing. By the next day some general malaise that led to aching, especially it seemed in connective tissue. More moodiness, crying, some yelling. By Wednesday it seemed to resolve."
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| 42 | 2021-01-06 | body temperature increased | Diarrhea, nausea, Temp 102, body achestx with Ibuprofen with some relief |
| 42 | 2021-01-06 | cough, headache, fever, dizziness | Dizziness, Headache, Myalgia, Fever, CoughWheeze, |
| 42 | 2021-01-06 | sweating, headache, body temperature increased, fatigue, weakness |
Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fa...
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Extreme weakness, profuse sweating, severe headache, body aches, Temp 102.4, nausea and vomiting, fatique
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| 42 | 2021-01-06 | headache, fever, chills | Fever, chills, headache, muscle aches |
| 42 | 2021-01-06 | headache | Headache, Myalgia, Arthralgia & Nausea Vomiting |
| 42 | 2021-01-06 | weakness, headache, fever, cough, fatigue |
I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vacci...
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I had previous diagnosis of COVID-19 in September 2020. No one asked me that question prior to vaccination. After the vaccination, I had a fever for 1.5 days, muscle aches, weakness, nausea, diarrhea, headache, fatigue, cough. I had a rash that appeared after I got COVID-19, the rash never went away. After the vaccination, the rash became redder, enlarged, and spread.
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| 42 | 2021-01-06 | fever | Myalgia & Fever Narrative: |
| 42 | 2021-01-06 | skin warm |
Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphe...
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Patient reported swelling, redness, itching, hot to touch above her left breast. Patient took diphenhydramine
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| 42 | 2021-01-06 | chills, headache, malaise |
Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a he...
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Roughly 12 hours after receiving dose number 2, I started to have body aches, general malaise, a headache, eye pane, and left ear pain. Around midnight, I started to experience severe chills along with the body aches. I woke up around 4:30 a.m. with a fever, 38.8?C orally. All other symptoms continued as well.
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| 42 | 2021-01-06 | weakness |
Transient weakness, numbness in bilateral lower extremities and cold left arm. Patient rested and s...
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Transient weakness, numbness in bilateral lower extremities and cold left arm. Patient rested and symptoms resolved
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| 42 | 2021-01-06 | throat irritation | Wheezing Rapid breathing Throat itching and tightness |
| 42 | 2021-01-06 | chills, cold sweat | chills, cold sweats, diarrhea, muscle aches |
| 42 | 2021-01-07 | weakness, lethargy, body temperature increased, chills, sweating |
1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and a...
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1/06/2021: 0200-severe body ache, chills 0700 to 1100- 103.2 temp climbing with use of Tylenol and aspirin. 1100 to 01/07/2021, 0200 severe lethargy lasting till around this time. Heart rate excess of 130, dizziness, severe weakness, muscle pain, fever 103 to 104 F. 650mg oral Tylenol and aspirin 325mg every 6 hours does not control temp. Intermittent periods of extreme perspiration. 0200 1/07/2021 to 1200, slow decline in body pain with ongoing Tylenol and aspirin every 6 hours. No more elevated temps. Injection site/arm remains painful.
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| 42 | 2021-01-07 | headache, fatigue, shortness of breath, dizziness, chills, nasal congestion, fever |
3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint...
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3:00p fever, 99.2, 5:00p 100.2, Itchy, Tired, headache, stuffy nose, inj site pain, muscle and joint pain, chills, shot area is swollen, nausea, lymph nodes swollen and sensitive to touch. Face is tender. SOB with movement and dizziness. Patient is a cancer survivor and she said that it feels like she had a chemo treatment.
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| 42 | 2021-01-07 | cough, shortness of breath |
After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the wait...
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After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vital signs were being taken when I started to have an increase in coughing, shortness of breath and vomiting. I was given an epipen and brought to the emergency room when I received Benadryl 50mg IV, Solumedrol 125mg IV, and Pepcid 20mg IV. Approximately 1 hour after receiving the medication my face again began to itch and I was given an additional dose of 25mg of Benadryl. My reaction resolved and I was discharged home with a prescription for prednisone.
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| 42 | 2021-01-07 | dizziness | BP: 120/70 - Lightheadedness, syncope. Outcome: rested, stabilized. |
| 42 | 2021-01-07 | fatigue |
Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination -...
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Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.
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| 42 | 2021-01-07 | headache, chills, thirst |
Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable othe...
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Chills; Headache; Bad dreams; Excessive thirst; This is a spontaneous report from a contactable other hcp, the patient. This 42-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number EL3246), intramuscularly on 02Jan2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 vaccination. Prior to the vaccination, the patient had been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. On 02Jan2021, the patient experienced headache, chills, bad dreams and excessive thirst. No therapeutic measures were taken as a result of the events. The clinical outcome of headache, chills, bad dreams and excessive thirst was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 42 | 2021-01-07 | chills, throat pain, dizziness, shortness of breath, headache, nasal congestion |
Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asth...
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Chills; Soreness at the injection site; generalized body aches/Body aches; Shortness of breath; Asthma attack; Difficulty sleeping; Light headed and dizzy; Nausea; high BP 140's; HR 110's to 120s; Nasal congestion; Swelling of the face; Sore throat; This is a spontaneous report from a contactable nurse. A 42-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730, expiration date not reported), intramuscular on the right arm on 31Dec2020 at 10:15 AM, at a single dose for Covid-19 immunization. Medical history included asthma, allergy, hypothyroidism, and some fish allergy. There were no concomitant medications (no other vaccine in four weeks and no other medications in two weeks). Patient previously took ibuprofen and experienced allergy. The patient is not pregnant. On 31Dec2020, after ten-15 minutes (10:30 AM) of receiving the vaccine, she was light headed and dizzy with some nausea. Monitored in the emergency room (ER) with high BP 140's and heart rate (HR) 110s to 120s. After an hour of saline bolus, she was better but she got nasal congestion and swelling of the face with sore throat. On 01Jan2021, after 24 hours, she got some soreness at the injection site with generalized body aches. Also she got some shortness of breath which lead to her asthma attack and difficulty sleeping. On 02Jan2021, after 48hours, she was feeling still light headed with some sore throat, chills, body aches and severe headache which lead her to go to the ER and got herself tested for flu, covid and strep, which came back all negative but her signs and symptoms (s/sx )still after discharge was getting worst especially the headache and generalized body aches. As well as congestion and sore throat. The patient had given "Ivf" for the events. The patient was not diagnosed with Covid prior to vaccination and was not Covid tested post vaccination. The outcome of the events was not recovered. The reporter assessed the events as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-07 | nerve pain |
Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache le...
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Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; Deep ache left deltoid at injection site with severe nerve pain when lifting left arm.; This is a spontaneous report from a non-contactable nurse. A 42-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 19Dec2020 11:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine. The patient experienced deep ache left deltoid at injection site with severe nerve pain when lifting left arm on 23Dec2020 16:30. The patient received no treatment. The outcome of the events was not recovered.
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| 42 | 2021-01-07 | chills, fever, headache |
Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin;...
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Fever up to 100.8 (unknown unit); chills; shaking; general muscle aches; generalized sensitive skin; mild headache lasting 1 day; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EK5730, intramuscular on Right arm from 22Dec2020 09:45 to 22Dec2020 09:45 as single dose for COVID-19 immunization. Medical history included hypertension, and glaucoma. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), fluticasone propionate (FLONASE), and latanoprost (XALATAN). On 24Dec2020 08:30 am, the patient experienced fever up to 100.8 (unknown unit), chills, shaking, general muscle aches, generalized sensitive skin, mild headache lasting 1 day. The patient was not tested for Covid post vaccination. The patient is not pregnant. The outcome of the events was recovered on 25Dec2020. No treatment was received for the events.
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| 42 | 2021-01-07 | fatigue, headache, malaise |
Headache Fatigue Narrative: 24 hours after vaccine administration onset of headache, malaise, feelin...
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Headache Fatigue Narrative: 24 hours after vaccine administration onset of headache, malaise, feeling poorly - subsequently missed work 12/22 in order to rest; resolved by 12/23
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| 42 | 2021-01-07 | headache | Headache lasted for a week.. |
| 42 | 2021-01-07 | body temperature increased, headache |
Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours l...
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Headache within 45 min of injection. Nausea and Headache after 24 hours. Currently almost 36 hours later I am still nauseous. I took Zofran. And extra strength tylenol. My blood sugars are running a little high despite insulin pump and frequent monitoring. No ketones. Temp is 100.
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| 42 | 2021-01-07 | fatigue, headache, dizziness | Headache, Fatigue, Body Aches, Lightheaded onset day after vaccine |
| 42 | 2021-01-07 | chills, fatigue, headache, fever | Headache, Myalgia, Fever, Tachycardia, temp 104.0, chills, fatigue Narrative: |
| 42 | 2021-01-07 | headache | Headache, nausea and vomiting |
| 42 | 2021-01-07 | fatigue |
I had my 2nd vaccine on 01/06/2021 and where the injection was done is now a big red spot around the...
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I had my 2nd vaccine on 01/06/2021 and where the injection was done is now a big red spot around the area and has spread a tiny bit and it's warm to the touch with a hard bump. No other symptoms, except tired. no fever ect
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| 42 | 2021-01-07 | headache, chills, fever |
I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a hea...
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I woke up on 1/8/20 at 2:00 am with my left arm hurting badly. I felt feverish, chilled, with a headache and full body muscles aches. I checked my temperature at 7am and it was 100.5 oral. I could barely get out of bed all day. My temperature peaked at 101 despite taking 400mg of Ibuprofen at 9am. It is currently 8 pm on 1/8/20 and I still have a fever, muscle aches, headache and fatigue.
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| 42 | 2021-01-07 | dizziness, throat irritation | Lightheaded and full sensation in throat 20 minutes after shot |
| 42 | 2021-01-07 | fatigue |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECT...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND A GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. CURRENTLY AWAITING INSTRUCTIONS FROM PRIMARY PROVIDER.
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| 42 | 2021-01-07 | fatigue |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTIO...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, AND GOLF BALL SIZED RED AREA AROUND INJECTION SITE THAT IS WARM TO THE TOUCH. AT THIS TIME AWAITING FURTHER DIRECTION FROM PRIMARY PROVIDER.
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| 42 | 2021-01-07 | fatigue |
ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SI...
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ON 1/6/21, DEVELOPED BODY ACHES, ARM SORENESS, FATIGUE, GOLF BALL SIZED RED AREA AROUND INJECTION SITE WHICH IS WARM TO THE TOUCH. AS OF THIS REPORTING IS AWAITING A CALL FROM HER PRIMARY PROVIDER.
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| 42 | 2021-01-07 | headache |
Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side o...
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Patient states she became hot and flushed about 2 minutes after receiving vaccine. The right side of her tongue became tingly. The rapid assessment team responded and noted her blood pressure was 186/103 and pulse was 146 and she had a headache. They had her rest for about 45 minutes and she felt better. Her blood pressure came down to 130/90 and pulse was 100. On 01/07/20 she still is experiencing a headache and body aches. She has never felt short of breath.
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| 42 | 2021-01-07 | headache | Report HA that improved with Tylenol |
| 42 | 2021-01-07 | headache |
When I woke up on the 21st to go to work I felt vertigo, nauseated and a terrible headache. I pushed...
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When I woke up on the 21st to go to work I felt vertigo, nauseated and a terrible headache. I pushed through and worked the whole shift. I was off due to the holidays for some days but symptoms did not improve. I had the vertigo and nausea for 11 days and on day 7 it prompted me to seek medical care at the clinic. The headache lasted only 2 days.
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| 42 | 2021-01-07 | headache |
When I woke up on the 21st to go to work at 5AM I felt Vertigo, nausea, and a slight headache the ve...
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When I woke up on the 21st to go to work at 5AM I felt Vertigo, nausea, and a slight headache the vertigo was the debilitation factor. I went to work because it was too late to call in sick, I managed to stay the whole day and then I was off some days due to the holidays. The nausea and vertigo lasted 11 days the headache lasted 2 days. I decided to go to the walk in clinic (day 7 - 12/29) because the vertigo and nausea would not go away. They run bloodwork all normal. They told me to take OTC meclizine. It took the edge off helped a tiny bit. I woke up 01/01 symptom free.
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| 42 | 2021-01-07 | chills, fever, headache, headache, chills, fever | body aches, chills, headache, fever |
| 42 | 2021-01-07 | fatigue, chills | chills, fatigue |
| 42 | 2021-01-07 | fatigue |
immediately after to covid vaccine, client started c/o difficulty swallowing. She was transported to...
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immediately after to covid vaccine, client started c/o difficulty swallowing. She was transported to their emergency care area, vitals were monitored. Approx 10mins after this episode, she told them she has had this problem for the last 2 weeks. She denies shortness of Breathe or chest pain. Client was release to a family member. Her husband said she never had any other problems, except the shot made her "tired and achey". She was referred to her PCP for follow up>
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| 42 | 2021-01-07 | dizziness |
patient complained of lightheadedness, patient initially declined any juice, patient was lowered bac...
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patient complained of lightheadedness, patient initially declined any juice, patient was lowered back in recliner to wait through the 15 minute wait time. After 20 minutes patient agreed to take juice. after wait time of 30 minutes patient felt good to leave.
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| 42 | 2021-01-07 | influenza like illness |
whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was...
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whole body ached/shingles like pain in my butt/legs/groin to where my skin hurt to touch it/pain was excruciating/the vaccine amplified the pain; sore arm; progressed to Flu like symptoms; Arthritis in her knee/vaccine amplified the pain; This is a spontaneous report from a contactable healthcare professional. A 42-year-old female patient received bnt162b2 (BNT162B2; also reported as COVID-19 vaccine; lot number: EH 9899; expiration date: unknown), intramuscular left arm on 30Dec2020 20:30 at a single dose for covid-19 vaccination. Medical history included arthritis in my knee, labrum hip tear, HSV2 (herpes simplex virus type 2), haven't had an OB [pending clarification] in over 2 years and herpes. Concomitant medication included omeprazole (PRILOSEC), ondansetron (ZOFRAN MELT), alprazolam (XANAX; reported as Xanax ER), lamotrigine (LAMICTAL), famotidine (PEPCID AC) , colecalciferol (VITAMINS D3; reported as vitamin D), ascorbic acid (VIT-C) and zinc. The reporter stated that after the vaccine (31Dec2020 12:00), the patient had a sore arm and it progressed to Flu like symptoms and pain in her joints. Her whole body ached. The patient mentioned that she has arthritis in her knee and a labrum hip tear, and the vaccine amplified the pain. She also has HSV2 and she haven't had an OB in over 2 years, and she had a bad OB and shingles like pain in her butt/legs/groin to where her skin hurt to touch it. The pain was excruciating. The patient did not received treatment for the adverse event. The patient considered the event as non-serious. She received the COVID-19 vaccine in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.
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| 42 | 2021-01-08 | headache, body temperature increased, dizziness, fatigue |
2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp w...
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2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.
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| 42 | 2021-01-08 | sweating | Palpitations, presyncope, tachycardia, elevated blood pressure, sweating, chest pain |
| 42 | 2021-01-08 | dizziness |
Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She ...
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Pt noticed that heart rate increased to 112 on watch about 10 minutes after vaccine was given. She also felt dizzy for about 30 seconds but this resolved on its own. Pt reported to staff. Vital signs were taken Temp 97.9, heart rate 84, BP 124/85. Pulse was regular. Pt denied any ongoing dizziness or other symptoms. She was given apple juice and monitored for another 15 minutes with no further symptoms
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| 42 | 2021-01-08 | weakness, malaise, dizziness |
The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the ...
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The day of vaccine: sore left arm. Took Ibuprofen to be able to sleep. Woke up in the middle of the night with pain. The day after: moderate to severe pain on the left arm that radiates to the neck and back. Took Ibuprofen in the morning. Pain was getting better as the day pass. At night, around 6 pm started to feel that something is not OK. I am not the same as before. My legs are not very strong (feeling it, not a problem that I can?t walk - it feels like). Feeling dizzy at times. Went to bed and pain on the left arm is much better. Two days after the vaccine: woke up with body aches, feeling dizzy at times, weak, nauseous. Not feeling OK. It is now around11:30 am two day after the vaccine and I am starting to get worried. Please contact me for advise. Thanks
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| 42 | 2021-01-09 | fever, headache | 1/7/2021 21:30 Headache 1/8/2021 0130 until 2330, Fever, body pain |
| 42 | 2021-01-09 | fever, chills, fatigue | Chills, Fever Fatigue |
| 42 | 2021-01-09 | chills, fever | Fever, chills and body aches |
| 42 | 2021-01-09 | malaise, chills, fatigue |
Morning after the 2nd dose of vaccine I developed chills, body aches, malaise/fatigue. It lasted app...
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Morning after the 2nd dose of vaccine I developed chills, body aches, malaise/fatigue. It lasted approximately 5-6 hours and then started to improve.
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| 42 | 2021-01-09 | shortness of breath, fatigue, sweating, dizziness |
Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions an...
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Once injected felt dizzy then sat down, it was hard to breathe I can fell rapid heart palpatiions and my my body get hot from the inside out. I started sweating and my skin was turning red. I notified staff and they kept me an additional 30 minutes. I started getting hives and my body felt hot. The fire fighters asked the nursing staff for Benadryl they advised they did not carry it and could not give it to me. I carry Benadryl in my work bag due to my list of allergies. Fire assisting at location advised me to take Benadryl. I notified my employer because Benadryl makes me sleepy. They sent me home and I continued Benadryl and missed work for three days. At this time I went to prestige emergency about 1200 pm because the hives, heat in my body did not go away. I was treated and placed on an iv cocktail and sent home with several medications. Diagnosed with urticaria allergic by DR. symptoms did not improve my skin was still red I felt hot, confused, dizzy and returned back to the same ER 01/09/2021 I was also involved in an unrelated motor vehicle accident earlier in the morning so got treated for that and continued my explanation and treatment of how my body is not doing well with the Covid 19 shot. I presented with tachycardia and was instructed to continue my medications prescribed from 1st visit on 1/7/2021. Today is 1/10/2021. My body still feels hot, fatigue, confusion and light headed. Remained out from work and continued bed rest.
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| 42 | 2021-01-09 | weakness, headache, fatigue, chills |
Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscl...
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Pain and tingling in entire left arm, severe chills, bluish lips, weakness, fatigue, headache, muscle and joint pain.
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| 42 | 2021-01-09 | chills, headache | Sore arm, cold chills, irritable skin all over, achy muscles, headache |
| 42 | 2021-01-09 | fatigue, cough |
Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extrem...
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Woke the morning of Friday, January 8th, 2021 with a slight cough, heaviness to my chest, and extreme fatigue. Had to use my inhaler twice, get rest, and plenty of hydration for 24 hours then felt fine.
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| 42 | 2021-01-10 | fatigue, fever |
"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling,...
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"I received the first dose in my right deltoid on 12/22/20, and started feeling tightness, tingling, and pain in my right shoulder and neck. It steadily progressed, and by the morning of 12/25/20, I had almost no range of motion in my neck and right shoulder, and severe pain in my right shoulder/neck/upper back area (heat/ice/ibuprofen/Aleve/Tylenol offered zero relief) . This lasted for a few days, then steadily improved until I returned to work on 12/28/20, where I had mild-moderate pain and most of my range of motion had returned. I still feel like the muscles in my neck and shoulder are tight, but I?m doing stretching exercises with heat/ice at home and it seems to be working its way out. The other symptoms were expected and mild: fever, muscle/joint aches, fatigue. These symptoms come and go ? I?ve had them since being COVID positive in March/2020. Just to be extra safe, I was swabbed for COVID on the 30th and was negative."
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| 42 | 2021-01-10 | body temperature increased |
- muscle ache in upper arm and should within first half hour of shot - extreme body aches began that...
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- muscle ache in upper arm and should within first half hour of shot - extreme body aches began that evening; continued throughout the day 1/10; still present morning of 1/11, not as intense - temperature spiked to almost 100 that evening; fluctuated throughout the next day
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| 42 | 2021-01-10 | body temperature increased, chills, headache |
-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache las...
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-day after vaccine, experienced headache, temp of 101, body aches/chills, no appetite. -headache lasted for 24hrs after, body aches chills decreased w/tylenol. Still decreased appetite until 3rd day fever was down to 99-100 w/tylenol
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| 42 | 2021-01-10 | fatigue, headache, fever |
1st dose 12/19/20 Symptoms 12/20/20 headache, severe body and joint pain, fever 101.0, fatigue lasti...
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1st dose 12/19/20 Symptoms 12/20/20 headache, severe body and joint pain, fever 101.0, fatigue lasting about 24hrs. 2nd dose 1/9/21 Symptoms 1/10/21 extreme fatigue, body aches, fever 100.4 duration was approximately 24hrs.
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| 42 | 2021-01-10 | sweating | 5 min - nausea 25 min- Nausea, diaphoretic, wheezing 30 min- Vitals WNL, symptoms resolving. |
| 42 | 2021-01-10 | fever, chills |
Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a ...
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Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiration date Mar2021, incomplete lot number L0140, not sure the first letter it is C or E), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. None medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced a little bit chills and fever she felt coming exactly on the 26th but she expected that and that was all fine but patient ended up in (Incomplete sentence). She went to work on 30th December and had some onset of severe acute abdominal pain and she ended up in an emergency appendectomy by 6 O'clock that evening. So she had an acute appendicitis and she did some research and it says that she can be listed in to the severe complications that the number in the vaccinated group was double back to the procedural group. The 26th it resided and patient felt better until the 30th when she have acute severe abdominal pain onset. She left work went for emergency room and she was in surgery within four hours. The outcome of events chills and fever was recovering, the other events was unknown. Because of the research that is on the website patient cannot help and think that it is related. Patient believed the relatedness of drug to events was related. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 42 | 2021-01-10 | dizziness, headache |
After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and develop...
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After receiving vaccine began to feel dizzy and lightheaded and sat in observation area and developed a diffused urticarial rash and was sent to ED. She also C/O of difficulty swallowing. Erythema B/L cheeks, Rash diffused B?L chest and behind left ear Patient given Benadryl 25 mg IV at 11:15, Pepcid 20 mg IV given 11:15, SOLU-MEDROL 125 given at 11:30 13:20 feeling much better and has fontal headache discharged home at 14:20
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| 42 | 2021-01-10 | sweating, night sweats, fever, fatigue |
Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and f...
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Bone deep body aches in back and legs, sweats like I had a fever that drenched the bed sheets, and fatigue. I slept most of the day on Sunday after getting the shot the day before. I never checked my temperature to tell if I had a fever. The night sweats continued into sunday night. I took 600mg of advil for the body aches and went to bed. When I woke up around 1:00 in the afternoon the body aches were gone and haven't returned. Sunday night I was sweating most of the night and felt over heated until around 11:00 Monday morning. I am always cold, I am the type who wears sweaters in the house all year long. For me to be that hot in the house is very unusual.
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| 42 | 2021-01-10 | headache, chills, cough, nasal congestion |
Covid positive 1.11.21. Sunday after Vaccine began with headache, body aches and chills. Cough start...
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Covid positive 1.11.21. Sunday after Vaccine began with headache, body aches and chills. Cough started on Monday and full nasal congestion by Friday, 11.8.21. Covid tested Monday, 1.11.21 due to post covid vaccine questionnaire followup through workplace recommendations for covid testing. Got covid positive results about 7pm 1.11.21
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| 42 | 2021-01-10 | chills, fever |
Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pai...
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Fever up to 102 degrees, severe body aches, uncontrollable shivering, lymphadenopathy, right arm pain
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| 42 | 2021-01-10 | headache, fatigue | Headache, chest pain, fatigue, feeling of near syncope |
| 42 | 2021-01-10 | shortness of breath | Hives, shortness of breath, treated at emergency department with Epinehrine & steriods |
| 42 | 2021-01-10 | fever, fatigue |
I was really fatigue, and I felt feverish. I checked my temp and it was greater than 104, I was unab...
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I was really fatigue, and I felt feverish. I checked my temp and it was greater than 104, I was unable to go to work. My hips hurt and some body ache and taking aspirin.
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| 42 | 2021-01-10 | shortness of breath, cough |
Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 mi...
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Mild shortness of breath and chest tightness 10 minutes after the injection that resolved after 5 minutes without intervention. Remained in the observation room symptom-free for additional 30 minutes. At home, symptoms of shortness of breath and chest tightness returned and worsened. Throat felt tight, able to move air, however had trouble swallowing. Voice was raspy and increased coughing. From past experience with allergy shots, this was my cue to use epi pen. Within 5 minutes after using epi pen, all symptoms were resolved.
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| 42 | 2021-01-10 | migraine |
Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergenc...
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Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular, on 17Dec2020 04:15, single dose arm left for COVID-19 immunization. Relevant medical history included hypothyroidism, hypertension, hyperlipidemia, obesity, and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), butalbital, caffeine, paracetamol (FIORICET 50-40- 325mg), dexamethasone 4mg Inj., diclofenac (VOLTAREN 1% Gel), Magnesium, valsartan (VASOFLEX) (pending confirmation), cyanocobalamin (VITAMIN B12), losartan potassium. The patient was not pregnant and did not received any vaccine in four weeks. The patient previously took cephalosporin and experienced allergy. On 24Dec2020, the patient experienced pain left side of the face and migraine, and came to emergency room where apparently they diagnosed facial paralysis. The events resulted in emergency room visit/ urgent care where the patient was administered dexamethasone 4mg Inj, Medrol dose pack, Vit B12 500mcg, and Fioricet 50-325-40. Facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. It was unknown if the patient was diagnosed with COVID-19 prior or since the vaccination. The events were assessed by the nurse as non-serious. Outcome of the events was recovering at the time of the report.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-01-10 | chills, headache | RED RAISED LUMP AT INJECTION SITE, HOT AND ITCHY ARM. HEADACHE. CHILLS. |
| 42 | 2021-01-10 | fatigue |
Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, alon...
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Received vaccine on 1/5, began having swelling in bilateral hands and lower extremities on 1/7, along with fatigue. On 1/8 she reports new swelling started in her face (eyes and cheeks). Swelling has not improved today and fatigue has worsened.
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| 42 | 2021-01-10 | fever | muscle aches, low fever. called in sick to work. |
| 42 | 2021-01-10 | malaise, fatigue, body temperature increased |
next day at approx 1030 felt fatigue, temp 103.6, temp today 99.5 had taking anipyretic at 0630. sti...
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next day at approx 1030 felt fatigue, temp 103.6, temp today 99.5 had taking anipyretic at 0630. still have malaise/fatigue. Negative COVID 1/6.
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| 42 | 2021-01-11 | fever, fatigue, headache |
1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things w...
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1/8 - Within 12 hrs had body, eye, and headache. Overall tired. Could not do normal daily things without feeling wiped out . 3 Advil did nothing- sat 1/9. Next day felt better.- sun 1/10. That evening low grade fever 99.6 and achy again., mostly eyes and head. Went to bed. Monday okay. But noticed right armpit a pit puffy.- same side as injection. Tuesday 1/12 woke up at 6:00am and had dull joint/bone pain bilaterally. Ranging from neck ache, to sternum/upper back, shoulders, triceps. Injection site still sore- slightly red off to the side. Did some stretches in bed and eventually got up. I am very in tune with my body- something is off. I never wake up feeling ?bad?. Fit, healthy and active normally. Almost like a bad nights sleep with a poor mattress but only affected my upper body. Took two Advil and hot shower- feel better but can tell something doesn?t feel right.
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| 42 | 2021-01-11 | fever |
Began running a temp of 99.8 degrees on the evening of 01/01/21. (Thermometer is accurate. My empl...
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Began running a temp of 99.8 degrees on the evening of 01/01/21. (Thermometer is accurate. My employer requires us to take our temps twice a day every day since mid-March. I have not run a fever since mid-March prior to 01/01/21, nor have I run one since. The temp was also checked four times prior to taking Tylenol to make sure the reading was not in error.) Tylenol was taken. The fever went away and never came back again. No other medical intervention was needed other than Tylenol.
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| 42 | 2021-01-11 | throat irritation, dizziness | Developed scratchy throat 15 min after shot, dizzy and sent to ED per MD |
| 42 | 2021-01-11 | dizziness | Dizziness for 4 days vomiting body aches and severe diarrhea |
| 42 | 2021-01-11 | weakness, fatigue, influenza like illness | Flu like symptoms, syncope, lymphadenopathy, nausea, fatigue, weakness. |
| 42 | 2021-01-11 | fatigue, headache, dizziness, chills | Headache, nausea, vomiting, dizziness, body aches, pain at injection site, chills,fatigue |
| 42 | 2021-01-11 | migraine |
Migraine started at approximately 7:30pm and lasted through midday Saturday. Migraine was intense e...
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Migraine started at approximately 7:30pm and lasted through midday Saturday. Migraine was intense enough for me to have to call off sick from work on Friday.
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| 42 | 2021-01-11 | dizziness, fatigue | Nausea, dizziness, fatigue, constipation, lower back pain. |
| 42 | 2021-01-11 | chills, headache, fever |
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccin...
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Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling and pain occurring still 4 days post vaccine, visit with PCP who prescriped 800mg ibuprofen 3x/day and rest, no work. Symptoms began 7am on 1/9/21. Fever, chills, headaches, body aches . symptoms began 9am on 1/9/21 and lasted 24 hours. utilized tylenol to control fever. Low grade fever until 3pm on 1/10/21 - more than 24 hours after symptoms began
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| 42 | 2021-01-11 | headache, fever, chills |
Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling, began 1/9/21 at 7am, it is still swollen, ...
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Pfizer-BioNTechCOVID-19 Vaccine EUA Left armpit swelling, began 1/9/21 at 7am, it is still swollen, had a PCP visit in clinic, off work for 3 days and prescribed anti-inflammatory. Fever, aches, chills, headaches, began 1/9/21 at 9am. Resolved within 24 hours. used tylenol as bottle dosage. Low grade fever until 1/10/21 at 3pm. used aleve as bottle dosage.
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| 42 | 2021-01-11 | chills, fatigue |
The day after the 2nd dose, I experienced mild side effects of chills, body aches and fatigue that l...
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The day after the 2nd dose, I experienced mild side effects of chills, body aches and fatigue that lasted approximately 4 hours.
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| 42 | 2021-01-11 | somnolence, headache, body temperature increased, fatigue |
The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had ...
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The day after the vaccine was given, 01/07/2021, I had a headache and nausea around 10:00am. I had to leave work early. I fainted when I got home on Thursday. Felt very tired. So I rested the remainder of the day and that night. On Friday 01/08/2021, I felt very tired and had a temperature of 100.6. I slept most of the day. Friday night I fainted again around 8:00pm. Slept all night. Felt much better on Saturday. Felt normal from Sunday on.
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| 42 | 2021-01-11 | dizziness |
Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken ...
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Vaccine given at 9;55 am and at 10;10 am patient c/o dizziness, nausea, fast heart rate. VS taken BP 116/78 HR 105, O2 sats 100. Pt was given water, raised her feet up and monitor her for additional 30 mins. 10:30am pt. states felt much better new VS taken BP 110/70 sats 100% HR 94, she left via walking.
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| 42 | 2021-01-11 | fever, chills, headache, fatigue |
Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush fa...
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Vomiting, Fever, Headache, Body aches, chills, fatigue, injection swelling and redness, red flush face
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| 42 | 2021-01-11 | fatigue, shortness of breath, respiratory tract congestion, headache |
While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she...
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While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose. Her arm had a hard, red, hot spot for approximately a week. At this time I told her we would like her to stay under observation for 30 Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm". Â Pt stated that her heart felt like it was "pounding". Â VS: 162/96, 99% RA, HR in the 70's. Â Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area. Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home. Â The symptoms resolved after approximately 40 minutes. By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present. It was verified that she did not live alone and would have someone with her that could assist. Â Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications. Â
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| 42 | 2021-01-11 | fever, chills, headache |
Woke up on 1/9 with major headache. During the day this progressed to nausea, body aches, chills an...
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Woke up on 1/9 with major headache. During the day this progressed to nausea, body aches, chills and fever 100.4.
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| 42 | 2021-01-11 | sweating |
became hot and sweaty in monitoring room. Stayed for 30minutes in monitoring room and symptoms reso...
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became hot and sweaty in monitoring room. Stayed for 30minutes in monitoring room and symptoms resolved and colleague returned to department to resume work. Symptoms re-occurred
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| 42 | 2021-01-11 | fatigue |
felt a little tired this morning; This is a spontaneous report from a contactable consumer. A 42-yea...
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felt a little tired this morning; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 04Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated she felt a little tired this morning (on 05Jan2021). It was unknown if treatment was received. It was unknown if patient was diagnosed with COVID-19 prior to vaccination, and unknown if patient had been tested for COVID-19 since the vaccination. Outcome of event was unknown.
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| 42 | 2021-01-11 | headache |
headache starting 1 hour after the injection and persists until present day, 1/12/21. Severe spasm l...
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headache starting 1 hour after the injection and persists until present day, 1/12/21. Severe spasm left trapezius muscle on same side as injection. I discussed by symptoms with my PCP and he advised I report as an adverse reaction.
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| 42 | 2021-01-11 | headache | headache, nausea, vomiting. called in sick to work. |
| 42 | 2021-01-11 | runny nose, headache, fatigue |
joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; develo...
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joint pain and muscle; joint pain and muscle; Vertigo; an itchy rash bilaterally on her arms; developing swollen, tender, and hard lymph nodes under the Left subclavian area/ swollen left subclavian lymph nodes; developing swollen, tender, and hard lymph nodes under the Left subclavian area; extreme fatigue; Runny nose; Headache; This is a spontaneous report from a contactable nurse (RN) reporting for herself. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 23Dec2020 h 09:00 intramuscularly in left deltoid (left arm) lot number: EK5730 at single dose for COVID-19 immunization. Concomitant medications were not provided. Patient stated that she has had double mastectomy, and missing a lot of lymph nodes, states she got the first dose of Pfizer Covid vaccine on 23Dec2020, states it made her left subclavian lymph nodes swollen and hard. States that when she gets the flu vaccine at her hospital every year, she gets swollen lymph nodes ever since she had a double mastectomy and chemotherapy. She originally was wondering if she could get the vaccine in another large muscle group. States she even went as far as to cross reference flu shot ingredients with the Pfizer Covid ingredients to see if something in the vaccines were causing the swollen lymph nodes but was unable to come to any conclusion, the only think in common is the Sodium Chloride and she does not feel like that would cause any issue. States the swollen lymph nodes occurred after the Sanofi brand flu vaccine (no other information known or provided). Patient is on day 15 post vaccination and they are still swollen and hard, she is wondering if there is any data on how long this side effect can last. She made an appointment with her oncologist, she knows that the swollen lymph had the first dose, lymph nodes are still swollen and hard, knows it can cause swollen lymph nodes but wants to know what is the typically length of the event. Patient also experienced other side effects, on 30Dec2020 (last week), she developed vertigo that lasted through the weekend intermittently, states she at first thought she was having a stroke. States it seems to have subsided as of 05Jan2021 (yesterday). Patient also reported she had an itchy rash twice as part of her side effects reported from the COVID 19 vaccine. She noticed an itchy rash and it went away but she is unsure exactly the day or time. Stated she definitely remembered the rash on 28Dec2020 as she took pictures. It was gone in about three hours on the same day. She did not treat the rash because it was gone and not itching. The rash came and went and had not come back. It was mostly on the bends of the arms, bilateral arms. Patient reported developing swollen, tender, and hard lymph nodes under the Left subclavian area the day after the injection, on 24Dec2020. They were not as tender at the time of the report but were continuing and this was 15 days from her vaccination. Patient also experienced an itchy rash bilaterally on her arms that occurred twice and only lasted a few hours each time, onset date reported as 25Dec2020. She was advised to take diphenhydramine hydrochloride (BENADRYL) for it however she did not take it. On 23Dec2020 patient experienced headache. On 24Dec2020 patient experienced extreme fatigue, swollen left subclavian lymph nodes and runny nose. On 30Dec2020 patient experienced joint pain and muscle and vertigo. The events headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms were considered serious as medically significant events. Patient had not recovered from swollen left subclavian lymph nodes, joint pain and muscle, extreme fatigue and swollen, tender, and hard lymph nodes under the Left subclavian area, she was recovering from headache, runny nose and vertigo and recovered completely from an itchy rash bilaterally on her arms on 28Dec2020.; Sender's Comments: The Causality between the events, headache, experienced extreme fatigue, swollen left subclavian lymph nodes, runny nose, joint pain and muscle and an itchy rash bilaterally on her arms, and the administration of the COVID 19 vaccine cannot be denied based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 42 | 2021-01-11 | headache, head discomfort, shortness of breath |
patient began to have headache (pressure back of head), some shortness of breath with an elevated bl...
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patient began to have headache (pressure back of head), some shortness of breath with an elevated blood pressure. Patient stayed for monitoring for 30 mins and symptoms aleviated
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| 42 | 2021-01-12 | headache |
1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted thro...
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1/8/21 - An hour after receiving the vaccine I experience a metal taste in my mouth that lasted throughout the day. 1/9/21 - I woke up at 4am the follow day after receiving the vaccine and my left side of my face was numb, I could still taste metal in my mouth, I had a headache and pain in my right arm. I watch my symptoms and checked to see if I was having a stroke, but nothing pointed to that. 1/10/21 - I still was experiencing the same symptoms from 1/9/21 with not increased or decreasing of symptoms. Watched them throughout the day but nothing changed. 1/11/21 - I continued to have the same symptoms and reported to the ED after work for the symptoms listed above with no improvement. 1/12 & 1/13 - I continue to have the same symptoms with no changes.
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| 42 | 2021-01-12 | fatigue |
1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 ...
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1st injection on 12/20/20 with side effects of sore R arm and pain/stiffness at R hand for about 24 hours. After 2nd injection on 1/10/21, I had soreness at R arm, fatigue on first day. 2 days after 2nd injection, I developed rash/swelling around both eyes, and on 3rd day had worse eye symptoms and rash across upper chest. I called employee health and my PCP to report symptoms.
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| 42 | 2021-01-12 | throat swelling, shortness of breath |
2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep chok...
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2230 feeling of unease, body aches, site arm tingling, general mild aches 0220 awoke from sleep choking, having difficulty breathing, felt very SOB, worse with exertion or trying to speak, great difficulty swallowing and speaking even in brief words. Took 50mg of Benadryl PO and went to the ED, about a 15 minute car ride. Had tingling and numbness of the tongue and back of throat by arrival but still able to breath with focus. Exertion of just walking into the ED greatly increased the SOB. Was triaged, Benadryl starting to help, was able to speak a little better, 3-4 words without too much SOB caused. Was walked to a room, SOB milder with that exertion. Seen by Dr. Given IV Sol-u-Medrol and 50mg Benadryl. Was observed on cardiac monitor/Q15VS for a few hours and discharged home around 5:30. Given Rx of Prednisone 20mg -3tabs x2 days, 2tabs x5 days all once a days and told to take 50mg of Benadryl Q4H for the next 24 hours at least and to return prn. I did need to stay on Benadryl, as the Sol-u-Medrol wore off some of the swelling in thr throat did return but not severe, Benadryl did help, along with taking my Asthmnex I already had. I also continued my normal HS antihistamines. I had SOB on exertion, progressively better from the 6th-10th with it mostly resolved to yesterday. Body aches have continued but also progressively better. Yeasterday1/12/21 the Rx of prednisone was completed and I did have some mild swelling /tingling in the throat/face/mouth return in the evening, took Benadryl 50mg again and inhaler used. I have an appointment today to seek further care at my primary doctor's office. Asthmnax used again this morning as well, only mild tightness in the throat currently with mild body aches this whole time.
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| 42 | 2021-01-12 | fever, chills |
Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report f...
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Chills; Low grade fever; Nausea; Pain; Swollen lymph nodes in armpit; This is a spontaneous report from a contactable Healthcare Professional (patient).This 42- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EL3246), via an Intramuscular route of administration, on 06Jan2021 09:15AM (at the age of 42-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. Medical history included: Mitral valve prolapse. Concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EH9899) via an Intramuscular route of administration, on 18Dec2020 at 03:30 PM (at the age of 42-years-old) as a single dose for COVID-19 vaccination, anatomically located on the right arm. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 at 01:30 AM, she experienced chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit. The patient did not receive treatment for the events. The clinical outcome of the events chills, low grade fever, nausea, pain, and swollen lymph nodes in armpit was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-01-12 | shortness of breath, cough, throat irritation |
Day 1 Started with throat itching followed by cough with in 20 mins post vaccine later in evening ...
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Day 1 Started with throat itching followed by cough with in 20 mins post vaccine later in evening left lung pain with SOB Day 2 Shortness of breath , left lung pain, cough Day 3 - Day 4 PVCs Taking Zyrtec and Pepcid for 4 days , Evaluated by EMTs onsite , did allergy treatment and evaluated by PCP
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| 42 | 2021-01-12 | headache |
Day 1: headache immediately following vaccine, lasting about 24 hrs Day 2: diffuse muscle aches, las...
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Day 1: headache immediately following vaccine, lasting about 24 hrs Day 2: diffuse muscle aches, lasting about 24 hrs Day 3: pruitis affecting palms of hands and feet as well as the scalp, ongoing
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| 42 | 2021-01-12 | head discomfort, runny nose, respiratory tract congestion |
Head pressure, runny nose, congestion. Tylenol with head pressure resolving. Referred for flu and CO...
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Head pressure, runny nose, congestion. Tylenol with head pressure resolving. Referred for flu and COVID testing
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| 42 | 2021-01-12 | headache, fatigue |
Headache; Mental foggy; body aches; tired; This is a spontaneous report from a contactable Nurse (pa...
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Headache; Mental foggy; body aches; tired; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in right arm on 06Jan2021 H 05:00 PM at single dose for COVID-19 immunization, lot number: EL3246. Medical history was reported as none. Patient had no known allergies and had no COVID prior vaccination. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications received within 2 weeks of vaccination included Antibiotic. On 07Jan2021 at 09:00 AM patient experienced headache, mental foggy, body aches and tired. She was not treated for the events. Patient had not been tested for COVID-19 post vaccination. Patient was recovering from the events at the time of the report. No follow up attempts are possible. No further information is expected.
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| 42 | 2021-01-12 | chills, dizziness, headache | Nausea, dizziness, chills, headache |
| 42 | 2021-01-12 | chills, fever, fatigue |
Patient reports nausea, very extreme and sudden, chills, mild fever (100.5 degrees) and extreme fati...
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Patient reports nausea, very extreme and sudden, chills, mild fever (100.5 degrees) and extreme fatigue.
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| 42 | 2021-01-12 | fatigue |
Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficul...
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Sore arm -24 hours Extreme fatigue 8 hours Brain fog Difficulty forming words physically Difficulty coming up with words to use Exhaustion
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| 42 | 2021-01-12 | fatigue |
Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid posi...
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Sore arm nausea fatigue 24-48 hrs. after vaccine administration. Today 1/13/2021- tested covid positive via PCR swab.
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| 42 | 2021-01-12 | discomfort |
Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM...
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Tingling of the tongue, heaviness began at 13:30 p.m., 50 mg Benadryl given at 13:35, BP 110/70, BPM-108 14:00 p.m. symptoms continuing, symptom improvement beginning at 13:00 p.m.
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| 42 | 2021-01-12 | shortness of breath |
Was unable to swallow, breathing was not affected. Throat muscles felt weaken. Was given a Benadr...
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Was unable to swallow, breathing was not affected. Throat muscles felt weaken. Was given a Benadryl, symptoms resolved soon after.
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| 42 | 2021-01-12 | headache, fever, chills | chills, fever,body aches,headace,nausea |
| 42 | 2021-01-12 | headache, fatigue |
fatigue; headache; body aches; This is a spontaneous report from a contactable healthcare profession...
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fatigue; headache; body aches; This is a spontaneous report from a contactable healthcare professional reporting for a 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0142), intramuscular on 04Jan2021 15:30 in left arm at single dose for COVID-19 immunization. Medical history included COVID-19, type 1 diabetes and penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included insulin. The patient experienced fatigue, headache and body aches on 05Jan2021 10:00. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 42 | 2021-01-12 | chills, fatigue, fever |
sudden onset nausea, mild fever (100.5), exhaustion. required 15 hours sleep, chills began 1 hour la...
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sudden onset nausea, mild fever (100.5), exhaustion. required 15 hours sleep, chills began 1 hour later. all considered mild but wanted to report for tracking.
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| 42 | 2021-01-12 | weakness, shortness of breath | weakness, breathlessness, pain at sight, body aches over two days I am not feeling better yet |
| 42 | 2021-01-12 | shortness of breath, fatigue |
wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling an...
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wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint, pain and swelling, fatigue requiring visit to hospital
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| 42 | 2021-01-13 | chills | 15 hrs after injection severe body aches, chills, muscle and joint pain. Lasted 24 hrs. |
| 42 | 2021-01-13 | dizziness |
1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with e...
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1700 felt increase in HR (120), warm feeling, B/P 132/80 Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
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| 42 | 2021-01-13 | respiratory tract congestion, fever, headache |
Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone...
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Exactly 15 hrs post injection I woke with uncontrollable shakes, fever 101.6, vomit x4, nausea, Bone pain especially neck, lower back and hips, headache and congestion.
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| 42 | 2021-01-13 | weakness, sweating, shortness of breath |
Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a st...
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Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Felt like a sticky film was in my throat and I could not swallow nor get any air in.; Woke up from a deep sleep diaphoretic and unable to breathe; I felt weak and had tightness in my chest; I felt weak and had tightness in my chest; diaphoretic; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number=Ek5730 and expiry date unknown, via an unspecified route of administration on the right arm on 30Dec2020 14:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included hctz (HCTZ) and valaciclovir hydrochloride (VALTREX). The patient previously took levaquin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity and influenza vaccine. On 02Jan2021, the patient woke up from a deep sleep diaphoretic and unable to breathe. She felt like a sticky film was in my throat and I could not swallow nor get any air in. It took over an hour to clear my airway enough to feel like I was getting a good breath and I felt weak and had tightness in my chest for 2 days after also. The outcome of the events felt like a sticky film was in my throat, could not swallow and unable to breathe were recovering while other events were unknown.
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| 42 | 2021-01-13 | malaise |
Flare of hidradenitis suppurativa in the left axilla, groin, labia and abdomen at once. Two of the ...
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Flare of hidradenitis suppurativa in the left axilla, groin, labia and abdomen at once. Two of the abscesses became infected with warmth around the site and causing extreme pain. General malaise was felt as well.
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| 42 | 2021-01-13 | fever, chills, headache, fatigue |
Injection site pain that lasted about three days, day one was the worst. Fever of 100.5F, muscle pai...
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Injection site pain that lasted about three days, day one was the worst. Fever of 100.5F, muscle pain, chills, and joint pain on the third day and lasted around six hours. Loss of appetite and nausea lasted about a week. Tiredness and headache lasted almost two weeks.
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| 42 | 2021-01-13 | dizziness | Lightheaded, body aches. Resolved |
| 42 | 2021-01-13 | sweating, headache, fatigue, dizziness, chills, weakness |
Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when g...
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Monday, 1/11/2021 (8:30a): 2nd dose administered ? I felt fine the rest of the day and when going to bed. Overnight, I started to experience chills followed by extreme perspiration and weakness to the point that I struggled to open a bottle of water I had by my bed. Tuesday, 1/12/2021: Headache, weak and tired but attempted to work. I had to leave shortly after arriving because my symptoms were becoming progressively worse to the point I almost passed out from standing. Upon arriving home, I started to experience nausea and vomiting x 3. Intense chills followed by the extreme perspiration still existed. Most of these symptoms subsided by 9:30p that evening. Wednesday, 1/13/2021: Intense headache, weakness and dizziness. Of note, my left underarm/armpit (the arm where the vaccine was administered) is sensitive to touch.
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| 42 | 2021-01-13 | sweating, cold sweat |
Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facia...
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Patient developed tight feeling in throat, difficulty swallowing, diaphoretic, clammy skin and facial swelling around eyes.
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| 42 | 2021-01-13 | body temperature increased, fatigue, chills |
Received the second dose of the COVID vaccine on 1/8/2021. She had some side effects including inje...
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Received the second dose of the COVID vaccine on 1/8/2021. She had some side effects including injection site soreness, chills, and fatigue over the weekend following the vaccine. The fatigue has been present all week and got worse last night (1/13). Her temperature has been fairly normal since the second dose, but today (1/14), her temperature went up to 100.1 and has been fluctuating throughout the day, staying mostly at about 99.4. States she does not feel sick, but reports feeling "off." Reporting the symptoms because it feels like they are continuing well after receiving the vaccine. Also reports that her arm was a little itchy over the weekend around the area where she received the injection
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| 42 | 2021-01-13 | fever |
Severe joint and muscle pain; Severe joint and muscle pain; It woke me up; 99.8 with a gram of Tylen...
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Severe joint and muscle pain; Severe joint and muscle pain; It woke me up; 99.8 with a gram of Tylenol on board; This is a spontaneous report from a non-contactable nurse, the patient. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included sertraline, cefixime (FLEXERIL), and paracetamol (TYLENOL). The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 07Jan2021 01:00 AM, the patient experienced severe joint and muscle pain. The patient was woken up even after taking cefixime which usually knocks the patient out (as reported). The patient had a temperature of 99.8 with a gram of paracetamol on board (as reported). The patient reported that she did not receive any treatment for the events. Since vaccination, the patient had not been tested for COVID-19. The outcome of the events severe joint, muscle pain, was woken and temperature of 99.8, were all recovering. No follow-up attempts are possible; information about lot number cannot be obtained.
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| 42 | 2021-01-13 | chills, headache, fever |
Starting at 8 pm on 1/12/21 she began experiencing chills, headache, fever, muscle pain, injection s...
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Starting at 8 pm on 1/12/21 she began experiencing chills, headache, fever, muscle pain, injection site pain. The symptoms continued until 9 am on 1/14/21 and have now completely resolve. T Max was 102.4 (tympanic).
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| 42 | 2021-01-13 | dizziness, dizziness | Systemic: dizzy and bp high 149/95 |
| 42 | 2021-01-13 | sweating |
acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling ...
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acute onset nausea; diaphoresis; presyncope; left arm weakness with numbness; numbness and tingling of first 3 fingers in left hand (median nerve distribution); tingling of first 3 fingers in left hand (median nerve distribution).; significant cervical lymphadenopathy; painful neck; This is a spontaneous report from a contactable physician reporting for herself. A 42-year-old adult female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number: EJ1686, via an unspecified route of administration, in left arm, on 06Jan2021 at 9:52 am, at 42-years of age, at single dose for COVID-19 immunization. The patient was vaccinated in Hospital. Medical history included overweight and no known allergies. Concomitant medications included the second dose of HPV VLP vaccine rL1 4v (yeast) (GARDASIL) received in left arm on 18Dec2020 and ergocalciferol (Vitamin D). On 06Jan2021 by 10:05 the patient experienced acute onset nausea, diaphoresis, presyncope and concomitant left arm weakness/flaccid arm with numbness and tingling of first 3 fingers in left hand (median nerve distribution). The patient informed vaccine staff of symptoms and advised ongoing observation. Flaccid arm/weakness/numbness continued for more than 24 hours, although at the time of the report it was slowly improving. At the time of the report the patient further reported significant cervical lymphadenopathy and painful neck (specific onset date not provided - captured as Jan2021). The events were reported as non-serious. The reporter specified that the injection was not given anywhere near brachial plexus. At the time of the report the events "Left arm weakness" and "Left arm numbness" were resolving, the outcome of the events "Nausea", "Diaphoresis", "Presyncope", "Tingling of first 3 fingers in left hand", "Cervical lymphadenopathy" and "Painful neck" was unknown.
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| 42 | 2021-01-13 | headache | body ache, headache. called in sick to work. |
| 42 | 2021-01-13 | chills, fatigue, headache |
chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous...
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chills; body ache; headache; fatigue; upper chest discomfort with deep breath; This is a spontaneous report from a contactable other health professional (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration on 02Jan2021 11:00 in left arm at single dose for covid-19 immunization. The patient medical history was not reported. Allergies to medications, food, or other products was no. Concomitant medication included escitalopram oxalate (LEXAPRO, 10 mg) and vitamins nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient experienced symptoms chills, body ache, mild headache, fatigue, and upper chest discomfort with deep breath on 06Jan2021. Patient never had a fever. Symptoms were resolved by the next day (07Jan2021). No treatment was received for the events. All events were reported as non-serious. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-01-13 | dizziness, headache, shortness of breath |
headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this o...
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headache; injection site is itchy and swelled up; injection site is itchy and swelled up; But this one turned red; can't lift her arm it's heavy and painful; can't lift her arm it's heavy and painful; shortness of breath; palpitation; Dizziness, lightheaded/ feeling dizzy; Uneasiness; hands are so cold; nauseous; This is spontaneous report from a contactable nurse reported for herself. This 42-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on Left arm on 29Dec2020 17:00 PM on left arm at single dose (Lot # EL1284) for COVID-19 immunisation. Medical history included None. No Allergies to medications, food, or other products. Concomitant medications included ascorbic acid, bioflavonoids nos, hesperidin, malpighia glabra, rosa canina, rutoside (VITAMIN C), collagen, colecalciferol (VITAMIN D), cynara cardunculus, malus spp. vinegar extract, taraxacum officinale (APPLE CIDER). No other vaccine in four weeks. The patient experienced Dizziness, lightheaded, palpitation, uneasyness, shortness of breath on 29Dec2020 17:15 pm. Then when the patient drove home, she felt so uneasy and hands are so cold, nauseous and feeling dizzy on 29Dec2020 17:15 pm. Felt the same way in the house for a good 2 hours after the vaccination. Drank water and didn't sleep right away. Tried to monitor herself. After that day the patient felt better but with bouts of headache and dizziness every now and then. The injection site was itchy and swelled up. But it went down if didn't scratch it. The patient didn't have allergies to any medications. But this one turned red. And the next day after the vaccination (30Dec2020) the patient can't lift her arm it's heavy and painful. Then pain went away. But now it was the itchiness in the site that bothered her. But the patient didn't scratch it. So it didn't swell up as much. Prior to vaccination, was the patient did not diagnose with COVID-19. Lab data on 07Jan2021 Nasal Swab post vaccination for Covid 19: result was pending. No treatments received for the events. Outcome of the events Dizziness, lightheaded/ feeling dizzy, palpitation, Uneasiness, shortness of breath, hands are so cold, nauseous was recovering. Outcome of the event pain in arm was recovered. Outcome of other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the dizziness, lightheaded, palpitation, shortness of breath and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-13 | shortness of breath, throat irritation |
reported hoarseness in the voice; itching and burning sensation around the throat; shortness of brea...
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reported hoarseness in the voice; itching and burning sensation around the throat; shortness of breath; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL0142), via an unspecified route of administration on 05Jan2021 17:00 at single dose in the right arm for COVID-19 immunisation. The patient had anaplasias to penicillin and COVID. The concomitant medications was none. The patient experienced hoarseness in the voice on 07Jan2021, itching and burning sensation around the throat in Jan2021. She had shortness of breath in Jan2021 related to COVID-19 infection. She has had COVID already so she isn't worried about that but wants to know if it is related to the vaccine or not, if this is something she needs to be aware of. The event started and gradually was getting worse. She had her inhaler from when she had COVID. The patient clarified she has also had some shortness of breath but this has been going on since having COVID. She did try the inhaler for the hoarseness and shortness of breath she had. She has been interment shortness of breath since having COVID and she is being tested for lung damage. The inhaler didn't change the hoarseness or shortness of breath. The product used was salbutamol (ALBUTEROL), Lot: PK0358, Expiry: Jun2022, NDC: 0093317431. She has had no reactions to vaccines previously, she had no vaccines on the day of or in the previous 4 weeks. She has not been to the doctor or ER related to the event. The outcome of the event hoarseness in the voice was not recovered. The outcome of other events was unknown.
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| 42 | 2021-01-14 | chills, fever, fatigue |
-Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprof...
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-Temperature of 101-102.3 for 36 hours, did not reduce with anti-pyretic medication (Tylenol/Ibuprofen). -Chills with shaking -Nausea/diarrhea -Body aches and joint pain -Fatigue
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| 42 | 2021-01-14 | sweating |
10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breath...
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10min post vaccine, patient reported feeling flushed, hot, and sweaty. No SOB nor difficulty breathing. BP 132/82 normally 110/60s. HR 70. 30 min post vaccine, palms felt itchy and slightly more sweat but overall improved. Within the hour, symptoms resolved and patient returned to work
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| 42 | 2021-01-14 | fever |
2nd Shot given 21 days after the first shot. Next day seemed like normal side effects. Day 2 those e...
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2nd Shot given 21 days after the first shot. Next day seemed like normal side effects. Day 2 those effects went away low grade fever, aches, but had a knot axillary lymph node, and my arm hurt worse then the swelling spread to my chest and neck. No trouble breathing. I went to the ER because the swelling was getting worse and they did a CT scan and gave me IV fluids. The CT scan revealed swollen lymph nodes.
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| 42 | 2021-01-14 | chills, fever, fatigue |
5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Conti...
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5 min after vaccine administration, developed 3 pre-syncopal episodes and low blood pressure. Continued with paresthesias in lips, mouth, tongue, finger, legs, and toes. 2-3 hours after administration developed lip, face and tongue swelling. Administered Zyrtec and tylenol. Symptoms improved but continued into next day. 18 hours after administering vaccine developed rigors, fever (Tmax 103), severe myalgias, fatigue, nausea, vomiting, diarrhea, abdominal cramping. These symptoms persisted for another 12 hours. Tylenol was given to assist fever and pain.
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| 42 | 2021-01-14 | chills, fever |
After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Conti...
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After 5 min following administration, developed low blood pressure and 3 pre-syncopal events. Continued with paresthesias in lips, tongue, mouth, fingers, legs, and toes. 2-3 hours after administration, developed lip swelling, facial swelling, and swelling of tongue. Zyrtec and tylenol were given. This improved but was still present the next day. At 18 hours following administration, developed rigors, fevers (Tmax 103), severe myalgias, nausea, vomiting, diarrhea, and abdominal pain. These persisted for another 18 hours.
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| 42 | 2021-01-14 | chills, headache, dizziness | After second vaccine: light-headed, chills, hot, muscle aches, headache, light feeling |
| 42 | 2021-01-14 | chills, fever |
Chills; body aches; nausea; vomiting; fever between 100 and 102 with Tylenol and Motrin that lasted ...
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Chills; body aches; nausea; vomiting; fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs; This is spontaneous report from a contactable nurse. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on the left arm first dose on 16Dec2020 06:00 (lot number: EK57303121) and second dose on 07Jan2021 16:45 (lot number: EL3246) at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 08Jan2021 05:00 AM, the patient experienced chills, body aches, nausea, vomiting, fever between 100 and 102 with Tylenol and Motrin that lasted 36 hrs. No treatment was received for the events chills, body aches, nausea, vomiting. The events resulted to a doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No known allergies to medications, food, or other products. Outcome of the events was recovering.
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| 42 | 2021-01-14 | runny nose, throat pain, headache, fatigue, chills |
Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is...
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Extreme Headache; chills; sore throat; water eyes; runny nose; tiredness; entire body aches; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 06Jan2021 14:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced extreme Headache, chills, sore throat, water eyes, runny nose, tiredness entire body aches on 07Jan2021. No treatment was received for the events. Since the vaccination, the patient has been tested for COVID-19, the patient underwent lab tests and procedures which included Covid-19 test/Nasal Swab: negative on 05Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 42 | 2021-01-14 | cold sweat, chills, body temperature increased |
I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 wit...
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I experienced injection site pain in the left upper arm which seemed intense. I woke up at 0100 with severe body aches, cold sweats and shivering. It was hard to walk the body aches were horrible. I checked my temp and it was 100.3 F
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| 42 | 2021-01-14 | fatigue, fever, chills |
I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had ...
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I had 100.2F at night and significant chills and fatigue and my fever went on until Thursday. I had a pretty big immune response. the right side of my face got numb into my neck and my chest and I feel my lymph nodes turned into marbles. I also have swelling in my lymph nodes, my neck and my back. I sought medical care on Thursday due to the swelling and my PCP does not have a clue what to do.
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| 42 | 2021-01-14 | chills, malaise, fever |
Malaise - within hours of vaccination, gradual onset, lasted ~36 hours Chills and low-grade fever - ...
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Malaise - within hours of vaccination, gradual onset, lasted ~36 hours Chills and low-grade fever - around 12:45 AM on 1/14/2021, resolved after 4 hrs with ibuprofen Chills and low-grade fever - another episode around 6:30 PM on 1/14/2021, resolved with ibuprofen (unclear duration since I was asleep)
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| 42 | 2021-01-14 | headache, chills |
Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that...
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Nausea and headache the evening of the vaccine. Chills, headache, aches and pains, nausea late that night into the early morning. Day 6 after receiving vaccine, lymph nodes swollen. Worsened on day 7 and 8. Day 8 after vaccine noticed hives on back. Still have headache and nausea off and on.
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| 42 | 2021-01-14 | cough, shortness of breath |
Patient received Pfizer COVID-19 vaccine without any immediate complication on 1/14/21approx 1455, w...
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Patient received Pfizer COVID-19 vaccine without any immediate complication on 1/14/21approx 1455, was then escorted to observation area for a 30 minute observation time. Pt had previously had a known reaction to contrast media. Approximately 5 -8 minutes into observation, pt had one audible cough. Nurse asked patient if this was a new onset cough. The patient stated she would try to "manage" cough. Pt escorted to bay for monitoring. Pt developed shortness of breath and wheezing rapidly. Rapid response team called and local 9-11 also called. Pt received albuterol nebulizer treatment, placed on O2 at 8L. O2 sat 99%, HR 115-120. Respiratory therapy assisted and Rapid Response Team monitored pt while waiting for EMS. Physician order to give Epinephrine 0.3 mg IM in right deltoid, given as directed at approx 1515. Second epinephrine 0.3 mg IM given approx 1530-1535. HR 144, O2 sat 99%. Patient transported to local ER, pt intubated approx 1927.
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| 42 | 2021-01-14 | malaise, fever, fatigue, headache, cough |
Pfizer-BioNTech COVID-19 Vaccine EUA Started to feel ill around 8pm 1/11. Woke up with nausea and h...
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Pfizer-BioNTech COVID-19 Vaccine EUA Started to feel ill around 8pm 1/11. Woke up with nausea and headache around 10am 1/12. Cough and fever developed by 4pm 1/12, cough was mild and fever never exceeded 101 degrees Fahrenheit. Also experienced fatigue and body aches. Nausea successfully treated with promethazine. All symptoms dissipated significantly or gone altogether around 1am 1/13.
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| 42 | 2021-01-14 | throat pain, shortness of breath |
Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and...
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Received 1st pfizer vaccine by IM at 10:00am on her left arm and felt throat soreness at 10:15am and needs to tilt head up. Advised patient to sit under observation. At 11am continues to have throat soreness and light shortness of breath. Continues to need to tilt head up. Light tingling around throat. Has never felt this before. No dermatologic symptoms. Moved her for observation at ED at 11:30am
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| 42 | 2021-01-14 | skin warm |
Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. O...
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Right axillary swelling, pain and warmth, redness at the injection site. Treatment: Tylenol, heat. Outcome: Able to move extremity with difficulty. Able to complete ADLs with out difficulty . No improvement with treatment. Will continue to monitor.
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| 42 | 2021-01-14 | malaise, fever, headache, fatigue |
Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Contin...
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Symptoms started next day with tiredness, low grade temp of 99 and over all not feeling well. Continued into Saturday. Sunday, Monday and most of Tuesday felt normal. Tuesday evening started to fell worse and Wednesday 1.13.21, 6 days after shot, headache, nauseous, very tired, could not go to work. Called Doctors office and spoke to two different nurses who advised these were normal reactions although maybe delayed. By end of day headache and nausea were gone but still felt unwell. 1.14.21 well enough to work, mostly normal. Took blood pressure and it was elevated by 20 points! BP is still elevated on 1.15.21.
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| 42 | 2021-01-14 | fatigue | fatigue and very swollen tender lymph node under left arm -same arm as shot received |
| 42 | 2021-01-14 | throat swelling |
from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and s...
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from patient: I got my 1st dose and waited the 15 minutes, feeling fine. When I got in the car and started driving home I began to notice that my face was slightly numb (Iike I'd had too much novicaine). This was maybe 20-25 minutes after the dose. When I was home I also noticed that the back of my throat felt a little swollen. This probably lasted for a couple hours.
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| 42 | 2021-01-14 | fatigue, influenza like illness | having flu like symptoms including fatigue, body aches, limb heaviness |
| 42 | 2021-01-15 | dizziness | Dizziness, nausea |
| 42 | 2021-01-15 | headache, fever, chills | Fever 101.8 Headache Pain behind eyes Aches Chills |
| 42 | 2021-01-15 | fever, throat pain, headache, chills, shortness of breath |
Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, sh...
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Headache, fever 101, severe body aches, joint pain, chills, sore throat, shakes, chest tightness, shortness or breath, muscle stiffness all over and muscle weakness, nausea
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| 42 | 2021-01-15 | nasal congestion, sweating, dizziness, chills, nasopharyngitis, fatigue |
Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fl...
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Times are approximate 20200115 1300 received Covid-19 #2 vaccine 1315 numbness, tingling, little ?fluttering? muscle spasms in deltoid 1330 numbness, tingling, muscle spasms in deltoid; 6/10 burning pain in upper arm/armpit, woozy/lightheaded 1345 driving home same as above, nausea, noticed more nasal congestion, post nasal drip 1400 increased nausea, increased symptoms in shoulder/armpit, 4/10 painful deltoid...soreness, burning pain; had a snack 1430 increased severity of symptoms 5-6/10 pain, weird numb feeling in shoulder, itchiness increased; took Tylenol 1530 increased nausea and now chills, cold, shooting cold pain left neck, neck/shoulder stiffness, intermittent ?fluttering? of heart but only for a few seconds (<15sec) 1615 5/10 worsening pain in L dorsal lower arm 1730 increased nausea, chills, cold shooting pain still present intermittently, numbness extends to medial & lateral upper arm 4-5inches from biceps tendon insertion 1830 feeling a little better after eating 2100 overwhelmingly tired, significantly less numbness and tingling, 6/10 pain/soreness in Left deltoid, stretched, took Tylenol, noticeable increase in nasal congestion, post nasal drip, no trouble breathing or cough, temp 97.5F 2200 increased L shoulder pain/muscle tightness, numbness gone, replaced by armpit 4/10 tenderness upon light palpation, alternating between chills and clamminess, feel really ?hot? despite oral temp 97.5F 01/16/2021 0100 6/10 shoulder pain/tenderness/stiffness, armpit significantly less tender 1/10, significantly less numbness or cold, shooting pain; feel really hot, almost sweating despite room temp 68F and oral temp 97.3F ?totally awake? 0130 got up, void x1, made chamomile tea, took 10mg melatonin, 500mg Tylenol, a ?little nauseated? 0800 woke up, 6/10 constant pain in left deltoid, no numbness, tingling or cold sensations 0830 Took Tylenol with breakfast and rest of vitamins 1200 increased pain (6/10) in L deltoid, mild nausea; increased lightheadedness, fatigue, and ?achy? feeling throughout body. 1230 Took Tylenol 1300 pain 5/10, mild nausea, and lightheadedness, but increased fatigue and ?achy? feeling throughout body 1700 mild/moderate constant pain in L deltoid, mild nausea, fatigue, achy feeling 1800 tookTylenol with dinner 2000 increased fatigue, mild achy feeling and chills, no nausea 2200 increased nausea, 5/10 constant pain in L deltoid Took Tylenol 500mg and went to sleep.
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| 42 | 2021-01-15 | chills, fever |
chills, followed by body aches and fever, rash on left arm- continued to develop on right arm and ne...
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chills, followed by body aches and fever, rash on left arm- continued to develop on right arm and neck/chest
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| 42 | 2021-01-15 | chills, fever |
fever, chills, & rigor for 24 hrs un resolved with ibuprofen muscle soreness and stiffness at inject...
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fever, chills, & rigor for 24 hrs un resolved with ibuprofen muscle soreness and stiffness at injection site for 4+ days itching at injection site for 7 days
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| 42 | 2021-01-16 | sweating, chills |
"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I...
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"I received my 2nd Covid vaccine on the morning of 1.14.21 in my left arm. Early yesterday morning I awoke with chills and sweats. No fever. Felt crummy all day. Today I have left shoulder and arm pain, swelling in my left armpit and under my arm. I also have some numbness and tingling through my arm down to my hand. I have a hard knot at the injection site but its not red. I also continue to have occasional chills."
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| 42 | 2021-01-16 | dizziness, lethargy, headache |
1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/202...
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1/11/21Insomnia - Went to bed by 9pm (woke up 11:30 pm and did not sleep through the night) 1/12/2021 Muscle spams (neck) - body ached, lethargy - Took Tylenol 1/12/2021 Headache (sinus pressure) started fading at around 8 pm 1/13/2021 Lightheaded 1/14/2021 Lightheaded 1/14/2021 back to normal
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| 42 | 2021-01-16 | throat swelling |
Less than 2 min after administration developed throat fullness and difficulty swallowing. This pers...
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Less than 2 min after administration developed throat fullness and difficulty swallowing. This persisted. Never any wheeze, never any SOB
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| 42 | 2021-01-16 | fatigue, throat pain |
On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigu...
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On 1/15/21, the day of the shot I had slight nausea, a sore arm around the injection site and fatigue in the evening. On 1/16/21, day two I had nausea after eating breakfast, extreme fatigue, muscle aches and joint pain. I also had a sore throat and odd sour taste in the morning, both days following the shot. This morning, day 3 I feel tired with less aches.
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| 42 | 2021-01-16 | fatigue, weakness, dizziness |
Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the mor...
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Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21. Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea. Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16. Also had hematuria that developed on 1/15. Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea. CBC, CK, CMP all normal but 1+ hematuria on U/A. Symptoms finally improved on 1/17
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| 42 | 2021-01-17 | shortness of breath |
About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB,...
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About 20 minutes after Dose 1 of vaccine administration, pt developed urticaria to neck. Denies SOB, resp difficulty, swelling of oral mucosa. Visual inspection of upper torso and extremities, no further urticaria noted. 5 minutes later, urticaria more pronounced. Pt sent to convenient care. pt presented with hives in the neck, slightly itchy. Pt denies respiratory distress, swollen lips, swollen tongue. Pt does have a history of asthma and has been on prednisone many times. Pt had urticarial rash with erythematous patches on anterior chest that are blanchable. No welts anywhere. No rashes anywhere else. Pt was given diphenhyramine 25 mg IM x 1 and rash/itchiness started to get better. Pt discharged home with a prescription for prednisone 40 mg PO QD x 5 days and instructions to take diphenhydramine Q6h PRN. Pt already on loratadine. Pt instructed to f/u with PCP.
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| 42 | 2021-01-17 | nerve pain, weakness, fatigue, headache |
couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind...
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couldn't differentiate the tingling in hands and feet from shot or from that; sharp pain jolt behind eyes/eyes hurt; icreamed; Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off; Whole body still weak; sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips; Twitching of face when do certain movements; brain zaps and brain buzzing began; numbness to right side of face to neck/made its way to left side; Horrible headache; fatigue; felt pressure behind her right eye; felt in a fog; forgetful mid conversation; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, EL0140), intramuscular on 23Dec2020 08:00 at single dose at right arm for COVID-19 immunization; prednisone via an unspecified route of administration from an unspecified date to an unspecified date (for 4 days) at 50 mg for an unspecified indication. Medical history included Known allergis: latex, contrast dye. Concomitant medication included the first dose of influenza vaccine (FLU) on 30Nov2020 at single dose at right arm for immunization. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient received other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Day 1: on 23Dec2020 08:15, the patient felt pressure behind her right eye after shot, felt in a fog, forgetful mid conversation. Day 2. (24Dec2020) Horrible headache started, fatigue. Day 3 (25Dec2020) brain zaps and brain buzzing began, headache, fatigue, numbness to right side of face to neck. By day 5 (27Dec2020) made its way to left side. Twitching of face when do certain movements. Her Dr gave her Prednisone and she took 50 mg for 4 days and stopped because she couldn't differentiate the tingling in hands and feet from shot or from that. Still brain zaps, newest issue sharp pain jolt behind eyes, left one in particular so bad she screamed and the nerves went all the way to finger tips. Her hand eye coordination was off as well and she wasn't able to be accurate on keyboard and her cursive was off. Whole body still weak, eyes hurt. Head a lot better than a day ago but still having buzzing and twitching. Today was day 18. She was awaiting an MRI with contrast on Friday hoping it got moved sooner as she was scared to what was going on. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included CT/MRI/Optic Nerve Scan/Pain Shot/Meds for Zaps. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 28Dec2020. The action taken in response to the events for prednisone was permanently withdrawn on an unspecified date. The outcome of the events reported as not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all these reported serious events might not be fully excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-17 | fatigue, dizziness |
difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nur...
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difficulty thinking; Extreme fatigue; dizziness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received her second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 11:15 at single dose at Arm Right for COVID-19 immunisation. Medical history included hypothyroidism, thyroid cancer, hypertension from an unknown date and ongoing, Known allergies: Latex, aluminium, nickel.The patient was not pregnant. Concomitant medication included gabapentin, propranolol, levothyroxine sodium (SYNTHROID), and pantoprazole. The patient has previously received her first dose of BNT162B2 on 20Dec2020 08:45 PM for COVID-19 immunisation at Arm left. There was no any other vaccines within 4 weeks prior to the COVID vaccine.The patient experienced difficulty thinking, extreme fatigue and dizziness resulted in Doctor or other healthcare professional office/clinic visit. All the events occurred on 11Jan2021 09:00 with outcome of recovering. No treatment was received. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The events were considered as non-serious. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the mental impairment and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-19 | cough |
5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins:...
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5 mins: mild site itching 15mins: whole body itching mod 20 mins: tongue swelling, coughing 25 mins: difficulty swallowing, tight breathing Pt was given 2nd round of 25 mg benedryl, epinephrine, Prednisone, albuterol breathing treatment and monitored for 3 hours. Sent home on 5 day course or prednisone
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| 42 | 2021-01-19 | headache |
EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting...
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EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
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| 42 | 2021-01-19 | fatigue, headache | Fatigue and "muscles feel heavy", headache all started 1/19 around 1940. |
| 42 | 2021-01-19 | fever, chills | Fever, chills, body aches |
| 42 | 2021-01-19 | dizziness | Heart was racing and lightheadedness |
| 42 | 2021-01-19 | weakness, headache, fatigue |
Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid...
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Immediate arm and neck soreness/12 hours later joint pain , Back pain, muscle aches, headache, rapid heart rate, metallic taste in mouth. weakness, fatigue, Symptoms still current after 2 weeks post vaccine.
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| 42 | 2021-01-19 | fatigue, shortness of breath |
Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no o...
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Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no other vitals available), gradually improving over about 30 minutes, followed by severe fatigue
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| 42 | 2021-01-19 | body temperature increased, headache, fatigue, chills, weakness |
Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 tha...
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Intense chills onset about 12h after vaccine and lasted for 3-4 hours, with a max temp of 101.2 that lasted around another 20 hours. Muscle aches, weakness, fatigue and decreased appetite for duration of fever. Took excedrin for severe headache once fever broke. Symptoms completely resolved 12h later, after sleeping.
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| 42 | 2021-01-19 | migraine |
Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until...
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Migraine on day 3. Started around 5 pm the first time, took ibuprofen and hydroxyzine to sleep until it passed. Day 6, another migraine. Ibuprofen and caffeine. Day 7 I went to get a haircut thinking the migraines may be caused by heavy long hair. Day 8 extremely painful migraine, can?t open eyes as light made it worse, nausea, vomiting. Called my PCP, they recommended going to urgent care after I vomited. I couldn?t get a ride so I took ibuprofen, Tylenol, and hydroxyzine to help me sleep until it?s gone.
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| 42 | 2021-01-19 | fever, headache, chills |
PERSISTENT BODY ACHES, HEADACHES AND CHILLS LASTING FROM AROUDN MIDNIGHT THROUGH MOSST OF THE FOLLOW...
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PERSISTENT BODY ACHES, HEADACHES AND CHILLS LASTING FROM AROUDN MIDNIGHT THROUGH MOSST OF THE FOLLOWING DAY, EASING OFF IN THE EVENING. TEMP AS HIGH AS 99.3. HEATING PAD TO LOWER BACK, ONE EXTRA STRENGTH TYLENOL TAKE ~4 HRS AFTER ONSET OF SYMPTOMS.
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| 42 | 2021-01-19 | malaise |
Tested positive for Covid/had the (Covid) infection; Tested positive for Covid/had the (Covid) infec...
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Tested positive for Covid/had the (Covid) infection; Tested positive for Covid/had the (Covid) infection; Swollen lymph nodes under my right arm; This is a spontaneous report from a contactable nurse. This 42-year-old female nurse (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: nurse stated she thought she had a lot# it looked like EK5703), via unspecified route at right deltoid on 21Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure (patient had taken blood pressure medicine but hadn't taking currently because her blood pressure was being controlled). Concomitant medications included unspecified vitamins. Patient was tested positive for Covid on the 29Dec2020. She stated she didn't know about causality, she was saying no but she did have swollen lymph nodes under the right arm before getting sick (Dec2020), now she thought that might get from her vaccination but in her understanding she could get it from Covid so, she couldn't answer that, she tested positive, she didn't think it's from vaccination but her concern was because she had got the vaccination the first one then had the (Covid) infection and right now she should get the second one or not. Regarding treatment, patient stated she was taking methylprednisolone sodium succinate (SOLU-MEDROL) and salbutamol (ALBUTEROL) inhaler, taking over the counter Vitamin D3, Zinc and Vitamin C and acetylsalicylic acid (ASPIRIN). Patient reported she did go to the physician office/ emergency room. Outcome of events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (8 days in this case). However, a causal relationship between events "Tested positive for Covid/had the (Covid) infection" (coded to Drug ineffective / COVID-19) and swollen lymph nodes and BNT162B2 vaccine cannot be completely excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-19 | headache, dizziness |
arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treat...
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arm pain for 5 days, nausea for a day or two then came back, on going dizziness and headache. Treated with ibuprofen, Tylenol, Zofran which has helped some, but all comes back and now for 2 weeks.
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| 42 | 2021-01-19 | fatigue, weakness |
within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all ov...
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within 10 minutes of vaccine. I became nauseous, vertigo. BP 86/87 HR 90 I became very itchy all over & I asked for Benadryl. I was taken to the ED dept. I was given zofran 4mg and Meclizine for vertigo and IV after 4 hrs. I Was told to go home and sleep it off. I've home with joint pain, muscle aches, nausea, abdominal pain, foggy mind, tiredness, weakness. Saw my PCP today. Rest, zofran and meclizine PRN hydration and rest.
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| 42 | 2021-01-20 | fever, headache |
Fever; body pain; Headache; This is a spontaneous report from a contactable Nurse (patient). This 40...
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Fever; body pain; Headache; This is a spontaneous report from a contactable Nurse (patient). This 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 07Jan2021 07:30 A.M. on Arm left at single dose (Lot # EL1283) for covid-19 immunisation. No other vaccine in four weeks. Medical history included Thyroid Cancer. None known allergies. No COVID prior vaccination. Concomitant medications included Levothyroxine and ubrogepant (UBRELVY). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 18Dec2020 04:00 P.M. on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient experienced headache started the day of 07Jan2021 at 21:30. Fever and body pain 08Jan2021 01:30 until 23:30. Lab data included Nasal Swab and COVID PCR on 08Jan2021: all Negative. No treatments were received. Outcome of the event headache was recovered. Outcome of the events Fever and body pain was recovered on 08Jan2021 23:30. No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-01-20 | weakness |
pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and ...
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pain on the joints, and legs (the feeling that inside the legs are stiff).; pain on the joints, and legs (the feeling that inside the legs are stiff).; woke and I was nauseus.; Pain is radiating to back and neck/I can't bend over that I feel pain from the neck to the head on the left side only.; I started to feel a little weaker, body aches.; I started to feel a little weaker, body aches.; unable to lift arm completely; Pain is radiating to back and neck; sore left arm after couple hours; This is a spontaneous report from a contactable other health professional (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 11:45 at left arm, at single dose for covid-19 immunization. Medical history was none. Known allergies was NKA/NKDA. Concomitant medication included methylcellulose (CITRUCEL), ergocalciferol (VIT D), vitamin b complex (B-COMPLEX), ubidecarenone (COQ 10) and birth control. The patient was not pregnant at the time of vaccination. The patient experienced sore left arm after couple hours on 07Jan2021 18:00. At night took Ibuprofen to help with pain. Pain woke the patient up at night. On 08Jan2021, left arm was very sore, unable to lift arm completely. Pain was radiating to back and neck. Took Ibuprofen. At night she wasn't feeling the same. She started to feel a little weaker, body aches. Her legs felt strange, as if there was some pressure, that veins were stiff. On 09Jan2021, the patient woke and was nauseas. Arm was not very sore but neck was. She couldn't bend over that she felt pain from the neck to the head on the left side only. At night her legs started to feel the pressure again. It seemed like pain on the joints. She didn't feel the same. On 10Jan2021, woke up with pain on the joints, and legs (the feeling that inside the legs were stiff). She was afraid that she was having an unusual, serious reaction and not aware of it. The outcome of the event was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 42 | 2021-01-21 | skin warm, headache |
12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client ...
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12/30/2020 Four hours after vaccination - left arm soreness, mild headache above right eye. Client improved that evening. 1/20/2021 Four hours after second vaccine dose - Body aches, intense headache over right eye, The evening of the same day - Heaviness to left arm, increased pain to left arm radiating to hands, tightness to the left arm with a feeling of "electricity" in the arm. The pain increased in intensity to the left arm during the night. Unable to sleep due to intense pain to the left arm and axilla. 1/21/2021 In the morning, client experienced abdominal pain and diarrhea once (loose stool). She noted swelling to the left axilla, intense pain, swelling below the left jawline. 1/22/2021 Early morning nausea without emesis, itching of the right forearm and nape of the neck, throbbing pain to left axilla with itching, throbbing to the left ear, which has not been sensitive to pain due to deafness.
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| 42 | 2021-01-21 | chills, body temperature increased, fatigue |
AFTER INJECTION - ABOUT 10 MINS- SWELLING DOWN THE FOREARM AND WRIST. AT 6:30PM, CHILLS, TEMP 99.1. ...
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AFTER INJECTION - ABOUT 10 MINS- SWELLING DOWN THE FOREARM AND WRIST. AT 6:30PM, CHILLS, TEMP 99.1. BY 10PM, TEMP CHILLS ALONG WITH FATIGUE. TOOK ADVIL.
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| 42 | 2021-01-21 | fatigue, dizziness, headache, chills | Body aches, chills, headache, dizziness, ringing in the ears, nausea, vomiting, and fatigue |
| 42 | 2021-01-21 | fever, headache, chills | Chills joint pain headache fever just felt generally bad this all lasted for 24 hours |
| 42 | 2021-01-21 | chills, headache, fever |
Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of...
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Headache with strobe light in periphery-left eye. Later, chills, body aches, slight nausea, fever of 101.2 at highest temp recorded. Started on 1/20 at around 9 pm. Symptoms subsided early morning of 1/22.
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| 42 | 2021-01-21 | headache |
Noticed a few hours after I got vaccine. Not exactly sure exact time because work nights and came ho...
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Noticed a few hours after I got vaccine. Not exactly sure exact time because work nights and came home and went to sleep after vaccine . Achy spine, front of my head hurt, nauseous. Same 2nd day. 3rd day just achy spine. Slept on and of last few days. Did not call Dr. Or go into office because symptoms didnt worsen. I work in hospital and kept in contact with EHO on monitoring steps i needed to take.
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| 42 | 2021-01-21 | shortness of breath, headache, fever |
Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up wit...
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Receiver second Pfizer shot on January 20 2021 and that night at 01:30 January 21,2021 I woke up with a rapid heart rate extreme headache and a fever of 102 I had shortness of breath and was taken to hospital. The ER performed a work up and my main complaint was my heart was hurting really bad I felt like my left carotid artery was swollen or occluded
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| 42 | 2021-01-21 | headache, chills |
Severe nausea, chills, joint pain, muscle aches, headache, itching. Still have the rash from prior v...
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Severe nausea, chills, joint pain, muscle aches, headache, itching. Still have the rash from prior vaccination so have MD visit later today for the nausea and rash/itching.
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| 42 | 2021-01-21 | chills |
Systemic: Chills-Medium, Systemic: Joint Pain-Medium, Systemic: Shakiness, weakness in the legs-Medi...
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Systemic: Chills-Medium, Systemic: Joint Pain-Medium, Systemic: Shakiness, weakness in the legs-Medium
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| 42 | 2021-01-22 | fever, discomfort, somnolence |
At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg...
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At minute 35 after the shot, I felt enough heaviness & pain near the injection site to take a 400 mg Advil max. At minute 45 after shot, I began to feel light tingling under my skin near the injection site, which slowly progressed to my elbow then my shoulder then my wrist, then to my neck and chin (all on left side) at which point I asked the HCP who gave the shot if I should take an antihistamine, she asked me if I was having trouble breathing and I said no, she recommended I take 500 mg of Benadryl 3x every 8 hrs. I took the dose about 75 min after my shot, by which time I felt tingling in my foot and pain in my wrist, slight feverishness. Fell asleep, woke up 4.5 hrs after the shot. The tingling sensation was gone. Only some drowsiness and pain in my arm. Applied ice pack to arm, took 250 mg Benadryl at 9.5 hrs after shot and woke up next morning with negligible symptoms, mild arm pain.
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| 42 | 2021-01-22 | fatigue, somnolence, chills, sweating, headache, shortness of breath |
Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetit...
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Day 1. Fatigue. Sleepiness. Loss of appetite Day 2. Muscle aches. Headache. Chills. Loss of appetite. Episode of severe abdominal pain, chest pain, right shoulder pain, shortness of breath, syncope, diaphoresis, vomiting Day 3. Fatigue. Headache. Chest pain.
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| 42 | 2021-01-24 | fatigue, body temperature increased |
12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injec...
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12/23/20 1st dose: very sore arm at injection site 1/14/21 2nd dose (lot: EJ1686): sore arm at injection site, extreme fatigue, high fever (103), shaking, muscle/body aches, nausea
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| 42 | 2021-01-24 | fever, fatigue, chills |
Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to sho...
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Chills, Fever (101.5F) lasted for 10-12 hours, pain at injection site, painful arm from elbow to shoulder, red swelling at injection site and hot to the touch, fatigue, and minor body aches. Pain at injection site started first at around 4pm on the day of the 2nd dose(Th). I woke the next morning (Fri) with arm pain and a little tired. Later that day around 4pm the fatigue, chills and fever started. Fever hit 101.5F overnight and then the fever broke by the morning (Sat). I felt a little tired on Sat, but all that remained as pain, redness and the feeling of a knot at the injection site (improved from Fri). Today (Mon) the knot still remains and the pain is gone. Slight pink around injection site, but much better.
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| 42 | 2021-01-24 | fever, dizziness, chills |
Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable c...
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Faint; Shaking; Febrile; Rigors; light-headed; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and unknown if there is any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and unknown if the patient had been tested for COVID-19 since the vaccination. On Jan2021, the patient experienced faint, shaking, febrile for around 36 hours, rigors, and light-headed. No treatment was received for the adverse events. Outcome of the events was recovered on Jan2021. The events were considered non-serious by the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 42 | 2021-01-24 | headache |
Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; m...
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Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19.
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| 42 | 2021-01-24 | fatigue, migraine, headache, fever |
Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I...
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Second round of vaccine at 7:20am. On Jan 6, 2021. By 4pm, I felt achy and low grade fever. By 6pm I had temperature of. 101.8. Achy, body/joints, headache. About 11pm I had a temp of 102.8. All the same symptoms, slightly heavy chest with breathing but not problematic. Very tired and no energy.The symptoms 36 hrs. Medication to help reduce fever did not work. After 36 hours I felt better except I still had no energy, and I had a migraine that lasted approximately 5 days ( lasted through Sunday January 10, 2021) I am a white female with red hair.
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| 42 | 2021-01-24 | headache | Severe headache (worse than a normal migraine) Nausea Diarrhea |
| 42 | 2021-01-24 | dizziness, shortness of breath, sweating |
Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, he...
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Shortness of breath, hot all over, diaphoresis, tightening of the throat, feeling of passing out, heart racing. Within 5 minutes of vaccine. Epinephrine auto injection and oxygen followed by steroid, Benadryl and omeprazole with oxygen in the ER.
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| 42 | 2021-01-24 | headache, nasal congestion, throat pain | Sore throat, then headache and nasal congestion with variable gastrointestinal upset |
| 42 | 2021-01-24 | shortness of breath | itching and the sensation of shortness of breath on vaccination date of 1/13/21. |
| 42 | 2021-01-24 | headache |
left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left j...
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left arm pain, sharp, stabbing, weak, painful to move.; increase ear and teeth pain including left jaw; face swelling including eyes; left ear and teeth pain; left ear and teeth pain; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; drooping of right side of face at mouth/neurology visit diagnosed with bells palsy reoccurrence related to vaccine; numbness/swelling to left side of face/some numbness and tingling intermittent left arm; numbness/swelling to left side of face; some numbness and tingling intermittent left arm; Left neck stiffnes and pain; Left neck stiffnes and pain; Left arm pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 15Dec2020 15:45 at left arm, at single dose for covid-19 immunization. Medical history included facial paralysis from 2010, ongoing chronic migraine, Known allergies was None. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); ibuprofen; paracetamol (TYLENOL); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient was not pregnant at the time of vaccination. The patient experienced left arm pain day of vaccine lasting through the week from 23Dec2020 06:00. Headache everyday after. On 28Dec2020 the patient noted numbness/swelling to left side of face, some numbness and tingling intermittent left arm. Left neck stiffness and pain. On 31Dec2020 increased left neck pain 10/10 and noted drooping of right side of face at mouth, left ear and teeth pain. On 02Jan2021 face swelling including eyes, increase ear and teeth pain including left jaw. Headache and neck pain continued. On 05Jan2021 Virtual visit with NNP started AbX and steroids (possible bells palsy flair up) and dentist visit no issues with teeth. On 08Jan2021 neurology visit diagnosed with bells palsy reoccurrence related to vaccine. Throughout the week increased numbness, tingling, and pain to left arm. With intermittent sciatic type pain to left leg. her whole left side had felt different since the vaccine. Constant left arm numbness, tingling, and pain since 09Jan2021. Minimal relief from headaches pain from 8 to 5. On 13Jan2021 10/10 left arm pain, sharp, stabbing, weak, painful to move. Treatment Steroids, pain meds, and MRI scheduled were received. All events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event headache was recovering, the outcome of the other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association, the facial paralysis recurrence is possibly related to suspect BNT162b2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-01-24 | chills, headache |
reports that on 1/21 she received 2nd dose of Covid vaccine. Went to work Friday 1/25--started havin...
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reports that on 1/21 she received 2nd dose of Covid vaccine. Went to work Friday 1/25--started having chills, body aches, HA. On Saturday,- fever and chills, body aches, HA. Reports on Sunday she felt slightly better, but still some s/s. Today 1/25: reports she feels flushed and HA still present.
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| 42 | 2021-01-25 | dizziness |
1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tig...
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1st 5 to 7 min dizziness, 10 to 15 min right tongue heaviness and left lower lip tingling, chest tightness. All mild symptoms. tongue and Lip Issues resolved in abt 1 hour and chest tightness in abt 2 hours.
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| 42 | 2021-01-25 | fever, chills, fatigue, headache, sweating |
Chills, nausea, fever, sweats x 24 - 48 hours; headache, fatigue, painful swollen lymph nodes (left ...
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Chills, nausea, fever, sweats x 24 - 48 hours; headache, fatigue, painful swollen lymph nodes (left posterior cervical) x 72 hours
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| 42 | 2021-01-25 | headache, fatigue |
Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going ...
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Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; Headache on the left side, left sided ear, jaw and neck pain going on 4 days. Extreme fatigue going on 4 days.; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3248), via an unspecified route of administration in left arm on 08Jan2021 14:15 at a single dose for COVID-19 immunization. Medical history included migraines, anxiety, arthritis, EOE, IBS, asthma, possible autoimmune disorder AS, and known allergies with caffeine. Concomitant medications included topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL), montelukast sodium (SINGULAIR), and multivitamin. The patient previously took scopolamine allergies. The patient experienced headache on the left side, left sided ear, jaw and neck pain going on 4 days, extreme fatigue going on 4 days, since 08Jan2021 22:00. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has no COVID prior vaccination, has not been tested for COVID post vaccination. Treatment for the events included MEDROL dose pack and TYLENOL. The outcome of the events was unknown.
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| 42 | 2021-01-25 | headache |
My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then abou...
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My initial reaction was headache, body aches, and brain fog, lasted about a day and half. Then about a week later i started just itching on my for arms and torso. I have little bumps and they itch. It comes and goes.
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| 42 | 2021-01-25 | cold sweat, chills, fever |
Woke up at 01:00 with severe body aches; was hard to walk or move; cold sweats; Chills; fever of 100...
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Woke up at 01:00 with severe body aches; was hard to walk or move; cold sweats; Chills; fever of 100.3 F; This is a spontaneous report from a contactable nurse reported for herself. A 42-years-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular on 14Jan2021 10:00 at single dose on left arm for covid-19 immunisation. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), clonazepam (KLONOPIN), quetiapine fumarate (SEROQUEL), aspirin [acetylsalicylic acid] (ASPIRIN). The patient received first dose of COVID 19 for covid-19 immunisation at 42-years-old, lot unknown=False, administration date=on 24Dec2020 09:00 AM, administrator route=Intramuscular, vaccine location=Left arm. The patient experienced woke up at 01:00 with severe body aches, was hard to walk or move, cold sweats, chills, fever of 100.3 f on 15Jan2021 13:00. Lab data included body temperature 100.3 f on 15Jan2021 13:00. The event outcome was recovering. No treatment was received for the adverse event. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 42 | 2021-01-25 | fever |
Woke up in excruciating pain; Fever; Joint and muscle pain; Joint and muscle pain; This is a spontan...
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Woke up in excruciating pain; Fever; Joint and muscle pain; Joint and muscle pain; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685), via an unspecified route of administration on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685), via an unspecified route of administration on 21Dec2020 04:00 PM at a single dose on left arm for COVID-19 immunization. On Tuesday morning, 12Jan2021, patient woke up in excruciating pain. She had fever, joint and muscle pain. The outcome of the events was recovering. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
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| 42 | 2021-01-25 | chills, fatigue |
myalgia; chills; fatigue; This is a spontaneous report from a non-contactable pharmacist. This pharm...
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myalgia; chills; fatigue; This is a spontaneous report from a non-contactable pharmacist. This pharmacist reported for 42-year-old female (pregnant: No) patient received 2nd dose of BNT162B2 (lot number=EL3246) Intramuscular on 12Jan2021 09:00 AM at single dose for covid-19 immunization. Medical history was Known allergies: sulfa, COVID prior vaccination. Concomitant drug was not reported. Historical Vaccine was 1st dose of BNT162B2 (lot number=EK5730, 22Dec2020, 09:00 AM, Intramuscular). No other vaccine in four weeks. After 12 hrs of taking 2nd dose of covid-19 vaccine (12Jan2021 08:00 PM), patient experienced myalgia, chills, and fatigue. The patient took Tylenol. All events resolved 24 hrs after. COVID tested post vaccination with unknown results. No follow-up attempts are possible. Information about lot/batch number has been obtained.
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| 42 | 2021-01-26 | weakness, fever, influenza like illness |
DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK ...
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DEVELOPED FEVER UP TO 100.4, JOINT PAIN, DIARRHEA, WEAKNESS, AND FELT LIKE HAD A HORRIBLE FLU. TOOK 5 DAYS TO RESOLVE. WAS PRESCRIBED AN INHALER BY PCP (UNSURE WHAT IT WAS)
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| 42 | 2021-01-26 | shortness of breath | Heart issues, palpitations, shortness of breathe. Seeing physician. reported this on 1/27/2021. |
| 42 | 2021-01-26 | fever |
Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at ...
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Less than an hr after the vaccine I suffered a gushing bloody nose. About 10pm I started having at gurgling, discomfort feeling in my stomach which had me in the restroom all night followed by fever and diarrhea. On 12/31 I was sent for a COVID test and results on 1/1 showed that I was positive resulting in me being out of work for a total of 3 weeks. And as of today I am still experience mild COVID like symptoms
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| 42 | 2021-01-26 | headache, fatigue |
Patient developed a quarter sized lump at injection site the days after receiving the injection. Thi...
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Patient developed a quarter sized lump at injection site the days after receiving the injection. This was raised and red according to patient's report. It persisted for 4 days and resolved on its own. Patient also developed muscle aches, fatigue, and slight headache. These persisted for 1.5 days.
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| 42 | 2021-01-26 | throat pain, weakness, chills, headache |
Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Sti...
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Sore Arm, itching on spot of Inj, headache , sore throat, chills, body ache, feeling very weak. Still have headache not as severe and weakness a little less but still have all symptoms except chills.
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| 42 | 2021-01-26 | chills, fever |
While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face ...
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While driving home after my 2nd vaccine and about 45 mins after my vaccine was administered my face began to feel numb and tingly. I immediately took Benadryl when I arrived home and had no further facial symptoms. However, approximately 23 hours post vaccination I developed a fever of 102 and chills that lasted approximately 6 hours. After the fever broke, I have had no further symptoms other than a sore arm and have not missed any work.
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| 42 | 2021-01-27 | headache |
mild headache; This is a spontaneous report from a contactable Other Health Professional (patient). ...
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mild headache; This is a spontaneous report from a contactable Other Health Professional (patient). A 42-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), via an unspecified route of administration on 22Dec2020 09:00 at single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously took nitroglycerin and experienced drug hypersensitivity. The patient had mild headache after the first dose on 22Dec2020 with outcome of unknown.
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| 42 | 2021-01-28 | fatigue, dizziness, headache |
1/28/21 5am headache and dizzy, 1/28/21 7am whole body aches, fatigue, unable to get warm. Tried to ...
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1/28/21 5am headache and dizzy, 1/28/21 7am whole body aches, fatigue, unable to get warm. Tried to sleep and drink water throughout the day. 1/29/21 7am woke up feeling better with just a massive headache.
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| 42 | 2021-01-28 | dizziness |
Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnanc...
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Given 1st dose of Covid vaccine on 1/5/21 and 24 weeks pregnant with hx of hypotension with pregnancy. Felt nauseous and lightheaded after about 15 minutes, near syncopal episode, pallor color, taken to ED for evaluation and discharged
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| 42 | 2021-01-28 | skin warm |
c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given...
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c/o weird taste in mouth, warm, rash on chest and right deltoid around injection site only, pt given benadryl 25mg , water, and ice pack, waited 30 minutes, rash subsided and pt feeling ok
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| 42 | 2021-01-30 | fever |
12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area...
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12/26/20: rec?d 1st dose Pfizer Vaccine?shortly afterward, she noticed swelling to the affected area Jan. 2 & 3: didn?t sleep well Jan. 4: mental fatigued Jan. 7: fever 101.2F, shallow breathing, upper quadrant pain, rash on neck Jan. 8: rash on abdomen; right flank pain?spoke with her Endocrinologist who think reactions are auto-immune related Jan. 15: increased blood pressure?consulted a Cardiologist and was prescribed a medication Jan. 15: had labs drawn?IgG 69 Jan. 28: consulted with a Neurologist who think she may have acute encephalitis related to the vaccine and recommended not to get the 2nd dose
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| 42 | 2021-01-31 | shortness of breath |
Allergic reaction; This is a spontaneous report from a contactable consumer (patient's spouse). A 42...
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Allergic reaction; This is a spontaneous report from a contactable consumer (patient's spouse). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 14Jan2021 15:00 at a single dose in a hospital for COVID-19 immunization. Medical history included allergy to sulfur and latex. There were no concomitant medications. The patient previously took dexamethasone (DECADRON) and experienced allergy. The patient had Covid vaccine at the hospital yesterday (14Jan2021) about 3pm and around 315-320, she had an allergic reaction. The patient was given epinephrine and stuff like that but ended up having to call an ambulance and took to another hospital. There, they had to put her in ICU and on a ventilator. The patient's spouse asked what might have been in the product that she would have been allergic to. The patient was transferred to hospital. She is a respiratory therapist. The patient was treated with epinephrine, albuterol and she was put on a bi-pap but she couldn't breathe and was told by the doctors that her body can't take it so they intubated her about 7:30 pm, she was put on a ventilator. The patient had an emergency visit. The patient had no prior vaccination (within 4 weeks). The outcome of the event was not recovered. Information about lot/batch number has been requested.
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| 42 | 2021-02-01 | fever, dizziness, fatigue, headache |
I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical obse...
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I am going to describe all my symptoms so far in detail. Shortly after the shot in the medical observation area I experienced mild nausea that went away for the rest of the day. About an hour after the injection, I experienced nasal drainage in the back of my throat that lasted about 30 minutes. 3 hours after my shot, the arm pain at injection site began, followed by 6 hours later moderate to extreme fatigue that did not cause me to be sleepy or drowsy--simply fatigued. I had enhanced sense of taste and smell. On Wednesday, 1/27 I woke up seeming okay and tried to work at my computer from home. I experienced light-headed and dizziness, and a headache that feels like pressure, and sinus pressure at the bridge of my nose. I had to disengage from work. After lunch around 2 PM I had extreme fatigue and had to lie down in bed the rest of the afternoon and evening. I have moderate nausea that comes in goes in waves. This morning, Wednesday, 1/28 I woke up with nausea and ate breakfast with a heightened sense of smell and taste. I logged into work and the lightheadedness and dizziness began again (also sort of in waves, though the headache is more pervasive and less wave-like than the nausea), along with waves of moderate nausea and headache. The arm pain at the sight of injection has significantly abated from a punch to mild pain. The "sinus" or sinus pressure on the bridge of my nose seems only a fraction improved. The headache or pressure has moved from the back of my head to the right side of my head. I had no body aches, but this morning has mild to moderate body aches this morning in my legs and hip bones. 1/29 I woke up with 20%-30% reduced symptoms of nausea and headache, but the dizziness and sinus pressure on the bridge of my nose remain the same. I still have enhanced taste and smell (a sensory plus it's not a distorted or odd enhancement, simply the same flavors and tastes enhanced). The ache that began yesterday in my lower body, my legs still ache, though it feels more like numbness than an ache. I tried doing some stretches which felt good, but my legs still feel the same after stretching. Pain at the site of injection is reduced 90%. There are some strawberries sitting next to me, and I can smell them acutely. Yesterday, 1/30, I woke up with mild nausea and fatigue. This nausea dissipated in the morning, but I felt too fatigued to do Pilates. The waves of dizziness and waves of nausea returned mid-day and I had a low-grade fever of 99.4 (my temp. Tends to run slightly lower than 98.6, as I take it regularly). The pain/pressure in the bridge of my nose has reduced 30%, but still remains. The ache or numbness in my thighs remains the same. This morning, 1/31, my temp is normal at 98.6, but I have mild waves of nausea and moderate waves of dizziness. The pain/pressure on my nose remains the same as yesterday. I have some mild ear pressure. My thigh weakness remains the same. I am too fatigued to attempt Pilates. Acute sense of smell and taste remains the same. The headaches or pressure also seem improved since Saturday 1/30. Monday, 02/01 - ah back to work I woke up with moderate nausea and pretty intense body fatigue and muscle aches in my lower body. I had to work, and I just wanted to crawl back into bed. I worked anyway, also the fatigue tends to worsen mid-day. The dizziness is moderate in waves, and the headache is still mild, along with that mild sinus pressure on my nose. I was in bed after dinner but could have rested all day. 02/02 I awoke with a very mild nausea! The intense fatigue (which worsened several days past my vaccine) was mild. I was ready to attempt my regular Pilates routine, and I did it! My muscle aches are mild to moderate (also, why are my muscle aches mostly confined to my thighs and hips I do have vague pain at the injection site, but its vague, and I use my whole body in Pilates) dizziness waves are back as I sit here typing and get ready to login online to my job staring at the computer screen is jarring to the dizziness waves and reminds me of the mild headache. This is the best I've felt since 1/27 through mid-day I tend to worsen and dizziness that is moderate is disturbing. The heightened sense of taste and smell also seems to have waned a bit in the past two days, back to what I was per usual? I tend to have an acute sense of smell and taste. *I would like it noted in light of new evidence that many people that have had COVID are experiencing intense reactions to the first dose that it is quite likely that I had COVID back in March when my learning center (I work with students age 4-adult, some of which are learning disabled and have autism) emergency closed because a client called to say she was positive for COVID. I had taken her sons temperature the day before. Me, and my two co-workers on my management team were also feeling sick. I had a sore throat and chest pains for approx. a month, but at the time COVID testing was not widely available. Since then, My co-worker has tested positive twice for the antibodies, and her husband, who was also sick at the same time, has tested negative twice. I tested negative once for the antibodies, though given my job, my commute on the subway during rush hour my co-workers positivity, and my intense reaction to the first dose I most likely had COVID. My boyfriend's roommate recently also revealed that he is positive to the antibodies, and he was literally sneezing and coughing in the same room with us this past summer and spring. I think a 2nd dose of the same vaccine will cause fainting and vomiting, and the need for two weeks off of my work. This dizziness is alarming. I'm also thinking not having antibodies means nothing in terms of my body and immune system recognizing the vaccine and the virus, making me more ill than when and if I actually had COVID in March or last year.
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| 42 | 2021-02-07 | dizziness, skin warm, headache, shortness of breath |
blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; Thi...
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blood pressure skyrocketed; body was really hot touch; Dizziness; Shortness of breath; Headache; This is a spontaneous report from a contactable consumer(patient). The 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 22Jan2021 13:10 at single dose for COVID-19 immunization. Medical history included ongoing injury to right foot. Concomitant drug included Steroid from 21Jan2021 and ongoing for injury to right foot. There was no prior Vaccinations within 4 weeks. On 22Jan2021, the patient experienced blood pressure skyrocketed and body was really hot touch with outcome of recovering, dizziness and shortness of breath with outcome of recovered on 22Jan2021, headache with outcome of not recovered. Patient went to Emergency Room for all events on 22Jan2021. It was reported that Patient received the first dose of the Covid-19 vaccine today. Patient had a severe reaction and went to the Emergency Room. Her blood pressure shyrocketed. She experienced dizziness, her body was really hot. You could feel it to touch. She had a headache and shortness of breath. Then She was given Benadryl, Zofran and steroids at the Emergency Room, no physician office. She was released because she was going home and going to bed. Information about Lot/Batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-02-08 | shortness of breath |
anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous...
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anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-14 | weakness, fever | developed diffuse tender adenopathy, weakness and fevers. Admitted with severe neutropenia - ANC 0. |
| 42 | 2021-02-14 | fatigue |
woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all...
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woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; woke with swollen tongue, throat, and all mucosal linings; Mallampati score 4, not my baseline; Moderate fatigue rest of the day; Sore arm was experienced within 5 hours of administration; This is a spontaneous report from a contactable Nurse reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at Left arm on 29Dec2020 17:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension (HTN), ablation corrected Wolff-Parkinson-White syndrome, pre-eclampsia. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), ibuprofen, naproxen sodium (ALEVE) and Women's multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took trolamine polypeptide oleate-condensate (CERUMENEX) and experienced allergy. The patient's sore arm was experienced within 5 hours of administration on 29Dec2020. Next morning 15 hours post, woke with swollen tongue, throat, and all mucosal linings. Mallampati score 4, not her baseline. Moderate fatigue rest of the day. Finally took Benadryl at 23-hours post vaccine, had to repeat Benadryl every 8 hours for 2 more days and monitor symptoms, events onset date was 30Dec2020 08:30. Adverse events result in: Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of Swollen tongue, Throat edema, Oral mucosa swollen, and Physical examination abnormal cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-17 | discomfort, dizziness, fatigue |
smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had ...
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smelled something like cigarette smoke; stomach cramps; left arm was in pain, more pain that it had been/pain was in her scapula, her left arm, all of her joints; pain was in her scapula, her left arm, all of her joints; could feel her blood surging through her body; she couldn't get comfortable; Crying; Allergic reaction; body aches; dizziness; hallucinations; up all night; exhausted/ fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9261), via an unspecified route of administration at the right arm on 22Jan2021 14:58 at a single dose for COVID-19 vaccination and ketorolac tromethamine (TORADOL), via an unspecified route of administration on 22Jan2021 16:30 at an unknown dose, single for pain. The patient medical history includes low iron anemia from Oct2020 and allergy to eggs, pecans, walnuts and latex. Also on 15Jan2021, she fell down the stairs and thought she broke her arm and was in severe pain. The has been taking iron supplements as concomitant medications. The patient reported having hallucinations, body aches, fatigue and dizziness on Jan2021. On 22Jan2021 09:00PM, she started smelling smoke, like cigarette smoke, like her home was filling with cigarette smoke, and no one in her house even smokes. On 22Jan2021, she also had severe stomach cramps like she was going to have diarrhea, but she never did. She says she was bowed over with the worst cramps like menstrual cramps, and her left arm was in pain, more pain that it had been. She says she could feel blood surging in her legs, it was almost surreal, she could feel the blood going through her body, which she never had felt something like that before. She says that the pain was in her scapula, her left arm, all of her joints. She says she could not get comfortable, and she was crying she was in that much pain. She says she does not typically cry and has a pretty good pain tolerance. She says she was getting freaked about that, and the next morning she was exhausted (Jan2021), she would assume since she was up all night in pain (Jan2021). The following day she laid around and felt extremely fatigued and dizzy, then by Sunday she was feeling better. For pain treatment she took Ibuprofen though her doctor also prescribed her another pain pill for her arm, she was scared to take it, so she took Ibuprofen 600mg which was also prescribed to her. The patient said that she did not think it was an allergic reaction but her doctor thought it might have been. The action taken in response to the events for ketorolac tromethamine was unknown. The outcome of the events was unknown.
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| 42 | 2021-02-18 | dizziness, fever, headache, chills |
could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; ...
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could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself. This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
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| 42 | 2021-02-21 | headache |
Developed acute pericarditis on 2/14/2021. Completely healthy 42 yr old with no recent illnesses oth...
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Developed acute pericarditis on 2/14/2021. Completely healthy 42 yr old with no recent illnesses other then the vaccine. Developed myalgia, severe headache, and slightly elevated blood pressures 24 hours post second vaccine. Then 4 weeks later acute pericarditis.
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| 42 | 2021-02-21 | fatigue, migraine, headache, fever |
Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after i...
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Itching in arm and torso immediately after injection-took standard dose of Benadryl 24 hours after injection, headache and some fatigue-took Ibuprofen 36 hours after injection, migraine, arm pain, fatigue, nausea-took flexiril, Zofran, and Ibuprofen 48 hours after injection, fever of 101, armpit pain, arm pain, fatigue-took Ibuprofen 72 hours after injection arm swollen in 3"x5" oval, bright red, hot to touch, armpit very tender, mild headache-took Ibuprofen
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| 42 | 2021-02-21 | dizziness | Palpaltations and dizziness |
| 42 | 2021-02-21 | chills, fever |
Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February...
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Patient reports that she received dose one of the Pfizer COVID-19 mRNA vaccine last Friday, February 5, 2021 at 2:03 PM. She received this here at facility campus vaccine clinic. She felt a strange tingling sensation immediately upon receiving the injection that extended from the injection site across her upper back but otherwise tolerated the injection well. Because of her history of food allergy she was advised to remain at the vaccination clinic for 30 minutes. During that 30-minute wait period she felt generally well however began to develop pruritus at her back in the legs. She did not mention this to the staff at the vaccine clinic and did not look at her skin. The pruritus was not too bothersome and she left the vaccine area after 30 minutes and walked down to our clinic to return to work. Her pruritus intensified very quickly upon returning to her desk and within a few minutes of after her return she went into the bathroom to look at her back and had patches of red, raised, urticarial lesions across her back. She began to feel itchy all over her body. She remained at work and did not take any medication or seek any medical help. She did not look at her legs. The pruritus intensified and when she looked at her skin of her legs approximately 1 or 2 hours later she had developed urticaria essentially head to toe. She had large confluent patches of urticaria at bilateral thighs, urticaria at her face, trunk, arms, legs. Â At this point she felt otherwise well. She went home and took 10 mg of Claritin and applied a topical Benadryl cream to her skin. This was not helpful. She had severe pruritus of her eyes and eyelids. She took 50 mg of oral Benadryl which also was not particularly helpful. Sometime in the middle of the night that night she developed chills, felt feverish, and developed intense muscle and joint aches. She took an unknown dose of ibuprofen with minimal improvement in muscle and joint pain. She did have improvement in fever. Following day was Saturday, she spent the whole day in bed in extreme pain. She describes the pain at her wrists as feeling as though "somebody was breaking my bones" with any movement of her wrists. She had pain even laying flat in her bed and had severe pain at all of her joints with movement. She tried taking a flexeril with no improvement. She recalls a T-max of 102 sometime on Saturday or Sunday. At that time she had been taking ibuprofen around-the-clock. She also took 10 mg of Claritin approximately every 4 hours. Each night she also took 50 mg of Benadryl. She continued to experience urticarial skin rash and intense pruritus of the skin. The urticaria waxed and waned during this time. She also developed a fever blister at her lower lip. She spent most of Sunday in bed also. She was feeling a bit better by Monday however still had intense pruritus. Skin rash was much improved at most of her body however she still had mild urticaria at her face. She did not have a fever on Monday but was continuing to take ibuprofen around-the-clock. She discontinued ibuprofen yesterday and has not had fevers or chills since Sunday. At this point her urticaria has essentially resolved. She continues taking claritin 10mg BID to 3 times a day and also 50mg bendaryl at bedtime. Â She did not experience any bruising related to this rash however did have excoriation from scratching particularly at her face. Â Throughout the course of these days she did not have any episodes of angioedema of the lips, tongue. She denies difficulty breathing, cough, wheezing, shortness of breath, throat tightening, nausea, vomiting, diarrhea, dizziness, lightheadedness, syncope. Â She has a history of oral allergy syndrome with peanut. Promethazine has caused diplopia, weakness. Simvastatin caused muscle weakness. She has never had any issues with vaccines. She has been getting a flu shot yearly with no difficulty. Her most recent vaccine was October 8, 2020, quadrivalent influenza vaccine. Â No known history of allergy to polyethylene glycol. Â No history of chronic urticaria. She takes NSAIDs frequently without any difficulty. She has not taken any NSAIDs prior to receiving this injection or developing this urticaria. She had however taken 10 mg of Claritin prior to receiving this injection. Â She has no history of anaphylaxis. She has undergone surgery under general anesthesia on more than one occasion without issue. No history of reaction to stinging insect venom. She receives immunotherapy for inhaled environmental allergens here in our office and has done well with this. Â She denies any recent medication changes or new over-the-counter medications. Â She has not previously been diagnosed with COVID-19.
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| 42 | 2021-02-22 | dizziness |
Approx. 10 minutes after receiving 2nd dose of vaccine, client stated she felt nauseous and light he...
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Approx. 10 minutes after receiving 2nd dose of vaccine, client stated she felt nauseous and light headed. BP 142/98, P 100 at 10:16am. Placed on floor with head down/feet elevated. Ice packs applied to neck. Given water to drink. Monitored for 30 minutes with no improvement. BP 112/80 P 80 @ 10:46am. Squad called to transport to ER.
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| 42 | 2021-02-22 | dizziness |
I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as...
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I woke up at 4:30am to shower. Once in the shower I got lightheaded, yelled for my husband, and as he was getting there I fainted in the shower. I came to, rested a second but when he helped me up I fainted a second time. Laid in bed for several hours. Took blood pressure/heart rate around noon and heart rate was 115.
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| 42 | 2021-02-22 | dizziness |
Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, ...
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Per patient report, 7 mins after vaccine she felt a head rush and felt faint. had a rash on chest, increased HR and BP. Given Benadryl, was monitored and released. She felt normal from 2/15 to 2/18. Then on 2/19 she felt dizzy, tongue felt fuzzy, heart rate erratic. Came to the ED. Had normal labs. Vitals normalized. Went home. Thereafter from 2/19 to 2/23, felt dizzy, had erratic heart rate, was light headed and was having a hard time focusing. Came back to the ED on 2/23 and had a HR of 135 and BP of 177/108. Got IV fluids and vistaril. Her HR improved to 119 and her BP improved to 161/98.
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| 42 | 2021-02-22 | headache | Second vaccine 02/19/2021 1150, first vaccine 01/29/2021@1150; Headache, aching and vomited once |
| 42 | 2021-02-22 | weakness | Site: Pain at Injection Site-Medium, Systemic: Weakness, Error: Wrong Dose of Vaccine - Too High |
| 42 | 2021-02-23 | throat pain, throat irritation |
anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue...
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anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-24 | chills, headache, dizziness, weakness |
tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appet...
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tachycardia up to 201; up to BP 210/101; chest pain; Extreme weakness; slept 36hrs; nausea; no appetite; stomach cramping; headache; site soreness; dizziness; full body aches; chills; diarrhea; This is a spontaneous report from a non-contactable nurse who reported for herself, a 42-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021, at the age of 42 years, at a single dose for COVID-19 immunization. Medical history included depression. Patient had no cardiac history. Patient had no COVID prior vaccination, and was not COVID tested post vaccination. The patient was not pregnant, and not pregnant at time of vaccination. Concomitant medication included celecoxib (CELEXA). On 22Jan2021, the patient experienced extreme weakness, slept 36hrs, tachycardia up to 201, up to BP 210/101, nausea, no appetite, stomach cramping, headache, site soreness, dizziness, chest pain, full body aches, chills, and diarrhea. No treatment was received for the events. The outcome of the events was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported events including serious events hypertension, tachycardia, and chest pain were likely related to due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 42 | 2021-02-24 | headache |
tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by ti...
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tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes; Brief period of pain in my right bicep; Headaches off and on; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 42-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN0201, expiry date: unknown), via an unspecified route of administration on the left arm, on 10Feb2021 09:30, at single dose, for covid-19 immunisation, at the hospital. Medical history included anxiety and bipolar II disorder (reported as bipolar2). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medications included fluoxetine hydrochloride (PROZAC), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), quetiapine fumarate (SEROQUEL) and "OTC vit" (as reported). The patient previously took lamotrigine and experienced allergies (known allergies: Lamotrigine). The patient did not receive any other vaccines prior to the COVID vaccine. On 10Feb2021 at 20:00, the patient experienced "brief period of pain in my right bicep, headaches off and on, tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". Treatment for the event "headache off and on" included 2 doses of 2 pills of acetaminophen. No treatment was given for the events "brief period of pain in my right bicep" and "tingling in 3 of my fingers on the left hand like it was asleep lasting a few minutes followed by tingling in my right hand like it was asleep for a few minutes". The patient recovered from the events on an unspecified date. The events were assessed as non-serious.
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| 42 | 2021-02-25 | dizziness |
felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; diff...
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felt like I might pass out /dizzy; brain fog/hard time thinking; tightness of chest and throat; difficulty swallowing; hard time thinking and talking normal; hard time thinking and talking normal; This is a spontaneous report from a contactable consumer (patient) A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en9815) on 11Feb2021 at 15:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included congenital adrenal hyperplasia and slight lactose intolerance. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), prednisone and naphazoline hydrochloride (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]). On 11Feb2021 patient experienced dizzy, felt like she was to pass out, brain fog/hard time thinking and talking normal, tightness of chest and throat, difficulty swallowing. Events resulted in visit to emergency room. The latter 2 events continued to get worse so they gave the patient an epinephrine injection (reported as EPI shot). Benadryl IV was also administered. At the time of the reporting the patient was recovering from reported events.
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| 42 | 2021-02-28 | dizziness |
light headed and dizzy, mild; This is a spontaneous report from a contactable consumer (patient). A ...
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light headed and dizzy, mild; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first single dose of BNT162B2 (Pfizer, solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Feb2021 10:30 to 11Feb2021 10:30 at SINGLE DOSE for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. There was no other medication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medication received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced light headed and dizzy, mild; lasted day of injection on 11Feb2021 16:00. The event was considered as non-serious by the reporter. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from the event on an unspecified date in Feb2021.
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| 42 | 2021-03-02 | headache |
Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactab...
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Bad headache; pain at location of injection; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number E13302), via an unspecified route of administration (arm right) on 15Jan2021 11:30 SINGLE DOSE for covid-19 immunisation, at 42 years old. Medical history reported as none. The patient is not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has no reported allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE), therapy date and indication unknown (received withing 2 weeks). The patient experienced bad headache lasting over 24 hours, pain at location of injection for two days, and diarrhea on 15Jan2021 11:30. Treatment was not given. Outcome of the events was recovered on Jan2021. The reporter considered the events as non-serious.
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| 42 | 2021-03-02 | chills, headache, fever |
Extreme muscle aches; fever; chills; headache; vomiting; This is a spontaneous report from a contact...
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Extreme muscle aches; fever; chills; headache; vomiting; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 29Jan2021 17:15 (at the age of 42-years-old) at single dose for COVID-19 immunization in the workplace clinic. Medical history included endometriosis, acid reflux, and history of blood clots. The patient had no known allergies. The patient was not pregnant. The patient did not have COVID prior to vaccination. Concomitant medication included methyldopa hydrochloride (ALDOMET [METHYLDOPA HYDROCHLORIDE]), omeprazole (PROTONIX [OMEPRAZOLE]), probiotics (PROBIOTICS), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and vitamins. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the left arm on 08Jan2021 at 06:15 PM (at the age of 42-years-old) for COVID-19 immunization. The patient did not receive other vaccines in four weeks. The patient experienced extreme muscle aches, fever, chills, headache, vomiting on 30Jan2021 at 11:00 AM. The patient did not receive treatment for the events. The patient was not tested for COVID post vaccination. The outcome of the events was recovered in Jan2021. Information on the Lot/Batch number has been requested.
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| 42 | 2021-03-04 | chills, fatigue |
chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable ...
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chills; increased heart rate; poor sleep; fatigued; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247), via an unspecified route of administration in the right arm on 25Jan2021, at 12:15 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jan2021, at 12:15 the patient experienced chills, increased heart rate, poor sleep, and fatigued, which were non-serious. The patient underwent lab tests and procedures which included heart rate: increased on 26Jan2021. Details were as follows: hours after injection (just after midnight), the patient had chills, increased heart rate and poor sleep; next day she was fatigued and side effects subsided 24 hours after onset (midnight). The outcome of chills, increased heart rate, poor sleep, and fatigued was recovered in Jan2021, with no treatment No follow-up attempts are possible. No further information is expected.
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| 42 | 2021-03-14 | weakness, fatigue, dizziness, headache |
unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Lo...
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unexplained bruising; hypotension; pale face; diarrhea; facial numbness; nausea; general weakness/Low energy; dizzy; mild headache/severe headache; Sore arm; tired/Fatigue; This is a spontaneous report from a non-contactable Pharmacist reporting for herself. A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration at right arm on 29Jan2021 13:45 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. The patient's medical history included allergies to Sulfa, PCN, Ceph. Concomitant medications included calcium, colecalciferol (VITAMIN D) and Multivitamin. Patient was not pregnant. On 29Jan2021 07:00 PM: Sore arm, tired at night, 30Jan2021: Sore arm, fatigue, mild headache, 31Jan2021: Fatigue, severe headache, hypotension, pale face, diarrhea, facial numbness, nausea, general weakness, dizzy, 01Feb2021: Fatigue, severe headache, unexplained bruising, facial numbness, nausea, general weakness, dizzy. Employee Health sent patient for COVID testing at 13:20 (result: Negative). 02Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 03Feb2021- 12Feb2021: Fatigue, severe headache, facial numbness, nausea, general weakness, dizzy. 11Jan2021: Fatigue, facial numbness. 12Feb2021: Fatigue, severe headache, facial numbness, general weakness. 23Feb2021 - Present: Low energy, intermittent mild-medium headaches. Adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of sore arm and headache included Pain relievers. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Considering temporal association and lacking of alternative explanation, a possible contributory role of BNT162B2 to all reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 42 | 2021-03-15 | chills, shortness of breath | n/v, chills, SOB, pulmonary embolism, pericardial effusion |
| 42 | 2021-03-19 | shortness of breath |
Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary ...
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Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.
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| 42 | 2021-03-21 | chills, headache |
Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the...
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Cold feet in the evening when vaccine was given. 1AM woke up with chills that continued through the next day. Extreme body aches that started in the middle of the night that continued into the next day. Extreme headache which made me nausea until 5PM the next day. Felt 100 percent better on Sunday at 1PM. Vaccine was given on Friday at 1PM.
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| 42 | 2021-03-22 | shortness of breath | Pulmonary Emboli, shortness of breath |
| 43 | 2020-12-31 | fatigue, chills, sweating |
Day 1: Severe fatigue Day 2: Fatigue and difficulty regulating temperature (chills and sweats) Day 3...
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Day 1: Severe fatigue Day 2: Fatigue and difficulty regulating temperature (chills and sweats) Day 3: Fatigue and minor nasal drainage
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| 43 | 2020-12-31 | chills, headache |
Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge bl...
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Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge blood clot from vagina, about the circumference of a clementine. was not old blood, looked like frank blood. over the next 30 hours, pt experiences more clots, much smaller, about the size of a pea. pt has a headache and chills throughout. 48+ hours, experiencing what feels like menstrual cramps. no blood clots 72 hours post injection
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| 43 | 2021-01-02 | dizziness | Racing heart, dizziness, lightheadedness |
| 43 | 2021-01-02 | skin warm, fatigue |
Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for...
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Swelling and redness at site of vaccine. Entire muscle of left arm swollen around injection site for 4 days. Painful to touch and hot. Increased tiredness within first 24 hours.
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| 43 | 2021-01-03 | dizziness |
Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post inje...
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Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell
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| 43 | 2021-01-03 | headache, chills |
Chills, rigors, body aches, headache, low body temp - started 24 hours after vaccine administration ...
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Chills, rigors, body aches, headache, low body temp - started 24 hours after vaccine administration and lasted about 8 hours.
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| 43 | 2021-01-03 | shortness of breath |
My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but...
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My arm was sore the 1st day, by noon the next day my HR was 160s, I was referred to go to the ER but I didnt and took benedryl went to sleep, woke up and I felt a little SOB but more like something was tied around my ribs preventing me from breathing. I saw the cardiologist who believed it to be sinus tackycardia as a result as an AE to vaccine. Felt as if my face and lips were swelling so I took benedry and laid down again and the next morning when I woke up and my face and lips were super swollen. But by the 3rd day the symptoms began to subside a little. By the 24th my HR had balanced out and I only had residual swelling around the eye area.
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| 43 | 2021-01-03 | headache | No treatment at this time |
| 43 | 2021-01-03 | migraine, headache |
On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea...
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On day 4 post vaccine, 12/27/2020, patient began with head and neck soreness, a migraine, and nausea/vomiting. Patient saw MD on 12/30/2020, MD stated patient had inflammatory response to the vaccine. Patient received a steroid injection. Patient states she feels better after steroid injection.
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| 43 | 2021-01-03 | dizziness | Pounding heart, fast breathing, warm/tingling in arms/hands, feeling like I might faint. |
| 43 | 2021-01-03 | nerve pain |
Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I ha...
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Right sided jaw pain started 12/22/20 in the am progressed through the evening. When I woke up I had numbness and weakness in the right of my tongue which I quickly realized included the right portion of my face. Included tongue was numb and I couldn't move it. An Er trip and CT scan confirmed it was Bells Palsy. Today, My symptoms continue. Top of my head all the way to the way to bottom of neck is experiencing paralysis. Can move tongue now and it's partly numb but it's cooperating a bit more now. Nerve pain has worsened all over all the right side of face. Feels like someone has kicked face and I have a deep bruise. It's a deep ache. Nothing will take away the ache away. My eye doesn't lubricate like it should. So I have to either manually close it and wet it manually or tape it closed.
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| 43 | 2021-01-03 | head discomfort, headache, fever, malaise |
She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spin...
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She suspected that she had an undiagnosed autoimmune disease.; Spinal pain that elicits nausea; spinal pain that elicits nausea; Headache that is worse at night/Headache worse at night time, sometimes gets better during the day/bad head ache; Body aches; Feeling crappy; Low grade fever; Pressure in the head; Terrible pain; Neck pain; This is a spontaneous report from a contactable other health professional (patient). A 43-yearsold female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Covid19 vaccine on 19Dec2020 and reported that at 36 hours she had body aches, feeling crappy, and low grade fever in Dec2020, she had since developed at headache that is worse at night, and spinal pain that elicits nausea. She suspected that she had an undiagnosed autoimmune disease. She was inquiring about duration of the reported AE's from clinical trials, and tried to decide how long she will feel this way. And going on 10 days and she's just struggling, bad headache and neck pain headache worse at night time, sometimes gets better during the day. Terrible pain and nausea. Any info on length of side effects: 36 hours- body aches feeling crappy. Low grade fever. Nausea with the spinal pain, pressure in the head. Difference in people with autoimmune issues- infertility - suspected autoimmune. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, there is no biological plausibility to implicate the suspect vaccine to the occurrence of the serious event autoimmune disease. More information such as medical history and concomitant medications and confirmative diagnostic workups are needed for full medial assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-03 | cough, shortness of breath, fatigue, respiratory tract congestion, headache, chills |
Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, sh...
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Vaccinated 12/19, had injection site pain for 2 days. Then on 12/25, developed cough, congestion, shortness of breath, fatigue, muscle aches, chills, and headaches. Starting 12/26, managed symptoms with albuterol 6 times/day. By 12/28 symptoms improved.
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| 43 | 2021-01-04 | somnolence, fatigue, chills |
1 hour post vaccine, started extreme fatigue and nodding off/sleeping which lasted 4 hours. Experien...
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1 hour post vaccine, started extreme fatigue and nodding off/sleeping which lasted 4 hours. Experienced chills 3 hours post vaccine which lasted 1 hour. The treatments I used were rest and warming myself.
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| 43 | 2021-01-04 | dizziness |
About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; Abo...
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About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; About 2-3 minutes after my vaccination, my heart rate went up, pounding, I got dizzy, dry mouth; This is a spontaneous report from a contactable other healthcare professional, the patient. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Dec2020 at 13:00 (at the age of 43 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included supraventricular tachycardia, asthma, seasonal and environmental allergies, anxiety, and allergies to latex, adhesives, ragweed, and Keflex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included buspirone hydrochloride (BUSPAR), piroxicam (PAXIL), cannabidiol, and levosalbutamol hydrochloride (XOPENEX), all for unknown indications from unknown dates and unknown if ongoing. Past drug history included epinephrine for dental work, where she experienced a similar reaction. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 21Dec2020, about 2-3 minutes after her vaccination, the patient experienced heart rate went up, pounding, she got dizzy, and dry mouth. She never had a hard time swallowing, no rash. This episode went on for about 2-3 minutes, they provided her a large amount of juice which seemed to help. Then it resolved completely and she finished off her 15 minutes without issue. It happened very suddenly and unexpectedly. The clinical outcome of about 2-3 minutes after her vaccination, her heart rate went up, pounding, she got dizzy, and dry mouth was recovered on 21Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 43 | 2021-01-04 | throat irritation |
Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 re...
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Became flushed and described a scratchy swallowing sensation. Blood pressure was elevated. SPO2 remained steady at 98%. Sat with healthcare staff for additional 40 minutes. Benadryl 25mg given.
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| 43 | 2021-01-04 | dizziness | Dizziness, nausea, light headedness, palpitations |
| 43 | 2021-01-04 | skin warm |
I had lymphadenopathy in my right armpit for three days post vaccine. I used a heating pad to treat....
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I had lymphadenopathy in my right armpit for three days post vaccine. I used a heating pad to treat. I also developed swelling on my right forearm that was hot to touch with pain. I used a heating pad as well on my right forearm and took Tylenol for two days-it resolved.
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| 43 | 2021-01-04 | headache, cough, fatigue |
No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after f...
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No appetite; congested head; congested head, cough; headache; fatigue; nausea; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant; This is a spontaneous report from a contactable other health care professional. A 43-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 18Dec2020 11:00 at single dose at arm (pending clarification) for COVID-19 immunization. Medical history included asthma, allergies, depression, penicillin allergy, allergies to: Mangoes, Cashews, Peaches. Concomitant medications included sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]). The patient previously took amoxicillin and experienced known allergies: Amoxicillin. On 18Dec2020: about an hour after flush, increased heart rate, very jittery - able to continue to work but unpleasant. Lasted about an hour. On 19Dec2020: afternoon - headache, nausea, fatigue started. On 20Dec2020: continued to feel fatigued and same symptoms. On 21Dec2020: headache, waves of nausea along with feeling flush (no fever ever) and elevated heart rate. On 22Dec2020: Same. The patient continued to work through all this but felt lousy. On 23Dec2020: stayed home from work because work wanted the patient to take a Covid Test (this was negative) - so laid around. Still with headache and nausea, easily fatigued. Cough started PM. On 24Dec2020: no nausea but continued headache, congested head, cough. On 25Dec2020: feeling better. No appetite. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19, and was negative on 23Dec2020. The outcome of the events was recovered. The patient did not receive treatment for the events. Information about lot/batch number has been requested.
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| 43 | 2021-01-04 | chills, nasal congestion, runny nose, headache, malaise |
Not feeling well; chills; muscle aches; headache; ears bothering; stuffy/runny nose; stuffy/runny no...
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Not feeling well; chills; muscle aches; headache; ears bothering; stuffy/runny nose; stuffy/runny nose; This is a spontaneous report from a non-contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), intramuscularly in the right arm, on 18Dec2020 at 06:00 (at the age of 43-years-old) at a single dose for COVID-19 immunization. Medical history included hypothyroid, breast cancer, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included levothyroxine (MANUFACTURER UNKNOWN) and tamoxifen (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose on 25Dec2020 at 20:00. The events were reported as non-serious. No therapeutic measures were taken as a result of the events. The clinical outcome of not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-04 | shortness of breath |
Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen t...
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Restricted respiration , muscle ackes and pain on my body, severe menstrual cramps from my abdomen to my armpit ( new and not experienced before).
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| 43 | 2021-01-04 | sweating |
Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burn...
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Symptoms started day after receiving vaccine. Started with a rash on upper back that itched and burned for a few days, followed by whole body burning and sweating with rash on lower arms and chest along with continued rash on upper back. These symptoms come and go and are worse on different days. This continues today and I have been advised by my healthcare provider not to receive second dose which was scheduled for today 1/5/21. I did take steroids for two days but then was advised by physician to allow my body to react if I can tolerate the symptoms. Symptoms are tolerable some days but not all. No fever with the burning and sweating. No other symptoms.
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| 43 | 2021-01-04 | fever, malaise, shortness of breath |
fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was ...
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fever; Nausea; suddenly felt there was something hot going through my body; suddenly felt there was something hot going through my body; She said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot.; It made it hard to breathe; felt like a rush of hot and felt horrible; My heart rate and BP was high; My heart rate and BP was high; she looked pale, and did not have rashes; This is a spontaneous report from a contactable Other HCP reporting for herself A 43-years-old female patient received bnt162b2 (BNT162B2; Lot # EH9899) vaccine , via an unspecified route of administration on 26Dec2020 10:15 at single dose for Covid-19 immunisation . Medical history included thyroid cancer from 2009 , blood calcium decreased from an unknown date , depression from an unknown date , anxiety from an unknown date. Concomitant medication included cetirizine hydrochloride (ZYRTEC) [fluoxetine (FLUOXETINE), calcium carbonate, colecalciferol, menaquinone (VITAMIN K2 + VITAMIN D3 + CALCIUM), calcium carbonate (TUMS) vitamin C (VITAMIN C) , vitamin D2 (VITAMIN D2), levothyroxine sodium (SYNTHROID). On 26Dec2020, about thirty minutes after receiving the vaccine the patient suddenly felt there was something hot going through her body it made it hard to breathe , felt like a rush of hot and felt horrible , her heart rate and BP were high, she said she felt a wave of heat going through her blood vessel, and her legs and arms felt hot. , she looked pale, and did not have rashes. The patient believed she was having an allergic reaction and gave a shot of epinephrine before going to ER. The doctors told her that her oxygen was fine (SatO2: 98%) and therefore she was not having an allergic reaction. She felt like she had trouble breathing. Her heart rate would go up to 120 to 150. Her blood pressure was high. She also received a shot of lorazepam (ATIVAN) at about 15:30 on 26Dec2020. She went bed and woke up on 27Dec2020, she had fever at 99.4°F and had nausea. The outcome of the reported events was unknown. The patient stated this was a terrible experience and she felt like she was going to die. Also she is not going to receive the second shot of the vaccine.
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| 43 | 2021-01-04 | fatigue |
had occasional diarrhea for about 24 hours, got shot on 12/21/2020 and had diarrhea 4 times on 12/22...
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had occasional diarrhea for about 24 hours, got shot on 12/21/2020 and had diarrhea 4 times on 12/22/2020, also felt tired.
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| 43 | 2021-01-04 | fatigue, chills, somnolence, headache |
sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I cou...
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sore arm; Extreme fatigue; My arms felt like lead for three days; I felt so sleepy/I felt like I could barely keep my eyes open for three days; mild headache; menstrual cramps; diarrhea; I had bizarre dreams like being attacked by zombies for three days; chills; This is a spontaneous report from a contactable pharmacist. A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration at Left arm on 23Dec2020 17:45 at single dose for covid-19 immunization. Patient known allergies included Imitrex, beef, grass, weeds, trees, Cats. Other medical history included Asthma, allergies, migraine, Premenstrual syndrome (PMS), overweight. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications in two weeks. The COVID-19 vaccine was administered at Hospital. The patient experienced extreme fatigue. Her arms felt like lead for three days, and she felt so sleepy. She felt like she could barely keep her eyes open for three days. She had a mild headache. It triggered menstrual cramps and diarrhea for three days. She had bizarre dreams like being attacked by zombies for three days. She had chills for a few hours. She had a sore arm for a couple of days. Adverse events start date was 23Dec2020 10:00 PM. Treatment included Tylenol. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of chills was recovered on 24Dec2020, of headache, chills, fatigue and sore arm was recovered in Dec2020, of other events was recovered on 26Dec2020.
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| 43 | 2021-01-05 | dizziness |
1815: pt complained mild dizziness, O2:97 %, BP: 115/83, HR: 86, pt given 50 mg Benadryl orally, ate...
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1815: pt complained mild dizziness, O2:97 %, BP: 115/83, HR: 86, pt given 50 mg Benadryl orally, ate some almonds and chips, not redness or swelling at site 1830: pt stated she was feeling better, requested to go home
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| 43 | 2021-01-05 | throat swelling, headache |
5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt ...
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5minutes post injection. I had Sour taste of medicine in back of throat. Couple minutes later. Felt throat swell. Not lymph nodes. Swelling sensation Inside throat. Had a mild headache. Was given 50mg of Benadryl. Taken to ER for observation. Swelling resolved couple hours later without any further reactions. Swelling never impeded my ability to breathe.
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| 43 | 2021-01-05 | fatigue |
Elevated HR up to 130 for a few hrs after administration and intermittently for several days; Severe...
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Elevated HR up to 130 for a few hrs after administration and intermittently for several days; Severe fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: eh9899, expiry date not reported), intramuscular on the left arm on 16Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. On 16Dec2020 14:00, the patient experienced elevated HR up to 130 for a few hours after administration and intermittently for several days and severe fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered with sequelae on Dec2020. Follow-up attempts are not possible. No further information is expected.
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| 43 | 2021-01-05 | headache | Headache |
| 43 | 2021-01-05 | headache, dizziness |
I have been experiencing body ache throughout my whole body, pain if stay in one position to long on...
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I have been experiencing body ache throughout my whole body, pain if stay in one position to long on right hip or lower; headaches; I experienced dizziness, felt giddy/light headed; Then at night my whole body felt sore, ached on lower back and right side of my hip; Then at night my whole body felt sore, ached on lower back and right side of my hip; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm) on 29Dec2020 at 07:30 AM, at a single dose, for COVID-19 immunization. The patient has no relevant medical history. The patient has no known allergies. Concomitant medications were not reported. Patient did not receive other vaccine four weeks prior COVID vaccination. The patient did not have COVID prior vaccination. The vaccine was administered in the hospital. Same day of shot, the patient experienced dizziness, felt giddy, then at night her whole body felt sore, ached on lower back and right side of her hip. In the morning of 30Dec2020, patient experienced body ache throughout my whole body, pain if stay in one position to long on right hip or lower back and legs, light headed and headaches. The patient did not receive treatment for the events. Outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.
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| 43 | 2021-01-05 | dizziness | Pt reported itchiness to her body and dizziness. |
| 43 | 2021-01-05 | headache, fatigue, fever |
extreme headache with sensitivity to light, low grade fever (99.8), large muscle body ache, fatigue ...
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extreme headache with sensitivity to light, low grade fever (99.8), large muscle body ache, fatigue lasted from around 2am 1/6 until 5pm 1/6.
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| 43 | 2021-01-05 | headache |
nausea; Headache; This is a spontaneous report from a non-contactable nurse. A 43-year-old female pa...
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nausea; Headache; This is a spontaneous report from a non-contactable nurse. A 43-year-old female patient received bnt162b2 (BNT162B2 also reported as COVID vaccine (brand Pfizer); lot number: 5730; expiration date: unknown), intramuscular left arm on 19Dec2020 11:00 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the patient had headache about 2 hours (13:00) after vaccination then about 6 hours (17:00) after she had nausea. The reporter considered the events as non-serious which did not result to death, not life-threatening, or did not caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect. No treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-05 | respiratory tract congestion, headache |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous re...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician reporting for a nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A 43-year-old female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. The physician was reporting that a nurse received the vaccine and had a headache after receiving it. She also tested positive for Covid 6 days after getting the vaccine (on 28Dec2020). He was asking if there was any connection with getting the first shot and testing positive. She was very keen with social distancing and wearing a mask. The physician is a medical oncologist. He was reporting on one of the nurses that worked at the hospital. She also developed nasopharyngeal congestion 4-5 days later. The nurse was at work today. She was disappointed because she had to go home. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 28Dec2020. The outcome of the events was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 43 | 2021-01-06 | headache, chills |
14 hrs after vaccination developed fever 101.4, headache, myalgia and chills. decreased the next da...
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14 hrs after vaccination developed fever 101.4, headache, myalgia and chills. decreased the next day but head ache and low grade fever remain.
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| 43 | 2021-01-06 | chills | Body aches and chills, no fever. Felt poorly. Sent home from her shift. |
| 43 | 2021-01-06 | dizziness, shortness of breath |
Dizzy, lightheaded, shortness of breath, tachycardic Vaccine given at approximately 1612 Benadryl gi...
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Dizzy, lightheaded, shortness of breath, tachycardic Vaccine given at approximately 1612 Benadryl given at 1614. 1615 Epi in L thigh. Pt transported to ED by wheelchair
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| 43 | 2021-01-06 | headache |
First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mil...
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First day tingling menthol feeling in mouth and jaw. Arm was sore. Mild headache, Shoulder pain, Mild pain arm. 12/17-12/18 arm pain got worse every day. 12/19 couldn't sleep at night. 12/20 limited motion in arm. Called doctor12/21. Took 400mg ibuprofen. Took Medrol for shoulder pain. 12/22 not able to sleep. Dr. wrote rx for Flexerol. Continued to take meds. Went back to work 12/23 with some pain. By 12/26 much better.
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| 43 | 2021-01-06 | headache | Headache Narrative: |
| 43 | 2021-01-06 | fatigue, chills |
I initially developed left arm soreness in the evening of administration of the injection. The follo...
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I initially developed left arm soreness in the evening of administration of the injection. The following day I developed chills and myalgias. On 1218 2021, I developed shooting pain down my right leg. Later that evening I developed persistent tingling and numbness in my hands, both, as well as tingling and numbness in both my feet. Since that time I have had persistent tingling and numbness. These symptoms have persisted since this time. They are worse with cold weather. Not associated with any weakness however I do have some increased fatigue ability in my right forearm, which may be unrelated.
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| 43 | 2021-01-06 | fever, chills, throat pain |
Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down wit...
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Intense pain at vaccination site, can't use my arm for anything, fever 38.9C that only goes down with ibuprofen. Chills, pain all over the body, can't put my feet on the floor because of plantar pain on my feet. Rib pain and axillary pain on my left side, lack of appetite, throat pain, stomach pain
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| 43 | 2021-01-06 | cough |
Pt received vaccine on 12/18 and developed erythematous, pruritic hives on 12/21. Was rx'd hydroxyzi...
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Pt received vaccine on 12/18 and developed erythematous, pruritic hives on 12/21. Was rx'd hydroxyzine without significant benefit (has brief relief is sx but recur before next hydroxyzine dos is due). Pt was seen twice in the ED for these sx. Pt was told sx were related to muscle strain. Pleuritic chest pain and cough. Ongoing cutaneous and respiratory adverse reaction.
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| 43 | 2021-01-06 | fever, headache |
Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea ...
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Rash over my back /neck/torso . Fever /body aches /left lower abdominal pain and cramping /diarrhea /lower back pain /headache
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| 43 | 2021-01-06 | headache, fatigue, chills |
Severe headache that brought tears due to pain. Chills. Nausea. Burp up bile. Exhausted. Subsided a...
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Severe headache that brought tears due to pain. Chills. Nausea. Burp up bile. Exhausted. Subsided after 7 hours. Intermittent headaches that only last for a few minutes and then subside.
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| 43 | 2021-01-06 | chills, body temperature increased | Temp 101. Chills |
| 43 | 2021-01-06 | headache |
report soreness at the injection started on 01/06/21 at 5:pm and today she began with achiness and h...
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report soreness at the injection started on 01/06/21 at 5:pm and today she began with achiness and headache with no fever which she states is tolerable at this time. There was no home remedies. continues to work and She will continue to monitor symptoms
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| 43 | 2021-01-07 | fever |
1/5/2021 received vaccination 1/6/2021 woke up at 6am with sore arm, muscle/joint pain, low grade fe...
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1/5/2021 received vaccination 1/6/2021 woke up at 6am with sore arm, muscle/joint pain, low grade fever of 100.4 . Treated with Tylenol and Ibuprofren. *I expected the second dose to be more 'hard hitting' then the first. The muscle / joint paint was a 6/10. 1/7 woke up at 4am and took Ibuprofren 1/8/ 'today i feel great'
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| 43 | 2021-01-07 | fever |
1/7/2021 Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with...
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1/7/2021 Woke up at about 6am with sore arm, muscle/joint pain, low grade fever 100.4. treated with ibuprofren and tylenol 1/8/2021 Took more ibuprofren at 4am, 'feel just fine'. *I think that severity of the symptoms, which i was expecting, the 2nd dose was more 'hard hitting' then the first; More side affects with muscle and joint pain.
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| 43 | 2021-01-07 | fatigue |
Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two...
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Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; Developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration in right arm on 29Dec2020 07:30 at single dose for Covid-19 immunisation. Medical history included rosacea, depression, asthma. The patient was not pregnant. No Covid prior vaccination. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included duloxetine hydrochloride (CYMBALTA), lisdexamfetamine mesilate (VYVANSE), spironolactone and multivitamin. The patient previously took cefalexin (KEFLEX) and experienced allergies: Keflex, rash. The patient developed face and chest rash accompanied by pronounced fatigue and stomach upset on 1/2 lasting two days on 02Jan2021 09:00 on 02Jan2021 09:00. No treatment received for the events. The events was reported as non-serious. No emergency room/physician office visit. The outcome of events was recovered on 04Jan2021.
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| 43 | 2021-01-07 | dizziness |
Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "le...
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Dizziness, NauseaVomiting, Tachycardia, Pt reported feeling "heaviness" in legs "can't move" and "left eye feels funny, like twitching and my blood pressure feels high" Narrative: Pt reports high anxiety along with stated symptoms.
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| 43 | 2021-01-07 | malaise, fatigue | FATIGUE, MALAISE, INJECTION SITE PAIN, VERTIGO, HYPOTENSION |
| 43 | 2021-01-07 | headache, fever | Fever 101, body aches, severe headache |
| 43 | 2021-01-07 | fever | Fever, Angioedema, SkinRash & Rash Narrative: |
| 43 | 2021-01-07 | headache |
Headache, Myalgia & Arthralgia Narrative: Mild symptom onset, presented to clinic to report. No furt...
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Headache, Myalgia & Arthralgia Narrative: Mild symptom onset, presented to clinic to report. No further actions.
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| 43 | 2021-01-07 | fever, headache, chills |
Headache, Myalgia, Fever, chills, generalized itching 7 days later Narrative: Took Benadryl and Zyrt...
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Headache, Myalgia, Fever, chills, generalized itching 7 days later Narrative: Took Benadryl and Zyrtec for the itching.
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| 43 | 2021-01-07 | fever, headache, weakness | Headache, muscle aches, weakness, low grade of fever |
| 43 | 2021-01-07 | fever, chills, weakness, fatigue, headache | I fever 102.2 , weakness, fitage , chills, head aches and arm sores. 48 hours recovered. |
| 43 | 2021-01-07 | discomfort |
I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began ha...
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I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; I began having muscle and joint aches throughout my body, discomfort 4-5 on a 0-10 scale; discomfort 4-5 on a 0-10 scale; I also noted stollen lymph nodes in my neck, throat, and subclavicular areas.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) (Brand: Pfizer), via an unspecified route of administration from 31Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. Patient is not pregnant. The facility type vaccine was Nursing Home/Senior Living Facility. Medical history included hypertension, aneurysm of ascending aorta, erbs-duchenne palsy right arm, asthma, seasonal allergies. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), diltiazem (DILTIAZEM SR), sertraline hydrochloride (ZOLOFT). The known allergies included PCN, bananas, passion fruit. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. 12h post vaccine at 01Jan2021 08:30 AM, patient began having muscle and joint aches throughout her body, discomfort 4-5 on a 0-10 scale. She also noted stollen lymph nodes in her neck, throat, and subclavicular areas. Patient didn't receive treatment for the adverse events. The outcome of events was recovered in Jan2021. Patient didn't experience Covid prior vaccination. She took Covid tested post vaccination, covid test type post vaccination Nasal Swab on 02Jan2021, the covid test result negative. The events were reported as non-serious.
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| 43 | 2021-01-07 | fatigue, fever, headache |
I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am...
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I had pretty severe symptoms about 12 hours after the vaccine. I received the vaccine on 1/6 at 8 am. Serve headache, body aches, chill, fever. They lasted about 12 hours and then most of today just overall fatigue. I now have discomfort in my back and chest. Is this normal?
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| 43 | 2021-01-07 | malaise |
Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a c...
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Nausea; malaise; injection site pain; injection site swelling; This is a spontaneous report from a contactable physician (patient herself). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) via an unspecified route of administration (arm right), on 04Jan2021 at 15:00, at a single dose, for COVID-19 immunization. Relevant medical history included migraines, seasonal allergies, and history of breast cancer in remission. The patient has no known allergies. Concomitant medication included (FLONASE) fluticasone propionate. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. On 04Jan2021, at 16:45, the patient experienced nausea, malaise, injection site pain, and injection site swelling. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 43 | 2021-01-07 | skin warm |
One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms ...
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One week after receiving the Covid vaccine, pt was seen by telemedicine in our clinic with symptoms of local cellulitis. The area was red, swollen and warm to touch.
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| 43 | 2021-01-07 | fever, headache, fatigue, sweating, weakness, throat pain |
Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mi...
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Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.
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| 43 | 2021-01-07 | shortness of breath |
RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of...
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RespDepression & HYPERtension Narrative: Employee reported difficulty breathing within 15 minutes of vaccine administration. She was given oral Benadryl and one dose of epinephrine per epi pen. She was taken to the ER for further evaluation.
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| 43 | 2021-01-07 | chills |
extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a sponta...
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extremely high heart rate (142bpm); muscle aches; chills; O2 sats "dropped to 97%"; This is a spontaneous report from a contactable healthcare professional (HCP) for herself. A 43-year-old female patient received first dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on 28Dec2020 at 13:30 for Covid-19 immunization. The patient had recently diagnosed with Covid-19 and "recover/off quarantine" on 12Dec2020. Concomitant medications were not reported. After vaccination, the patient experienced extremely high heart rate (142bpm), muscle aches, chills, O2 saturation dropped to 97%. The patient did seek medication attention/went to ER. She had to miss work. High heart rate resolved on the same day and other events resolved after 48 hours. The patient stated that she believed she took it too soon because she still had the antibodies from Covid, the doctors were saying they were not sure it was from vaccine, but she was sure it was. The patient made up her mind to not take the 2nd dose as she was scared. She stated that she did not want to go through that again, she could have had cardiac arrest. Information on the lot/batch number has been requested.
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| 43 | 2021-01-07 | fatigue, headache | headache , body aches, fatigue, injection arm pain |
| 43 | 2021-01-08 | headache | Body aches severe Headache |
| 43 | 2021-01-08 | chills, headache | Body aches, chills, slight headache |
| 43 | 2021-01-08 | shortness of breath | Generalized edema, shortness of breath, change in taste |
| 43 | 2021-01-08 | fatigue, headache |
Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was abl...
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Headache fatigue, injection site pain/arm soreness more severe than the 1st dose Narrative: Was able to sleep off her side effects. Took 800mg Ibuprofen OTC which helped. Afebrile.
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| 43 | 2021-01-08 | sweating, headache, chills, fever |
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever co...
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Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills alternating with sweats as well, fever continued for 2 days, also reporting swollen glands Narrative: Symptoms persisted for 48 hours, with some lingering symptoms beyond 48 hours (headache, aches, swollen glands)
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| 43 | 2021-01-08 | headache, fever, malaise, chills |
I recievwd my 2nd dose of Pfizer Covid vaccine on 01/06/2021. I started feeling sick on 01/07/2021 e...
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I recievwd my 2nd dose of Pfizer Covid vaccine on 01/06/2021. I started feeling sick on 01/07/2021 early morning. I had a fever (ranging between 99.7 to 100.1), had chills, bodyache, and a headache. I did not have the strength to get out of bed all day (on 01/07/2021). Today my symptoms have improved to some extent but I still have a bodyache and headache.
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| 43 | 2021-01-08 | headache, chills, weakness |
Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours pos...
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Severe chills, headache, stiff neck, nausea, diarrhea, weakness. Onset of chills approx. 8 hours post immunization. Severe shaking chills occurred with decreasing frequency over next 48 hours. Headache more intense for 48 hours, but persists still today (1/9/21). Nausea for 48 hours. Diarrhea lasted 4 days with decreasing frequency. Stiff and painful neck and base of skull has steadily decreased but is still present today (1/9/21).
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| 43 | 2021-01-09 | throat irritation, shortness of breath, headache, cough |
Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later...
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Dry cough, itchy throat, wheezing, SOB, heaviness in chest, headache. Resolved about two hours later after taking Benadryl and aleve.
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| 43 | 2021-01-09 | headache, fatigue, chills |
Headache, chills, body ache, severe fatigue, nausea. Symptoms were most severe about 16 hours after...
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Headache, chills, body ache, severe fatigue, nausea. Symptoms were most severe about 16 hours after vaccine
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| 43 | 2021-01-09 | skin warm |
Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swol...
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Hives (face, neck, ribcage, stomach, arms, hands, back, legs, underarms, elbows), Swollen eyes; Swollen lips; Hard Ears; Warm Skin; Itching; Wheezing.
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| 43 | 2021-01-09 | headache |
Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg...
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Immediately after injection, had headache, nausea, vomiting and metallic taste in mouth. Given 50mg Benadryl with improvement. Nausea/vomiting, metallic taste resolved after 24 hours. Headache and muscle aches lasted 48 hours and improving.
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| 43 | 2021-01-09 | headache | Moderate to sever Joint pain HA PHOTOPHOBIA Moderate soreness and swelling at injection site |
| 43 | 2021-01-09 | headache |
Patient experienced headache, muscle aches in the neck and back, and a sore throat. Symptoms were mo...
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Patient experienced headache, muscle aches in the neck and back, and a sore throat. Symptoms were moderate in severity. Patient self-treated with ibuprofen. Symptoms resolved approximately 24 hours after onset.
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| 43 | 2021-01-09 | nasal congestion, fatigue |
fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. A...
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fatigue and body aches developed about 12 hours after 1st injection which resolved after two days. About 3-4 days after injection had stuffy nose with extreme dryness and sores throughout both nasal passage resulting in epistaxis. It has been over 1 week without resolution of sores despite keep nasal passages moist and running humidifer.
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| 43 | 2021-01-10 | chills, fatigue, headache, fever, throat pain |
Body aches, chills, sore throat, headache, low grade fever, fatigue-approximate 12 hours Alternate T...
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Body aches, chills, sore throat, headache, low grade fever, fatigue-approximate 12 hours Alternate TYL and IBU
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| 43 | 2021-01-10 | fever | Body aches, lump on arm, Fever |
| 43 | 2021-01-10 | fatigue |
Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle ...
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Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle followed by droopy right eye and then right sided mouth drooping that comes and goes.
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| 43 | 2021-01-10 | fatigue, headache, fever, chills |
Extreme headache, fever for 3 days from 100.0 as high as 101.8, body aches, chills, extreme fatigue(...
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Extreme headache, fever for 3 days from 100.0 as high as 101.8, body aches, chills, extreme fatigue(4 days)
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| 43 | 2021-01-10 | headache, fatigue, shortness of breath |
Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortne...
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Friday evening - arm soreness, headache, Saturday morning - achy, chest pain, shoulder pain, shortness of breath, fatigue - all resolved
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| 43 | 2021-01-10 | headache | Headache started then I developed dry mouth that turned to ulcers on tongue |
| 43 | 2021-01-10 | chills, headache, fatigue | Headache, chills, muscle aches, fatigue |
| 43 | 2021-01-10 | chills, fatigue, headache |
I received the vaccine on Friday evening at 6:45 p.m. . Starting early morning on Saturday around 3:...
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I received the vaccine on Friday evening at 6:45 p.m. . Starting early morning on Saturday around 3:00 in the morning I begin to have extreme body aches causing me to wake up and my whole body was aching and I was shivering and it was difficult to move my right arm, which is the arm that took the injection. I was barely able to prop myself up to take Advil. I was down for the rest of the weekend in bed in pain. On Sunday the 10th of January the pain was less but it was more focused as a headache and I was extremely fatigued and slept the whole weekend.
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| 43 | 2021-01-10 | weakness |
L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose ...
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L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose #2 of the Pfizer-BioNTech vaccine
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| 43 | 2021-01-10 | fatigue | Left axillary lymphadenopathy, fatigue/body aches |
| 43 | 2021-01-10 | dizziness | Left side burning. Flushed, Lightheaded, Heaviness in her Chest Tylenol |
| 43 | 2021-01-10 | skin warm | Swelling, pain, muscle weakness, redness, heat |
| 43 | 2021-01-10 | chills, fatigue, body temperature increased | Temp 100.5, chills, body ache, fatigue |
| 43 | 2021-01-10 | headache | axillary adenopathy on injection side 48 hrs headache |
| 43 | 2021-01-11 | fatigue, nasal congestion |
1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 07...
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1/9/2021 0400-Chills 1/9/2021 1400-leg pain-8 on 0-10scale, overall body aches, fatigue 1/10/2021 0700-Facial swelling, mostly around eyes, forehead, and nose 1/11/2021 0700-Continued facial swelling limited to around eyes only 1/12/2021 0530-Continued facial swelling limited to around left eye only
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| 43 | 2021-01-11 | fever, headache |
After almost 24 hours, there was fever 100.2F, headache, joint pain, redness pain and swelling at th...
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After almost 24 hours, there was fever 100.2F, headache, joint pain, redness pain and swelling at the injection site. The pain and swelling has continued to grow every day until now my arm is swollen from the shoulder to the elbow and around to the inner arm. It is hot, hard to the touch, very swollen, and painful to any touch including clothing. It is now 96 hours later.
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| 43 | 2021-01-11 | fever |
After my first vaccination, I had tingling all the way down to my fingertips. While I was driving ho...
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After my first vaccination, I had tingling all the way down to my fingertips. While I was driving home that night, my face, mouth, tongue, and cheeks became tingling. I got my second dose and and the same symptoms happened. Last night I felt feverish and was achy.
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| 43 | 2021-01-11 | headache |
C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im...
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C/O neck pain followed by headache , nausea, vomiting, respiratory issues, itching, benedryl 50mg im given, VS, med called, started IV, BP 189/102, HR 80 Temp 98.5, 98.1, sent to ED
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| 43 | 2021-01-11 | influenza like illness, chills, headache |
Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body a...
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Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; Flu like symptoms like headache, chills, body aches; This is a spontaneous report from a non-contactable Other-HCP. This Other-HCP reported for a 43-year-old female patient that received second dose of bnt162b2 (BNT162B2, Pfizer COVID-19, Batch/lot number: EL0142), via Intramuscular on 05Ja2021 02:00 PM at single dose on Left arm for covid-19 immunisation. She is not pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products: Sulfas and first dose of bnt162b2 (COVID 19) for covid-19 immunisation. Concomitant medications were none. Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. The patient experienced Flu like symptoms like headache, chills, body aches from 05Jan202108:00 PM. No covid prior vaccination. No covid tested post vaccination. The event was assessed non-serious. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-11 | chills, fatigue, influenza like illness | Flu like symptoms, chills, tiredness |
| 43 | 2021-01-11 | fever, fatigue, influenza like illness, chills, dizziness |
I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and sta...
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I almost blacked out around 8:30 AM the morning after my vaccination. I took my dogs outside and started feeling woozy and seeing spots. By the time I got back into my house, I had tunnel vision and could not see directly in front of me. I went to lay down, but ran into a piece of furniture because I was so disoriented and hit my shin on it. I collapsed on my bed. I stayed there for few hours and then I was ok. I had severe, flu-like symptoms for most of the day - fever, chills, low energy, joint pain (specifically back and hip) - that waxed and waned. I finally felt almost back to normal approximately 50 hours after the injection.
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| 43 | 2021-01-11 | headache, fever, chills | Muscle aches, headache, chills, low grade temp |
| 43 | 2021-01-11 | sweating, fatigue, headache, fever |
Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM mod...
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Recieved vaccine on Friday 1/8 in AM, by evening had heaviness in shoulders and headache. 1/9 AM moderate fatigue and muscle aches with headache. By 4pm nausea began and temp of 99.4. Severe muscle/joint pain and fatigue progressed from there with temp reaching high of 102.6 before fever broke around 5AM 1/10. Sunday 1/10 - moderate/severe fatigue with low grade temp of 99.6., nausea, headache. Little energy to do anything other than sit on couch. Attempted to go to work Monday 1/11, did have fatigue and headache prior to leaving for work. Once at work developed severe hot/cold flashes on and off with profuse sweating spells anytime I would move around. 1/12 still with headache and nausea.
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| 43 | 2021-01-11 | fatigue, headache |
Severe diarrhea for 3-4 hours starting 2 hours after vaccine; headache; Fatigue for several day; Thi...
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Severe diarrhea for 3-4 hours starting 2 hours after vaccine; headache; Fatigue for several day; This is a spontaneous report from a contactable other HCP. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 20Dec2020 17:30 at a single dose for covid-19 immunisation. The vaccine was administered in the hospital. Medical history included asthma. The patient was not diagnosed COVID-91 prior to vaccination. There were no concomitant medications. On 20Dec2020 21:00, the patient experienced severe diarrhea for 3-4 hours starting 2 hours after vaccine, fatigue for several days and headache. The outcome of the events was recovered on an unknown date. No treatment was required for the events. The patient was not tested for covid-19 post vaccination. Information about lot/ batch number has been requested.
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| 43 | 2021-01-11 | headache, shortness of breath |
first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the...
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first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU
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| 43 | 2021-01-11 | fatigue, runny nose, nasal congestion, chills |
lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; ...
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lost the sense of smell and taste; lost the sense of smell and taste; nasal congestion/stuffy nose; runny nose; tiredness/felt tired; eye pain; pain in the muscles; chills; sore pain in the arm; This is a spontaneous report from a contactable Other HCP (Dentist) reporting for herself. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 31Dec2020 at 10:00AM in the left arm for COVID-19 immunization. Lot number was EJ1685. Medical history and concomitant medications were none. On 01Jan2021 in the morning, she had a sore pain in her arm, and by nighttime she had chills. On 02Jan2021 and on 03Jan2021, Saturday and Sunday she had pain in her muscles, felt tired, and had some pain around her eye every time she moved her eyes. On 04Jan2021, Monday everything went away but she had stuffy nose and runny nose. Her stuffy and runny nose was better but she still had some congestion, but she could not blow anything out of her nose. On 05Jan2021, Tuesday she noticed she could not smell and she still could not smell. On 06Jan2021, she had no smell and no taste either. Stated everything was good at the time of report but she still could not smell or taste anything. She treated herself with Tylenol for the muscle aches. She took one 500mg Tylenol by mouth on 02Jan2021 at bedtime and then one Tylenol 500mg by mouth again on 03Jan2021. She was scheduled for the next dose 19Jan2021. Mention she was planning to get a COVID 19 test to see if she had the disease. The patient recovered from fatigue, eye pain, pain in muscles on 03Jan2021, the patient recovered from chills on 02Jan2021, the patient recovered from sore pain in the arm on 01Jan2021, the patient was recovering from nasal congestion/stuffy nose, the patient did not recover from runny nose and loss the sense of smell and taste. Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported pain in her muscles, felt tired,had some pain around her eye every time she moved her eyes, had no smell and no taste, and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 43 | 2021-01-12 | throat pain |
After vaccine I began to have sore throat, shoulder and neck discomfort. I experienced also right a...
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After vaccine I began to have sore throat, shoulder and neck discomfort. I experienced also right arm soreness which has diminished.
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| 43 | 2021-01-12 | chills, headache, dizziness, body temperature increased |
Became dizzy, headache, felt like she was going to faint, rigors and a temperature of 101.5. Next m...
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Became dizzy, headache, felt like she was going to faint, rigors and a temperature of 101.5. Next morning she had upset stomach, feeling dizzy, thought she was going to faint and a headache.
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| 43 | 2021-01-12 | chills | Chills, upset stomach, soreness at injection site, abdominal gas pain |
| 43 | 2021-01-12 | fatigue |
DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED M...
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DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED MY FACE WOULD BE TINGLY AND NUMB FEELING-THEN ON SUNDAY HAD DROOPING OF RIGHT EYE LID WHEN I WAS TIRED-I NOW HAD SOME DROOPING OF MY MOUTH, ONLY SMOETIMES, AND MY EYE LID WHEN I AM TIRED. THE NUMB FEELING IS STILL THERE.:
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| 43 | 2021-01-12 | headache, body temperature increased, dizziness | Dizziness, full body aches, temp, headache. No treatment |
| 43 | 2021-01-12 | headache, weakness, fatigue, fever |
Fever 101.7, fever off and on for 24 hours beginning 14 hours after dose. Headache, muscle aches, ex...
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Fever 101.7, fever off and on for 24 hours beginning 14 hours after dose. Headache, muscle aches, extreme fatigue and weakness, same duration.
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| 43 | 2021-01-12 | fever, chills, headache | Fever up to 102.9 Chills Nausea and vomiting Earache Headache Backache For |
| 43 | 2021-01-12 | fever, chills, somnolence | Fever, Chills, severe body aches, sleepiness, arm soreness at injection site for about 40 hrs. |
| 43 | 2021-01-12 | fever | Fever, mayalgias, fatigue, swollen and sore lymph node under right arm pit |
| 43 | 2021-01-12 | chills, body temperature increased, fatigue, headache |
Headache, Fatigue, Body Aches, Chills, Shakes, Temp 100.6 also diagnosed with Bells Palsy after see...
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Headache, Fatigue, Body Aches, Chills, Shakes, Temp 100.6 also diagnosed with Bells Palsy after seeing PCP on Monday 01/11/2021. Patient also went back to see PCP on 01/12/2021 for follow up.
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| 43 | 2021-01-12 | fatigue, headache | Headache, extreme fatigue, burning in muscles, burning in lungs |
| 43 | 2021-01-12 | influenza like illness, chills, fever |
I am feeling like I have flu; Rash; Chills; Low fever; Muscle pain; Joint pain; This is a spontaneou...
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I am feeling like I have flu; Rash; Chills; Low fever; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose (first dose) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer stated, "I want to ask of side effect on Covid Vaccination (captured as Covid Vaccine) because I have already got first dose yesterday and like after few hours I got chills, low fever and the chills, it was like muscle pain, joint pain about today morning it was worse and I am feeling like I have flu already. It is like the same symptoms but muscle, joint pain. I got a little rash on my skin. I ask my doctor he said its better to call them and ask like what's going on that I supposed to do or just wait." The outcome of the event rash and Flu like symptoms was unknown, while the outcome of the other events was not resolved. Information on the lot/batch number has been requested.
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| 43 | 2021-01-12 | headache, fatigue |
I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I w...
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I had a rash on the arm from the injection site to half way down my arm. I had a weird headache. I was tired, and had no smell and slept all weekend. My arm was very, very sore. The rash lasted until 12/23/2020.
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| 43 | 2021-01-12 | headache |
I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9...
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I received the vaccine 1/7. I had mild arm soreness for 1.5 days. I had a mild headache at 1pm 1/9 and took an aleve at 3pm. at 4pm i noticed mild left undereye tenderness to palpation. at 11pm i noticed left undereye swelling and and bruising. i iced and took a zyrtec. by morning on 1/10 the swelling was worse and i called my dermatologist. she felt it was a reaction to the undereye filler i had >2.5 years ago. she started me on a medrol dose pack. the swelling resolved by the morning on 1/11.
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| 43 | 2021-01-12 | weakness |
Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of ...
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Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Too weak to perform normal activities/slept for 2 days straight; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: El1284 and Expiration Date unknown) via intramuscular route of administration on 05Jan2021 11:00 AM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: Eh9894) via intramuscular route of administration on 17Dec2020 05:00 PM (Left arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included known allergy and None other medical history. The concomitant drug was reported as Birth control medication. On 06Jan2021 1:30 am the patient woke up with severe all over muscles pains, with spasms that Tylenol 1000mg did not resolve. The patient had nausea, lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit. The patient slept for 2 days straight, too weak to perform normal activities. The patient continued to have some symptoms 3 days later. No treatment received for the adverse events of nausea, lymphadenopathy, pain in armpit, slept for 2 days straight, too weak to perform normal activities. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was recovering.
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| 43 | 2021-01-12 | fatigue, chills |
Pain at site of injection, L shoulder, started several hours after injection, worsened by the end of...
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Pain at site of injection, L shoulder, started several hours after injection, worsened by the end of the day to the point that it was difficult to use L arm. In addition, there were diffuse body aches, chills and fatigue overnight. Chills resolved by next morning. Body aches and fatigue still present.
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| 43 | 2021-01-12 | migraine |
Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 0...
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Patient recieved Pfizer vaccine 01/10/21. On 01/11/21 patient started to experience a migraine. On 01/12/21 patient started to expereince a worsened mirgraine accompanied with vomiting and severe back pain.
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| 43 | 2021-01-12 | fever, fatigue |
Patient started developing a fever the evening of the vaccine. Fever was 104 degrees and broke about...
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Patient started developing a fever the evening of the vaccine. Fever was 104 degrees and broke about 3am. Patient had extreme fatigue the next day, felt better 2 days after.
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| 43 | 2021-01-12 | headache |
Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took ...
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Received vaccine on 1/7. Had mild arm soreness for 1.5 days. Mild headache 1/9 about 1 pm. Took 1 aleve at 3pm. at 4pm noticed some left undereye tenderness to palpation. at 11pm noticed left undereye swelling and bruising. took zyrtec and iced. in the morning 1/10 swelling was worse. continued to ice. I contacted my dermatologist who felt it was a reaction to the previous underye filler i had >2.5 years ago. she started me on a medrol dose pack. swelling resolved by 1/11 in the morning.
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| 43 | 2021-01-12 | headache, chills, fever |
Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pa...
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Red raised circle with severe swelling in the upper arm, chills in the morning, whole body muscle pain, and nausea starting Thursday afternoon. Started a fever of 100 f and a headache Thursday night. The headache, nausea, and swelling in the arm lasted until Sunday night.
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| 43 | 2021-01-12 | fatigue, fever | Swollen lymph nodes, fever, chills, fatigue, stiff neck, arm soreness |
| 43 | 2021-01-12 | lethargy |
The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent s...
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The night after the injection, I was very lethargic, my mind was "cloudy" I couldn't form coherent sentences. Took Tyelenol before bed because my arm was very sore. Next morning, my whole body ached and had a severe tension headache, my jaw was very tense also. I was still very lethargic and my mind still "cloudy". Took Tylenol again after dinner, that night I started to feel relief from aches, headache and my mind can think more clearly.
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| 43 | 2021-01-12 | fever, headache, fatigue, shortness of breath |
sob, headache, fatigue, joint /muscle pain, fever. Worst part is the right shoulder joint/muscle pai...
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sob, headache, fatigue, joint /muscle pain, fever. Worst part is the right shoulder joint/muscle pain. This pain is very bad it has kept me up for 2 night and pain still present
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| 43 | 2021-01-12 | throat pain, body temperature increased, fatigue, headache |
soreness to injection site for two days, fatigue, headache, elevated temperature, sore throat, musc...
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soreness to injection site for two days, fatigue, headache, elevated temperature, sore throat, muscle aches
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| 43 | 2021-01-13 | chills, fatigue, migraine |
8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54...
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8hrs Post vaccine- Fatigue/mild chills/ leg aches 12hrs Post vaccine-Vertigo/nausea lasted 24hrs 54hrs post vaccine-Pounding Migraine that lasted 24hrs Pain at injection arm 24 hrs post vaccine.
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| 43 | 2021-01-13 | shortness of breath, cough |
Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, prog...
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Began with tingling/itching to tongue and roof of mouth approx 15 minutes after administration, progressed to tingling of lips, was sent to the ED for observation. Within 20-30 minutes developed cough, throat tightness, difficulty swallowing, breathing, vomiting, shortness of breath. Noted to have uvular swelling and wheezing on examination. Given Benadryl, Pepcid, Solumedrol, Zofran, Albuterol MDI, Epi IM. within a few minutes symptoms returned and were worse where I felt like I could not breathe, throat was closing, could not talk. Noted to be pale, HR in 140?s. Given second dose of epi IM and symptoms improved. Was transferred to Obs Unit., within 2 hours (approx 6 hours after administration), developed SOB, throat tightness, cough, vomiting, difficulty breathing. Again noted to have swelling of uvula, wheezing on exam. Given Solumedrol, Benadryl, SQ epi, Albuterol, Racemic Epi nebulizer. Was transferred to ICU, all meds held except Pepcid. Day #2 ~10 am (25 hours from administration) developed throat tightness, diffuse red rash to arms, difficulty breathing, vomiting. Again noted to have uvular swelling and wheezing. Given Solumedrol, Benadryl, Pepcid, Albuterol MDI, Racemic Epi neb. Solumedrol started q12hour dosing. Strange feeling/fullness in throat continued all day, got additional racemic Epi neb that night with improvement of symptoms. Following morning (day#2 after vaccine) noted to have diffuse red rash to chest and face, spread to arms, then began coughing. Given Solumedrol, Pepcid, Benadryl, Advair, Racemic Epi nebulizer. Solumedrol changed to q8 dosing. Approx 4 hrs later nurse noted rash worse on face, associated with itching, throat tightness. Given additional Benadryl, Racemic Epi neb with improvement. Rash continued that night with throat tightness, got additional Benadryl and Racemic Neb that night (total of 3 Racemic nebulizer on Day#2 post vaccine). Transferred to telemetry floor. Day#3 post vaccine rash improved, but still present to chest and face. Throat fullness present, especially after drinking. Am still hospitalized while writing this report
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| 43 | 2021-01-13 | headache, fever | Body aches, fever, headache, nausea |
| 43 | 2021-01-13 | dizziness |
I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It to...
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I felt dizzy as soon as I got the vaccine. My heart rate increased but nothing to worry about. It took me at least 30 min to feel myself. That afternoon I felt L hip pinching pains and joints pain. A week later I had sudden vertigo , unable to walk normally with no tinnitus or loss of hearing . I took meclizine 50 mg and it helped. It?s already day 5 , vertigo has subsided , I still don?t feel myself but I am able to go around, drive and move. I only feel dizzy at times and feel vertigo when laying down
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| 43 | 2021-01-13 | skin warm |
I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a...
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I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a fungal infection of the nail, however it had felt fine until it woke me up in the night. I thought I had developed cellulitis. However by the next morning it was completely gone back to how it was which is a little painful and irritated but not bad at all.
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| 43 | 2021-01-13 | headache, fatigue |
Injection site pain Tender/tight lymph nodes (L axillaire, L neck, L jaw) Muscle Aches (whole body, ...
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Injection site pain Tender/tight lymph nodes (L axillaire, L neck, L jaw) Muscle Aches (whole body, esp L shoulder, L upper back, L neck, L jaw) Joint aches (whole body, esp L shoulder, L jaw) Fatigue Sharp, intermittent shooting pain in shoulder Headache Effects most pronounced night of and day after vaccine, but persisting to lesser degree still on day 3 (today)
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| 43 | 2021-01-13 | headache, chills |
Last night having chill and headache. This morning was better. Went to work. But now around 5 pm st...
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Last night having chill and headache. This morning was better. Went to work. But now around 5 pm started having chill and headache again.
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| 43 | 2021-01-13 | headache, chills, dizziness, fever | Low grade fever, chills, headache, muscle aches and dizzy |
| 43 | 2021-01-13 | headache, influenza like illness, fever |
My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spont...
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My armpit is swollen; Swelling in the arm; Fever; Ache; Headache; Flu like symptoms; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), birth control. Concomitant medication included omeprazole for GERD, estradiol pills for birth control. The patient got the second dose of the Pfizer vaccine and she had some pretty severe flu like symptoms afterwards in Jan2021. But she noticed something odd and that was her armpit was swollen. She thought that is listed as one of the side effects but she wanted to know more about it. She had a pneumococcal vaccine (Unspecified vaccine) reaction and she wanted to make sure that there was nothing that would cross reactivity associated with this vaccine (Covid19 Vaccine). The weight is like 160. About 10 hours, she got 2 or 3 symptoms. Fever, aches, headache, bad headache. That lasted about overnight on the 05Jan2021. Swelling in the arm only started on 06Jan2021. That was when the armpit got swollen. The outcome of the events were unknown.
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| 43 | 2021-01-13 | fatigue, headache |
My lymph nodes were very swollen after receiving the vaccine. I also developed headaches and body ac...
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My lymph nodes were very swollen after receiving the vaccine. I also developed headaches and body aches, and fatigue. The result of my mammogram and ultrasound confirm the swollen lymph nodes. If they are still the same in 3 months we will schedule a biopsy.
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| 43 | 2021-01-13 | fatigue |
Pain at the injection site. That night and next day I felt fatigue and slept most of the day. I had...
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Pain at the injection site. That night and next day I felt fatigue and slept most of the day. I had no appetite and had nausea that would come and go. Decreased exercise for a couple days after. The following Monday I still had some fatigue but felt tired and low level nausea and not really hungry, There were waves when I felt like I was coming down with something. I felt tired enough that I went home early from a shift and tested for Covid. Test came back negative.
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| 43 | 2021-01-13 | dizziness |
Patient reported no contraindications at the time of prescreening and received vaccine around 1.35p...
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Patient reported no contraindications at the time of prescreening and received vaccine around 1.35pm. Around 1.38pm, patient reported of feeling dizzy, BP was taken 110/71 mmHg, at 1.46pm BP was 96/67 mmHg, at 1.57pm BP was 109/73 mmHg. After drinking water patient reported of feeling much better.
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| 43 | 2021-01-13 | weakness |
Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beat...
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Patient started feeling shaky and felt weak, said chest felt heavy and felt like her heart was beating fast. She also said that arms and feet felt "tingly". Patient felt this immediately after injection upon standing. Patient was escorted to chair for assessment. She was given water and pulse was normal. Patient said that she was feeling a bit better after a couple of minutes but then started experiencing chest heaviness and shakiness again. Patient alert, oriented, pulse normal, respirations normal. ER called and nurse came to clinic for assessment. Pulse was still normal upon his assessment but offered to take patient to ER via wheelchair for further assessment and patient agreed. Patient left clinic at approximately 8:55am to go to ER.
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| 43 | 2021-01-13 | shortness of breath |
Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was exa...
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Right sided chest pain and shortness of breath 2 hours after vaccine administration. Patient was examined in ER. CT of chest showed "questionable minimal small airway inflammation in upper lobes". Patient was discharged from ER home with Methocarbamol 750mg PO Q12 hours as needed.
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| 43 | 2021-01-13 | somnolence |
She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried ...
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She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried for a long time; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# either GL0140 or EL0140, Expiry date and NDC number were not written), via an unspecified route of administration in left arm on 23Dec2020 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient pregnant: No. She has had No positive test for covid before the vaccine, and No Antibody test before the vaccine either. She has had No issues with vaccines in the past. The patient had the vaccine on 23Dec2020 and then on 01Jan2021 she began to experience eye twitching and it hasn't gone away and it's very bothersome. It's still happening. Her first dose was on 23Dec2020. The eye twitching began on 01Jan2021, it's just the left eye, she can see the eye lid moving when it twitches, she felt it, like the eyeball itself was twitching or spasming. There were no issues with the vision in that eye. She did feel she was getting sleep, she was conscious about seeing if she was tired, both eyes felt as if she had cried for a long time but she had not cried at all and the eye that was twitching she felt it more in. She thought it was getting better in the morning because at that time she didn't feel it, but by mid-afternoon it was consistent. The twitching happened often sporadically every couple of minutes, and she was annoyed of it. Investigation Assessment: No. The outcome of the event left eye twitching was not recovered, outcome of other events was unknown.
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| 43 | 2021-01-13 | fever |
Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at a...
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Soreness and swelling at injection site. Chills at about 34 hours post-injection. Fever (100.5) at about 34 hours post-injection.
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| 43 | 2021-01-13 | headache, headache |
We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on...
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We have an employee who was vaccinated with Pfizer on 12/28/20. That evening she developed a rash on her arms that progressed to her legs and torso. The rash it itchy and burns. She still has the rash today. The next day after vaccination she experienced headache and aching that subsided within 3 days. This employee has a history of Lupus and breaking out in a rash is not uncommon for her, it is actually sort of common. When asked if this is the same sort of rash she experiences after too much sun exposure or stress (due to the Lupus) she says she would describe it as the same. She did miss one day of work due to the headache, aching, and just being miserable with the rash on top of it. She did not experience hives, trouble breathing, or swelling.
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| 43 | 2021-01-13 | skin warm |
arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightne...
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arm is red, warm, and itchy; arm is red, warm, and itchy; arm is red, warm, and itchy; Chest tightness; bitter taste in her mouth; funny feeling; arm was hurting; swelling; patient thinks the vaccine was given to her subcutaneously instead of intramuscularly; This is a spontaneous report from a contactable nurse (reporting for herself). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), subcutaneously in the left arm on 05Jan2021 15:00 at 0.3 mL, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included an unspecified multivitamin, taken at one tablet daily by mouth for supplementation therapy. The patient previously took the flu vaccine (MANUFACTURER UNKNOWN) in 2016 for immunization and experienced chest tightness, which she took diphenhydramine hydrochloride (BENADRYL). The patient experienced arm is red, warm, and itchy on 05Jan2021, which was reported as being medically significant. On 05Jan2021, the patient experienced chest tightness, bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly. On 06Jan2021, the patient experienced arm is red, warm, and itchy was reported as worsened. The outcome of arm is red, warm, and itchy, chest tightness and arm is red, warm, and itchy was reported as worsened was not recovered and of bitter taste in her mouth, funny feeling, arm was hurting, swelling and patient thinks the vaccine was given to her subcutaneously instead of intramuscularly was unknown. The reporter assessed the relatedness to the event, arm is red, warm, and itchy to the Covid-19 Vaccine as related; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events pruritus, erythema and feeling hot cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-13 | fever, fatigue, headache | fever, aches, head pain, elevated heartrate, fatigue for 24- 48 hrs, elevated hr still intermittent |
| 43 | 2021-01-13 | chills, fever, headache, fatigue | headache, chills, fever, sore arm, fatigue |
| 43 | 2021-01-14 | dizziness |
1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and...
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1015-felt dizzy; tingling starting in hands and feet. EE ate a granola bar and drank some water and related she was feeling much better
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| 43 | 2021-01-14 | headache, chills, dizziness, fever |
12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, ...
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12 hours after injection writer experienced high fever, chills, leg aches, low back pain, headache, and the feeling of dizziness or fogginess for 36 hours. Writer missed 2 days of work due to symptoms. Continued symptom - injection site is swollen, red, firm, tender to touch, arm sore to lift, and pain noted in arm pit.
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| 43 | 2021-01-14 | shortness of breath |
5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of ...
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5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction
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| 43 | 2021-01-14 | shortness of breath |
Began with hives, itching. Quickly progressed to difficulty breathing. Brought to ER, IM Epi given i...
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Began with hives, itching. Quickly progressed to difficulty breathing. Brought to ER, IM Epi given in ER triage. Caregiver given racemic Epi and another dose of IM Epi in ED. Further care please refer to ED MD
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| 43 | 2021-01-14 | dizziness |
Dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old fe...
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Dizziness; This is a spontaneous report from a contactable nurse (patient herself). A 43-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EL1283, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 17:00 at a single dose for COVID-19 immunization. The patient received her first dose of bnt162b2, via an unspecified route of administration on the left arm on 19Dec2020 at 13:00. Both doses were administered at the hospital. The patient had no medical history. The patient had no known allergies; she had no allergies to medications, food, or other products. Concomitant medication included unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced dizziness on 10Jan2021 at 20:00, or 24 hours after the shot had been given. At the time of the report, at the 12 hour mark, she was still being dizzy. The reporter assessed the event as non-serious. The patient did not receive any treatment for the adverse event (AE). The patient was not recovered from the event.
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| 43 | 2021-01-14 | shortness of breath |
During 30 minute observation period patient began to have a rash across their chest consistent with ...
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During 30 minute observation period patient began to have a rash across their chest consistent with hives and reported numbness and tingling of the R arm. Denied any other symptoms including SOB. Patient was taken to the ER for further observation where 50mg PO Benadryl was given.
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| 43 | 2021-01-14 | fever, influenza like illness, weakness | FEVER, BODY ACHES, NAUSEA, LOW APPETITE, WEAKNESS (FLU-LIKE SYMPTOMS) FOR 24 HOURS |
| 43 | 2021-01-14 | malaise, headache |
HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does...
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HA, eye puffiness and redness, generalized body aches, malaise. Treatment - Ibuprofen. Outcome- does not interfere with ADL's continue to work. No improvement in symptoms will continue to monitor.
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| 43 | 2021-01-14 | headache |
Headache that began on 4 days later. Treatment was ASA with mild improvement and report hives on fa...
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Headache that began on 4 days later. Treatment was ASA with mild improvement and report hives on face after taking ASA lasting for 30 minutes and resolved. Outcome: Continue working did not interfere with ADL's.
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| 43 | 2021-01-14 | chills |
I have had chills. Even though the shot was given in my arm the pain has moved into my right shoulde...
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I have had chills. Even though the shot was given in my arm the pain has moved into my right shoulder blade and up the side of my neck.
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| 43 | 2021-01-14 | shortness of breath |
Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Ta...
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Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area. Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.
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| 43 | 2021-01-14 | headache, chills |
On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenop...
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On 1/9/21, patient reported to urgent care for lower back pain. Patient also reported chills, adenopathy, headache, and hypertension. Patient was given prescription of diclofenac and cyclobenzaprine. No further escalation of care.
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| 43 | 2021-01-14 | headache |
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Co...
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Patient to ED for evaluation of symptoms after a Covid vaccine earlier today. She had her second Covid vaccine here at the hospital where she works about 8:30 AM. About 10:00 she started having shakes and a headache and just not feeling right. She has had some periods of palpitations and feeling like her heart is racing as well. She called employee health and was referred in to see us. At this time she says she still has some headache and overall feels weird but no other new symptoms. No chest pain or shortness of breath or palpitations at this time. No trouble breathing. No fever. No visual changes but the light does bother her eyes. She does have a history of migraine headaches that are like this at times. The pain is in her forehead, not globally or in her neck. She has no neck pain or stiffness. She did not have much of reaction after her first vaccination. She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled. She states that she does check them regularly at home and they have been okay. She denies any other recent sick symptoms. No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
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| 43 | 2021-01-14 | headache |
Patient was nauseous, threw up slightly and had a headache. This lasted for about 30 minutes, which...
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Patient was nauseous, threw up slightly and had a headache. This lasted for about 30 minutes, which occurred about 15 minutes after the vaccine administration. She also had a headache that persisted through till the next day,
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| 43 | 2021-01-14 | dizziness |
Reports tingling in arm that she received the shot at entry site. Feels slightly dizzy. She reports ...
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Reports tingling in arm that she received the shot at entry site. Feels slightly dizzy. She reports she had similar reaction when she had gotten the Hep B shot. BP 137/93 HR 92 O2 97%. RR 16. Reports history of HTN. No SOB or tightness of throat. No other symptoms. Sat for 15 more minutes. BP 133/96 HR 88. No further issues except small amount of tingling at shot sites. Patient discharged from clinic with instructions to plan for 1/2 hour sit time with next shot. Any further issues to seek care through PCP.
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| 43 | 2021-01-14 | throat pain |
Sore throat with white patches in back of throat started 2 days after vaccine. Missed work (work at ...
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Sore throat with white patches in back of throat started 2 days after vaccine. Missed work (work at hospital) the next day and went to urgent care. Tested negative for strep. Sore throat resolved that evening.
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| 43 | 2021-01-14 | respiratory tract congestion, malaise, influenza like illness, fatigue |
Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? Patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-14 | malaise, respiratory tract congestion, fatigue, influenza like illness |
Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning...
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Symptoms - ? patient reports approx. 1 hour after vaccination, burning at injection site and burning sensation up her arm and behind her L ear. Approx. 4 hours after vaccine, + fatigue, abd pain, abd cramping and chest tightness. Patient report cardiac hx. + nausea and feeling ?flu like?. Patient called off of work the night of 13th and 14th due to feeling unwell. Patient denies fever. At time of call, patient reports still feeling very fatigued, congested and abd pain/cramping. Patient denies COVID-19 exposure without proper PPE and travel. Last day of work and shift - ? 1/12 (night shift) Home remedies? - rest Any improvement? ? mild improvement Recommendation? Patient has been referred for testing. Patient reports previously tested in March (negative result). Patient encouraged to remain quarantine at home and to contact EH command center for assistance with testing. Patient verbalized back understanding and denied further questions at this time.
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| 43 | 2021-01-14 | fever, chills |
approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node te...
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approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node tenderness. At present, large reddened area at and below injection site and lymph tenderness
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| 43 | 2021-01-14 | headache, fatigue |
tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; mu...
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tiredness; headache; Injection site pain; injection site swelling; swollen lymph nodes under arm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot/batch number not reported, via an unspecified route of administration from 07Jan2021 12:45 to 07Jan2021 12:45 as SINGLE DOSE for COVID-19 immunisation. Medical history Known allergies: penicillin, almonds, raw carrots. Other medical history: Thyroid cancer, seasonal allergies, asthma. The patient previously tested positive for COVID-19 prior vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. On 07Jan2021 18:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, swollen lymph nodes under arm. The outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 43 | 2021-01-15 | fever |
Arm pain-heavy feeling, painful when moving Low grade fever 99.5 Moderate Body aches, especially lo...
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Arm pain-heavy feeling, painful when moving Low grade fever 99.5 Moderate Body aches, especially low back
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| 43 | 2021-01-15 | fatigue, headache | Fatigue, body aches, headache, injection site pain |
| 43 | 2021-01-15 | fever | Rash, swollen lymph node, fever |
| 43 | 2021-01-15 | runny nose |
Red skin/hives on my chest one-two minutes of vaccine administration. My muscle tensed up as the vac...
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Red skin/hives on my chest one-two minutes of vaccine administration. My muscle tensed up as the vaccine was injected and the person giving my shot said that she never experienced it before. Arm had a weak feeling. Runny nose as I was being taken down to the emergency room.
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| 43 | 2021-01-15 | dizziness |
Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute int...
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Right arm cold feeling progressed to neck and legs. Tried to return to facility after 25 minute interval after the vaccination. Then felt faint and called 911 who responded reported passed out while on 911 dispatch.
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| 43 | 2021-01-15 | fatigue, fever |
Severe muscle and joint pain, fatigue, low grade fever for 2 days. Loss of appetite. Treatment Tyle...
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Severe muscle and joint pain, fatigue, low grade fever for 2 days. Loss of appetite. Treatment Tylenol 650 mg and Ibuprofen 400 mg. Symptoms resolver after 2 days
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| 43 | 2021-01-16 | fatigue, body temperature increased |
Extremely tires about 9pm normal soreness to left arm started developing Wike up at 1:00 shaking, t...
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Extremely tires about 9pm normal soreness to left arm started developing Wike up at 1:00 shaking, temp 101.3 Ibuprofen 600 mg taken. Its 3:55 temp is 101 1
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| 43 | 2021-01-16 | throat swelling, fatigue, thirst |
I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole l...
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I got really thirty at first. Then lips, tongue, throat swelled. Talked funny. Lips tingled. Whole left arm and hand felt weird. Tired.
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| 43 | 2021-01-16 | fatigue, shortness of breath |
Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to m...
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Shortness of breath Sp02 in high 80s Chest pains Severe pain everywhere Exhusted Inability to move with out shaking
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| 43 | 2021-01-16 | skin warm |
red area warm to touch first appearing 8 days after vaccine, doctor diagnosed as cellulitis/allergic...
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red area warm to touch first appearing 8 days after vaccine, doctor diagnosed as cellulitis/allergic reaction to COVID-19 vaccine. Was prescribed medrol dose pack and clindymiacin
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| 43 | 2021-01-17 | headache |
3 days of very bad headache; This is a spontaneous report received from a contactable consumer (pati...
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3 days of very bad headache; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (BIONTECH COVID-19 VACCINE lot number and expiry date not reported), via an unspecified route of administration in left arm, on 09Jan2021 19:00, at single dose, for COVID-19 immunization. Medical history included food allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in four weeks. The patient experienced 3 days of very bad headache on 10Jan2021 at 08:00. No treatment was received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
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| 43 | 2021-01-17 | chills, sweating |
Covid vaccine #1 3 days ago. Last night she started having chills diaphoresis broke out in sweats an...
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Covid vaccine #1 3 days ago. Last night she started having chills diaphoresis broke out in sweats and having abdominal pain
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| 43 | 2021-01-17 | fatigue, throat pain, fever, cough |
Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spon...
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Fever for 5 days; rash on neck; body aches; sore throat; bloody nose; cough; fatigue; This is a spontaneous report from a contactable nurse. A 43-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly on 05Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), zolpidem tartrate (AMBIEN), cyanocobalamin (B12), lamotrigine (LAMICTAL), paracetamol (TYLENOL), vilazodone hydrochloride (VIIBRYD), colecalciferol (VITAMIN D). The patient experienced fever for 5 days, rash on neck, body aches, sore throat, bloody nose, cough, fatigue, all on 06Jan2021 04:00. The adverse events resulted in Emergency room/department or urgent care. No treatment received. This is a non-serious repot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 08Jan2021, test name: PCR, pending result. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 43 | 2021-01-17 | dizziness, shortness of breath |
Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachyc...
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Three hours after I received Vaccine I became extremely dizzy , had shortness of breath, was tachycardic and hypertensive. I was taken to the Emergency room . 48 hours after exam I had extreme periods of confusion and extreme forgetfulness.
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| 43 | 2021-01-17 | fever, chills, throat pain, headache |
about 12 hour after injection chills, fever, bone pain, joint pain, muscle aches, headache, sore thr...
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about 12 hour after injection chills, fever, bone pain, joint pain, muscle aches, headache, sore throat, nausea. Symptoms lasted about 36 to 48 hours with lingering muscle aches and headache
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| 43 | 2021-01-18 | shortness of breath, dizziness |
Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy...
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Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.
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| 43 | 2021-01-19 | chills, dizziness |
1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl ...
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1500: Sx: Tingling legs, dry mouth, chills, dizziness; BP: 160/70, HR: 106, SpO2: 98%; Tx: Benadryl 50mg 1505: BP: 134/88, HR: 91, SpO2: 100% 1510: BP: 122/81, HR: 80; SpO2: 100% 1545: BP 135/84, HR: 80, SpO2: 100%
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| 43 | 2021-01-19 | headache |
About 24hrs later on the 12/24/2020 I started getting a headache it lasted until 12/30/2020. But on ...
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About 24hrs later on the 12/24/2020 I started getting a headache it lasted until 12/30/2020. But on 12/27/2020 I stated feeling nauseas & I was vomiting. On 12/30/2020 I had to see a doctor.
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| 43 | 2021-01-19 | fever |
Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less ...
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Arm pain that lasted for approximately one day-no treatment needed Low grade fever that lasted less than 12 hours-no treatment needed Mild body aches that lasted less than 12 hours-no treatment needed Gastrointestinal upset/diarrhea that lasted less than 12 hours-no treatment needed
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| 43 | 2021-01-19 | fatigue |
Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopa...
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Body and muscle pain, joint pain, fatigue, site pain-started within 24 hrs of injection lymphadenopathy and nausea- started 48 hrs after injection
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| 43 | 2021-01-19 | fever, chills |
During the night had uncontrollable chills, diarrhea, fever that started at 99.6 and jumped to 102.4...
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During the night had uncontrollable chills, diarrhea, fever that started at 99.6 and jumped to 102.4. Muscle aches mostly to lower back. Felt like back was crushing
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| 43 | 2021-01-19 | fever, chills, headache | Fever 103, chills, shaking, major body and joint aches, pain at injection site, headache |
| 43 | 2021-01-19 | headache, chills | HEADACHE AND CHILLS. TOOK MOTRIN 200 MG @ 12PM 1/13/2021 TYLENOL 500 MG @ 9PM 1/13/2021 |
| 43 | 2021-01-19 | headache | Headache, stomach ache, diarrhea |
| 43 | 2021-01-19 | fatigue, chills, shortness of breath, headache, fever |
Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after s...
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Patient called to report a severe reaction today, 1/20/21. She stated approximately 12 hours after she received the vaccine, she began having severe chills and muscle aches with fever up to 102.6 that did not respond to Tylenol. Also had headache, vomiting, fatigue, shortness of breath, and chest tightness. After approximately 12-18 hours, her symptoms started improving, but still having mild to moderate muscle aches, fatigue, and shortness of breath. Using albuterol prn. Currently recovering at home.
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| 43 | 2021-01-19 | throat swelling |
Patient received 2nd dose Pfizer @ 1549, after 10 minutes of monitoring patient c/o of tightness & f...
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Patient received 2nd dose Pfizer @ 1549, after 10 minutes of monitoring patient c/o of tightness & felt "slow swelling" in her throat. Also reporting "slow swallowing sensation" Patient brought out to back triage area, vitals stable, NO SOB, no wheezing, no lip or tongue swelling noted. 167/95, 63, 99% RA. Reporting feeling anxious. Only allergy or similar event patient reports is medication, ephedrine during delivery which was treated w/ O2 during her delivery Repeat vitals 134/90, 59, 99% Allergy MD on call notified of event, per MD continue to monitor for additional 30 minutes and call back w/ any further symptoms 136/93, 60 & 99% After 30 minutes, patients vitals stable, sensation has resolved & felt well enough to go home 127/92, 59 & 99%
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| 43 | 2021-01-19 | headache |
Patient stated that she received the 2nd dose of the Pfizer vaccine on 1/13/2021. At 5:00 am on 1/14...
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Patient stated that she received the 2nd dose of the Pfizer vaccine on 1/13/2021. At 5:00 am on 1/14/2021, she noticed her right eye was swollen and red. Patient also complains of a headache. Patient took Benadryl and Ibuprofen without resolution of symptoms. Denied any problems with breathing or swallowing. Patient advised to see PCP or go to Urgent Care.
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| 43 | 2021-01-19 | body temperature increased, fatigue |
Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and naus...
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Soreness in left upper arm and neck. The next day also had a 100.2 temperature with fatigue and nausea.
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| 43 | 2021-01-19 | weakness, shortness of breath |
Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ...
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Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.
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| 43 | 2021-01-19 | fever, shortness of breath, fatigue, headache, chills |
approximately 12 hours after vaccine was administered, patient experienced the following symptoms: s...
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approximately 12 hours after vaccine was administered, patient experienced the following symptoms: severe chills and muscle aches; fever of 102.6 that did not respond to Tylenol, headache, vomiting, fatigue, shortness of breath, and chest tightness. She states they lasted for approximately 18 hours, and have started improving in the past 24 hours. Still having symptoms of mild to moderate muscle aches and some shortness of breath. Using albuterol inhaler as needed. Patient is recovering at home currently.
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| 43 | 2021-01-19 | chills |
back ache; intense achy; rigors and chill; Could not sleep; second dose of BNT162B2 on 08Jan2021, fi...
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back ache; intense achy; rigors and chill; Could not sleep; second dose of BNT162B2 on 08Jan2021, first dose was given on 19Dec2020; This is a spontaneous report from a contactable physician (reported for herself). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), via an unspecified route of administration (left arm) on 08Jan2021 (10:00 AM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 19Dec2020 (10:00 AM). Medical history included Celiac disease and allergies to medications, food, or other products: Latex, salicylate, wheat (celiac). Concomitant medication included melatonin (MELATONIN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that at around 30 hours after second vaccine dose (09Jan2021, 05:00 PM), the patient experienced back ache. At 36 hours post vaccine she developed intense achy and rigors and chill that lasts about 6 hours. The patient could not sleep during that time (10pm-330am). The patient took Tylenol at 1:30am. The symptoms abruptly stopped and felt perfectly fine after. There was a treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 43 | 2021-01-19 | headache, fever, fatigue, chills |
myalgias; severe headache; rigors; low-grade fever; nausea; fatigue; This is a spontaneous report fr...
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myalgias; severe headache; rigors; low-grade fever; nausea; fatigue; This is a spontaneous report from a contactable Physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly in right arm on 06Jan2021 11:30 at single dose for COVID-19 immunization. Facility type Vaccine: Hospital. Medical history included acne. Known allergies: No. Other medical history: none (on aldactone for acne). The patient was not pregnant. Concomitant medication in two weeks included spironolactone (ALDACTONE) for acne. The patient previously received the first dose of BNT162B2 (lot number EH9899) intramuscularly in right arm on 16Dec2020 11:30 for COVID-19 immunization. If other vaccine in four weeks: No. The patient experienced myalgias, severe headache, rigors, low-grade fever, nausea, fatigue 06Jan2021 15:00. The patient received treatment Ibuprofen and Acetominophen for the events. If Covid prior vaccination: No. If covid tested post vaccination: No. The outcome of all the events was recovered in Jan2021. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
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| 43 | 2021-01-19 | headache, chills, dizziness, fatigue |
near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observat...
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near syncope w/in 30 min. of vaccine- taken to ER immediately monitored, EKG, and kept for observation increased heart rate, light headed, orthostatic after vaccine continued w/ rapid heart rate, light headed and orthostatic for 3 days day 2 severe body aches, chills, fatigue and headache,, arm pain only at injection site, swollen lymph nodes- Tylenol taken but barely touched pain day 3 still joint aches and headache, fatigue and chills, slight arm pain only at injection site, swollen lymph nodes- Tylenol and rest day 4 felt better, rash began on torso and spread to arms, groin , neck, swollen lymph nodes day 4 rash which began to itch lasting day 4,5,6,7,8- took Benadryl so I could sleep, swollen lymph nodes Continue w/ intermittent chills, body aches, headache and light headed for day s 4,5,6,7,8 Continue w/ swollen lymph nodes under left and right arm and today is day 14
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| 43 | 2021-01-19 | dizziness, headache |
painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated ...
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painfully sore left arm beginning the evening of the shot and continuing for 3 days. Pain radiated from elbow up to neck and caused limited range of motion light headed, headache, severe muscle ache every joint lasting 3 days rash on torso at day 3 not itchy but red
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| 43 | 2021-01-21 | dizziness | Dizziness numbness tingling body aches |
| 43 | 2021-01-21 | dizziness, sweating |
Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later t...
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Dizziness, lightheadedness, sweating, blurry vision, nausea immediately following injection. Later that day/evening patient developed rheumatoid arthritis flair up that resolved over the course of two days and use of prescription medications (diphenhydramine and prednisone). Patient has a long standing history of rheumatoid arthritis.
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| 43 | 2021-01-21 | dizziness | ELEVATED BP 180 SYS, TINGLING IN FACE , DIZZY, WEAK IN LEGS. |
| 43 | 2021-01-21 | chills, fever | FEVER (103.8), CHILLS, ACHY |
| 43 | 2021-01-21 | fatigue, somnolence |
I started with under arm- armpit pain last night and this morning noticed that my glands and or lymp...
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I started with under arm- armpit pain last night and this morning noticed that my glands and or lymph nodes under the left arm are very swollen- knots. It alarmed me. I have also had diarrhea since the day of vaccine and just feel over all flushed and very sleepy/tired.
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| 43 | 2021-01-21 | cold sweat, dizziness | Lightheaded, pale, rapid pulse, chest pain, anxiety, clammy. |
| 43 | 2021-01-21 | fever, fatigue | body aches fever of 101 lasted for 5 days fatigue |
| 43 | 2021-01-21 | discomfort |
crushing feeling all over, left neck/shoulder stiff-PT taking Tylenol around the clock but does not ...
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crushing feeling all over, left neck/shoulder stiff-PT taking Tylenol around the clock but does not touch neck/shoulder discomfort.
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| 43 | 2021-01-21 | discomfort |
swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; Th...
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swelling in her lymph nodes on the right side/ neck; soreness on the side of my face; Discomfort; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via unspecified route single dose for protection from COVID-19 2 o' clock or 3 yesterday (09Jan2020), at 43-year-old. Medical history included: multiple sclerosis. Concomitant medication included: sertraline 50 mg once daily at night; antidepressant (unspecified). The patient previously took glatiramer acetate (COPAXONE) once for multiple sclerosis and amantadine, was allergic to both. The patient didn't notice soreness on the side of her face, was probably from the vaccine started yesterday (09Jan2020). The patient was doing fine but then noticing was getting swelling in her lymph nodes on the right side. The patient did not notice the swelling, but she noticed the discomfort first last night (09Jan2020), '9th, 10 pm' (not clarified further). The patient thought that it was a 'pimple' (not further clarified) there. And then later today (10Jan2020), or just maybe an hour ago, when she felt that on her neck, she found lymph nodes swollen. So far, no treatment was taken. No lab work done. Action taken for BNT162B2 was not applicable. Outcome of the events was resolved.
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| 43 | 2021-01-24 | fatigue, headache |
I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand...
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I received an instant headache, my left arm swelled and was painful from my shoulder down to my hand. Later in the day i became extremely tired, had pain in my neck. The next day i was still very tired, arm pain, headache, body aches, vomiting. Day 4 i am still very tired with body aches.
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| 43 | 2021-01-24 | weakness |
Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose...
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Parsonage-turner syndrome, confirmed by neurologist and primary care provider. 5 days after 2nd dose, the patient developed severe pain around vaccination site and arm, followed by muscle atrophy, weakness and clinical signs consistent with acute brachial neuritis.
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| 43 | 2021-01-24 | chills, fever, headache, fatigue, dizziness |
Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fev...
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Received vaccine at 4pm. Woke at 1:30 on 1/23 with headache . At 4pm aches settled in. At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills. Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs. Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
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| 43 | 2021-01-24 | headache, dizziness |
Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hemato...
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Red blood cells are a little low; Hemoglobin and hematocrit were slightly low; Hemoglobin and hematocrit were slightly low; fluttering in chest; Rash on left side of face and neck; skin started burning; Anxiety and fear; Anxiety and fear; Racing heart beat; Dizziness/Lightheadedness; Headache; Nausea; Has been on her period for three weeks/Is premenopausal/Was bleeding at time of vaccination; This is a spontaneous report from a contactable Nurse reporting for herself. A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration at right arm on 06Jan2021 15:22 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital, No agency site. Medical history reported included breast implants, She was healthy and had no medical diagnoses. The patient's concomitant medications was reported as none, She took no medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient wanted to report a possible reaction to the COVID Vaccine. Has been to the ER three times. Had a racing heart beat, dizziness, lightheadedness, and nausea on 08Jan2021. Developed a rash and skin started burning on 11Jan2021. The rash was on the left side of her face and neck. Racing heart beat started first. Then dizziness, headache, lightheadedness, and nausea began. She also had anxiety and fear. All symptoms began on 08Jan2021. Went to the ER on 08Jan2021. Was discharged from the Emergency room. Last night, 11Jan2021, she felt fluttering in chest, but it wasn't as severe as two nights ago. Her EKG was normal. Patient Hoped nothing occurs today. Took three Benadryl last night. Racing heart beat, rash, dizziness, headache, lightheadedness, nausea were all ongoing. The patient was wearing a Halter monitor until 12Jan2021 at 15:00, total duration for Halter monitor is 24 hours. Seriousness: Definitely disabling. Sunday night she thought she might not wake up Monday. She was fearful of all of the weird. Investigations: The patient was advised her labs were ok. Red blood cells are a little low. Hemoglobin and hematocrit were slightly low. Thought hemoglobin was 10.7. EKG was normal, Chest X-Ray was negative. The patient was just trying to figure out why reaction occurred. She Had been on her period for three weeks, was pre-menopausal. Was bleeding at time of vaccination on 06Jan2021. She did have breast implants, and didn't know if that was related or not. The patient Would not be getting the second injection. The nurse assessed the events of Racing heart beat, Anxiety and fear and Rash on left side of face and neck as related. The outcome of the event fluttering in chest was recovering, the outcome of the events Racing heart beat, rash, dizziness/ lightheadedness, headache, and nausea was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cardiac flutter, palpitations, headache, dizziness and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-01-24 | fatigue, dizziness, chills, headache |
Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, ...
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Sore arm noted day of vaccine. Following day noted fatigue, dizziness, nausea, chills, body aches, headache. Most symptoms subsided the next day, headaches and dizziness continue daily one week later.
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| 43 | 2021-01-24 | body temperature increased, fatigue |
patient had fever of 2 days between 100.9-101.4. tylenol was given with some relief but temp went ba...
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patient had fever of 2 days between 100.9-101.4. tylenol was given with some relief but temp went back up again. patient had muscle aches and joint pains. pain at the injection site. tylenol was given with some relief. patient had severe fatigue for 2 days.
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| 43 | 2021-01-25 | dizziness |
As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain ...
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As soon as patient received vaccination her left arm became heavy, she became dizzy with chest pain on deep inspiration. Patient has a PMHx of anxiety which they believe instigated the side effects. Patient was transported via EMS to Palms of Pasadena hospital with non-urgent acuity.
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| 43 | 2021-01-25 | fever |
Caregiver received Dose 1 12/29/20. Her vaccination card had the previous date's sticker on it indi...
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Caregiver received Dose 1 12/29/20. Her vaccination card had the previous date's sticker on it indicating Pfizer. The 12/29/20 vaccination was distributing Moderna. Ignoring what was said to her verbally that she received Moderna and the different prompts for timing of 2nd dose, she signed up and received a Pfizer Dose 2 on 1/20/21. She developed a fever and achiness after her first Moderna administration in alignment with typical vaccine reaction. She developed similar reaction after her Pfizer second dose. She recovered fully both vaccinations after 48hrs. We disclosed this misadministration and recited the CDC guidelines to monitor and not vaccinate with a 3rd dose. Caregiver took the finding well.
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| 43 | 2021-01-25 | headache, fever, chills |
Chills; Body aches; Fever of 101.4; Headache; This is a spontaneous report from a contactable nurse ...
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Chills; Body aches; Fever of 101.4; Headache; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL7249; Expiration date was not reported), intramuscularly on the left arm, on 12Jan2021 (17:30) at a single dose for COVID-19 immunization at the hospital. Medical history included migraine headache and arthritis of knees. Concomitant medication included topiramate (TOPAMAX). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported) on the left arm on 22Dec2020 for COVID-19 immunization (when the patient was 43 years old). The patient was not pregnant at the time of reporting. On 13Jan2021 (12:00 AM), the patient had chills; body aches; fever of 101.4 (unit was not reported); and headache. It was unknown if the patient had received treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'fever', and 'headache', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-25 | chills, fever | Fever 102.3 Joint pain Chills Nausea |
| 43 | 2021-01-25 | chills, fatigue, influenza like illness |
Flu like symptoms, fatigue, chills; Flu like symptoms, fatigue, chills; Flu like symptoms, fatigue, ...
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Flu like symptoms, fatigue, chills; Flu like symptoms, fatigue, chills; Flu like symptoms, fatigue, chills; This is a spontaneous report from a contactable pharmacist (patient). A 43-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231, expiration date not reported), via an unspecified route of administration on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included sulfa allergies. Concomitant medications included ergocalciferol (VIT D) and docusate sodium (COLACE). The patient previously took first dose of bnt162b2 (Lot number: EK5730, lot unknown: False, administration date:21Dec2020 :01:00 PM,vaccine location: Right arm, dose number:1), azithromycin and experienced allergies. On 11Jan2021 at 23:30, the patient experienced flu like symptoms, fatigue, chills. Outcome of the events was not recovered
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| 43 | 2021-01-25 | headache, fatigue |
Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't ta...
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Forgetfulness; brain was foggy; She was very tired; couldn't move her arm; Headache/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; generalized body pain/If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back; swollen lymph nodes in her left arm pit/couldn't move her arm; This is a spontaneous report from a contactable nurse reporting for herself. A 43-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included received first dose of BNT162B2 on unspecified date for COVID-19 immunization and her arm was inflamed, and so swollen, she couldn't move it. Caller was instructed to call after getting the COVID vaccine. She had a reaction after the vaccine. Her doctor said to call Pfizer. It was after she received the 2nd dose of the vaccine, Saturday (09Jan2021). She had a reaction. She developed a headache and fatigue. She had had these side effects since Saturday. They have lasted Sunday, Monday, and today/Tuesday. She was very tired, and she has generalized body pain. The pain was in her arm, shoulders, knees, spines, scapula's, hips, hands, legs, feet, and back. Literally, her whole body was so painful. She had been taken Ibuprofen 800mg and Tylenol 1g. She had been taking those every 8 hours. She took them together. When she took them, her headache and body pain was maybe a 5-6/10. If she didn't take the Ibuprofen and Tylenol her body pain and headache was probably an 8/10 pain. She also had swollen lymph nodes in her left arm pit. Which is the arm they injected the vaccine into. She just noticed it Saturday night. She couldn't move her arm. Now, after the second, she had a swollen lymph node the size of a quarter. It had been the same size since Saturday. She was wondering if it would go away? She was also becoming forgetful. Her brain was foggy-ongoing. Like she forgot her doctors appointment today. The outcome of event "brain was foggy" was not resolved while outcome of other events were unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-25 | dizziness |
Immediately following vaccination, the patient reported her left arm "becoming heavy", then she beca...
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Immediately following vaccination, the patient reported her left arm "becoming heavy", then she became dizzy with chest pain on deep inspiration. EMS transported patient to hospital under non-urgent acuity. Primary impression was generalized anxiety consistent with PMHx of anxiety episodes.
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| 43 | 2021-01-25 | fatigue, chills, fever |
Injection site pain; fever; chills; fatigue; myalgia; This is a spontaneous report from a non-contac...
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Injection site pain; fever; chills; fatigue; myalgia; This is a spontaneous report from a non-contactable pharmacist (patient). A 43-year-old female patient (no pregnancy) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at site of left arm at 13:30 on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced injection site pain, fever, chills, fatigue and myalgia in Jan2021. Facility type vaccine was in hospital. No other vaccine in four weeks. Adverse reactions did not result any serious consequences. The patient received paracetamol (TYLENOL) as treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovered in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 43 | 2021-01-25 | headache, fever |
Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, ha...
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Joint pain; Arm swelled up from the shoulder to the elbow and around to the inner arm; It is hot, hard, swollen, and extremely painful; from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful.; Arm swelled up from the shoulder to the elbow and around to the inner arm; Headache; Low grade fever of 100.2F; This is a spontaneous report from a contactable other healthcare professional. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176; expiry date: unknown) via an unspecified route of administration in the left arm on 08Jan2021 on 15:00, at a single dose, for COVID-19 immunization. Medical history included gastrooesophageal reflux disease (GERD), bariatric surgery, seasonal allergies, and known allergies to bee stings, flu vaccine, and monosodium glutamate (MSG). Concomitant medications included famotidine (PEPCID) and cetirizine hydrochloride (ZYRTEC), and multivitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) on 17Dec2020, at 01:00 PM, in the left arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 09Jan2021, at 14: 30, the patient's arm swelled up from the shoulder to the elbow and around to the inner arm. It was hot, hard, swollen, and extremely painful. She also had joint pain, headache, and low-grade fever of 100.2 Fahrenheit (F). The patient did not received therapy for the events. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 43 | 2021-01-25 | headache, chills, fatigue, fever |
Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report fro...
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Tired; legs and arms felt sore; mild headache; fever 101.1; chills; This is a spontaneous report from a contactable pharmacist (patient). A 43-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=EK9231) on 10Jan2021 03:30 PM (vaccine location=Left arm, dose number=2) at single dose via unknown route of administration for unknown indication. Medical history was not reported. Concomitant medications included ibuprofen (MOTRIN); vitamins NOS (MVI); calcium carbonate, colecalciferol (OSCAL D); vitamin c. Historical vaccine included patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer, lot number=Ek5730), on 19Dec2020 03:15 PM, (vaccine location=Left arm, dose number=1) via unknown route of administration at single dose for unknown indication. There were unknown allergies. Patient did not receive other vaccine in four weeks. Patient did not have covid prior vaccination and did not have covid tested post vaccination. Patient experienced Tired, legs and arms felt sore, mild headache, fever 101.1, chills on 11Jan2021 01:30 PM. Patient did not receive any treatment. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 43 | 2021-01-25 | shortness of breath, cough |
chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetir...
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chest tightness, shob, lip tingling, facial edema, peripheral edema, cough - improved w/ 10 mg cetirizine x 1 po vital signs stable
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| 43 | 2021-01-25 | headache, migraine, fatigue |
headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; T...
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headache; Sore arm; Fatigue; bodyache/Slight linger of achiness; muscle ache; migraine; fogginess; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female non-pregnant patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3249; expiration date: unknown), intramuscular right arm on 08Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included exercise induced asthma. The patient has no known allergies. There were no concomitant medications. The patient did not receive other vaccines in the last four weeks. The patient was not diagnosed with Covid prior to vaccination. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EJ1685) intramuscular left arm on 19Dec2020 10:00 at a single dose for covid-19 immunization but she had zero side effects. The patient reported that on her second dose, she had sore arm, fatigue, body ache, muscle ache, migraine and fogginess beginning 24 hours after receiving injection and lasting 72 hours. Slight linger of achiness and headache on the fourth day (12Jan2021) but able to work again. No treatment was received for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was recovering.
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| 43 | 2021-01-26 | somnolence, dizziness |
1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, j...
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1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch; eye lower lid internal tenderness; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Behind lower Rt (right) ear pain, Rt (right) sided neck pain, Rt (right) side buttocks pain, Rt (right) side thigh pain, swelling, Rt (right) knee pain, and swelling; Dizziness; sleepiness; increased blood pressure and pulse; increased blood pressure and pulse; Then sleeplessness till 4am next day; This is a spontaneous report from a contactable Nurse A 43-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 15Jan2021 14:45 at single dose for covid-19 immunisation. Vaccine location was right arm. Medical history included attention deficit hyperactivity disorder from an unknown date, hypothyroidism from an unknown date. The patient's concomitant medications were not reported. The patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. The patient experienced 1st 24hrs= Rt (right) side Facial, cheek, jaw, swelling, numbness, tingling. Begin of Rt (right) eye pain, tingling, Rt (right) eye lower lid internal tenderness, softness, sensitivity to touch on 15Jan2021 15:15 with outcome of not recovered, behind lower rt (right) ear pain, rt (right) sided neck pain, rt (right) side buttocks pain, rt (right) side thigh pain, swelling, rt (right) knee pain, and swelling on 15Jan2021 15:15 with outcome of not recovered, dizziness on 15Jan2021 15:15 with outcome of not recovered, sleepiness on 15Jan2021 15:15 with outcome of not recovered, increased blood pressure and pulse on 15Jan2021 15:15 with outcome of not recovered, then sleeplessness till 4am next day (as reported) on 15Jan2021 15:15 with outcome of not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-01-26 | malaise, chills, headache, discomfort, head discomfort |
Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick...
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Around 11:30pm 1/25, I muttered "I don't feel good," which reminded me of being a child getting sick. within 30 minutes of then end escalating over the next hour, I had a severe headache, bilateral, occipital, pressure in entire head and neck. The headache as also in my eyes and in my ears. Back was also painful - not as bad as neck, but i can't explain how horribly a hope a massage could fix me. There was no comfortable position to alleviate any of that. I also got the chills, constantly, suddenly switching from shivering cold to so hot i needed to take blankets off - but soon as i took the blankets off I'd be freezing cold again. I was also super nauseous, though i didn't vomit. I pretty much couldn't get out of bed much for 24-36 hours. During that time, i was unable to sleep as well, i think mostly due to the chills, constantly having to move about to keep warm or cool off, but not sure. I did take acetaminophen around 10pm 1/26 (36 hours after injection)- i felt like I knew you're not supposed to, but I couldn't take it any more and it might have less anti-inflammatory impact than ibuprofen. It dulled the pains some, but didn't make it stop. the chills and nausea mostly stopped and was able to sleep more the second night, last night. I'm now up and trying to work today (1/27). Head still has pressure headache throughout. Neck is still sore, like a pressure headache. I feel generally foggy and heavy.
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| 43 | 2021-01-26 | fatigue, fever, headache, chills | Fatigue, chills, high fever(101.4), body aches, diarrhea, headache-lasted 24 hours and still going |
| 43 | 2021-01-26 | chills, headache, fever |
Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 2...
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Reaction to second COVID vaccine fever of 100.8 chills body aches joint pain nausea HA lasted over 24 hours
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| 43 | 2021-01-26 | nasal congestion, headache |
Shot #1-headache, nasal congestion; Shot #1-headache, nasal congestion; This is a spontaneous report...
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Shot #1-headache, nasal congestion; Shot #1-headache, nasal congestion; This is a spontaneous report from a contactable nurse. This 43-year-old female nurse (no pregnant) reported for herself, received 1st dose of BTN162B2 Intramuscular on 21Dec2020 06:15 PM on Left arm for covid-19 immunization. Medical history was allergy to Latex and Adhesive; Anxiety, migraines, palpitations. Concomitant drug included piroxicam (PAXIL), alprazolam (XANAX), multivitamin. No other vaccine in four weeks. It was reported that patient experienced headache, nasal congestion. No covid prior vaccination. No covid tested post vaccination. Outcome of the event was unknown. Information on the Batch/Lot number has been requested.
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| 43 | 2021-01-26 | fever |
Woke up the first night with body aches and fever. The next day felt nauseous with vomiting and bod...
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Woke up the first night with body aches and fever. The next day felt nauseous with vomiting and body aches. Day 3 still had some body aches. Day 4 the pt returned to feeling normal.
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| 43 | 2021-01-26 | fatigue |
a little tiredness and achiness the next day; a little tiredness and achiness the next day; This is ...
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a little tiredness and achiness the next day; a little tiredness and achiness the next day; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140, expiry date: 31Mar2021) intramuscular on left arm (left deltoid) single dose for COVID-19 immunization on 21Dec2020, 10:20 am, at 43-year-old. No medical history, drug allergies and family history. Concomitant medication included: multivitamins (unspecified) daily whenever she remembered to take them. The patient had no issues with that vaccination, maybe a little tiredness and achiness the next day (22Dec2020), but no reactions, no asthma, anaphylaxis or anything. Had a CBC, CMP, and 2 chest x-rays and they were all normal. The patient was not deceased. Relevant tests included: CBC, CMP and twice Chest X-ray; all with normal results. Action taken for BNT162B2 was not applicable. Outcome of the events was unknown.
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| 43 | 2021-01-26 | chills, sweating, headache |
extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneo...
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extreme headache; muscle aches; chills; nausea; diarrhea; sweating; tachycardia; This is a spontaneous report from a contactable nurse. This 43-year-old female nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 11Jan2021 06:15 PM at single dose for COVID-19 immunization. Patient was not pregnant. Medical history included anxiety, migraines, palpitations and known allergies: latex, adhesive. Concomitant drugs included paroxetine hydrochloride (PAXIL), alprazolam (XANAX), and unspecified multivitamin. Historical vaccine included the first dose of BNT162B2 on 21Dec2020 06:15 PM via intramuscular at left arm for COVID-19 immunization, and patient had headache and nasal congestion. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Jan2021 09:45 PM, patient experienced extreme headache, muscle aches, chills, nausea, diarrhea, sweating, tachycardia. No treatment was received. Outcome of events was unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-01-26 | dizziness |
hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her...
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hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side; dizzy; Heart racing; Her arm was very sore- it was difficult to lift it; Her arm was very sore- it was difficult to lift it; She did feel a little out of it, as it produced a little bit of anxiety; A mild allergic reaction; This is a spontaneous report from a contactable Other Health Professional (patient). A 43 years old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248, Expiration Date: Apr2021), via an unspecified route of administration on 12Jan2021 at 13:22 at single dose on right arm for covid-19 immunisation. Medical history included vasovagal (she did have a history of vasovagal. She talked to her doctor about this prior to the vaccine. At first when she had it her previous doctor felt a little confused. She was unsure if it was vasovagal or a blood clot in her lungs. She did get it checked out with a cat scan and there was no clot. They had to have tested her for anaphylaxis at that time. It was not a clear diagnose. Then she saw a cardiologist. She was diagnosed with vasovagal at that time. It lasted only a few months and she was fully recovered). Concomitant medications included ongoing ergocalciferol (VIT D) and ongoing vitamins NOS (MULTIVITAMIN). Patient received the vaccine on Tuesday, 12Jan2021. Her appointment was at 12:54, but she got the vaccine at 13:22. She was looking at her phone to re-schedule her second dose. She felt totally fine. At 13:27 she had this weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side. She looked up from her phone and was very dizzy. She stood up and as she did her heart started to race. It was a really weird feeling that she has never felt. She was a little out of it. She had no trouble breathing. Within 30 seconds she was completely fine. She did feel a little out of it, as it produced a little bit of anxiety. She had no other symptoms. She stayed at the facility for 30 minutes. As she was leaving one person asked how she felt and she was told to let the EMTs know. She let them know what happened. One woman working there said it could have been an anxiety attack. She did not have a lot of anxiety but she did have some. It did not feel like that. She had never had the warm sensations or heart racing. She was totally fine when talking to the EMTs. They did not seem concerned and they let her schedule her second shot. She read on Pfizer about allergic reactions. She was assuming this was what happened. A mild allergic reaction. She had no breathing issues or hives. Her arm was very sore- it was difficult to lift it. She had also never had this type of soreness with vaccines. Dizziness: She has had the dizziness a couple of times. Twice now. One when she had gotten home. It was very mild and nothing compared to what she had when she got the vaccine. Then another last night at bedtime. It was a woosh of dizziness. Arm soreness: very improved now. felt like she would normally have after getting a vaccine. The first day was intense but after a few hours was less. The next day she woke up and it was pretty much gone. She still had a little but it has mostly improved. Caller stated she would still like to get the second dose but she was a little nervous. She had it maybe once or twice since then and it has been mild with no extreme pressure drops. They thought maybe it was a virus that affected her. Her reaction to the vaccine was different. The difference was pretty significant. Vasovagal felt like her heart will stop and she will pass out. After the vaccine she felt dizzy but didn't feel faint, and had a racing heart. Nobody seemed concerned about her reaction and getting the second dose. But she read that Pfizer does not recommend getting the second dose even if you had a mild reaction. She was wondering what she should do. Her second dose is scheduled for 02Feb2021. Outcome of hot sensation/weird very hot rush down her right arm that was vaccinated and went up the back of her neck only on the right side and heart racing was resolved on 12Jan2021, dizzy was resolved on 13Jan2021, outcome of anxiety was unknown, outcome of her arm was very sore- it was difficult to lift it and a mild allergic reaction was resolving.
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| 43 | 2021-01-27 | dizziness, headache, fatigue |
Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nau...
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Vertigo/dizzy/room spins starting; dizzy/room spins starting; Fatigue; Sore body; HA (headache); Nausea; Racing thoughts; trouble sleeping; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 10Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies, anxiety, depression, high cholesterol, tinnitus and GERD; all from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX), omeprazole magnesium (PRILOSEC), iron, atorvastatin (LIPITOR), melatonin and BCP. The patient was previously vaccinated with first dose of BNT162B2 via unspecified route in left arm on 20Dec2020 15:00 for COVID-19 immunization and experienced vertigo/dizzy/room spins starting on 08Jan2021 23:30. The patient was not pregnant. The experienced vertigo/dizzy/room spins starting 1-2 days prior to 2nd vaccine 10Jan2021 then it was worsened in Jan2021 after 2nd vaccine. The patient experienced fatigue, sore body, HA (headache), nausea, racing thoughts and trouble sleeping in Jan2021. No treatment was given to the patient for the events. The outcome of the events was not recovered. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 43 | 2021-01-28 | chills, fatigue |
About 24 hours post 2nd COVID vaccine by Pfizer, experiencing increasing fatigue, chills and body ac...
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About 24 hours post 2nd COVID vaccine by Pfizer, experiencing increasing fatigue, chills and body aches impairing my ability to work.
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| 43 | 2021-01-28 | fatigue |
Metallic taste in mouth about an hour after receiving the vaccine - lasted about 5 hours. Body Ache...
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Metallic taste in mouth about an hour after receiving the vaccine - lasted about 5 hours. Body Aches, Fatigue all over starting 24 hours after receiving vaccine. Lasted for about 8 hours. Fully recovered by next morning.
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| 43 | 2021-01-28 | headache, weakness, chills, fever, dizziness |
Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit ...
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Next day fever 100.8 and chills. 2 days later very bad headaches that lasted until 1/23. ER visit on 1/21 for chest pressure, lightheadedness, dizzy. Cardiac work up- negative. Discharged. Still lightheaded and dizzy 1/22 - 1/24. On 1/25 sharp chest pains went to see my PCP. She prescribed a steroid pack. 1/26 at 3:30 pm felt weak, felt like I was going to black out. Went back to the ER- full cardiac work up, head CT, admitted to the hospital for observation. Stress test on 1/27. Everything normal. Follow up with PCP on 1/29 still very lightheaded. Ordered a 48 hour heart monitor and Neurology consult.
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| 43 | 2021-01-28 | headache |
worst headache; This is a spontaneous report from a contactable consumer. A 43-year-old female patie...
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worst headache; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3247), via an unspecified route of administration in the left arm on 15Jan2021 at a single dose for covid-19 immunisation. The patient has no medical history. Concomitant medication includes hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). On 15Jan2021, 1 hour after the shot, the patient experienced worst headache she ever had in her life. The patient took Tylenol which hasn't done anything for it. The outcome of the event was not recovered.
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| 43 | 2021-01-31 | fatigue, headache |
Fatigue; headache; constipation; then extremely loose stools and 1 event of loss of bowel control.; ...
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Fatigue; headache; constipation; then extremely loose stools and 1 event of loss of bowel control.; then extremely loose stools and 1 event of loss of bowel control.; This is a spontaneous report from a contactable Other healthcare professional (patient). A 43-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration on 13Jan2021 16:00 at single dose in Left Arm for COVID-19 immunization. The patient medical history was not reported. There were no known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). There were no other vaccines received in four weeks. The patient did not have COVID-19 prior vaccination and COVID-19 was not tested post vaccination. The patient experienced Fatigue, headache, constipation, then extremely loose stools and 1 event of loss of bowel control on 13Jan2021 17:00, no treatment received for these events. The outcome of the events was unknown.
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| 43 | 2021-02-01 | chills, headache |
Headache; Pain at site of injection; Chills; This is a spontaneous report from a non-contactable hea...
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Headache; Pain at site of injection; Chills; This is a spontaneous report from a non-contactable healthcare professional (HCP) (Patient). A 43-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 15Jan2021 19:45 at a single dose in left arm for COVID-19 immunization. There were no medical history or concomitant medications. No known allergies. No other vaccine in four weeks and no other medications in two weeks. On 16Jan2021, the patient experienced headache, pain at site of injection, chills. No treatment received for events. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No COVID prior vaccination and no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021. No follow-up attempts are possible. Information about batch/ lot number cannot be obtained. No further information expected.
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| 43 | 2021-02-02 | dizziness |
felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twi...
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felt numbness in mouth; felt numbness in mouth. It spread to arms and hands; Eexperienced muscle twitching in hands; feel dizzy; A light rash covered my chest and arms; My heart rate and blood pressure were elevated; My heart rate and blood pressure were elevated; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 19:45 for covid-19 immunization, via Left arm in hospital. Medical history included arthritis from an unknown date and unknown if ongoing. She had no allergies to medications, food, or other products. Concomitant medication included probiotics (PROBIOTICS) and Multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 20 minutes following injection, the patient experienced felt numbness in mouth, felt numbness in mouth, it spread to arms and hands. She went to ER (Emergency room/department or urgent care) and started to feel dizzy and experienced muscle twitching in hands, a light rash covered her chest and arms, heart rate and blood pressure elevated, all on 19Jan2021 20:15 with outcome of recovering. She had no history of these symptoms and was in good health. The action taken in response to the event(s) for bnt162b2 was not applicable. She received Benadryl as a result of events.; Sender's Comments: The reported events were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 43 | 2021-02-07 | somnolence, lethargy, shortness of breath, dizziness |
Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:9...
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Three min after vaccine, pt started feeling SOB racing heart. BP 148/100, HR 80, SPO2 100% RA, T:97 Six minutes after: dose, lethargic, sleepy, eyes dropped (look tired) & dizzy & c/o anxiety. Friend P/U to take her to ER. BP 144/92
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| 43 | 2021-02-10 | chills, weakness, sweating, headache | Headache, chills, body aches, Muscle pain, weak, sweats |
| 43 | 2021-02-21 | dizziness | Dizziness at time of injection |
| 43 | 2021-02-21 | fatigue |
On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on...
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On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on the tissue. This happened a second time and then it was finished. I felt really tired and not myself. Then later that night my arm began to hurt so bad that I could not lift it. I began to rub the area that was hurting and noticed that I now had a nice size lump there . I took a Tylenol 500mg and a hot shower. When I woke up the next morning my arm was still hurting but not as bad. When I went to use the bathroom I had began to start spotting again. This continued throughout the day and now I am bleeding as if I was having my period. I am super tired. It is to the point that i cant function at work.
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| 43 | 2021-02-21 | shortness of breath, fatigue, cough, dizziness |
Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. res...
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Patient reported light headedness and cough 45 min after injection. with rest and oral fluids. resolved. over the next few days. patient reported increased fatigue and SOB. advised patient to seek medical attention for symptoms which she did today. reports she has now left sided chest discomfort. and left arm pain.
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| 43 | 2021-02-22 | cough |
Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping....
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Began feeling itchy in the roof of mouth. Began coughing. Felt like her blood pressure was dropping. Received 20 mg IV Famotidine, 10 mg IV Dexamethasone, 0.3 ml sub Q Epinephrine, 25 PO Benadryl and 1 liter Normal Saline. RN documents that blood pressure did drop to 107/64, but did not become hypotensive. Discharged in stable condition at 1500. Doctor recommended that she not receive second dose.
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| 43 | 2021-02-22 | dizziness | Tightness in left arm immediately; dizziness - 2 hrs later; significant diarrhea from 8pm - 4am. |
| 43 | 2021-02-22 | headache, fever |
Within two hours of injection, headache and fever symptoms with body aches for appoximately 56 hours...
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Within two hours of injection, headache and fever symptoms with body aches for appoximately 56 hours. Approximately 40 hours after injection, noticable drooping of right side of face, which resolved 90% after 24 hours; doctor assessment was that this was likely a temporary case of Bell's Palsy.
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| 43 | 2021-02-22 | discomfort, body temperature increased |
at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and f...
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at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and felt warm. States she started feeling pressure and warmth to her face with some itching. At 1500 she came to employee health. RN gave her 25 mg liquid benadryl. Her BP was 126/89, HR 87. No hives or swelling to Right arm noted. BP 117/80, HR 75. at apprx 1520, bp 137/85, HR 67. No other signs or symptoms noted. 1528, bp 121/82 At 1532, "patient states she feels good, almost back to normal".
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| 43 | 2021-02-22 | shortness of breath |
pt initially noted palpitations and shortness of breath. After several minutes improved and then pt ...
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pt initially noted palpitations and shortness of breath. After several minutes improved and then pt developed lip and tongue swelling
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| 43 | 2021-02-23 | shortness of breath, headache |
"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination...
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"Received 2nd Covid vaccination have had headaches, earaches, tachycardia, and SOB since vaccination" TM was hospitalized 3xs after vaccination. On 1/24/21 TM was hospitalized and kept overnight for tachycardia and SOB and has to f/u with cardiology this week. The second time TM went to the hospital for a headache where an MRI was done. The third time she was also treated for a headache
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| 43 | 2021-02-23 | malaise, fatigue, fever, night sweats, headache |
Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely ...
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Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
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| 43 | 2021-02-23 | weakness, lethargy, fatigue, shortness of breath, discomfort |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
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| 43 | 2021-02-23 | discomfort | Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe |
| 43 | 2021-02-24 | fatigue, dizziness, shortness of breath, throat swelling |
About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt lik...
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About 10 minutes after injection, my throat started feeling really thick - hard to breathe. Felt like I was wheezing. Super shaky and dizzy. I gave myself my epi-pen. I notified them and they took me to ER - IV - Benadryl and Solumedrol . I got really shaky for about an hour afterwards and then they discharged me. It cleared up my throat issues. within 4 days, I had significant shortness of breath again and I was directed to ER Gave me evaluated me for a pulmonary embolism - I did not have one. They gave me Solumedrol again. They gave me a prednisone taper. And then a week after that - or two weeks after - the shortness of breath returned - Dr had me go to ER room again - They gave me another prednisone taper which I'm still on and I have significant fatigue still and 24/7 out of breath still. Currently: Flonase 50 mg - twice a day - Admerdiscus 100 mg - twice a day
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| 43 | 2021-02-25 | fatigue, nasopharyngitis, fever | Fever tiredness cold |
| 43 | 2021-02-25 | fever, weakness, dizziness |
Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spon...
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Neck/back chest pain; Neck/back chest pain; Neck/back chest pain; dizzy; weak; fever; This is a spontaneous report from a contactable nurse (the patient). This 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 AM (at the age of 43- years-old) for COVID-19 vaccination. The patient's medical history included hypertension, hyperlidemia, pre-cancer cells in cervix, hysterectomy and allergy to penicillin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: ELO1423, expiration: 1/2021), single dose, dose 1 in the right arm on 05Jan2021 at 10:00 AM. Concomitant medications included atorvastatin, hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), fluoxetine (PROZAC) and zolpidem (AMBIEN). On 27Jan2021, the patient had neck, back and chest pain, dizzy, weak and fever. The events were reported as non-serious. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. No therapeutic measures were taken as a result of neck, back and chest pain, dizzy, weak and fever. The clinical outcome of neck, back and chest pain, dizzy, weak and fever was not recovered . The patient has been tested for COVID-19 since having the vaccine. On 25Jan2021, COVID rapid test was negative.
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| 43 | 2021-02-25 | somnolence, chills, fever |
swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't co...
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swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't comprehend conversations (needing to ask the person talking to me to repeat 2 times); getting snappy almost because they repeated it; Felt a few times while standing/walking I could all the sudden fall asleep; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date unknown), via an unspecified route of administration on the left arm, on 09Feb2021, at single dose, for COVID-19 immunisation, at a nursing home. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), budesonide, formoterol fumarate (SYMBICORT), and ethinylestradiol, norethisterone (ALYACEN). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV3247, expiry date: unknown) received at age 49 years, via an unspecified route of administration on the left arm, on 19Jan2021 10:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 11Feb2021 at 08:00, the patient experienced "swollen lymph node the size of an egg under my left arm, I had a temp of 100.8, chills and body aches. I have felt like I can't comprehend conversations (needing to ask the person talking to me to repeat 2 times, then getting snappy almost because they repeated it) and felt a few times while standing/walking I could all the sudden fall asleep but then few minutes later I feel normal and alert again." The patient had no headache or foggy head feelings. No treatment was given for the events. The outcome of somnolence was resolved, outcome for the rest events was not resolved. The reporter assessed the events as non-serious.
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| 43 | 2021-02-28 | headache, malaise |
she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have...
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she may have been panicked; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems; left arm soreness; she felt ugh, like she was getting sick; sensation like she was going to pass out; Headache; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EM9810, intramuscular on left deltoid on 04Feb2021 as single dose (at the age of 43 years) for Covid-19 Immunization. No medical history reported, and no concomitant medication reported. Historical vaccine included BNT162B2 for Covid-19 Immunization. Medical history included Pacemaker in Jun2019 and ongoing, sick sinus syndrome, and pre-existing cardiac arrhythmia ongoing. Historical vaccine included Tetanus, Tetanus made her arm sore, the soreness from tetanus was worse than the soreness from COVID vaccine since it lasted a week with tetanus, no lot number reported. No concomitant medication was reported. The patient experienced she already has a pre-existing cardiac arrhythmia, but it seemed to have gotten worse after receiving the 1st dose/More arrhythmia problems on 05Feb2021 considered medically significant with outcome of not recovered, Within 15 minutes after receiving the vaccine she felt like she was going to pass out three times on 04Feb2021 considered medically significant and recovered on 04Feb2021, she may have been panicked on unspecified date with outcome of unknown, left arm soreness on 05Feb2021 with outcome of recovered on Feb2021, and she felt ugh, like she was getting sick on 05Feb2021 with outcome of unknown. The patient did not receive treatment for events. She stayed an extra 30 minutes to be monitored after the initial waiting of 15 minutes since she had to drive home, then she felt better. She has not called her cardiologist since she has the history of arrhythmias. She had the more arrhythmias start on the evening of the 05Feb2021, states it was weird because it seems to happen more in the evening between 6 and 9pm, sometimes as late as 10pm. However, 'yesterday' it started happening during the day, and it is more frequent, not constant, it just happens. States it is hard not think about it when her heart is having hiccups since that is what it feels like. She knows what it feels like because when her pacemaker goes off ventricularly she can feel it. She had arrhythmias before the vaccine but has not had issues with arrhythmias continuously. She was diagnosed with sick sinus syndrome and they do not know if it is cardiology or neurology, states it has been an issue for her for the last two years (2019). Lab data included weight of 284-286. She is asking if there is any data that supports her getting the second dose on 25Feb2021. She has read that some people tend to have more side effects with the second dose. The patient had no prior vaccinations (within 4 weeks).; Sender's Comments: Based on vaccine-event chronological association, a causal relationship between events worsening arrhythmia and pre-syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 43 | 2021-03-01 | dizziness |
heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous rep...
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heart rate jumped up; thought she was going to pass out; eyes were blurry; This is a spontaneous report from a contactable consumer. A 43-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 10Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included autoimmune issues diagnosed in 2006-2007. Concomitant medications were not reported. After 4 days from vaccination on 14Feb2021 the patient experienced blurred vision, increased heart rate, and feeling that she will pass out (as such) . She went to the Emergency Room and they did two EKGs, two COVID tests, and blood work to check the enzymes in her blood for her cardiac muscle, but there was no reason, nothing they could find about why her heart rate spiked. Patient also reported that her heart rate went up from about 03:00PM up thru midnight last night, and was still not down completely, it was a little erratic, but it was better than it was. She was prescribed treatment at the hospital to bring her heart rate down, but they didn't want to give her more and risk lowering her blood pressure. Patient was monitored through the night, and she was supposed to see a cardiologist there but they didn't show up, so she put a phone call in to hers. She was admitted to the hospital overnight. The patient recovered from the events on an unspecified date.
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| 43 | 2021-03-02 | cough, throat irritation |
Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphy...
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Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.
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| 43 | 2021-03-02 | throat irritation |
Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; faci...
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Red flat itchy rash on torso, face, arms, legs; Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth; Received first dose on 25Jan2021 and second dose on 11Feb2021; Received first dose on 25Jan2021 and second dose on 11Feb2021; This is a spontaneous report from a contactable Other Health Professional. A 43-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266), intramuscularly in Left arm on 11Feb2021 17:15 at single dose for covid-19 immunisation. Medical history included allergy to dairy products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) at the age of 43 years old and Intramuscularly in Left arm on 25Jan2021 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Red flat itchy rash on torso, face, arms, legs; facial swelling; eyes swollen; itchy throat; cotton mouth on 12Feb2021 12:00. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has been tested for COVID-19 via Nasal Swab on 02Feb2021 with result Negative. Therapeutic measures (reported as 'IV Epinephrine, Solumedrol, 'Pepcid', 'Benadryl', prednisone) were taken as a result of red flat itchy rash on torso, face, arms, legs, facial swelling, eyes swollen, itchy throat, cotton mouth. The outcome of the events was not recovered. This case reported as non-serious.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 43 | 2021-03-02 | headache |
pupils were abnormally small/ Both pupils were constricted and fixed; Had a headache; This is a spon...
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pupils were abnormally small/ Both pupils were constricted and fixed; Had a headache; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on the left arm on 29Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included migraines, endometriosis, allergic reaction to sulfa (both hives and skin flushing, elevated heartrate) and anaphylactic sting allergy. The patient is not pregnant. Concomitant medication included estradiol (VIVELLE DOT) and estradiol (IMVEXXY). The patient previously took codeine and experienced allergies (hives, skin flushing and elevated heart rate). It was reported that about 2 hours (reported as "11:45") after vaccination a coworker noticed that the patient's pupils were abnormally small for the lighting in the room. She had a headache as suggested with typical side effects. The patient took a picture. Both pupils were constricted and fixed. They have remained this way since that time. The patient have taken pictures periodically since it was noticed. The headache remains, but all other (typical) side effects have abated. No treatment was received for the events. The outcome of the event pupils were constricted was recovered on an unspecified date, while the event headache was not recovered.
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| 43 | 2021-03-03 | fever, nasopharyngitis, chills |
eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbne...
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eight minutes after the vaccine I was waiting for my after dose evaluation, I started feeling numbness on left side of my face, I was taken to the ER, it went down to the left side of my neck and my left arm, after an hour I couldn't move the entire left side of my body, they did an MRI and admitted me to overnight observation. next morning I was discharged (friday), physical therapy and occupational therapy came in to help me adjust because I was still numb I was given a walker and a knee brace, I went home. Saturday I started getting feeling in my face and neck. Sunday I was still gaining more sensation, Monday I had full sensation every where except my leg, Tuesday I had complete feeling on my entire left side. 7 days after my shot on wednesday I started having cold chills body aches and fever nausea and diarrhea, by thursday I couldn't eat anything in me I would have diarrhea. I went to the ER on Saturday, they ran tests CT scan and found entera colitis and was admitted again, they started me on iv antibiotics and fluids , no solid food, they tested my stool and everything came back normal. I was discharged because the diarrhea had stopped, I was having regular bowl movements. Dr said it may or may not have been a cause from the vaccine, they weren't sure.
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| 43 | 2021-03-07 | shortness of breath | See notes from Dr Shortness of breath later determined as vocal chord dysfunction |
| 43 | 2021-03-09 | headache, fatigue, shortness of breath, dizziness, cough | Fatigue swelling of face Shortness of breath Cough Joint pain Headache Chest pain dizziness |
| 43 | 2021-03-09 | fatigue |
tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable ...
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tired; sore arm; Facial droop (left eye and mouth); This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at left arm 23Feb2021 08:00 at single dose for covid-19 immunisation. Medical history included Known allergies: Sulfa drugs, codeine, diastolic dysfunction type 1 from Jul2020, and anxiety depressive disorder (she took a medication for that and it had been diagnosed more than ten years). Concomitant medication included bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). The patient experienced facial droop (left eye and mouth) on 23Feb2021 14:30, tired and sore arm on an unspecified date. The clinical course was as following: She said her appointment for the vaccine was at 08:00AM, and around 02:30PM she was in a video meeting and her left side of her face started to droop and her coworker messaged her to ask if she was ok since she looked pretty funny with the eye and mouth droop. She said that this droop lasted about 4 hours and by 06:30PM it was mostly resolved, if she was not looking at it or trying to raise her eyebrows. She said that the only other side effects were she was tired and had a sore arm. She said doctor asked her to got to the emergency room (ER) to rule out a stroke or transient ischemic attack (TIA) so they did a couple of Computerised tomogram (CT) scans, one with contrast and one without, and a MRI and they did full blood lab work up, and did an Electrocardiogram (EKG) to rule out central nervous system events. She says that they didn't think it was a TIA, they felt it was a peripheral nervous event related to an autoimmune response and all the tests said that they did not thought she had TIA event. She said doctor said it was likely an auto immune response to receiving vaccine, since there were no intervening events between getting the vaccine and the droop, she has not been sick or had any dental events recently. the main reason she was calling was to see if she should get the second dose, since she wanted to get it but has heard the side effects can be stronger for the second dose. She says she would like to know can she or should she take it. The patient was tested was for a stroke but that test came back negative. The patient would like to know if it is contraindicated for her to receive the second dose after having this reaction. The outcome of the event Facial droop was recovering, and the outcome of the event tired and sore arm was unknown.
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| 43 | 2021-03-14 | shortness of breath |
Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on...
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Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on March 2, 2021 I was unable to breathe in all the way and was getting a sharp pain in my side/back when I tried to breathe in more than half way. I then went to the emergency room recognizing the symptom as likely being a pulmonary embolism, as I had experienced one four years earlier. It was, in fact, a PE. I was in the hospital for five days as they treated the clots with blood thinners. I slowly got my breathing more back to normal and was discharged. They are still runnying myriad tests to try to determine the cause or causes, but I thought it wise to report here in case the vaccine is a factor. I received my second dose on 2/26/21, a few days before I went to the hospital but my symptoms started a few days before that.
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| 43 | 2021-03-14 | sweating, dizziness |
sweating; palpitations; severe dizziness; This is a spontaneous report from a contactable other heal...
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sweating; palpitations; severe dizziness; This is a spontaneous report from a contactable other health professional (patient). A 43-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Left arm on 01Feb2021 13:45 at single dose for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 03Feb2021 07:30, patient had sweating, palpitations, severe dizziness. The patient not received treatment for the event. the patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19.The seriousness was reported as non-serious. The outcome of the events unknown. Information on the lot/batch number has been requested.
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| 43 | 2021-03-15 | discomfort |
The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 ...
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The time prior to the vaccine, I had no pelvic pain or limitations in physical activity. 1/7/2021 Received Pfizer Vaccine #1 experienced left arm soreness at the injection site. The evening of 1/7/2021 following the injection, developed dull lower pelvic pain. Pelvic pain worsened over the next two days 1/9/2021 Symptoms of pelvic pain intensified to now excruciating, sharp pain 1/10/2021 Seen at nearby urgent care and evaluated by healthcare provider; referred to nearby emergency department for further evaluation, work up and recommended imaging. Evaluated by emergency room physician, lab work collected and imaging were completed. CT scan showed 7cm mass in the right pelvis, small amount of pelvic fluid. Pelvic ultrasound was also completed and confirmed 7 cm round lesion in the right adnexa. Discharged home with pain medication and instructions for outpatient follow up. 1/12/2021 Seen by PCP and referral sent OB/GYN; Symptoms are now as dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and weight loss. 1/14/2021 Seen by OB/GYN, repeat pelvic ultrasound ordered 1/22/2021 Repeat pelvic ultrasound completed showed 7.4 cm right adnexal cystic lesion increased in size 1/28/2021 Received Pfizer Vaccine #2, staff at vaccination clinic informed of pelvic pain onset after Vaccine #1 injection. Approximately 4 hours after Vaccine #2, I developed severe sharp pain again similar to after Vaccine #1 which required pain medication for relief. 1/29/2021 Pain improved with medication 1/30/2021 Symptoms have now returned to dull pelvic pain, associated with rectal pressure and a pelvic pulling sensation position dependent, also associated with intense internal rectal pain at the time of bowel movements and continued weight loss until scheduled surgery 2/26/2021. 2/12/2021 Seen by PCP, cleared for surgery; labs completed 2/17/2021 Seen by OB/GYN for preoperative visit 2/23/2021 Seen at hospital for COVID Preop Testing 2/26/2021 Surgery completed under general anesthesia ? Laparoscopic myomectomy with mini-laparotomy, lysis of bowel adhesions to degenerating fibroid tumor The time prior to the vaccine, I had no pelvic pain or limitations in physical activity.
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| 43 | 2021-03-15 | throat pain, malaise, nasal congestion |
stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This i...
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stuffy nose; body aches; sore throat; swollen glands in the throat; general not feeling well; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL-9265), intramuscular in left arm on 04Feb2021 at 04:30 PM at single dose for COVID-19 immunization in pharmacy or drug store. Medical history included penicillin allergy. Concomitant medications included bupropion, buspirone and several different vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL-1283) in left arm on 14Jan2021 at the age of 42 years for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced stuffy nose, body aches, sore throat, swollen glands in the throat, general not feeling well on 05Feb2021 at 05:00 AM. No treatment was received for the adverse events. Patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 44 | 2020-12-31 | dizziness |
Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving v...
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Rash from L arm, up to neck and down back, palpitations and dizziness within5 minutes of receiving vaccine, elevated Bp. Treated with benadryl25mg oral. Symptoms returned within 45 minutes. Received another 25mg benadryl orally plus 40mg pepcid. Symptoms mostly resolved after that. Rash flared up again 4hours later. 25mg benadryl orally administered at home. Rash was present the next morning but resolved with no treatment.
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| 44 | 2020-12-31 | body temperature increased |
itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on si...
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itching & rash (both arms & chest) started 10 minutes after injection; treated by paramedics on site with benadryl 25 mg po; VS monitored for approx 15 minutes- remained normal, slightly elevated temp, lungs sounds clear, hot flashes throughout afternoon. About 45 minutes after injection took 1000 mg tylenol and 800 mg ibuprofen. additional 50 mg benadryl and 800 ibuprofen at bedtime for continued rash & itching. Next day symptoms still present, but minor. injection site became red, warm, tender to touch with small knot, 8-00mg ibuprofen taken in the morning and then 50 mg benadryl & 800 mg ibuprofen taken at bedtime. Day 3, slight itching, faint rash remains, injection site remains red, warm, tender to touch with small knot,
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| 44 | 2021-01-01 | chills, fever, headache | Fever chills severe myalgia headache |
| 44 | 2021-01-01 | chills, fever |
I had a series of symptoms that culminated with a 103.9 fever at around 3:00 a.m., the morning after...
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I had a series of symptoms that culminated with a 103.9 fever at around 3:00 a.m., the morning after my first vaccination. Most symptoms were in the list of common side effects. What seemed different was how extreme my symptoms were extreme shivering and very high fever. The fever lasted several hours and seemed to go don rather quickly after shedding the layers I put on to manage the extreme shivering/chills, took two Advil, and used a cold compress on my head.
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| 44 | 2021-01-01 | shortness of breath, nasal congestion |
Within 2 hours of the vaccine, patient had shortness of breath, urticaria, nasal congestion and EKG ...
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Within 2 hours of the vaccine, patient had shortness of breath, urticaria, nasal congestion and EKG and CXR were normal in ED and she was given albuterol, decadron, famotodine, and epinephrine and resolved.
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| 44 | 2021-01-01 | fatigue, headache, discomfort |
Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection ly...
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Woke up next day very fatigued, left work after 1/2 day and slept 20hrs Two days after injection lymph nodes very sore and swollen in armpit (pain with applying deodorant) Four days after injection bruising with about 3x3 cm area of redness/swelling present at injection site Daily headaches managed with ibuprofen Not anything too concerning but not comfortable. I have never reacted to a vaccine prior
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| 44 | 2021-01-02 | sweating | Diaphoretic palms, palpitations, jitteriness. |
| 44 | 2021-01-02 | fatigue | numb pockets on face, a little swelling of tongue and a little tired/flushed |
| 44 | 2021-01-03 | cough, night sweats, headache, respiratory tract congestion, fever |
12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the a...
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12/19 - fever, congestion, headache, cough 12/24 - body aches and night sweats in addition to the above 12/31 - add hypertension 1/04 - still have body aches, headache, cough, fever, hypertension
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| 44 | 2021-01-03 | respiratory tract congestion, headache, fever, cough, night sweats |
12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cou...
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12/19 Started with fever, congestion, headache. 12/24 additional symptoms to include body aches, cough, night sweat. 12/31 additional symptom of hypertension . As of today experiencing body aches, headache, cough, and hypertension. Medical Treatment 12/27/20 Urgent Care - 01/04/21 (virtual visit on 12/20)
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| 44 | 2021-01-03 | headache, fatigue | Arm pain at injection site, fatigue, mild headache, swollen lymph nodes |
| 44 | 2021-01-03 | fever | Fever (102.5 - 103.9), Pulse - 118, O2 - 94, Stabbing chest pain, Mediastinum tightness |
| 44 | 2021-01-03 | fatigue, fever, headache | Fever to 101.4, myalgia, extreme fatigue, headache, nausea (Pfizer-BioNTech COVID-19 Vaccine EUA) |
| 44 | 2021-01-03 | headache, runny nose, throat pain, nasal congestion, cough |
Headache from 2hrs post injection. the following week developed nasal congestion, sore throat, cough...
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Headache from 2hrs post injection. the following week developed nasal congestion, sore throat, cough, runny nose. no fever.
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| 44 | 2021-01-03 | fatigue, headache, nasal congestion |
I started getting a headache on 12/22 with nasal congestion worsening over night the next day I cont...
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I started getting a headache on 12/22 with nasal congestion worsening over night the next day I continued having congestion and headache, I called employee health and received a covid test which was negative. I continued to have headache and congestion for two more days and the 25th I was really tired and took a nap. By the 26th I felt completely normal
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| 44 | 2021-01-03 | migraine | INJECTION SITE TENDERNESS PIXELATED VISION MIGRAINE |
| 44 | 2021-01-03 | fatigue, cough, headache, throat pain |
first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong ...
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first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.
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| 44 | 2021-01-04 | throat swelling, dizziness, headache |
Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin...
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Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen
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| 44 | 2021-01-04 | headache, fatigue |
Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-1...
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Day 1: (12/23/20) fatigue, mild headache Day 2: (12/24/20) fatigue mild headache Day 3-5 (12/25/20-12/29/20)- large painful lymph node inflammation approx. size of a baseball. Right axilla.
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| 44 | 2021-01-04 | nasal congestion |
Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she...
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Ee entered observation @ 1630. This nurse asked Ee if she was feeling okay around 1645. Stated she felt as if she had a "lump in her throat". Denied any type of SOB or breathing issues. @ 1650, Ee stated she felt an itching, burning, and tingling to her lips and chin. Ee also had mild edema noted to her lips. Also stated that she had onset nasal congestion. Benadryl 25mg given @ 1652. Ee remains @ observation @ present time, 1706. @ 1715 Ee stated that she had mild itching to entire body. Around 1720, stated that the symptoms were easing up. @ 1725, Ee stated that the symptoms were better, but slight itching still remained. Insisted on leaving observation, stated she was okay. Ee left observation @ 1726.
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| 44 | 2021-01-04 | malaise, chills, fever, chills, fever, malaise | FEVER, CHILLS, BODY ACHES, MALAISE |
| 44 | 2021-01-04 | somnolence, fatigue |
Fatigue, sleepiness; Fatigue, sleepiness; This is a spontaneous report from a contactable physician....
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Fatigue, sleepiness; Fatigue, sleepiness; This is a spontaneous report from a contactable physician. A 44-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number EK5730), intramuscular in left arm on 19Dec2020 14:00 at a single dose for covid-19 vaccination administered in the hospital. Medical history included asthma and Known allergies to sulfa. The patient was not pregnant. The patient's concomitant medications were not reported. On 20Dec2020 14:00, the patient experienced Fatigue and sleepiness starting 24 hours after vaccination, resolved by 48 hours post vaccine. The patient did not receive any treatment for the events. The outcome of the events was recovered on 21Dec2020. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 44 | 2021-01-04 | lethargy, headache | Headache, lethargy, body aches for 24 hours |
| 44 | 2021-01-04 | night sweats, chills, fever |
Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got wors...
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Initially I was fine, but after 2 hours I started feeling joint pain. The next day the pain got worse and caused me to limp at work. I started feeling down. That night, I went home and had chills and fever. I was sweating in my sleep. I was fine on Christmas and now I have bronchitis like symptoms. I've seen 3 different providers at urgent care and was told that they don't know much about the vaccine. They told me to use Albuterol and go to the hospital if I get worse. I was told that I still have the antibodies from already having COVID twice and it may be causing me to have problems now. The first time was really bad and I developed pneumonia, but didn't go to the hospital due to all of the deaths occurring in city.
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| 44 | 2021-01-04 | fatigue, chills, fever, headache |
Pain at injection site; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contac...
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Pain at injection site; Chills; Fever; Fatigue; Headache; This is a spontaneous report from a contactable nurse (patient herself). This 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route, on 26Dec2020 (at 02:30 PM) at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was not pregnant. Relevant medical history included depression, endometriosis, and COVID-19 in Aug2020. The patient did not have relevant concomitant medications. No other vaccine was received in four weeks. No known allergies. No congenital anomaly/birth defect. The patient was vaccinated at hospital, age at vaccination was 44-year-old. On 27Dec2020 (at 02:00 AM) the patient woke up with chills, fever, fatigue, headache and fever 99.5. After taking 2 paracetamol (TYLENOL) (1.5hr after med temp was taken), she felt like it did when she had COVID in Aug2020. She also had pain at injection site as well (onset date not provided). Post-vaccination COVID test was not performed. Therapeutic measures were taken for fever, no treatments were given for chills, fatigue and headache. The patient had not recovered from fever, chills, fatigue and headache while the outcome from pain at injection site was unknown.
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| 44 | 2021-01-04 | headache |
Patient's reaction(s) noted during COVID vaccine observation period: headache, actions Taken: VS ta...
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Patient's reaction(s) noted during COVID vaccine observation period: headache, actions Taken: VS taken x2 and stable both times. Pt felt okay enough to go home. Â Disposition: Patient declined ED visit
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| 44 | 2021-01-04 | dizziness, headache, fatigue, fever |
fatigue; Swollen left elbow (tender to touch); dizziness; headaches; high temperature; Swollen left ...
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fatigue; Swollen left elbow (tender to touch); dizziness; headaches; high temperature; Swollen left elbow (tender to touch); This is a spontaneous report from a contactable other health professional (HCP, reported for herself). A 44-year-old female patient (not pregnant at the time of vaccination) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1830), intramuscular on 22Dec2020 12:45 at single dose at left arm for COVID-19 immunization. Medical history and concomitant medications were none. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 22Dec2020 16:45 (04:45 PM), the patient experienced swollen left elbow (tender to touch), dizziness/headaches, high temperature, fatigue. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
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| 44 | 2021-01-04 | cough |
lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips...
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lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; developed a cough once the numbness and tingling reached my throat; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 15:30 at a single dose for COVID-19 immunization. Medical history included thyroidectomy for thyroid cancer, anaphylaxis to mangoes and allergic to multiple medications. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine and liothyronine. The patient received the vaccine at 3:30pm, ten minutes later her lips, tongue and throat became numb and tingly. She developed a cough once the numbness and tingling reached my throat. She was given Benadryl at the time, 15 minutes after injection. She was still having numbness and tingling to the back of her tongue currently (8 days after injection). The patient was not hospitalized for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.
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| 44 | 2021-01-04 | headache, throat pain |
pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; te...
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pain with the turning of the head; enlarged lymph nodes on her neck; severe sore throat; earache; teeth hurting; cheeks were flushed and the neck; chin being red/redness on the chin; itching on the face; This is a spontaneous report from a contactable Other HCP (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in left arm on 18Dec2020 at single dose for covid-19 immunisation. Medical history included lymphoma, hodgkin's disease, inflammation. Concomitant medication included prednisone. She had to finished 2 weeks worth of prednisone, it was for inflammation in her abdomen, she had finished the prednisone either on the 18Dec2020 the following day. The patient got her first dose of the covid vaccine on 18Dec2020. She was schedule for her 2nd dose of the covid vaccine on 08Jan2021. On 18Dec2020 after receiving the vaccine her cheeks were flushed and the neck, it first started with the chin being red, an hour later her cheeks and neck were flushed, but she felt this symptom was normal. She also added that on the day of the vaccine she had itching on the face, and redness on the chin, this was on 18Dec2020 about an hour after receiving the vaccine. The enlarged lymph nodes on her neck were noticed on 23Dec2020, as well as the severe sore throat, earache, and teeth hurting. Her pain with the turning of the head was more so noticed on 24Dec2020. It's painful to turn her head back and forth but she thought this was because of lymph nodes. She stated that she had a history of lymphoma and so swollen lymph nodes did worry her. The doctor gave her an antibiotic for it, and she was actually on a second round because she was not any better. The antibiotic was prescribed on 24Dec2020, and the second round started today 29Dec2020. The first antibiotic she was prescribed was Azithromycin also known as a Z-pak. The second antibiotic she was prescribed was amoxicillin clavulanate (AUGMENTIN). Her lymph nodes were getting better starting today 29Dec2020, today was the first date that she was feeling better overall. The patient underwent lab tests and procedures which included rapid covid test negative on 24Dec2020, strep throat swab negative on 24Dec2020. She has had no positive test for Covid prior the vaccine. She had been tested like 5 times now, all negative. She had no Covid antibody test prior to vaccine. She had no issues with vaccines in the past. The outcome of event cheeks were flushed and the neck was unknown. The outcome of events enlarged lymph nodes on her neck, severe sore throat, earache, teeth hurting was recovering. The outcome of events chin being red/redness on the chin, itching on the face was recovered on 18Dec2020. The outcome of event pain with the turning of the head was recovered on 28Dec2020.
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| 44 | 2021-01-05 | headache, body temperature increased |
15 minutes after the injection, I got some itching on my right shoulder near the injection site. I w...
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15 minutes after the injection, I got some itching on my right shoulder near the injection site. I waited around a bit longer and the itching and heat started to grow down my arm and across my chest and back. I was asked to go to the ER as it was not resolving. At about one hour, I started to get some mild chest pain, My BP was 173/101 and around 100+ for heart rate. O2 was 100% . ER staff did an EKG. The ER DR gave me Pepcid, Benadryl and Prednisone and 1 liter of normal saline. I was observed for about 3 hours. I went home and was feeling much better. The next 3 days I had a moderate headache and sore arm. I took Tylenol. I had some hot flushes and mild spikes of temperatures 100-101F, through the next couple of days.
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| 44 | 2021-01-05 | headache, chills | Cold chills,body aches and major headache that lasted about 12 hrs |
| 44 | 2021-01-05 | dizziness |
Felt faint. Did not faint; however, assisted to floor to prevent falling/passing out. Resolved in ...
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Felt faint. Did not faint; however, assisted to floor to prevent falling/passing out. Resolved in 30 seconds Laid down and given water. Symptoms resolved. Vitals WNL. History of vasovagal reactions. Monitored for 15 minutes and released to home.
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| 44 | 2021-01-05 | headache |
Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to ca...
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Had tingling in feet shortly after vaccine. Waited 15 minutes, was cleared to go home, on walk to car, migraine aura started. I rarely get migraines. Got worse and worse as I drove home, could barely see. Severe headache followed.
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| 44 | 2021-01-05 | fever, headache |
Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shak...
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Headache; Low grade fever - 99.3; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; Shaky and jittery feeling that kept me from sleeping soundly; This is a spontaneous report from a contactable Healthcare Professional reporting for a patient. A 44-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 09:00 as a single dose, for COVID-19 immunisation. The patient had no known medical history or allergies. Concomitant medication included rosuvastatin calcium (CRESTOR). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 2300, the patient experienced Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly. No treatment was given for the events. The clinical outcome of Headache, Low grade fever - 99.3, Shaky and jittery feeling that kept me from sleeping soundly was recovering.
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| 44 | 2021-01-05 | chills, headache, fever |
It started with a neck ache, then chills ,muscle aches , headache, bone pain to my forearms and feve...
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It started with a neck ache, then chills ,muscle aches , headache, bone pain to my forearms and fever. 101.8 after Motrin, this morning 100.5.
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| 44 | 2021-01-05 | shortness of breath | Moderate difficulty breathing for about 36 hours, relieved somewhat by Albuterol Inhaler. |
| 44 | 2021-01-05 | fatigue, headache |
Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscl...
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Nausea; Headache; Fatigue started about 5 hours after injection and seems to be getting worse; Muscle aches-started about 5 hours after injection and seems to be getting worse; Stiff Arm; Slight pain at injection site; This is a spontaneous report from a contactable nurse, the patient. A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration, in the right arm on 30Dec2020 at 06:45 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included crohn's disease, ankylosing spondylitis, gastroparesis, and sulfa allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Dec2020 at 07:45 AM, about an hour after injection, the patient experience nausea and headache. Fatigue and muscle aches started about 5 hours after injection and seemed to be getting worse. The patient experienced stiff arm 12 hours after injection, and slight pain at injection site after 12 hours. The events were reported as non-serious. The patient did not receive any treatment for the nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site. The clinical outcome of the events nausea, headache, fatigue, muscle aches, stiff arm, and slight pain at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-01-05 | migraine | Persistent migrane pain with nausea |
| 44 | 2021-01-05 | headache | Pounding headache, neck pain |
| 44 | 2021-01-05 | chills, headache |
arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous ...
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arm pain/arm is sore where she got the shot; shivering; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the arm on 29Dec2020 at 15:20 at single dose for COVID-19 immunization. Medical history included thyroid issue, low blood pressure from an unknown date and unknown if ongoing, surgery for an ovarian cyst in 1999 (She had surgery for an ovarian cyst 21 years ago), cyst on her tailbone removed in 2016 (had cyst on her tailbone removed 5 times. The first removal was in 2016. It was removed twice in 2017 and then twice in 2018). Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid issue. The patient got the vaccine on Monday (29Dec2020) and waited the 15 minutes then felt okay. Then on Tuesday (30Dec2020) she developed/woke up with arm pain and shivering, body aches and mild headache. She woke up with arm pain, shivering, body aches, and headache. The patient states it is very mild. She is sitting there shivering and has body aches. No joint pain. Her arm is sore where she got the shot. When you feel pain, you automatically have a headache. Side effects started this morning around 9:30AM or 9:45AM. She felt nothing when she was in the bed. When she went into living room for breakfast she felt shivering. She called her friend that got the injection yesterday too and her friend feels ok and gave her the number to call. Therapeutic measures were taken as a result of the events which included treatment with Tylenol. The patient was recovering from the events. Information about lot/batch number has been requested.
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| 44 | 2021-01-05 | fatigue |
developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfo...
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developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfort; arm discomfort; Pain felt similar to sciatica; a full nagging pain and the muscles of my arm are fatigued from constant tension; a full nagging pain and the muscles of my arm are fatigued from constant tension; This is a spontaneous report from a contactable Nurse reported for herself. This 44-year-old female Nurse (patient) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1685), via an unspecified route of administration on 22Dec2020 09:30 at single dose on left arm for Covid-19 immunisation. There was no known allergies, medical history nor concomitant medications. Prior to vaccination, it was not unknown if the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 4 days following the vaccination on 26Dec2020 18:00, the patient developed chest pain with radiation into axilla, shoulder, scapula and down the arm. The chest pain and axilla discomfort subsided but the arm discomfort continued and intensified. Pain felt similar to sciatica. The patient took ibuprofen and paracetamol (TYLENOL) also placed ice pack under her arm and on top of shoulder. The following day the patient started on a methylprednisolone (MEDROL) dose pack. The patient received minor relief with the steroids and NSAIDs after 2 days she took a gabapentin (NEURONTIN) which was given to me by a family member. The gabapentin had given the most benefit. On day 4, the patient continue to have a full nagging pain and the muscles of her arm are fatigued from constant tension. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
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| 44 | 2021-01-05 | fatigue, headache |
immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing ...
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immediate nausea, headache, dizziness (feeling of motion sickness) and arm pain, tiredness. ongoing headaches, fatigue, dizziness and nausea on and off every day
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| 44 | 2021-01-05 | chills, headache | pt noted feeling chills, then developed nausea and dry heaves and sl headache |
| 44 | 2021-01-06 | dizziness | Approximately 10 minutes after vaccination developed increased heart rate, dizziness, and shakiness. |
| 44 | 2021-01-06 | fever, cough, nasal congestion |
EE reports symptoms fever of 102.0 not going down with Ibuprofen, joint and muscle pain, congestion...
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EE reports symptoms fever of 102.0 not going down with Ibuprofen, joint and muscle pain, congestion and cough. Treatment include Ibuprofen with no improvement. Referred for COVID testing.
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| 44 | 2021-01-06 | fever, headache | FEVER,BODY ACHES, AND HEADACHE |
| 44 | 2021-01-06 | headache, body temperature increased, chills, fatigue |
Facial numbness bilaterally with headache 3 hours post injection. 15 hrs post injection: 101 tempera...
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Facial numbness bilaterally with headache 3 hours post injection. 15 hrs post injection: 101 temperature, severe chills and joint pain (making it difficult to walk), body aches and extreme fatigue. Headache continued but facial numbness subsided. Symptoms less severe at 48hrs, low grade temp and body aches persisted, joint pain resolved. All symptoms resolved at 72 hrs.
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| 44 | 2021-01-06 | fever | Fever |
| 44 | 2021-01-06 | fatigue |
Following administration of the first dose of COVID-19 vaccine (Pfizer), pt reported feeling tired a...
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Following administration of the first dose of COVID-19 vaccine (Pfizer), pt reported feeling tired and having a "metallic taste" in her mouth. Pt reported very little fluid or food intake prior to the vaccine. Given Gatorade and crackers; monitored for 30 min. Symptoms resolved. Patient received 2nd dose of vaccine on 1/6/2021 and no adverse reactions were reported during the 30 minute monitoring period.
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| 44 | 2021-01-06 | weakness, throat pain, runny nose | Generalized Weakness, arm sore, sore throat, runny nose |
| 44 | 2021-01-06 | headache, fever |
Headache & Fever Narrative: Employee reports experiencing headache and fevers that started a few hou...
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Headache & Fever Narrative: Employee reports experiencing headache and fevers that started a few hours after vaccine was administered, incapacitated from coming to work but not severe enough to seek medical care.
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| 44 | 2021-01-06 | nerve pain, fatigue |
Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hur...
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Metallic taste in mouth Body aches fatigue arm and fingers burned like it was nerve pain armpits hurt swollen lymph nodes tingling on the left side of her face
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| 44 | 2021-01-06 | throat irritation |
Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and F...
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Patient has history of anaphaylyxsis, she pre medicated at home this morning with Zyrtec 20 mg and Famotadine 40 mg prior to going to F13 clinic for her covid vaccination. Patient stayed an hour after vaccine administration to be monitored. She came to ER for further monitoring and allergic reaction concerns and received 2 doses of 25 mg diphenhydramine. She was reporting itching of her trunk and arms, itchy throat, and hot flashes. She was monitored in ER, she maintained airway and stayed on RA the entire visit.
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| 44 | 2021-01-06 | headache, chills |
Pfizer BioNTech COVID 19 vaccine EUA- Chills, nausea, muscle aches, headache. Motrin 400 mg taken Q...
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Pfizer BioNTech COVID 19 vaccine EUA- Chills, nausea, muscle aches, headache. Motrin 400 mg taken Q4-6 hours
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| 44 | 2021-01-06 | migraine | Severe joint pain, migraine headache |
| 44 | 2021-01-06 | fever, chills | fever 101.0, chills, aches |
| 44 | 2021-01-06 | discomfort, dizziness |
tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BIL...
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tingling in both hands - along ulnar nerve to 4th/5th fingers - severe - reports 8/10 discomfort BILATERALLY - felt like she was going to pass out and have diarrhea and vomit at same time - these symptoms awakened her from sleep at 11:45pm; sxs lasted about 15 minutes and then abated; tingling in 4th/5th fingers BILATERALLY persists today- though much less intense - reports at level of 1/10; never did vomiting and never had diarrhea; never passed out; feeling well today - able to run 4 miles and teach yoga and work at a physical therapist
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| 44 | 2021-01-07 | influenza like illness, chills, fatigue |
Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu bu...
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Beginning at 10:30 pm, I had severe chills and body aches through the night. It felt like the flu but no fever. I slept until 1:30 the next day (1/6) I noticed a rash on the outer border of my left shoulder blade around 1:30 on 1/6. I was tired but ok the rest of 1/6. I felt totally normal on 1/7.
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| 44 | 2021-01-07 | thirst, shortness of breath |
Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became ha...
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Driving home 18-20 mins post injection, my heart started racing, my hands were shaking, it became hard to breathe, my fingers were tingling and my mouth got very dry. I pulled over and called 911. The paramedics stated my BP was within normal limits of around 140/80. My normal is closer to 90/65. Once symptoms resolved I attempted to drive home. Once again, the same symptoms returned. I pulled over. I then made my way to a safe location and waited for family to come. Since the event I have had times of mild labored breathing while walking. While driving I become very anxious and the feelings of an anxiety attack return. I saw my nurse practitioner 2 days ago who referred to the driving anxiety as a form of PTSD and prescribed Prozac and Xanax. I have not take the Xanax, but have taken two nighttime doses of Prozac. Yesterday, I did not feel as though I had taken medication. My drive to work was uneventful. My drive home involved tightening of the chest, labored breathing and anxiety. This morning I cannot tell if I am feeling the vaccine or Prozac in my system, but I feel off. Swimmy headed, watery mouth, heaviness in my arms and shoulders. I need guidance on taking the 2nd vaccine or if I should seek further medical treatment. I have added a vit B vitamin a day to my regimen since the date of the vaccine.
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| 44 | 2021-01-07 | headache, chills, influenza like illness |
FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, L...
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FLUL LIKE SYMPTOMS SINCE 3AM 1/8/2021, CHILLS, SEVERE MUSCLE PAIN BACK NECK AND HEAD, HOT FLASHES, LOSS OF APPETITE , PAIN AT VACCINATION SITE, LEFT AXILLARY PAIN ON ABDUCTION. UNABLE TO GO TO WORK DUE TO SYMPTOMS
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| 44 | 2021-01-07 | headache, fever, fatigue, chills |
Fever 100.2; headache; Body aches; Joint pain; chills; Diarrhea; Fatigue; This is a spontaneous repo...
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Fever 100.2; headache; Body aches; Joint pain; chills; Diarrhea; Fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 04Jan2021 14:00 at single dose Covid-19 immunisation. The patient was not pregnant. Medical history included hypothyroidism, tachycardia, fibromyalgia, and Covid prior vaccination. No known allergies. No Covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included unspecified medications with 2 weeks of vaccination. The patient experienced Fever 100.2, Headache, Body aches, Joint pain, Chills, Diarrhea, Fatigue on 05Jan2020 02:00. The outcome of events was not recovered. This case was reported as non-serious. No emergency room/physician office visit. No treatment received for the events. Information on the lot/batch number has been requested.
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| 44 | 2021-01-07 | headache, chills, fever |
Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and he...
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Fever to 101.4, rigors/ chills. Nausea and vomiting. Swollen axillary lymph nodes, body aches and headache.
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| 44 | 2021-01-07 | throat irritation |
Following administration of COVID19 vaccine (Pfizer), patient experienced a "scratchy feeling" in he...
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Following administration of COVID19 vaccine (Pfizer), patient experienced a "scratchy feeling" in her throat and feeling that her throat might be closing up. She denied any other symptom. Patient had no history of anaphylaxis. Patient was monitored until symptoms resolved. No treatment was required. Note: Patient received second dose of vaccine (from same lot# EH9899) on 1/6/21 and no adverse reactions were observed after 30 minutes monitoring. Patient reports that she felt much less anxious when receiving the second dose of vaccine.
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| 44 | 2021-01-07 | fever |
I am a physician and received 2 doses of the Pfizer COvID vaccine. First dose 12/20/20. Second dose ...
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I am a physician and received 2 doses of the Pfizer COvID vaccine. First dose 12/20/20. Second dose 1/6/2021. Forty- eight hours after second dose I had moderate to severe under eye swelling at site of dermal fillers I received May 20,2020 requiring steroids and antihistamine. I also had severe myalgias and fever 12 -36 hours after my second dose.
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| 44 | 2021-01-07 | fatigue, fever | I had fever and arm was sore. I felt fatigue and very tired. |
| 44 | 2021-01-07 | headache |
I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning...
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I had the worse headache I've ever had in my life, soreness in my arm. When I woke up in the morning it was pounding, spread to the right half of my head, nausea, photo sensitivity, vertigo. It took 36 to 48 hours before I could function. 48 to 72 hours later I had another headache with vertigo. I had complete vision loss in my left eye.
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| 44 | 2021-01-07 | migraine |
Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatr...
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Migraine with auras (no previous hx of auras), currently for 2 days and ongoing. OTC meds and rizatriptan having no effect
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| 44 | 2021-01-07 | discomfort | Myalgia bottom lip feels heavy, jaw feels heavy, bottom lip and jaw numbness Narrative: |
| 44 | 2021-01-07 | throat pain |
Pain in actual site my shoulder is actually throbbing; Sore throat; This is a spontaneous report fro...
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Pain in actual site my shoulder is actually throbbing; Sore throat; This is a spontaneous report from a contactable consumer. A 44Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02Jan2021 at single dose for COVID-19 immunization. The patient did not have medical history or concomitant medications. Patient informed she received the vaccine, her first round of dose yesterday at 2'O clock (02Jan2021) and she was experiencing pain in her shoulder, that was actually throbbing. She also noticed it within a couple of hours, she had a sore throat. Treatment received included Aleve. At the time of the reporting event outcome was unknown. Information on lot/ batch number has been requested.
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| 44 | 2021-01-07 | chills, fever | Reported chills,body aches, fever 100.3 |
| 44 | 2021-01-07 | chills | Severe painful shingle like rash , chills, |
| 44 | 2021-01-07 | fatigue, headache, fever | Sore arm, Joint pain, Fever, Fatigue, Back pain(muscles in back), Headache x 2 days so far |
| 44 | 2021-01-07 | fatigue, shortness of breath, somnolence, cough, chills, throat pain, headache |
Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; m...
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Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; metallic taste in the mouth; burning in the eyes; chills; shaking; This is a spontaneous report from a contactable physician, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection on 24Dec2020 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020 at 07:00, the patient experienced sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking which lead to doctor or other healthcare professional office/clinic visit. Treatment was provided for the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking with NSAIDs. The outcome of the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking was not recovered. Since the vaccination, the patient has been tested for COVID-19 on 30Dec2020 via Nasal Swab and Antigen test and both were negative.
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| 44 | 2021-01-07 | shortness of breath |
Sxs started 15 minutes post vax, difficulty breathing, rash. Sent to ED. Sxs resolved by 12/29/2020...
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Sxs started 15 minutes post vax, difficulty breathing, rash. Sent to ED. Sxs resolved by 12/29/2020.
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| 44 | 2021-01-07 | chills, fever |
Symptoms - ? 1/7 at approximately 2:00 pm: feelings of nausea; 10:00 pm: myalgias, midnight: chil...
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Symptoms - ? 1/7 at approximately 2:00 pm: feelings of nausea; 10:00 pm: myalgias, midnight: chills and fever (Tmax 101.3). EE denies COVID-19 exposure without proper PPE and denies travel. Home remedies? - none Any improvement? ? at time of call at approx. 9:10 am, EE reports significant improvement in symptoms and denies fever at this time Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns. EE verbalized back understanding and denied further questions at this time.
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| 44 | 2021-01-07 | chills, headache, fever |
Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5...
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Symptoms started 1/1/21 Pm. Headache, ear ache, chills, fever. COVID and influenza swabbed 1/5/21 both negative. Symptoms continued ear infection 1/6/21, nausea and chest pain. 1/7/21 vomiting and diarrhea started. Going in for COVID swab this am. And seeing a provider.
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| 44 | 2021-01-07 | headache, fever | fever, neck stiffness, headache |
| 44 | 2021-01-07 | fatigue, weakness | moderate myalgias, fatigue, back pain, extremity pain and weakness |
| 44 | 2021-01-07 | fatigue, cough, shortness of breath |
slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positiv...
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slight cough; diarrhea; shortness of breath; no sense of smell; positive for covid 19 virus; positive for covid 19 virus; feel tired; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 20Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was Diagnosed with covid 19 virus on the 31Dec2020, she was set to have the second vaccine on the 10Jan2021. She wanted to know if she can get the second dose and if so, when. Also asked if she should get tested before taking the 2nd dose of the covid 19 vaccine. Her Adverse effects are sore arm on vaccination day (20Dec2020), and she began to feel tired on 27Dec2020 and thought that was normal. She went to a Christmas eve party 24Dec2020 and no one was masked, friend had several people from work tested positive. was tested and was positive for covid 19 virus on 31Dec2020. She also was experiencing slight cough, diarrhea (which is normal for her), shortness of breath is improving and she had no sense of smell but she was able to taste. The outcome of event shortness of breath is recovering. The outcome of other events was unknown. No follow-up attempts are possible. information about lot/batch number cannot be obtained.
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| 44 | 2021-01-08 | chills |
1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelli...
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1st Dose Vaccine - I had localized itchy rash in my chest area 2nd Dose Vaccine - Right Cheek swelling, chills and dry mouth
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| 44 | 2021-01-08 | headache, fever |
Approx 16 hours after 2nd vaccination on 1/7/21, I felt nauseous. Then fever, body aches, joint pai...
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Approx 16 hours after 2nd vaccination on 1/7/21, I felt nauseous. Then fever, body aches, joint pain, severe headache. Second day I still have severe headache and nauseousness.
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| 44 | 2021-01-08 | dizziness | Dizziness Narrative: transient lightheadedness 60 seconds or less |
| 44 | 2021-01-08 | dizziness, headache | Dizziness, Headache & NauseaVomiting Narrative: Need to stay home due to N/V, missed work day. |
| 44 | 2021-01-08 | headache, fever, chills | Fever 101.2 Chills Body aches Headache Losses of appetite |
| 44 | 2021-01-08 | headache, fever, chills | Headache, chills, joint and muscle pain, fever of 102, nausea, lymphadenopathy Lt Axilla. |
| 44 | 2021-01-08 | headache |
Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling i...
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Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling in armpit. Rash on upper chest itchiness of upper coast and left lower leg
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| 44 | 2021-01-08 | chills, headache, dizziness, malaise, throat pain |
Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days...
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Injection site and entire arm soreness x 48 hrs Nausea x 3 days Chills x 2 days Sore throat x 2 days Severe headache x 2 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Mild headache x 1 day (OTC Ibuprofen 400mg PRN) Dizziness x 2 days (Ensured proper hydration) Body aches x 3 days (OTC Ibuprofen 600mg Q6-8 hrs, OTC Acetaminophen 1000mg x 1 dose) Malaise x 3 days
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| 44 | 2021-01-08 | fever | Myalgias, fever, nausea, 2 episodes of vomiting |
| 44 | 2021-01-08 | respiratory tract congestion |
Nurse Practitioner in Emergency Dept. Exposed to household member with possible sxms, but no confirm...
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Nurse Practitioner in Emergency Dept. Exposed to household member with possible sxms, but no confirmed dx. Developed personal sxms of ST and congestion on 02 Jan 2021. NP swab PCR performed 02 Jan 2021 was positive for COVID-19. Being followed as outpatient.
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| 44 | 2021-01-08 | fever, cough |
On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a...
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On 12-23-2020, I developed symptoms of sinus congestion along with a cough, fever, body aches and a tightness sensation in my chest. I got tested for Covid on 12-27-2020 and was positive. I also had diarrhea and nausea. I did telemedicine with my primary healthcare doctor and I discussed with him that I felt tightness with pressure sensation to my chest and he said that it was cause of my asthma and he told me to take prednisone medication.
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| 44 | 2021-01-08 | chills, body temperature increased | Woke at 4am with chills. Temperature 101.1F temporal. Otherwise feeling ok. Just drinking fluids. |
| 44 | 2021-01-09 | fever, chills |
I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face ...
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I woke up the next morning 1/9/21 about 6am after receiving the vaccine the evening before, my face and mainly my eye lids were extremely swollen. Later in the day, ~noon I spiked a fever of 102.4. I had overall body aches and chills.
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| 44 | 2021-01-09 | fever |
Moderate pain in the injection site (upper right arm) followed by severe fatigue, back ache, and a ...
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Moderate pain in the injection site (upper right arm) followed by severe fatigue, back ache, and a slight fever (37.8 Celsius). Symptoms started 8 hours after the vaccination. No treatment other than strict rest and ibuprofen taken once (600 mg).
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| 44 | 2021-01-09 | fever, headache, fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA Chills (low temp), fever (102), bad headache, overall body ache...
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Pfizer-BioNTech COVID-19 Vaccine EUA Chills (low temp), fever (102), bad headache, overall body aches, fatigue. Taking Tylenol and Aleve around the clock. Still ongoing.
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| 44 | 2021-01-10 | fever |
1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent che...
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1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent chest pain in the morning. Then in the evening it became constant. Went to ER that evening due to chest pain. EKG showed t wave abnormality. 1st Trop was negative went from 0.08 to 2.3 Had 2 Echo's done and they were normal. Platelets were 85. Was discharged without chest pain. Troponin on discharge was 0.67 and platelets 61. Was admitted due to Chest pain and troponin. Attending provider diagnosed as myocarditis and thrombocytopenia R/T vaccine.
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| 44 | 2021-01-10 | chills, fever |
1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore ar...
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1/7/21 9pm- low grade Fever, chills, sore arm at injection site. 1/8/21 2pm-low grade fever, sore arm at injection site, left axilla pain and swollen left axillary lymph nodes 1/9 to- present: swollen axillary lymph nodes and tenderness left axilla
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| 44 | 2021-01-10 | chills | Achy, chills, arm pain |
| 44 | 2021-01-10 | headache |
Both times I received the injection about 48 hours later I had a headache all over my head and naus...
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Both times I received the injection about 48 hours later I had a headache all over my head and nausea. Today I was so nauseous that I vomited about 4 times. I also noticed strangely that my birthmark on my leg which is normally a light pink had turned a very dark purple.
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| 44 | 2021-01-10 | chills |
Chills, severe body aches - Tylenol taken at 7:40 PM which resolved most of the symptoms. No fever. ...
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Chills, severe body aches - Tylenol taken at 7:40 PM which resolved most of the symptoms. No fever. Body aches the next day but manageable without medication. All symptoms resolved after 48 hours.
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| 44 | 2021-01-10 | shortness of breath, dizziness |
Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of...
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Day of vaccination (Day 0) - felt mild chest tightness/difficulty breathing, relieved with 1 puff of albuterol Day 1 - lymphadenopathy of left axilla lasted 2 days Day 2 - tachycardia HR 100, feeling faint, wanting to pass out for a couple of hours Day 4 - tachycardia HR 120 feeling faint, wanting to pass our for couple of hours
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| 44 | 2021-01-10 | fever, headache | Fever 100.4/body aches/headache 24 hours-ibuprofen x 2 doses |
| 44 | 2021-01-10 | throat pain, sweating, night sweats |
Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on r...
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Friday night - Sore arm and sore throat. Saturday morning - Woke up sweaty. Swollen lymph node on right side of neck, close to collar bone. Very sore. As of today, Monday, 1/11, it is more swollen and hurts. And I'm still having night sweats plus am extremely hot but not having a fever.
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| 44 | 2021-01-10 | dizziness | Light headedness, Foggy head, body ache, swelling in the axilla for 3 days after injection |
| 44 | 2021-01-10 | fever, headache, chills |
Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those...
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Next Day - Wake up with fever, chills, headache, back pain, joints pain and a little nauseous. Those symptoms last for two days. Area of vaccination was red, hot and swelled for 4 days, with left axilar ganglion and both neck ganglion swelled for 4 days too.
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| 44 | 2021-01-10 | headache, fatigue, shortness of breath | Strong headache, strong body aches, shortness of breath (fatigue) |
| 44 | 2021-01-10 | shortness of breath, fatigue, headache | Strong headache, strong body aches, shortness of breath (fatigue), tearful eyes |
| 44 | 2021-01-10 | throat pain |
about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even ...
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about 2 hours after injection I got very itchy, face, arms torso red and itchy lasted for twos even with Bendryl. End of second day had sore "fiery" throat. Felt like throat was on fire lasted for a week. Nothing made it better.
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| 44 | 2021-01-10 | chills, dizziness | chills, shakes, nausea, vomiting, lightheaded |
| 44 | 2021-01-10 | fever, shortness of breath, fatigue |
difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fati...
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difficulty breathing; woke with 102 fever; Body aches; injection site soreness; Fatigue/extreme fatigue; This is a spontaneous report from a contactable healthcare professional. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular in right arm on 30Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included asthma. The patient has no known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient experienced fatigue, injection site soreness day of vaccine, following extreme fatigue on 30Dec2020 16:00. Five days after (04Jan2021), woke with 102 fever, body aches, fatigue, and difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with an unspecified antibiotic. The patient underwent lab test and procedures which included nasal swab and Rapid Saers on 04Jan2021 with negative results. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 44 | 2021-01-10 | fever, chills | fever body aches head ache chills |
| 44 | 2021-01-11 | fever, weakness, cough, dehydration, fatigue, runny nose |
1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a...
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1/7/21 2nd shot. Pain with injection, tasted in mouth lasted 20 minutes. Sore arm got worse within a couple hours. Took ibuprofen which helped. Low grade fever 99.8, EXTREME weakness and fatigue, body aches devloped evening with profuse watery diarrhea 1/7-1/10, poor appetite (NO nausea, NO vomiting) also had mild symptoms of intermittent runny nose, itchy eyes, mild cough. Symptoms improved 1/11/21 with decr freq diarrhea, improvement energy level. I pushed fluids in home and ate soup. Visit to urgent care 1/11/21 for IV hydration after receiving covid testing req for job d/t symptoms. 1/12/21 feeling improvement in symptoms but not fully recovered at this time-monitoring symptoms in home
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| 44 | 2021-01-11 | chills, fever, headache |
100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body ac...
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100.4 low grade fever; chills; arm pain was so bad I could hardly list my arm from the pain; body aches; Extreme arm pain where the injection was given/Minor aches following the injection; headache; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on 04Jan2021 18:15 at SINGLE DOSE for COVID-19 immunization. Medical history included high cholesterol. The patient's concomitant medications were not reported. It was reported that the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since vaccination. On 04Jan2021 18:30, the patient immediately had extreme arm pain where the injection was given and a headache. The next day (05Jan2021), the patient's arm pain was so bad on which she could hardly list her arm from the pain (minor aches following the injection). The patient also had extreme Body aches that night. Twenty-four hours after extreme body aches (06Jan2021), the patient had 100.4 low grade fever and chills for 2 to 3 hours. The patient did not receive any treatment for the events. The patient recovered from the events of low grade fever and chills on 06Jan2021 while the remaining events were in Jan2021 Information on the lot/batch number has been requested.
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| 44 | 2021-01-11 | fatigue, chills, fever |
11hours 30min after vaccine administration, Pt. starts to experience fever 103.1, Chills, body aches...
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11hours 30min after vaccine administration, Pt. starts to experience fever 103.1, Chills, body aches, fatigue. 28 hrs. from vaccination Pt still experiencing fever 102.3 with the use of fever reducing medications. body aches, fatigue
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| 44 | 2021-01-11 | somnolence |
About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rat...
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About 10 minutes after shot, felt hot sensation go from ahoulders down rest if my body. My heart rate went to 140bpm. I alerted RN, gave me water, juice took about 20 minutes for HR to fo down to around 100. Did not go to ER. Went home, rested. HR returned to 80bpm around 3pm. Metoprolol taken two hours prior vaccine.
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| 44 | 2021-01-11 | respiratory tract congestion, weakness, chills, dizziness, fatigue |
Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset st...
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Body aches, temperature 99.5, weak, dizzy, chills, fatigue, upper chest congestion, nausea, upset stomach
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| 44 | 2021-01-11 | fever, chills |
Chills; Fever; Body ache; This is a spontaneous report from a contactable consumer, the patient. A ...
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Chills; Fever; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Jan2021 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included already tested positive for COVID. There were no concomitant medications. On 04Jan2021 the patient experienced chills, fever, and body ache. Therapeutic measures taken as a result of chills, fever, and body ache included Tylenol 500 mg. The clinical outcome of the events chills, fever, and body ache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 44 | 2021-01-11 | somnolence, fatigue |
Felt extremely fatigue and sleepiness for two days beginning the day of injection. On 12/23/2020 my ...
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Felt extremely fatigue and sleepiness for two days beginning the day of injection. On 12/23/2020 my period came which was two weeks early. I am normally regular for years and this was unusual. Period lasted 4 days and then stopped and now my cycle is off.
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| 44 | 2021-01-11 | fever, lethargy, sweating, headache, chills | Fever 100-101degrees x 24hrs, Chills. Sweats, lethargy, headache |
| 44 | 2021-01-11 | fever, dizziness | Fever 101 degrees Severe Bodyaches Dizziness Symptoms lasted 24 hrs |
| 44 | 2021-01-11 | headache, shortness of breath |
First Day after the injection I had a headache and nausea the entire day into the next day. The sec...
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First Day after the injection I had a headache and nausea the entire day into the next day. The second day I still had the headache and the nausea. I work overnights. When I awoke in the afternoon, my throat was closing up. It was hard to swallow and I struggled to breath. I immediately drank liquid Benadryl and called my doctor in the morning.
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| 44 | 2021-01-11 | dizziness |
I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was i...
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I had a reaction 20 minutes after the shot. My heart rate jumped up. The numbness and tingling was in my arm and up into my chest and back. I felt like I was going to pass out. The numbness and tingling still hasn't gone away and my heart still races.
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| 44 | 2021-01-11 | migraine |
I received the vaccine in the morning on 12/31/2020 and woke up on 01/01/2021 with a migraine, much ...
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I received the vaccine in the morning on 12/31/2020 and woke up on 01/01/2021 with a migraine, much worse than my usual migraines. It was gone by the morning of 1/2/21. I was advised to report this.
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| 44 | 2021-01-11 | dizziness |
Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessmen...
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Immediately following shot developed facial flushing,nausea,dizzy. Transoported to AFM for assessment
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| 44 | 2021-01-11 | respiratory tract congestion, runny nose, weakness, fatigue, fever, cough |
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild f...
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Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells. Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
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| 44 | 2021-01-11 | cough |
Patient complained of itching starting on her legs, which went upwards; Redness on her arms, neck, f...
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Patient complained of itching starting on her legs, which went upwards; Redness on her arms, neck, face; Redness on her arms, neck, face; Redness on her arms, neck, face; Itching up to her scalp; Dry cough; Rash; This is a spontaneous report from a contactable nurse (patient). A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 26Dec2020, at 09:00 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included asthma, hypertension, hypothyroidism, penicillin allergy, food allergy (melon and pineapple) and latex allergy. Concomitant medications, received within 2 weeks of vaccination, included omalizumab (XOLAIR), levothyroxine sodium (LEVOXYL), levocetirizine dihydrochloride (XYZAL), losartan and formoterol fumarate, mometasone furoate (DULERA). After covid vaccination, the patient was advised to stay 30 minutes for observation. On 26Dec2020 at 09:15, less than 15 minutes later, the patient complained of itching starting on her legs, which went upwards. The patient took 25 mg oral diphenhydramine hydrochloride (BENADRYL). She noted to have redness on her arms, neck, face, itching up to her scalp. By then she started to have a dry cough, removed her mask, nurse who was with her called for a rapid response team. Patient's epi pen was used, they then started IV and pushed emergency meds and transported to ED. Emergency room/department or urgent care was required. Another dose of epinephrine IM and additional meds were given. Placed on oxygen via non-rebreather with albuterol. Epinephrine drip started. Stabilized after 3 hours, stayed in observation for 12 hours then discharged to home. Around the clock 50 mg diphenhydramine hydrochloride (BENADRYL) at home x 2 days, then levocetirizine (ZYXAL) thrice daily x 7 days to control itching and redness/rash. Other treatment included steroids, pepcid. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (PCR, Nasal Swab) on 26Dec2020 and the result was negative. Clinical outcome of the adverse events was recovering at time of this report. Information on the lot/batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-11 | shortness of breath, throat irritation |
Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult brea...
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Patient reported a heavy feeling in the chest, with tightness and fullness as well as difficult breathing. Patient also reported numbness of the lips. Symptoms occurred within 5 minutes of vaccine administration. Epinephrine 0.3mg pen was administered at 11:05 per protocol. One diphenhydramine 50mg capsule was administered at 11:07 per protocol. Patient reported easier breathing and increased heart rate almost immediately. Her throat felt like she "swallowed an ice-cube sideways". Within 10 minutes, the patient reported that her lips and throat felt better, but still tingles. States that it was "like she had recently shaved". A wheelchair was provided by the long-term care facility staff, and the patient was wheeled to the ER within the facility. Patient arrived at ER at 11:18 and pass-off to the ER team was completed around 11:20.
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| 44 | 2021-01-11 | weakness, fever, dizziness |
Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Five minutes after I received the vaccine, my arm was sore and my throat felt a little tight. Then, I started to feel kind of lightheaded and my legs were weak. I let the staff know and they offered me benadryl but I declined. I waited about 35 minutes then I went home. I continued to feel lightheaded and weak for about 4 hours and I also began to fill nauseous. My arm continued to be sore for a few days and I ran a fever of around 100 from the following day 1/9 and I am still running a fever now on 1/12.
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| 44 | 2021-01-11 | fever, chills, headache, sweating |
Really bad chills; Body aches; Mild low grade temperature/fever; Sweating; Slight headache; Joints a...
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Really bad chills; Body aches; Mild low grade temperature/fever; Sweating; Slight headache; Joints are popping and cracking; Joint pain/joints hurt; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported), intramuscularly on the upper left arm on 05Jan2021 (07:00) at a single dose for COVID-19 immunization at the hospital (not in a military facility). The patient had no relevant medical history and concomitant medications. On 05Jan2021 (14:00), the patient had really bad chills. On 05Jan2021, the patient had body aches; and had mild low grade temperature/fever. In Jan2021, the patient's joints were popping and cracking; had joint pain/joints were hurting; had slight headache; and was sweating. The patient was treated with ibuprofen for the events, 'chills' and 'mild low grade temperature/fever'. The outcome of the events was recovering for 'really bad chills' and 'body aches'; was not recovered for 'joint pain/joints were hurting' and 'slight headache'; was recovered on 06Jan2021 for 'mild low grade temperature/fever'; and was unknown for all the other events.
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| 44 | 2021-01-11 | headache, malaise, chills, fatigue |
Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm follow...
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Thursday - immediately after receiving the vaccine, I felt a warm sensation down my right arm followed by numbness and tingling (pins and needles), a few minutes later I experienced a dull headache. The arm sensation slowly subsided by the time my fifteen minutes was up. The dull headache lasted through the night Around 9 pm, I experienced chills, that lasted for 2 days with body aches and sore right and left arm. During the night, I had a hard time sleeping experiencing nightmares. Woke up at 2 am took a walk felt a little better. Chills continued throughout the night. Friday- chills continued with body aches and a general feeling of malaise. Temp was 98.7 at highest, bp 122/79, hr 80, and blood sugar 149, I have no hx of diabetes. Saturday- "hungover feeling" - headache that came in waves with a general feeling of malaise. Sunday- Pounding headache, extreme fatigue-slept until 1500 woke up and then went back to bed, body aches-worst I have felt in years. Monday shaky feeling somewhat better still malaise. Tuesday vomited all my breakfast, feeling of phlegm or something stuck in my throat. BP 120/77 hr 64 temp 98.4. Continued body aches.
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| 44 | 2021-01-11 | headache, chills | Uncontrollable chills, achiness, headache, nightmares |
| 44 | 2021-01-11 | cough, nasopharyngitis, headache, respiratory tract congestion, head discomfort, fever |
slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positi...
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slight sore arm; slight chest congestion; positive COVID-19 test after first dose of vaccine; positive COVID-19 test after first dose of vaccine; Fever; cold like symptoms; stuffy head; horrible headache; Cough; This is a spontaneous report from a contactable healthcare professional (patient) from a Pfizer-sponsored program, Pfizer First Connect. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 16Dec2020 as a single dose (reported as 0.3 mL) (at the age of 44-years-old) for COVID-19 immunization. Medical history included ongoing hypothyroidism, one thyroid gland removed due to a nodule on an unspecified date (years ago), ongoing acid reflux, ongoing hypercholesteremia, ongoing fluid retention, and ongoing history of headaches. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism and for one thyroid gland removed due to a nodule from an unspecified date and ongoing, dexlansoprazole (DEXILANT) taken for acid reflux from an unspecified date and ongoing, atorvastatin (LIPITOR) taken for hypercholesterolemia from an unspecified date to an unspecified date, and hydrochlorothiazide (MANUFACTURER UNKNOWN) taken for fluid retention from an unspecified date and ongoing. Additional concomitant medications included unspecified vitamins. The patient had a positive COVID-19 test after first dose of vaccine on 01Jan2021; cold like symptoms, stuffy head, horrible headache, cough, and fever on 31Dec2020; slight chest congestion on 02Jan2021; and slight sore arm on an unspecified date. The events, stuffy head and horrible headache, were reported as medically significant. The events, cough, fever, and slight chest congestion, were reported as non-serious. The clinical course was reported as follows: It was reported that the patient was vaccinated on 16Dec2020, became symptomatic on 31Dec2020, and tested positive for COVID-19 on 01Jan2021. The patient stated that she became symptomatic one day prior to testing positive for COVID-19, on 31Dec2020. She initially had cold-like symptoms with a stuffy head, cough and a horrible headache; the worst headache she had ever had. These symptoms occurred earlier in the day on the 31Dec2020. Then later that night about 10:00 PM, she had a fever with a body temperature of 102 degrees Fahrenheit. Her body temperature had been normal at 98 degrees all day that day until that night. She also had slight chest congestion and then was fever free for over 48 hours. The patient stated that she had a history of headaches and can tolerate a headache. The headache started 31Dec2020 and was significant. It was reported that after the vaccine, she had no other symptoms other than a slight sore arm, which lasted a day; maybe 24 hours after she received the vaccine. The patient stated that she does not think any of the other symptoms, other than the sore arm, have anything to do with the vaccine. The clinical outcome of positive COVID-19 test after first dose of vaccine and slight sore arm was unknown; cold like symptoms, horrible headache, and cough was recovering; fever was recovered on 02Jan2021; and stuffy head and slight chest congestion was not recovered. The reporter assessed the causality assessment between the events, positive COVID-19 test after first dose of vaccine, cold symptoms, stuffy head, cough, horrible headache, fever, and slight chest congestion, as unrelated. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-12 | sweating, shortness of breath |
10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was swea...
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10 min after shot i felt extreme warmth throughout my body, my face was flushed and warm. I was sweating and short of breath. My peripheral vision was cloudy. This lasted approx ten minutes.
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| 44 | 2021-01-12 | body temperature increased, headache, fatigue, chills |
18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Ty...
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18 hours after second dose I had Temp 99.0, chills, body aches, fatigue, headache not relieved by Tylenol or Advil, injection site pain. The symptoms were so severe that I was unable to go to work this morning. I have a headache, fatigue, feel foggy, and injection site pain still.
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| 44 | 2021-01-12 | headache, migraine, dizziness |
About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't...
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About 10min after vaccine given, patient complained of pain to the injection site. Flushed. "I don't feel right." No SOB. C/o 7/10 migraine headache. Nausea but no vomiting. Frontal lobe pain. Dizzy. Felt like she was drunk. BP 136/29, HR 79. Became slower to respond to questions and a rapid response was called. Transported to ED for observation where patient received acetaminophen 975mg po x 1 and metoclopramide 10mg po x 1. Patient declined NS 1L bolus. Per ED note, patient presented with likely vasovagal episode after receiving COVID-19 vaccination. Patient's symptoms improved and patient was discharged home.
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| 44 | 2021-01-12 | headache, fever | Fever, body aches, headache. Resolved. |
| 44 | 2021-01-12 | fever | Golf ball sized knot at injection site. Fever |
| 44 | 2021-01-12 | headache |
Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Ras...
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Headache and right eye pain started on 01/06/2021. Skin burning sensation started on 01/08/2021. Rashes started on 01/09/2021. I went to the emergency room on 01/10/2021, diagnosed with shingles, started treatment with Valacyclovir.
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| 44 | 2021-01-12 | headache, fever |
Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, ...
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Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, severe headache 2 days after vaccination. Was treated with Benadryl, Solumedrol IM, and Prednisone taper at local urgent care center.
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| 44 | 2021-01-12 | chills, fatigue |
Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symp...
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Severe bodyaches, chills, fatigue, nausea last in two days. Used Tylenol and ibuprofen to treat symptoms. Still have left arm soreness on day 2 after injection . Body aches are better on the day 2 but not resolved yet, so his fatigue.
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| 44 | 2021-01-12 | fever, headache |
The night of the vaccine I experienced trouble sleeping and could not go to sleep. The morning after...
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The night of the vaccine I experienced trouble sleeping and could not go to sleep. The morning after I had a very bad headache and a rash on my right arm and shoulder where near proximity of where the shot was given. It was red dots, no itching, no discomfort. I felt feverish as the day proceeded but never had a temperature. The second day after the shot I had the headache the rash was 75% resolved.
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| 44 | 2021-01-12 | chills, headache, fatigue |
The symptoms started after the second shot.Fatigue, muscle aches, chills, headache were the most de...
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The symptoms started after the second shot.Fatigue, muscle aches, chills, headache were the most debilitating symptoms started at 8am the morning after administration of shot. Fatigue and chills have continued into the next day and evening.
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| 44 | 2021-01-12 | dizziness, malaise |
Waves of nausea starting approximately 12.5 hours after vaccine dose received. General malaise and ...
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Waves of nausea starting approximately 12.5 hours after vaccine dose received. General malaise and feeling "faint" though blood pressure, temperature, heart rate, respiration and pulse oximetry WNL.
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| 44 | 2021-01-12 | headache |
Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/202...
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Whole headache and right eye pain started on 01/06/2021, Skin burning sensation started on 06/08/2021. Rashes started on 06/09/2021. On 06/10/2021, I went to the emergency room, diagnosis with Shingles, and the doctor prescribed Valacyclovir.
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| 44 | 2021-01-12 | chills, fever |
muscle aches beginning with shoulders and neck before spreading over entire body; low-grade fever of...
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muscle aches beginning with shoulders and neck before spreading over entire body; low-grade fever of 100 degrees, chills, nausea- all lasting for about 24 hours
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| 44 | 2021-01-12 | fatigue | nausea, syncope, LOC, fatigue |
| 44 | 2021-01-12 | chills, body temperature increased, headache, respiratory tract congestion | temp 101 body aches chills massive HA congestion |
| 44 | 2021-01-13 | cold sweat |
"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild ...
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"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious." c/o mild soreness to back of tongue. sent for obs. took zyrtec, tylenol prior to getting vaccine. eupneic, a/ox4, skin w/d. no distress" Blood pressur 160/91
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| 44 | 2021-01-13 | fatigue, weakness, fever |
12 HOURS AFTER INJECTION, SEVERE JOINT PAIN, FLUSHING, LOW GRADE FEVER AND WEAKNESS. LASTED UNTIL 24...
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12 HOURS AFTER INJECTION, SEVERE JOINT PAIN, FLUSHING, LOW GRADE FEVER AND WEAKNESS. LASTED UNTIL 24 HOURS AFTER THE VACCINATION AND THEN JUST TIREDNESS AND SLIGHT MYALGIAS FOR FURTHER 12 HOURS.
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| 44 | 2021-01-13 | pneumonia, fever, fatigue, headache |
12/23/20 - RECEIVED 1ST DOSE OF COVID-19 VACCINE IN AM FROM EMPLOYEE HEALTH CLINIC 12/24/20 EVENING ...
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12/23/20 - RECEIVED 1ST DOSE OF COVID-19 VACCINE IN AM FROM EMPLOYEE HEALTH CLINIC 12/24/20 EVENING - ACUTE ONSET OFSYMPTOMS HIGH FEVERS >101 - 103 F, SEVERE CONSTANT HEADACHES (PAIN SCALE AT 10), BODY ACHES, NAUSEA, FATIGUE, DIMISHED TASTE AND SMELL AND DIARRHEA SYMPTOMS CONTINUED TILL 1/7/2021 - SLOWLY IMPROVING
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| 44 | 2021-01-13 | dizziness, cough, chills, fatigue, runny nose, sweating, headache |
5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpita...
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5 minutes later - perfuse sweating, entire body hot, dizzy, elevated pulse and BP 147, heart palpitations; drank a juice & some water 10 minutes later - sweats/chills, still dizzy, BP decreasing 135, agitated 20 minutes later - still sweating,/chills, head clearing, heart palpitations subsiding, Tired, legs/body very heavy. Dizzy when walking, told to rest longer 30 minutes - still sweating/chills, could only walk short distance with heavy legs and dizziness, told to rest longer 40 minutes - massive headache, slight dizziness, continued leg heaviness. nausea, light sensitive, very itchy arm. Did not feel better until 11:30 PM that night Woke in the morning with just a sore arm, runny nose and an over-all fatigue, a little cough
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| 44 | 2021-01-13 | night sweats, sweating, chills |
Approximately 28 hours post injection I developed profuse sweating that lasted all night (approximat...
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Approximately 28 hours post injection I developed profuse sweating that lasted all night (approximately 8 hours). I do not normally sweat in my sleep. I did not check my temperature. I had a brief moment of chills lasting <5 minutes at 10pm. I did not feel like I was febrile. I did not take any medication for any side effects.
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| 44 | 2021-01-13 | headache, chills, fever |
Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling;...
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Chills; 100 temperature; Whole body soreness; Left arm severe pain; Left axilla lymph node swelling; Headache; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; the first dose administered on 19Dec2020 10:00 and the second dose administered on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EJ1685) via intramuscular on 19Dec2020 10:00 on left arm at a single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch EL0142) via intramuscular on 05Jan2021 07:45 on left arm at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Prior to vaccination, the patient did not diagnose with COVID 19. The patient was not allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive within 2 weeks of vaccination. The patient experienced chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache on 05Jan2021 19:00. No treatment received for the adverse event. No covid tests post vaccination. The outcome of the events chills, 100 temperature, Whole body soreness, left arm sever pain, left axilla lymph node swelling and headache was recovering.
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| 44 | 2021-01-13 | headache | Headache |
| 44 | 2021-01-13 | headache, fever, runny nose |
I had a runny nose on Tuesday 22nd, then got a headache that afternoon (took Tylenol). When I got ho...
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I had a runny nose on Tuesday 22nd, then got a headache that afternoon (took Tylenol). When I got home from work I ran a low grade fever 100.9. I called my work and they set me up for a covid test in the morning. Ended up testing positive in the morning.
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| 44 | 2021-01-13 | chills, cough |
Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I ...
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Later that evening on the 23rd I began having chills which lasted for about an hour. The next day I lost my sense of smell which lasted about 1.5 week and my arm was sore, heavy and red at the injection site. The soreness and the feeling of heaviness ended the next day but the redness stayed for about 5 days and changed to a bruise which then stayed for about 1 another week. On the 29th I was given a COVID-19 test which came back positive. I noticed when I lay flat I cough alot but when I prop myself up I dont.
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| 44 | 2021-01-13 | headache |
Myalgia in arm of vaccination on day 0 of vaccine. Then with severe headache, myalgias, joint pain, ...
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Myalgia in arm of vaccination on day 0 of vaccine. Then with severe headache, myalgias, joint pain, upset stomach for 2 days after vaccine.
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| 44 | 2021-01-13 | shortness of breath, cold sweat |
Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness imme...
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Patient is a 44 Y female who presents reporting facial flushing and tongue soreness and dryness immediately after getting her first dose of the Pfizer COVID-19 vaccine at 1030 this morning. 26 minutes later the symptoms are followed by cold sweats. She feels much better now, does not now, did not have shortness of breath, nausea, vomiting, wheezing, change in voice, difficulty swallowing. Patient reports the symptoms are similar to but much milder than the symptoms she gets during rituximab infusion for her myasthenia gravis. Patient notes that she took Zyrtec and acetaminophen at 9:00 as premedication. Prior to this patient had been well, no fevers, nausea, vomiting, diarrhea, chest pain, shortness of breath, cough, sore throat, urinary problems, or other problems. Patient did not receive any additional therapy in the ED. She was observed for 2 hours in the ED and was subsequently discharged home.
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| 44 | 2021-01-13 | dizziness |
Patient reported feeling dizzy and lightheaded. Vitals listed below: 1214 - 122/68; 97%; 74; 16 1...
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Patient reported feeling dizzy and lightheaded. Vitals listed below: 1214 - 122/68; 97%; 74; 16 1219 - 110/66; 96%; 74; 18 1225 - 115/63; 96%; 75; 18 Patient was given water/juice and was discharged home in stable condition
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| 44 | 2021-01-13 | fatigue, headache, fever |
Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck),...
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Per patient report: On 1/1/2021 she started to have a fever, HA, ear pain, neck pain (back of neck), and muscle aches in upper back. This continued through the weekend. On Wednesday, 1/6/2021, she saw a provider for ear pain, chest pain (radiating to right arm). She was not prescribed/given treatment regimen. On Thursday, 1/7/2021, night, she started to have vomiting diarrhea, and chest pain. On Friday, 1/8/2021, she went in to be seen for chest pain and r/o PE. States she has a history of PE and had a CT performed, no clots found. EE states does not have vomiting and diarrhea from 1/13/2021 for the first time since the start of this symptoms. Continues to have GI issues: decreased appetite and upset stomach. Also states she feels very fatigued.
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| 44 | 2021-01-13 | headache |
Staff had her 2nd dose on 01/12/2020 yesterday. This morning 6am wake up with bad headache. Went t...
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Staff had her 2nd dose on 01/12/2020 yesterday. This morning 6am wake up with bad headache. Went to work, 3:30 had blood pressure checked 174/102 and pulse was 98. Took Tylenol. Not dizzy. Monday covid negative
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| 44 | 2021-01-13 | fatigue, chills, fever, headache, weakness, dizziness |
THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,J...
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THREE DAYS OF SYMPTOMS, DIZZINESS,WEAKNESS,PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,SWELLING ON INJECTION SITE,NAUSEA,INFLAMATION OF NODES.
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| 44 | 2021-01-13 | sweating, dizziness |
With second COVID vaccine, patient experienced flushing, dizziness, lightheadedness, and diaphoresis...
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With second COVID vaccine, patient experienced flushing, dizziness, lightheadedness, and diaphoresis. Patient was given water/juice and was discharged in stable condition home.
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| 44 | 2021-01-13 | fatigue, chills | chills, body aches, fatigue |
| 44 | 2021-01-13 | headache, chills, fever |
low grade fever (99.1), arthralgia, chills, malgia, mild headache. started in the night around 1am. ...
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low grade fever (99.1), arthralgia, chills, malgia, mild headache. started in the night around 1am. Fever started around 6am
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| 44 | 2021-01-14 | headache, fever, fatigue |
01/11/2021: Same day at 8 pm started to have body ache, headache, a little fever 100.1 and very tire...
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01/11/2021: Same day at 8 pm started to have body ache, headache, a little fever 100.1 and very tired. Took Tylenol. Got up next day at 12:30 a lot better. Today ok but not 100%.
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| 44 | 2021-01-14 | headache, weakness, chills |
0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives...
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0845 flush to chest and throat 0850 vitals checked BP: 90/60 0930 Benadryl 50 mg PO taken 1000 hives to left side of neck 1005 another 50 mg of Benadryl PO taken and Tylenol 650 mg PO for chills and headache 1200 famotidine PO taken for burning to stomach 1400 diarrhea and weakness. Hives had subsided 1800 another round of Benadryl and Tylenol and famotidine. Saturday at 0200 woke up abruptly itching all over. Took more Benadryl. Saturday all day medicated every six hours with Tylenol, Benadryl and Pepcid. Diarrhea continued with abdominal cramps. Sunday continued same treatment for same symptoms. Hydration was aggressive and added Bentyl. Monday, Tuesday and Wednesday symptoms continued except for the itchiness. Continued Tylenol. Diarrhea persists as well as body aches, weakness and headaches. Friday, it is now a week and I still have diarrhea and chills and weakness.
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| 44 | 2021-01-14 | fever, dizziness, headache, malaise |
1/8/2021 soreness/pain at the injection site, fever, muscle ache, malaise, headache. Tylenol 1000mg ...
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1/8/2021 soreness/pain at the injection site, fever, muscle ache, malaise, headache. Tylenol 1000mg was taken around the clock every 6 hours. It helps with the fever and also for the headache. 1/9/2021 woke up at 4:00 am with vertigo plus the above side effects. In addition to the Tylenol, I had taken dramamine in the morning and had been taking Meclizine 25-50 mg for the dizziness/vertigo. I also had done epley maneuver to help get rid of the vertigo since I am more dizzy turning on my right side and thinks that it is positional vertigo. 1/13/2021 still dizzy and taking Meclizine because it helps for the dizziness. I don't have anymore fever, the pain at the injection site is now mild, still moderate pain for the headache, some body aches but not as much as before. I had gone to the urgent care at this point to be seen since the vertigo is still there since Saturday 1/9 and it is now Wednesday 1/13. The doctor at the urgent care told me to continue taking Meclizine, hydrate and rest for a total of one week since the onset of the vertigo.
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| 44 | 2021-01-14 | headache | 8 hours after injection Chest palpitations Nausea Vomiting Diarrhea Headache |
| 44 | 2021-01-14 | shortness of breath |
After the administration of the COVID-19 vaccine, during the observation period, the patient showed ...
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After the administration of the COVID-19 vaccine, during the observation period, the patient showed a swollen tongue and shortness of breath
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| 44 | 2021-01-14 | weakness, lethargy, headache, head discomfort, chills, dizziness |
Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the c...
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Dizzy; headaches; flu feeling; side effects she had were like the COVID symptoms she had, like the chills and everything; lethargic feeling; weak; Nausea; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling/left leg went numb; whole left side of face swelled up; left eye turned red; pressure in head; felt like someone squeezing her eyeball out; eye went black/left eye looked bruised/blackness around the eyes; whole face went numb/left side of face slightly numb; bells palsy; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 05Jan2021 at single dose for COVID-19 immunization. Medical history included cutaneous t-cell lymphoma from 2017 and ongoing, ongoing cholesterol, ongoing thyroid, covid-19 from Nov2020 to an unknown date not ongoing (lasted about 1-1.5 months; she did not have any breathing problems) and blood cancer. Concomitant medication included bexarotene ongoing for cutaneous T-cell lymphoma, rosuvastatin ongoing for cholesterol, levothyroxine ongoing for thyriod. The patient underwent lab tests and procedures which included COVID 19: positive in Nov2020, found out tested positive around holiday. Clinical course: onset about 26 hours after administered the first dose; onset as soon as she got back to work next day: 06Jan2021. The side effects were at their worst for at least 24-48 hours. Further described as all side effects occurred only on left side of her body: whole left side of face swelled up on 06Jan2021; left eye turned red on 06Jan2021; whole face went numb/left side of face slightly numb on 05Jan2021; eye went black/left eye looked bruised on 05Jan2021; pressure in head on 06Jan2021; felt like someone squeezing her eyeball out on 06Jan2021, within the first 24-48 hours, her 'left leg went numb'. She called to talk to physician and nurse who advised her to take Benadryl; which she did take and the Benadryl stopped the side effects; but she could not take a lot of Benadryl or anything because she was at work. She stayed at work because at least there were healthcare professionals, adults in case she passed out; at home she has 7 young children and is also raising her grandchild. The side effects did not completely go away. The arm thing was normal; The next day she was at work and had the swelling on left side of face; blackness around the eyes; arriving home she had headaches on 07Jan2021 and then her leg went numb for like 20 mins; the whole left side of her body went numb including even her vagina; left side of her body was so numb and weird and tingly feeling that she started panicking because she was driving on 06Jan2021. She calmed herself down thinking it's only the left side; you can drive with your right side to get home and be fine. It was more like left side of her body was asleep, tingling, she has never had that happen before. Everything else like the headache, flu feeling was about 48 hours later (on 07Jan2021). She had COVID already back in Nov2020 for about 1-1.5 months; the next side effects she had were like the COVID symptoms she had, like the chills and everything on 06Jan2021. She had the lethargic feeling again, her head was hurting, she felt extremely weak on 06Jan2021. Patient also felt nausea on 06Jan2021, Dizzy on 08Jan2021. Another doctor said it sounded like the side effects she experienced with the vaccine sounded like allergic reaction or Bell's palsy. Patient was asking the doctor if she could get like an Epi-pen or prescription Benadryl or something because she is afraid to get the second dose of Pfizer COVID-19 Vaccine and not have something to respond to side effects with. The outcome of event whole face went numb/left side of face slightly numb was recovered on 07Jan2021, for headaches was recovering, chills and nausea was recovered on 08Jan2021. Outcome of other events was unknown. Information about lot/batch number has been requested.
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| 44 | 2021-01-14 | fatigue |
I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my ski...
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I am a doctor. I think the nurse went a little subcutaneous in retrospect (she pinched up on my skin). I developed left supraclavicular lymphadenopathy on 12/25 and that is still present and unchanged. I reported that prior. I developed a rash similar to pityriasis rosea on 1/11. This is progressive and still present. I do currently also have fatigue and possible conjunctivitis.
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| 44 | 2021-01-14 | headache, chills, fever |
Severe side effect post 2nd covid vaccine. Started about 9-10 hours post vaccine. Fever (101.9+ F) ...
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Severe side effect post 2nd covid vaccine. Started about 9-10 hours post vaccine. Fever (101.9+ F) Rigor Severe body aches Severe headache Nausea
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| 44 | 2021-01-14 | chills, fever | So far 12 hours of pain, body aches, chills and fever. Taking Tylenol and Benadryl |
| 44 | 2021-01-14 | chills, fever, headache |
feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm...
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feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect. No further information was provided or obtained.
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| 44 | 2021-01-14 | shortness of breath |
throat closing up; struggled the breath; This is a spontaneous report from a contactable consumer (p...
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throat closing up; struggled the breath; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Pfizer EL 3302), via an unspecified route of administration on 09Jan2021 07:30 am at single dose at left arm for covid-19 immunization. Medical history included diabetes, high blood pressure, allergies. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 10Jan2021 14:30, patient woke up with throat closing up and struggled the breath. Patient immediately drank a dose of diphenhydramine hydrochloride (BENADRYL). Patient did that two more time in the evening of 10Jan2021. Patient called the doctor in the morning. Events were considered serious per life-threatening. The adverse events resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient received treatment liquid diphenhydramine hydrochloride, epinephrine (EPI-PEN) for events. Outcome of events was recovered in Jan2021.
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| 44 | 2021-01-15 | weakness, headache, fatigue, body temperature increased |
2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a hea...
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2nd shot: Very different experience. Got the shot in my left arm after work like before. I had a headache and felt tired so took some melatonin, had a hot toddy, and went to bed early. Woke up roughly 18 hours post vaccine with back aches and lower rib pain when I took a breath. Took my temp, it was 100*. By 21 hours I had a temp of 102*. My groin, neck, and left arm pit lymph nodes were enlarged as well. After sleeping most of the day away, it felt like my fever 'broke' at 28 hours, it came down to 101*. Finally I took some Tylenol at 34 hours so I could sleep from the back pain. Woke up the next morning at 45 hours with a stiff back/neck but temp down to 99*. I also had a swollen and reddened entire deltoid where the shot had been given (painless when shot given and no blood after), almost like a cellulitis or allergic reaction. My left armpit lymph node remains enlarged but not as painful. Now almost 72 hours out, the only residual effects are a decreasing but enlarged left armpit lymph node, improving swollen/reddened deltoid, decreased appetite, and decreased energy level.
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| 44 | 2021-01-15 | headache, dizziness, fatigue |
About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed heada...
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About 10 mins after injection, felt chest tightness, palpitations, b/p 168/118. Then developed headache, dizziness, felt something stuck in throat and difficult to swallow. Also acid reflux. Sent to ER. B/P 170/98, still had feeling of difficulty swallowing, headache and acid reflux. Was given Tylenol, Pepcid and Ativan. After several hours B/p was normal and had slight headache when I went home. Following day felt tired and still with headache. Tylenol not helping.
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| 44 | 2021-01-15 | chills, fever | Fever 100 at 24hrs after shot Chills 6hrs Aches 24 hrs Joint pain 24 hrs Brain fog 1-2 days |
| 44 | 2021-01-15 | headache, fatigue, fever | Headache, Myalgia, Fever, NauseaVomiting, fatigue, sore arm Narrative: missed work 1/8/2021 |
| 44 | 2021-01-15 | fever, fatigue | Myalgia, Fever, NauseaVomiting, fatigue Narrative: |
| 44 | 2021-01-15 | headache, fever, fatigue |
tired and headache started at 2:30pm. I slept all afternoon/evening. I had a fever of 102.3. I had b...
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tired and headache started at 2:30pm. I slept all afternoon/evening. I had a fever of 102.3. I had body aches. I'm still tired and achy.
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| 44 | 2021-01-16 | headache |
1/9/2021: 0230: Woke with headache and generalized muscle aches 1200: Generalized muscle aches, seve...
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1/9/2021: 0230: Woke with headache and generalized muscle aches 1200: Generalized muscle aches, severe headache and blurry vision
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| 44 | 2021-01-16 | lethargy | Extreme lethargy, nausea, ?foggy brain? |
| 44 | 2021-01-16 | headache, fatigue, chills |
Within hours of receiving vaccine had headache, took Ibuprofen and went to bed early. When woke up s...
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Within hours of receiving vaccine had headache, took Ibuprofen and went to bed early. When woke up still had headache, as the morning went on developed muscle aches, chills, nausea, fatigue and aching joints. These symptoms lasted for 48 hours, and were debilitating. Took Tylenol q6 hours.
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| 44 | 2021-01-18 | fever, headache, cough |
Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fev...
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Diarrhea; nausea and vomiting; nausea and vomiting; rash on her right arm, like a hive or whelp; Fever; Headache; really sore right arm; right arm felt numb; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (Pfizer COVD 19 vaccine), lot number: EL0142, via an unspecified route of administration on 07Jan2021 17:00 at single dose in right arm for COVID-19 immunisation. Medical history included blood pressure abnormal, had a cough from having COVID 19 on 16Dec2020, cough was ongoing and unknown for COVID-19. Concomitant medication included amlodipine from an unspecified date (taking for 2 years) and ongoing at 10mg once daily by mouth for blood pressure abnormal. No other vaccines were administered on same date and no prior vaccinations (within 4 weeks). Registered nurse (patient) was calling regarding Pfizer COVID 19 vaccine. Reported she received the first dose last Wednesday 07Jan2021 17:00 in the right arm. Reported she noticed the next day (08Jan2021) fever and a headache. On 08Jan2021, Friday she had a really sore right arm and her right arm felt numb. On 09Jan2021, Saturday, she experienced nausea and vomiting and also noticed a rash on her right arm, like a hive or whelp. On 10Jan2021 Sunday, again with the fever, nausea, vomiting and she had diarrhea. Today she stated she woke up a new woman. She feels felt with no fever and her arm was better. She still had a cough from having COVID 19 on 16Dec2020. Stated she was used to coughing. Added she treated the fever with Tylenol 1000mg. Stated she didn't remember exactly but she took a little everyday starting on Thursday the day after the vaccine. Stated she was unsure if she would have the next dose. The events didn't require a visit to physician office or emergency room. The outcome of fever was recovered on 10Jan2021, of Headache, sore arm, rash on right arm, nausea and vomiting was recovered on 11Jan2021, of arm numb was recovered on 09Jan2021, of diarrhea was recovering. Serious criteria for fever was reported as yes, medical significant, for Headache, sore arm, arm numb and Diarrhea was non-serious, for rash on right arm, nausea and vomiting was unspecified.; Sender's Comments: Based on the compatible time association, the event fever is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-19 | fever, headache, chills, fatigue |
01/13: same day had staff having chill, fever 99.4, fatigue, headache. Friday 01/15; bodyache, head...
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01/13: same day had staff having chill, fever 99.4, fatigue, headache. Friday 01/15; bodyache, headache, no fever. Sat resolved. Now back to work.
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| 44 | 2021-01-19 | headache |
ACHINESS AND HEADACHE- A LITTLE OVER 24 HRS STARTING THE NIGHT VACCINE WAS RECEIVED. RASH ON NEC, CH...
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ACHINESS AND HEADACHE- A LITTLE OVER 24 HRS STARTING THE NIGHT VACCINE WAS RECEIVED. RASH ON NEC, CHEST, UPPER BACK AND STOMACH STARTING 2ND DAY AFTER VACCINE. LASTED A LITTLE LESS THAN 24 HRS. TOOK TYLENOL AND MOTRIN
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| 44 | 2021-01-19 | malaise, chills, fever, lethargy, headache |
Fever (as high as 101.8), rigors, joint/muscle aches, headache, lethargy, malaise, injection site pa...
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Fever (as high as 101.8), rigors, joint/muscle aches, headache, lethargy, malaise, injection site pain & swelling
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| 44 | 2021-01-19 | headache, chills | Headache, bodyaches, chills, |
| 44 | 2021-01-19 | fever, chills, fatigue, headache | Headache, pain in left arm, fever, chills, body aches, nauseous, fatigue |
| 44 | 2021-01-19 | fever |
Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team ...
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Patient received first Pfizer SAR COVID vaccine dose at 18:16 pm. Patient advised vaccination team of previous allergic reactions to H1N1 vaccine (anaphlyxis - swelling of mouth, lips and tongue) and flu vaccine (head to toe hives). Patient was counseled by lead pharmacist regarding risk and and data related to vaccine. Patient agreed to receive vaccine. Informed patient that we would monitor for potential reaction for 30 minutes, patient agreed to stay. Patient was observed by nursing. At approximately, 1850 patient reported that she felt her lips swelling, and noted to have difficulty in her speech. She has administered 50mg Benadryl suspension. Vital signs taken: 1900: 147/92; 82; 97% room air 1905: 132/101; 84; 97% room air 1910: 145/104; 84; 97% room air. 1915: 147/104; 81; 97% room air RN observer called vaccine physician on call at 1915 regarding patient status. Patient was then observed to have hives around her neck, upper chest and arms. RN then called again at 1924. Was advised to send patient to the ED. RN called ambulance and was advised to administer epinephrine. Pharmacist pulled up 0.3mL of epinephrine. Administered injection in right thigh at 1934. Ambulance called and arrived on site at 1936. Patient was assessed, IV access secured and transferred to ED for further observation. Observed for 4 hours with improvement in symptoms. sent home with prednisone. Patient contacted the next day and reported hives on arms, face, back, hands as well as swollen lips and fever to 101.6. Contacted again the following day and symptoms were resolving. Patient is tracking symptoms in VSAFE
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| 44 | 2021-01-19 | fever, shortness of breath, cough, fatigue |
Started having Covid-like symptoms, mainly cough and shortness of breath along with fatigue. Ran a l...
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Started having Covid-like symptoms, mainly cough and shortness of breath along with fatigue. Ran a low-grade fever for two days. Cough progressed and worsened and by the third day of symptoms I was bound to bed. Each time I moved, I couldn't breathe and coughed excessively.
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| 44 | 2021-01-19 | chills, fever | WOKE UP WITH CHILLS AND FEVER (103) AT 3AM. TOOK TYLENOL |
| 44 | 2021-01-19 | migraine, fever, sweating | migraine, fever, sweat, body aches, vomiting |
| 44 | 2021-01-20 | shortness of breath |
approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptom...
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approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; approx 34 hours after vaccine awoke unable to breath. symptoms consistent with laryngospasm. symptoms lasted approx 2 minutes; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot ek9231) on 08Jan2021 03.00 pm intramuscular in the left arm for COVID-19 immunization. Medical history included RA, spondylitis, GERD, known allergies to sulfa, penicillin, cefalexin monohydrate (KEFLEX), sulfamethoxazole, trimethoprim (BACTRIM), adalimumab (HUMIRA), ankylosis. Concomitant medications included acetylsalicylic acid (ASPIRIN), omeprazole, loratadine (CLARITIN) and infliximab (RENFLEXIS). First dose of BNT162B2 was administered on 21Dec2020 11:00 am (lot ek5730) intramuscular in the left arm for COVID-19 immunization. Approx 34 hours after vaccine (also reported as 03Jan2021) awoke unable to breath. Symptoms consistent with laryngospasm, symptoms lasted approx 2 minutes. No treatment provided. No COVID test performed prior or after vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of unable to breath/ Laryngospasm cannot be excluded, considering the plausible temporal relationship. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of allergic reaction to vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-20 | fatigue, headache, somnolence, cough |
near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for C...
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near syncope; Sinus Tachycardia; Hypothyroidism; tested positive for Covid 19; tested positive for Covid 19; lost weight; No sense of taste or smell; No sense of taste or smell; losing hair; heart rate started increasing; high blood pressure; Increased cough; Sleepy; tired; Headache; This is a spontaneous report from a contactable other healthcare professional (patient) through the Medical Information Team and Pfizer-sponsored program Pfizer First Connect. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly on the arm on 19Dec2020 11:15 at a single dose for COVID-19 immunization. Medical history included tachycardia and stroke from 2019 and diabetes mellitus diagnosed in summer of 2020 and ongoing. Family medical history included father had type 2 diabetes. Concomitant medication included metformin hydrochloride, sitagliptin (JANUMET) for diabetes. The patient previously took regular flu shot and had body aches; it did not happen at the year of report but in years past she did have it. The patient took the COVID vaccine for precaution as she was a healthcare worker/paramedic and stated there was no prescriber. She received the vaccination at a health department facility, not a military facility. She had no previous immunizations and no additional vaccines were administered on the same date as COVID-19 vaccine. The patient received her first dose of COVID-19 vaccine on 19Dec2020 and after nine days, she tested positive for COVID-19 on 30Dec2020 and had an inpatient hospital stay. She mentioned she was so happy that she did not have any symptoms for those days. She stated that she got the shot on the 19th and later that evening was when she started having symptoms. She tried to sleep and it woke her up, she felt sleepy, tired and experienced headache on 19Dec2020 20:00 to 21:00. On 28Dec2020 23:00, she had an increased cough. She initially had increased cough from wearing mask and was having post nasal drip, then she got wet cough and that was when she decided to get tested. She went back and forth on dates; stated she was confused with the dates because of being in the hospital, it had been a while and the dates were all meshing in together. Her specimen was collected and they did the test on 29Dec2020 then found out that she tested positive for COVID virus with a COVID test nasal swab on 30Dec2020 17:30. She mentioned she lost weight after she got COVID, had no sense of taste or smell on unspecified dates. She did not know if it was related to her thyroid but she started losing hair and her heart rate started increasing on Monday, so they took her off all her meds and said the COVID was doing crazy things to the body. She had to go on Carvedilol for the sinus tachycardia and had high blood pressure now. This was all new after she tested positive. She has had bouts of tachycardia before and did have a heart monitor as she had a stroke last year. So those have never been persistent or symptomatic. If she did have a high heart rate, it always went down. This one was symptomatic. She did fine the whole week after the shot, just had that little bit of sleepiness, was tired, and had a headache. The patient reported near syncope with sinus tachycardia due to COVID-19 and hypothyroidism on 08Jan2021 14:30 to 15:00, which required hospitalization from 08Jan2021 to 10Jan2021 (2 days). ER or physician's office was required. She never went to the ER for the vaccination, it was just for the near syncope with sinus tachycardia due to COVID-19 and hypothyroidism that she went and was then admitted to hospital. She just got out of the hospital the day before report (10Jan2021), was there for two days and was still recovering. She was supposed to receive her second vaccination on the day of report however her doctor did not know if she should get the second dose due to double antibodies. She did not ask if she still had the virus or it went away. She has not been to work in two weeks. Outcome of the events tested positive for COVID virus was not recovered; near syncope with sinus tachycardia due to COVID-19 and hypothyroidism was recovered with sequel; sleepy, tired and headache was recovering; while the remaining events was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-21 | throat irritation, chills, cough, headache, fever |
48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes...
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48 hours after vaccine, at 3 pm, I developed an allergic response. I had diarrhea, hives, itchy eyes, mouth, and throat, coughing, and slight constriction in my lungs. Within 30 minutes of taking Benadryl the symptoms began to subside. After the allergic reaction, I developed the normal symptoms of the vaccine with chills, fever, body aches and a headache. Injection site had increased soreness for the rest of the day.
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| 44 | 2021-01-21 | chills, fatigue, fever |
AT 530PM ON 1/19/21, DEVELOPED BODY ACHES, FEVER, CHILLS, FATIGUE, EXCRUTIATING ARM PAIN AT INJECTIO...
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AT 530PM ON 1/19/21, DEVELOPED BODY ACHES, FEVER, CHILLS, FATIGUE, EXCRUTIATING ARM PAIN AT INJECTION SITE
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| 44 | 2021-01-21 | throat swelling, weakness, dizziness, shortness of breath |
COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchines...
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COVID-19 Vaccine EUA; Difficulty breathing, swelling of my face and throat, fast heartbeat, itchiness all over, dizziness and weakness.
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| 44 | 2021-01-21 | fatigue, chills |
Extreme swollen lymph node to lt axilla, approximately size of a baseball. Chills and significant fa...
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Extreme swollen lymph node to lt axilla, approximately size of a baseball. Chills and significant fatigue.
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| 44 | 2021-01-21 | somnolence, fatigue, dizziness, headache |
I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my...
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I woke up earlier that usual , I had a terrible headache and by lateral tenatis. I felt dizzy and my left arm all the way to the finger was swollen. I had pain in the wrist arm, joints and fingers. I determined it was due to the swelling. I had some lymph node enlargement, and was really fatigue and slept most of the day. (36 hours). I did not have a fever. I'm a doctor and did some evaluations on myself. I didn't have trouble breathing of swallowing. If I wasn't medically trained I would have gone into the doctor. I did see an ENT for hearing test to make sure there was no damage and there was not.
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| 44 | 2021-01-21 | dizziness, discomfort, fatigue |
Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye...
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Severe arm pain and was unable to sleep even with tylenol Right eye swelling Right eye whites of eye bloody Abdominal pain for 3 days unable to sleep due to discomfort Nausea off and on for 3 days with abdominal pain Fatigue Faint with abdominal pain Light headed off and on
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| 44 | 2021-01-21 | shortness of breath |
Started with flushing. Recieved 25mg Bendaryl po, which did not seem to help. progressed to nausea, ...
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Started with flushing. Recieved 25mg Bendaryl po, which did not seem to help. progressed to nausea, some SOB, received epi, then started to break out. Prepare to take to BMC. Another dose of epi was given prior to transport. BP 176/106 HR 84 P 22
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| 44 | 2021-01-21 | lethargy | Two grand mal seizures and went unconscious. Prior to seizures felt very lethargic. |
| 44 | 2021-01-21 | shortness of breath, cough |
Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "c...
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Within 15 minutes: L. side numbness/tingling, chest tightness, coughing/sob, HTN, Tachycardia -- "code called" -- pt. given epi, oxygen, transferred to ED.
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| 44 | 2021-01-21 | skin warm |
woke up with left sided chest pain and thought she may be having an MI; Injection received in left a...
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woke up with left sided chest pain and thought she may be having an MI; Injection received in left arm, resulting in extreme left side pain and soreness; woke up with left sided chest pain and thought she may be having an MI; Left upper body continues to be sore, not only at injection site but also left axillary area; Left arm is still warm although vaccine was received 72 hours ago; This is a spontaneous report from a contactable pharmacist (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284), via an unspecified route of administration in the left arm on 08Jan2021 07:45 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has no known allergies. Patient was not pregnant. Patient has no COVID-19 prior to vaccination. No other vaccines was given in four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) given in the left arm on 21Dec2020 at 02:00PM for COVID-19 immunization. On 09Jan2021 at 03:00 PM, the patient experienced injection received in left arm, resulting in extreme left side pain and soreness. She woke up with left sided chest pain and thought she may be having an MI. Left upper body continues to be sore, not only at injection site but also left axillary area. This pain was not noted with her first vaccination. Left arm was still warm although vaccine was received 72 hours ago. This was not noted with her first vaccination. No treatment was given for the reported events. Patient was not tested for Covid post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-24 | fatigue, fever, headache, chills |
1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue...
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1 pm was vaccine admin time on Wed (1/20). By 8 pm, her arm was very sore & with significant fatigue. 1am that night, awoke with chills, fever (102), generalized muscle aches. By midday Thursday, these symptoms began to dissipate slightly and she developed a h/a. Friday, fever, chills, h/a were gone & nausea and abdominal pain started. No vomiting or diarrhea occurred. By SAturday evening, nausea improved but upper legs became tremulous and weak. Weak, tremulous legs have continued and persist up until today (monday, 1/25).
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| 44 | 2021-01-24 | headache |
A few days after receiving the first Pfizer Covid 19 vaccine I have an insidious mark running down m...
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A few days after receiving the first Pfizer Covid 19 vaccine I have an insidious mark running down my right forearm. I initially thought it was a bruise but don't recall hitting my arm in such a violent way to create this big purple mark on my arm. After weeks-the mark is still there and is not fading. I've also been getting short flashes of headaches that I don't recall experiencing in the past.
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| 44 | 2021-01-24 | chills | Chills |
| 44 | 2021-01-24 | night sweats, headache, fever, chills, nasopharyngitis |
Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold w...
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Couldn't walk; Terrible body aches; Every joint was aching; Mild, headache; Cold with chills; Cold with chills/ Was shivering; Fever; Sweating all night; This is a spontaneous report from a contactable nurse. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 31Dec2020 10:02 at a SINGLE DOSE for covid-19 immunisation. Medical history included tuberculosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took BCG vaccine. The patient received Pfizer COVID Vaccine on 31Dec2020. On 04Jan2021, the patient got a couple of symptoms and started with a mild headache, not sharp pain and she took Tylenol. After she showered when she came home from work, she got chills. She took a couple more Tylenol, but doesn't know when. When she went to bed, she sweated all night and still feel cold with chills and was sweating all night. She didn't really check temperature, but knew she had a fever. On 05Jan2021, she woke up and felt like someone had hit her from her head to toes and every joint was aching, terrible body aches and couldn't walk. She went to emergency room on 05Jan2021 and thought she may have been exposed a couple of days before. She was working with patients who had COVID. She had a rapid COVID test that was negative and came home and symptoms continued. Today was the first day she was feeling a little better. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of mild, headache, cold with chills, cold with chills/ was shivering, fever, sweating all night , couldn't walk, terrible body aches, every joint was aching. The outcome of the events was unknown. Information was requested on Lot/ Batch number.
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| 44 | 2021-01-24 | weakness |
Decreased range of motion and pain same day as administration. Pain resolves after 1 week. 3 weeks p...
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Decreased range of motion and pain same day as administration. Pain resolves after 1 week. 3 weeks post administration, range of motion is still decreased and weakness in that arm. Patient referred to specialized medicine.
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| 44 | 2021-01-24 | influenza like illness, fever, fatigue, discomfort, headache, sweating, chills |
Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short dur...
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Fever, chills, sweats, headache, tooth pain, skin sensitivity, finger locking in left arm (short duration), slight lymph node enlargement in neck, tiredness, aches and discomfort, "flu-like" lasted approx. 30 hours
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| 44 | 2021-01-24 | headache, fatigue |
The day after the first shot, I got a severe headache and felt very tired. I don't normally get hea...
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The day after the first shot, I got a severe headache and felt very tired. I don't normally get headaches or feel tired, but I was aware that they can be side effects of the vaccine. I have trigeminal neuralgia type II, which causes facial pain headaches, but this was not that type of headache. Since getting the first shot, I have had at least 5 trigeminal neuralgia headaches when I normally only have 1 per month if that. I take Amitriptyline 150 mg nightly to regulate my trigeminal neuralgia and have not had any changes to my dosage or medication in several years. I am concerned because I read (unfortunately after having the shot) that PEG's are in the vaccine and also in Amitriptyline and am wondering if the vaccine has caused my trigeminal neuralgia flare ups. It has taken me several years to finally find the right medication to regulate my trigeminal neuralgia, and I am hoping the vaccine hasn't set me back. I had been hesitant to have the vaccine, but I work in an emergency department and felt obligated to do so. I wish I had consulted my neurologist or another health care provider of mine before having the shot. I am due for my second shot on 1/28/21, and I will still have it.
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| 44 | 2021-01-24 | dizziness, fever, sweating, chills, headache |
Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck,...
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Woke up from sleep at 3:02am (13hrs post injection) Severe headache (most prominent at base of neck, behind eyes, and top of head) throbbing pain. Hurt to move eyes. Photosensitivity (eyes must remain shut at all times) Nausea, fever (102.3), sweats, chills Severe body aches (most prominent in lower back, hips, and legs/knees) Tylenol/ibuprofen alternating (reduced pain down to 4/10) 1st applied ice to lower back and surrounded head. This allowed me to sleep for almost 4 hours. Then applied heat to lower back. Continued to drink normally and eat bland diet These symptoms lasted all day. Around 11:30pm on 1/25 symptoms resolved with the exception of a headache requiring ice packs again throughout the night and tylenol. 9:22am today, still mild headache and get dizzy or a vertigo feeling if I change position too quickly or rotate my head too quickly
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| 44 | 2021-01-24 | fatigue, fever |
very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; ...
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very low grade fever; it was 99.5 degrees Fahrenheit; getting a GI cold; Arm pain; General fatigue; This is a spontaneous report from a contactable nurse, reporting for herself. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration at the left arm on 17Dec2020 at single dose for COVID-19 vaccination. Vaccination was done in a hospital. Medical history included celiac disease from 2011 and ongoing (very well controlled, she eats gluten-free. This is an autoimmune disease, but she is not immunocompromised like they ask with the Pfizer COVID-19 Vaccine. She is typically very healthy) and irritable bowel syndrome from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that following the first dose, she just experienced arm pain and general fatigue, just the basics. Arm pain and general fatigue with first dose she described as she did not really have a negative effect from; just the basics what everyone was saying. She did not feel anything when the first dose was injected; she did not have any issues until about 3 hours later that day on 17Dec2020 when she had onset of arm pain and general fatigue where she just felt tired for a few days; nothing big; she was able to work after the first dose; she just took ibuprofen for the first 2 days and the arm pain went away. She also mentioned that before getting the second dose of the vaccine she had a very low grade fever; it was 99.5 degrees Fahrenheit but she felt fine. Her stomach she was kind of having a little issue with loose stools for a few days before the second dose of the vaccine. She had celiac disease and a history of irritable bowel syndrome; and her uncle died on 02Jan2021 so she blamed the symptoms going on stress due to that. She does not know if maybe she was getting a GI cold at that time, the symptoms were a little mild before getting the second dose of the vaccine, she never felt sick or anything like that. She told the doctor about these symptoms during her appointment on 06Jan2021. Seriousness criteria of very low grade fever and a little issue with loose stools unknown. The patient underwent lab tests and procedures which included body temperature: 99.5 degrees fahrenheit on an unspecified date and COVID-19 test: negative on 06Jan2021. The outcome of the events was unknown. The reporter assessed the events arm pain and general fatigue as related to BNT162B2.
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| 44 | 2021-01-25 | chills, headache | 1hr after - Headache, nausea. 2nd day - body aches and chills |
| 44 | 2021-01-25 | dizziness, chills, headache, fever, weakness, fatigue |
7pm-Dizziness, weakness, tiredness, chills. 1/26-530am - Chills, body aches, slight fever -101.0, he...
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7pm-Dizziness, weakness, tiredness, chills. 1/26-530am - Chills, body aches, slight fever -101.0, headaches, dizziness,
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| 44 | 2021-01-25 | cold sweat, sweating, dizziness |
Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizzines...
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Approximately 20 minutes after receiving the COVID vaccination (2nd dose), patient reported dizziness and blurred vision. Patient was walking at the time and was then sat down. Patient was clammy and diaphoretic, blood pressure was elevated from her normal and O2 was normal. Patient reported feeling a thickness in her throat, similar to mucus but no trouble breathing. Ambulance was called and she was taken to the ER by paramedics, was not able to stand to get on stretcher and was helped on by paramedics.
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| 44 | 2021-01-25 | chills, headache, fever |
Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, hea...
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Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; Chills, low grade fever, body aches, headache " brain fog"; This is a spontaneous report from a contactable other healthcare professional. A 44-year-old female patient received (not pregnant) her first dose of bnt162b2 (BNT162B2 also reported as Covid 19brand Pfizer BioNTech, lot EJ1685), intramuscular in the left arm 22Dec2020 10:00 at SINGLE DOSE for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included covid prior vaccination: Yes. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced chills, low grade fever, body aches, headache " brain fog" on 23Dec2020 01:00. No treatment was given. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-01-25 | fatigue, fever | DEVELOPED FEVER GREATER THAN 102, JOINT PAIN AND EXTREME FATIGUE THAT LASTED 2 DAYS. |
| 44 | 2021-01-25 | dizziness, fever, weakness |
I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; ...
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I started running a mild fever the next day and I still have a fever today; feel lightheaded; weak; feeling nausea; my legs were weak; my throat got tight; This is a spontaneous report from a contactable HCP. This 44-year-old female (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) at left arm at single dose for COVID-19 immunization on 08Jan2021 05:30 PM. Relevant medical history included osteoporosis and menopause. Known allergies included: soy, dairy, all nuts, sunflower, cottonwood, lentils, chickpeas, Vit E, cephalexin, Amoxicillin, sulfa, Bactrim, lisinopril , estrogen, moxifloxacin, Pseudoephedrine, paroxetine, trimethoprim, doxycycline, azithromycin, cipro, clindamycin, colestipol. The patient was not pregnant. Relevant concomitant drug included Vit D, calcium, ibuprofen. Five minutes after receiving the vaccine, her throat got tight then she started to feel lightheaded and her legs were weak. She notified the staff there who offered her Benadryl but she declined. She began feeling nausea about an hour later and she felt lightheaded and weak for about 4 hours. She started running a mild fever the next day and she still had a fever on 12Jan2021. The patient did not receive other vaccine in four weeks. The outcome of events was recovering. No treatment was received. The patient was not COVID infected prior vaccination. The patient did not have COVID tested post vaccination.
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| 44 | 2021-01-25 | fatigue | Nausea, loss of appetite, muscle aches and fatigue beginning on 1/21. Diarrhea beginning on 1/22. |
| 44 | 2021-01-25 | headache |
had a massive headache; nausea; throwing up for a couple of hours; This is a spontaneous report from...
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had a massive headache; nausea; throwing up for a couple of hours; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, Expiry Date: 30Apr2021), via an unspecified route of administration on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient had the vaccine yesterday on 11Jan2021 at 12:00. Then by 3:30pm on 11Jan2021, patient had a massive headache, nausea, and throwing up for a couple of hours. She saw nausea as a side effect, but not the others. She also didn't think there were side effects really after the first shot. The patient asked if these are reported side effects after first dose and what about 2nd dose? Should there be any issues after the 2nd dose?. She is an ophthalmic tech. She doesn't have a prescribing doctor. She got it with the (health department name) for healthcare workers. The nausea stopped last night (recovered) at 10PM on 11Jan2021, and her headache stopped (recovered) at 9 am this morning on 12Jan2021. The patient also recovered from the event 'throwing up' on 11Jan2021.
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| 44 | 2021-01-25 | headache, chills, fever |
joint pain; chills; headache; severe injection arm pain; Fever; This is a spontaneous report from a ...
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joint pain; chills; headache; severe injection arm pain; Fever; This is a spontaneous report from a contactable nurse. A 44-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in arm right, on 13Jan2021 14:15 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2, intramuscular in arm right, on 23Dec2020 13:15 at single dose for covid-19 immunisation. The vaccine was administered at Physician Office. No other vaccine was administered in four weeks. COVID was not tested post vaccination. No known allergies. Medical history included migraines from an unknown date and unknown if ongoing. The patient had COVID prior vaccination. The patient's concomitant medications included butalbital, caffeine, paracetamol (FIORICET). On 13Jan2021 the patient experienced joint pain, chills, headache, severe injection arm pain, fever. The patient was treated for the events with OTC fever and pain reducer and IBUPROFEN. The outcome of the events was resolving. Information on the lot/batch number has been requested.
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| 44 | 2021-01-26 | headache, fever, chills | Cold chills, fever, throwing up,diarrhea,extreme headache and body aches |
| 44 | 2021-01-26 | dizziness |
Complained of blurred vision, and feeling lightheaded and dizzy. Vital signs were within normal limi...
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Complained of blurred vision, and feeling lightheaded and dizzy. Vital signs were within normal limits. O2 saturation normal. Started about 15 minutes after vaccination and lasted another 15 minutes. No medications or other interventions needed. Will follow up with their physician.
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| 44 | 2021-01-26 | fatigue | Fatigue |
| 44 | 2021-01-26 | headache |
I have been having an increase in headaches almost daily after receiving the first dose of the covid...
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I have been having an increase in headaches almost daily after receiving the first dose of the covid vaccine. I am not sure if it is related or not but was told by my scc to fill out a pearl
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| 44 | 2021-01-26 | shortness of breath |
Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Vis...
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Received Pfizer COVID 19 vaccination (Dose 1) at 10:07a.m. Itching - 10 minutes post vaccination Visible hives, shortness of breath, and rapid heart beat- 25 minutes post vaccination Decreased BP, followed by increased BP - 30 minutes post vaccination Given 50 mg chewable children's Benadryl at facility: 35 minutes post vaccination EMS called: approximately 40 minutes post vaccination EMS placed IV, pushed epinephrine and solumedrol, and transported me to Hospital. Emergency Department: pushed another dose of epinephrine, Benadryl, and Pepcid. I also received an EKG. Discharged from ED at 4pm Relapse in symptoms (Shortness of breath, nausea, rapid heart rate, and hives): 7p.m. Return to ED at 9pm and discharged at 1 a.m. 1/16/2021
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| 44 | 2021-01-26 | shortness of breath |
Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat...
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Received allergy immunotherapy on 1/21/21 and had itching, difficulty breathing, tightness in throat/chest, flushed skin and tachycardia after. Received Antihistamines, Albuterol treatment and steroid for treatment.
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| 44 | 2021-01-26 | chills, fever, fatigue |
arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior c...
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arthralgia; fatigue; insomnia; soreness at site of injection; swollen lymph nodes on left anterior clavicular region; Fever (99.9 at highest); chills; first dose was received on 27Dec2020/2nd dose on 13Jan2021; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date:May2021), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for covid-19 immunisation. The first dose was received on 27Dec2020 13:30 on the left arm, Medical history included hypertension, anxiety, GERD (gastrooesophageal reflux disease) and insomnia. Concomitant medication included atenolol, omeprazole (PRILOSEC), hydroxyzine hydrochloride (VISTARIL) and unspecified multivitamins. The patient previously took neomycine and experienced drug hypersensitivity. The patient experienced fever (99.9 at highest), chills, arthralgia, fatigue, insomnia, soreness at site of injection, swollen lymph nodes on left anterior clavicular region on 14Jan2021 05:45. No treatment was given for the events. Outcome of the events was recovering. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The reporter considered the events non-serious.
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| 44 | 2021-01-26 | fever |
feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body n...
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feeling cold/coldness; increased temperature/she took her temperature and it was 100.2/fever; body numbness/body started to feel numb; This is a spontaneous report from a contactable nurse reported for herself. A 44-year-old female patient receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular at left deltoid on 13Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient historic vaccine included the first dose of BNT162B2 on 22Dec2020 for covid-19 immunization. The patient body started to feel numb on 13Jan2021, she was feeling cold/coldness on 14Jan2021, increased temperature on 14Jan2021 and she took her temperature and it was 100.2, stated that she knew that a fever is a side effect. She was only concerned with the body numbness and wanted to know if body numbness was anything to be concerned about. The reporter assessed events was related to Pfizer Covid vaccine and as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible temporal association, the Company considers the reported events of hypoesthesia, pyrexia and feeling cold are possibly related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-26 | headache, dizziness, fatigue | headache, lightheadedness, fatigue, joint pain, diarrhea, normal vaccine site tenderness, chills |
| 44 | 2021-01-26 | headache |
surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue...
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surface blisters, like deep blisters all over her body/blistering rash all over; Hives; Itchy tongue; Headache; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176 and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving the vaccine, patient had hives and an itchy tongue on an unspecified date in Jan2021. Patient received some Benadryl at site. She spoke for about two hours and it seemed to ease a little bit. Patient came home and slept a quite a bit. As soon as she woke up, patient had the itchy tongue and hives again, so she took another the Benadryl. She woke up and then had a blistering rash all over on Jan2021. But the blisters were like surface blisters, like deep blisters all over her body. She went to the urgent care and received some IM steroid and Benadryl as treatment. Patient also had the headache on Jan2021. Outcome of the events was unknown. Patient was asking if she should get her second dose as back in the emergency room, they said they would not suggest to get the second dose.; Sender's Comments: Based on the time association, the blistery rash is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-01-27 | headache |
I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This i...
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I was just hot, I got hot; Hands started hurting; Really bad headache; Feeling kind of boozy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure and diabetic. Concomitant medications included lisinopril for high blood pressure, metformin for diabetes, and amlodipine. Today (11Jan2021), the patient just got hot and her hands started hurting. She was just feeling kind of boozy. She really had a bad headache. The patient was thinking why the lady didn't ask her if she was taking any medication or anything, she just asked if the patient was allergic to anything. The patient was not allergic to anything but she was taking medications. The patient asked if she should go and take her medication for tonight or hold until her symptoms go away. No treatment was received for the adverse events. The patient just lied down and have been sleeping for two hours. Outcome of the events was unknown.
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| 44 | 2021-01-27 | fever, chills |
fever; hip pain; 'pretty intense joint pain, felt like it was on fire; She feels ''like death today"...
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fever; hip pain; 'pretty intense joint pain, felt like it was on fire; She feels ''like death today"/she did not feel good; Chills; This is a spontaneous report from a contactable nurse. A 44-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248) intramuscular on 14Jan2021 single dose for COVID-19 immunisation. Vaccine location was deltoid left. No other vaccine was received in four weeks. The patient medical history was not reported. Historical vaccine included first dose of BNT162B2 (Lot: EL1284) received on 28Dec2020 around 7pm, intramuscular injection right deltoid. There were no concomitant medications. The patient experienced fever (she woke up with a fever of 101.3 at 6am), pretty intense 'joint pain, felt like it was on fire' on 14Jan2021; with the first dose of the covid vaccine she had really bad hip pain about 24 hours after (as reported) and it lasted about 12 hours but she could still walk and move, it was just annoying. The patient was ''like death today"/ she did not feel good' on 14Jan2021, chills on 14Jan2021. Her temperature has improved and it is around 99. The outcome of fever and chills was recovering, of 'pretty intense joint pain, felt like it was on fire' was recovered on 15Jan2021, of she feels 'like death today'/ she did not feel good and hip pain was unknown.; Sender's Comments: A possible contributory effect of suspect BNT12B2 on reported fever cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 44 | 2021-01-27 | malaise, fatigue, chills, throat irritation, fever |
her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; T...
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her eye is still swollen with chills; low grade fever; chills; muscle cramps; general muscle ache; Tiredness; scratchy throat which got worse with time; tenderness around the injection site; it felt really bad almost like a flu; it felt really bad almost like a flu; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: 30Apr2021, NDC number: 59267100001), intramuscular in the left deltoid, on 08Jan2021, at 0.3 mL, single, for COVID-19 immunization. There were no medical history and concomitant medications. The patient reported she had side effects after receiving the first dose (Jan2021). She had a scratchy throat which got worse with time. She had a general muscle ache, tenderness around the injection site. The muscle ache increased with chills and low grade fever. She said it felt really bad almost like a flu. She reported her eye is still swollen with chills and low grade fever. She further clarified that she was given the vaccine on 08Jan2021, Friday afternoon. On 09Jan2021, Saturday, she had muscle aches, tiredness, and by Saturday night she had a scratchy throat. On 10Jan2021, Sunday, she experienced tiredness and muscle cramps. She worked half day on 11Jan2021, Monday, and by the afternoon she had chills and low grade fever. On 12Jan2021, Tuesday morning, she woke up and her eyes were swollen. She noticed the swelling has decreased a little bit. She didn't have any symptoms such as difficulty breathing. The reporter asked what have caused these side effects and why did her immune response react this way after receiving the vaccine. She mentioned that her second dose is set up for the end of January and asked if she will be able to get the second dose since she had a reaction and she was wondering if had an illness when she got the vaccine could that have caused her to have a hyper response in her immune system to the vaccine. The outcome of the events scratchy throat which got worse with time, general muscle ache, tiredness, muscle cramps, eye swelling and low grade fever was recovering; chills was not recovered; and the outcome of the remaining events was unknown.
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| 44 | 2021-01-28 | shortness of breath, throat irritation |
1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash o...
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1/26--diarrhea, 1/27--hives on face and eyes, diarrhea has worsened, 1/28--itchy throat, SOB, rash on face, watery stools, 1/29--rash has resolved with benadryl, still severe diarrhea
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| 44 | 2021-01-28 | dizziness, headache | Headache, dizziness, burning tingling lips, nausea, rash on chest, drop in blood pressure |
| 44 | 2021-01-28 | chills | Hives, chills, hypertensive, bradycardia, pallor, felt like she was going to pass out |
| 44 | 2021-02-07 | nasal congestion |
tested positive for COVID/stuffy nose/couldn't smell; tested positive for COVID/stuffy nose/couldn't...
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tested positive for COVID/stuffy nose/couldn't smell; tested positive for COVID/stuffy nose/couldn't smell; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 44-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, Lot Number: ER5730 or EK5730), via an unspecified route of administration at Arm right on 18Dec2020 17:00 at the 44 years old at single dose for COVID-19 immunization. The medical history was none. The Family Medical History Relevant to adverse events was none. The concomitant medication was none. The patient was supposed to work the day she tested positive but had a stuffy nose on 01Jan2021. She wasn't sure if that was what it was but when she took a shower she couldn't smell the body wash and so she knew she had COVID. She had a rapid test used for the positive test for COVID on 01Jan2021. There was no hospitalization due to testing positive. The events did not require a visit to Emergency Room and Physician Office, but she did go to the urgent care to get the rapid test.There was no Prior Vaccinations (within 4 weeks). There was none additional Vaccines Administered on Same Date of the product. The patient underwent lab tests and procedures, which included tested positive for COVID on 01Jan2021. The outcome of the events was unknown.
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| 44 | 2021-02-08 | headache |
Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle...
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Events lasting approximately 48 hours (onset 18 hours after vaccine): Allodynia (whole body) Muscle aches (whole body) Debilitating headache Pain and swelling at injection site (right arm) Painful joints *Safe dose range of OTC Tylenol ineffective Ongoing effects (onset approximately 24 hours after first vaccine): Painful lump right breast/armpit
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| 44 | 2021-02-08 | chills, fever |
cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic ther...
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cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis.; Fevers to 102 F; chills x 48 hours; severe Right arm swelling; This is a spontaneous report from a contactable physician (patient). A 44-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number 4121 EL 1283) , via an unspecified route of administration from 19Jan2021 13:15 at single dose on right arm for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced cellulitis from right shoulder to right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis. The patient experienced fevers to 102 f, chills x 48 hours, severe right arm swelling on 20Jan2021 02:00. The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 20Jan2021. Therapeutic measures taken as a result of the events included Keflex times 10 days. No covid prior vaccination, no covid tested post vaccination, no other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported events cellulitis, fever, chills and swelling arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-02-09 | fatigue |
I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for abou...
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I went to sleep for four hours when I woke up I had a hard time walking. My legs were sore for about 24-36 hours. I was very tired for about 7 days all I did was sleep.
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| 44 | 2021-02-15 | dizziness, throat pain |
Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. ...
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Severe dizzyness, vomiting, tongue swelling,. Took ambulance to hospital. Stay at hospital 6 hours. Started at home for there days from work. Tongue and throat are still sore.
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| 44 | 2021-02-21 | sweating, dizziness, shortness of breath, throat irritation |
1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. ...
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1/27/21-About 2 hours after injection; developed facial, neck and chest rash, and itchy throat. 75mg Benadryl taken orally. - 1 hour later dizziness, heart rate 44, lost voice, face looked swollen. - 5 hours after vaccine administered went to outpatient clinic, heart rate 48 there. - After 1 hour, heart rate 120, sweaty, dyspnea and went to Emergency Room. 1/27/21-Amitted to Hospital -Given Solumedrol, Benadryl and Pepcid. Slowly improved. 1/29/21-Discharged Home on Pepcid 20mg BID x15 Days and PRN Benadryl. 2/8/21-Returned to work, but still has to take Benadryl daily for rash and uses Albuterol inhaler intermittently for "tightness" in throat.
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| 44 | 2021-02-21 | fatigue |
I started feeling really tired (couldn't move type tired). I called off worked for few days. On the ...
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I started feeling really tired (couldn't move type tired). I called off worked for few days. On the 1/7 noticed right of my face was drooping about 10 days couldn't smile and wiggle both ears.For me to talk it was very difficult due to right side of my face being so weak. I went to walk in clinic was diagnosed with Bell's Palsy. As of today I still couldn't lift my eyebrow (right) and smile still slightly cooked.
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| 44 | 2021-02-21 | dizziness |
Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed...
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Immediately after the injection became dizzy, light headed and nauseous. 24 hours later, I developed swelling in my right breast and lymph nodes in my right armpit. It is painful to the touch and swollen to the size larger than a golf ball. Pain radiates down my inner arm to my forearm.
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| 44 | 2021-02-21 | migraine, fatigue, shortness of breath, weakness, throat pain |
Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migrai...
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Intermittent Loss of taste, rash, body aches, muscle aches, sore throat, tiredness, weakness, migraine, shortness of breath, ear pain
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| 44 | 2021-02-21 | throat irritation |
Patient came to us with complaints of her heart racing, feeling like she needed "fresh air" and slig...
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Patient came to us with complaints of her heart racing, feeling like she needed "fresh air" and slight itch to throat. NP and RN on sight assessed patient and had her sit in reclining chair with some water. 50 mg of Benadryl were administered orally at 1630. By 1720 patient was feeling better and her husband came to pick her up
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| 44 | 2021-02-21 | headache |
Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report fr...
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Shot 2-Nausea; vomiting; couldn't eat or drink; headache; skin pain; This is a spontaneous report from a contactable other HCP. A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 22Jan2021 18:00 (at the age of 44 years old) at single dose for covid-19 immunisation. Medical history included vestibular problems, allergies Cipro, migraines, concussion, all from an unknown date and unknown if ongoing. Concomitant medication included budesonide (BUDES), levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR), nortriptyline, olopatadine. The patient previously took cipro [ciprofloxacin] and experienced allergies. Patient also had BNT162B2 dose 1 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) lot unknown, on 02Jan2021 at 11:45 AM on left arm. The patient did not have any other vaccines in four weeks. The patient has not had covid-19 prior to vaccination. The patient experienced " Shot 2-Nausea, vomiting, headache, skin pain, couldn't eat or drink" on 23Jan2021 09:00 with outcome of recovering. The events resulted patient in Emergency room/department or urgent care. Patient was also received IV fluids, nausea medication, 2 pain medications for headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Jan2021. Therapeutic measures were taken as a result of the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Nausea, Vomiting, and Eating disorder cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 44 | 2021-02-21 | headache, dizziness |
Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwi...
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Started with nausea and Headache the day of the vaccine shot. The following day I had nausea, throwing up, light-headed, and actually blacked out momentarily. Treatment included: taking Excedrin for Migraines and an anti nausea medication. I slept for most of the day following the shot and the entire night the next day and the next night. All total sleep was probably a total of 25 - 30 hours of a 48 hour period following the vaccine. Still feeling nauseous and having headaches five days after taking the shot.
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| 44 | 2021-02-22 | chills, fever, sweating |
5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever...
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5:30pm 2/22/21 started feeling ache ate dinner: 7:30pm started vomiting with fever of 100: 9pm sever chills with sweats: 9:30pm vomited layed down: 1am woke sweating shivering fever still 100 took a shover started extreme body aches with chest pain: drove myself to Stony Brook ED: labs ran covid swabbed still with all symptoms: chest xray preformed: released at 6am was told to monitor symptoms and if I can not keep anything down like water and or still with chest pain after 24hrs return to ED
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| 44 | 2021-02-22 | weakness, dizziness |
Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; Th...
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Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 44 | 2021-02-22 | dizziness, fatigue |
I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facilit...
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I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facility for 15 minutes and did not have any issues at that time. My arm was a bit sore and I felt tired for a couple days following the 2nd vaccine. On 12 Feb early afternoon (around 1100am), I noticed I was dizzy and feeling a bit nauseated like I had motion sickness. I already had the following week off work, so I napped when I could. I have been tired as well. I have been experiencing waves of dizziness daily now since 12 Feb (today marks the 12th day). I spoke with my PCM's team at the Spokane VAMC and they recommended I try to take Meclizine at night to see if I improve. I was advised to have someone drive me to urgent care if my condition worsens where I lose consciousness, faint, or cannot stand up straight.
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| 44 | 2021-02-22 | fatigue | Sore arm at injection site and fatigue |
| 44 | 2021-02-22 | throat irritation |
patient had itching of hands My symptoms were were primarily mild itching in the palms and throat an...
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patient had itching of hands My symptoms were were primarily mild itching in the palms and throat and a rash on my chest and hands (was wearing a jacket and mask). On an itching scale of 1 to 10, I told them 2 to 3. According to my nurse, the rash on my chest and hands seemed to peak around 15-20 minutes after (not crimson) and when I finally got to go to the bathroom at the one hour mark and check myself in the mirror
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| 44 | 2021-02-23 | fatigue, chills | Chills, Body ache, extreme tiredness. |
| 44 | 2021-02-24 | weakness, fever, headache, chills | Chills, Muscular pain, Fever, Headache, Weakness. |
| 44 | 2021-02-25 | productive cough, dizziness |
I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to ...
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I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support. A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D). The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
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| 44 | 2021-02-28 | discomfort |
Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin...
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Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.
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| 44 | 2021-02-28 | chills, malaise, sweating, headache, fever, fatigue |
injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tyle...
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injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old) at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
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| 44 | 2021-03-02 | sweating, fatigue, dizziness |
Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP...
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Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.
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| 44 | 2021-03-02 | shortness of breath, weakness, fever |
Within minutes, Xavier felt burning sensation but did not report it while she was in the observation...
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Within minutes, Xavier felt burning sensation but did not report it while she was in the observation room because she thought it will go away just like it did with first dose. She then started to have rashes, low grade fever, and felt weak same day, and went on the following day. On 2/21/21 she had generalized swelling and rashes, difficulty breathing and went to the hospital.
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| 44 | 2021-03-04 | dizziness |
Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower l...
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Loss of balance, dizziness, numbing and tingling to left side of tongue, face, gums and left lower lip
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| 44 | 2021-03-09 | weakness, headache |
Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid hea...
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Flushed; over heated; rash/hives on chest; rash/hives on chest; dry mouth; swollen tongue; rapid heart rate; nausea; headache; weakness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies, some environmental allergies, some heart issues specified as SVT, slight asthma, and lung damage. Prior to vaccination, the patient was diagnosed with COVID-19 on 26Dec2020 (also reported as possibly had COVID in Mar2020, however no tests were available; patient was told to quarantine). On 31Dec2020, COVID-19 test showed a positive result. The patient recovered on 09Jan2021, two weeks from onset of symptoms. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. On 21Jan2021 at 16:15, the patient experienced the following adverse events: flushed, over heated, rash/hives on chest, dry mouth, swollen tongue, rapid heart rate, nausea, headache, and weakness. The events resulted to emergency room visit and doctor office visit. The patient received two epi shots, allergy and anti-nausea medications as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.
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| 44 | 2021-03-09 | chills, fatigue |
lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injection...
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lymph node under my left arm, close to my left breast is swollen; it is sore; felt chills; injections site pain; tiredness; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 11:15 (Lot number: EN5318) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included high blood pressure from an unknown and unknown if ongoing. Concomitant medications included lisinopril, amlodipine, metoprolol and levocabastine hydrochloride (Zyrtec). The patient had no allergies to medications, food or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that the lymph node under his left arm, close to his left breast was swollen. The patient also felt chills, injections site pain, and tiredness on 27Jan2021 04:00. The events assessed as non-serious by the reporter. It was unknown if the patient received treatment. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-03-10 | weakness, headache, chills |
Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored ...
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Headache; general weakness, in her legs especially; No energy; No appetite; Diarrhea; Green colored stools; Very faint/thought she was going to pass out; Eyes were watering; blotches on her neck and chest; tingly experience on her tongue and lips; Severely shaking; Overwhelming chills; Extreme nausea; This is a spontaneous report from a contactable consumer (patient). This 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: E19266) via intramuscular at single dose on 20Feb2021 09:30 for COVID-19 immunization. The first dose was on 30Jan2021 in left arm. Medical history included splenectomy from Feb2017; pancreatic surgery from Feb2017, they removed her spleen as part of that; soy allergy; poultry allergy. Patient confirmed she had splenectomy. The surgery was sort of emergency based so knowing most likely they were taking her spleen out; she was given 4 vaccinations. In the hospital, she did break out in what appeared to be like a chicken pox type rash. The rash lasted a month and then it started to fade. She did not have any breathing sort of symptoms. The doctors did attribute the rash to one of the vaccinations, she was not clear on what vaccine caused the reaction. Ideally, she was supposed to have 2 weeks prior to the surgery so her body had time to reabsorb but she did not have that kind of time, but she had nothing internally going on. She confirmed she had no names, NDC, Lot number or expiration dates for the vaccines she received at that point in time. Having the splenectomy was the biggest thing. In the past, she did not have any allergies to medications, but did have allergies to soy and poultry. She did break out from certain food and her skin develops those blotches. She did have an extra work up in Feb2020, where they tested a bunch of food sensitivities and allergies, and nothing came back. This was right before COVID hit so she did not really follow back up after that, but she was tested for all major foods and household things and nothing came up. In her late 20's, she definitely tested for a soy allergy and allergy to poultry. She did check off yes, she had a reaction previously when she was filling out the form at the COVID-19 vaccine site knowing that she had this prior experience. She was held 30 minutes each time for that reason. Concomitant medication was none. Prior vaccinations (within 4 weeks) was no. On 20Feb2021, patient was very faint, thought she was going to pass out, eyes were watering, blotches on her neck and chest, tingly experience on her tongue and lips, severely shaking, overwhelming chills, extreme nausea. On an unspecified date, patient experienced headache, general weakness, in her legs especially, no energy, no appetite, chills that come and go, diarrhea and green colored stools. Patient received her second shot of Pfizer's vaccine on 20Feb2021. She had had symptoms ever since. She had a reaction on site at the vaccine center. She eventually had to go to the Emergency Room by ambulance. Her symptoms were still going on and tomorrow would mark a week since she received the second dose. The symptoms she experienced on site were different than what she was currently experiencing. She felt like she had a true reaction at the vaccine facility site. Within 6 minutes of receiving the second vaccine, she became very faint, her eyes were watering. She thought she was going to pass out for a bit. She was told she had blotches on her neck and chest. She had a tingly experience on her tongue and lips. She was severely shaking and had overwhelming chills. She stated this happened for a couple of hours. Basically, there were 3 waves of these symptoms kind of happening. The third wave happened probably a couple hours after receiving the vaccine. At that point, she had been given two pills of diphenhydramine hydrochloride (BENADRYL), taken orally. With the third wave, she thought she was going to pass out, which she thought multiple times before, but then with this particular wave, she experienced extreme nausea which was kind of a new symptom. The doctor on site said to the EMT that he wanted her to go to the Emergency Room. Patient confirmed she was taken to the ER via ambulance the day she received the vaccine, 20Feb2021. She was never admitted into the hospital; she was only seen in the Emergency Room for a couple of hours. She was given IV fluids, she had blood work done. She didn't have a copy of her labs but she was told they were okay. She was injected with diphenhydramine hydrochloride (BENADRYL) via IV before she was released. A lot more symptoms came after she was released from the hospital (ER). She came home and she had just a crazy headache that she really woke up with every single day until this morning. She had been taking a lot of caffeine/paracetamol (EXCEDRIN, Lot#: H044G, Expiry Date: Jun2022) for her headaches. She experienced extreme weakness, nausea. She clarified she had weakness in her legs. She had this exhaustion, and she felt this general weakness sort of in her legs especially. She was still taking stuff for a headache, and she was taking nausea pills. She had been out of work all week. She had no energy, no appetite really. She had chills that come and go. She had diarrhea. She clarified she had more diarrhea in the beginning days after receiving the vaccine, but it was always been a green colored stool as well. The ER called and checked in and were very surprised she had been having the symptoms still so severely. They wanted her to go get an actual COVID test. She went to the Urgent Care to get COVID tested on 23Feb2021 and had a rapid and PCR test. The rapid test came back negative. She had not received the results for the PCR test yet. She was taking diphenhydramine hydrochloride but she stopped taking that. The hospital directed her stop taking the diphenhydramine hydrochloride earlier in the week. She clarified she was taking a generic version (Lot#: P113966, Expiry Date: Feb2021), coated mini tablets. She clarified the nausea pills she had been taking was the generic for ZOFRAN, ondansetron 4 mg tablet, by mouth, every 8 hours. She confirmed this product was dispensed in a pharmacy bottle with no NDC, Lot number or expiry date on it. She clarified she also had been taking the generic version of TYLENOL EXTRA STRENGTH, it was the Up and Up Brand acetaminophen (Lot#: P122699, Expiry Date: Nov2022) gel caps, 500mg. COVID-19 rapid test was negative on 23Feb2021; COVID-19 PCR test on 23Feb2021 was unknown results. Patient asked if there was a hotline she can call or an information number where she can talk to somebody about her symptoms. She also reported this to her doctor but the doctor made it clear since it was a private practice, they had limited information. The doctor did take down similar information, she just did not know if there was any further information or a hotline she could call. The outcome of events was unknown.
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| 44 | 2021-03-11 | headache, dizziness |
dizziness on the verge of passing out; welts all over midsection from upper legs through hips and on...
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dizziness on the verge of passing out; welts all over midsection from upper legs through hips and onto torso lasting for weeks; Intense headache; dizziness on the verge of passing out; flushed face and ears; This is a spontaneous report from a non-contactable other healthcare professional. This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1283), dose 1, single dose via an intramuscular route of administration in the left arm on 10Feb2021 at 10:30 AM (at the age of 44- years-old) for COVID-19 vaccination. Medical history included complete thyroidectomy with neck dissection (removed lymph) for papillary thyroid cancer with neck dissection (removed lymph) for papillary thyroid cancer- otherwise healthy and penicillin allergy. The patient was tested for COVID-19 on 14Aug2020 by nasal swab and was negative. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 10Feb2021 at 10:30 AM, the patient experienced intense headache within 5 minutes, dizziness on the verge of passing out (waited in the lobby for 1 hour before leaving), flushed face and ears, headache for several days, welts all over midsection from upper legs through hips and onto torso lasting for weeks. The clinical outcome of headache, dizziness on the verge of passing out, flushed face and ears, headache and welts was unknown. No follow-up attempts are possible. No further information is expected.
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| 44 | 2021-03-14 | headache, chills, fever |
Chills; fever; body aches; dull headache; vomiting; This is a spontaneous report from a contactable ...
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Chills; fever; body aches; dull headache; vomiting; This is a spontaneous report from a contactable consumer (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL926lt) via an unspecified route of administration in the left arm on 07Feb2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunization. Medical history included ulcerative colitis from an unknown date and unknown if ongoing. The patient did not have allergies to medications, foods or other products and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications. The patient previously received infliximab (REMICADE) infusions from an unknown date for ulcerative colitis; and received the first dose of BNT162B2 (lot number El3247) in the left arm on 17Jan2021 at 12:00 (at the age of 44-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within the 4 weeks prior to the COVID vaccine. On 08Feb2021 at 00:15 the patient experienced chills, fever, body aches, dull headache, and vomiting. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The events of chills, fever, body aches, dull headache, and vomiting were recovering. It was also reported the patient had not been tested for COVID-19 since vaccination.
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| 44 | 2021-03-14 | fever |
Fever; severe body aches and pain; This is a spontaneous report from a contactable Other Health Prof...
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Fever; severe body aches and pain; This is a spontaneous report from a contactable Other Health Professional (patient herself). A 44-years-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: Unknown) via an unspecified route of administration from 29Jan2021 10:00 (at the age of 44-years-old) at single dose for covid-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included lurasidone hydrochloride (LATUDA), lisinopril and metoprolol. The patient experienced fever and severe body aches and pain on 30Jan2021 at 12:00 AM. No treatment was received for the adverse events. The outcome of the events was reported as recovered. The events were assessed non-serious. Information on the lot/batch number has been requested.
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| 44 | 2021-03-14 | fever, shortness of breath, headache, pneumonia |
I thought was a sinus infection exp wheezing, headache, achiness. By week two went to ER got tested ...
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I thought was a sinus infection exp wheezing, headache, achiness. By week two went to ER got tested diagnosed with pneumonia was prescribed two inhalers. On week three started running fever even after two antibiotics.Im recovering still exp shortness of breath at times.
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| 44 | 2021-03-14 | headache, fever, fatigue |
fatigue; headache; body aches; fever; This is a spontaneous report from a contactable consumer (pati...
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fatigue; headache; body aches; fever; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: unknown), via an unspecified route of administration on 10Feb2021 08:15 (at age of 44-year-old) at single dose in left arm for COVID-19 immunisation. Medical history includes diabetes mellitus. There was no known allergies. No other vaccine was received in four weeks. Concomitant medication included empagliflozin (JARDIANCE), metformin for diabetes, semaglutide (OZEMPIC), atorvastatin (LIPITOR), sertraline. The patient experienced fatigue, headache, body aches, and fever on 10Feb2021 14:00. No treatment was received for the events. There was no COVID prior vaccination or no COVID tested post vaccination. The events did not result in emergency room visit or physician office visit. The outcome of events was resolving. Information on the lot/batch number has been requested.
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| 44 | 2021-03-15 | chills, headache |
lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel ...
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lymph nodes under arm pits feel like golf balls was reported as worsened/lymph nodes under arm feel like golf balls was reported as worsened; lymph nodes under her arm pits and under her arm feel like golf balls/lymph nodes in neck swollen; Fever is 99.6 this morning; hurt all over from her toes to her fingers and from her fingers to her toes; lack of sleep; Headache; Chills; feels like wires are squeezing and pressing her/Feels awful; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 13:00 at single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia Diagnosed with it 5-6 years ago, ongoing chronic lymphocytic leukaemia Diagnosed almost a year ago. The patients concomitant medications were not reported. The patient experienced, lack of sleep on 05Feb2021 21:00. It was reported that she got the vaccine more than 48 hours ago. Stated that she feels awful on 05Feb2021 10:00. Stated that she has a fever on 06Feb2021, chills and headache on 05Feb2021 19:00, hurt all over from her toes to her fingers and from her fingers to her toes on 05Feb2021 22:00. Stated that she is in a lot of pain and that it feels like wires are squeezing and pressing her on 05Feb2021. Stated that it is horrible. Stated that the lymph nodes under her arm pits and neck feel like golf ball under arm and arm pit on 06Feb2021 12:00. Stated today the doctor will see her because it will have been 3 days in a few hours. Clarified that this is for the Covid vaccine. Stated that she is working in a retirement place with an older person. Stated that they decided to give to it to her. Stated that she asked her doctor and he told her that it was okay. Later clarified that the lymph nodes in her neck are just swollen and the lymph nodes under her arm pits and under her arm feel like golf balls. Stated that her fever is 99.6 this morning (06Feb2021). Stated that it improved when she took three Advil (600mg). Stated that she feels like wires are squeezing and pressing her again when the Advil wears off. Was told to alternate with Tylenol and is taking a lot of liquids. Clarified that she thought that the pain was fibromyalgia but that it felt worst than fibromyalgia. Stated that the lack of sleep improved because she takes a higher dosage of Advil or Ibuprofen for sleep. Outcome of the event fever is 99.6 this morning, hurt all over from her toes to her fingers and from her fingers to her toes, feels awful, lack of sleep recovering. Outcome of the event lymph nodes under arm feel like golf balls was reported as worsened (Condition worsened) was unknown. Outcome of the other events was not recovered. Information on the lot/batch number has been requested.
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| 44 | 2021-03-17 | dizziness |
Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to am...
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Patient stated that she almost immediately felt nausea after the injection appx 3:15, was able to ambulate to observation on her own and then signaled staff for help, felt hot, felt dizzy, felt nausea, staff immediately assisted to chair, RN @ side; inquired re food; had lunch; sips of beverage w sugar given able to eat cracker. She stated she felt better, was upright in her chair, no SOB, no complaints of swelling throat, itchy etc. After some initial sips of liquid, still feeling dizzy lowered to floor by staff w wedge cushion and legs and feet elevated above heart per protocol b/p 140/96 pulse 86. Stated she had been anxious re injection, but denied ever having this experience after injection. Additional information for Item 18: Reviewed the POD form questions again with her, denied any issues. She then stated she was feeling much better again, her warm feelings were going away from ice in a glove that we had used from her initial dizzy, warm/hot feeling. Around 3:30 she felt nausea again, so we sat her up and gave her a bucket to use to vomit if needed. She was unable to vomit. She wanted to sit up on floor. We sat with her and she sipped on clear beverage. She began to get cold. We put her legs back up took b/p 140/91 pulse 86. No change. We called nursing DON for District to make her aware and by that time patient experiencing chills. We called her husband to be on his way to drive her home after 30 minutes @ 3:45. She continued to tell us she felt better for a few minutes only to then tell us she was feeling nausea again. Rolled her to left side, helped her to prop us to vomit but she was unable to vomit anything. B/p readings 147/91, 150/90, 140/87,150/88She desired to sit upright again. So on floor with nurse holding and b/p cuff on sat her up to try to vomit, unable to do so. Lowered back to floor with legs upright where she remained local Paramedic on site and he came to assist, a portable recliner that allowed for legs to be elevated above heart was set up. Patient felt that she could transfer with paramedic and staff help and passed out while attempting briefly, chilling when she was alert, then passing out again; 911 was called and arrived by 3:55, patient and husband initially wanted to take patient home after hearing patient state she felt better once paramedics had evaluated her. However in front of husband, patient again passed out, and after she was conscious stated she could not feel her arms. and when he observed this he agreed it was best for her to be evaluated and then was transported to ER. Per phone conversation this morning, at 10:41 husband stating that patient still not able to stand without passing out on her own and they were continuing to evaluate her. No additional medication given on site at Mass vaccine site.
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| 44 | 2021-03-22 | fatigue, dizziness, headache |
I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea...
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I have Epstein barre and it feels like it has been reactivated.; waves of dizziness; fatigue; nausea; diarrhea; headache; I have been having vivid nightmares during this time as well; metallic taste; This is a spontaneous report from a contactable consumer (patient). The 44-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 24Feb2021 09:45 AM (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history included Chronic fatigue syndrome, Epstein barre. The patient was not pregnant. No other vaccine in four week. No covid prior vaccination. The patient did receive other medications in two weeks. The patient experienced i have epstein barre and it feels like it has been reactivated, waves of dizziness, fatigue, nausea, diarrhea, headache, i have been having vivid nightmares during this time as well, metallic taste on 24Feb2021 14:00. Reported as: I have Epstein barre and it feels like it has been reactivated. I have waves of dizziness , fatigue, nausea, diarrhea, headache and metallic taste. I have been having vivid nightmares during this time as well. I developed a metallic taste in my mouth. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care.The patient had covid tested post vaccination via Nasal Swab on 03Mar2021 and was negative. It's unknown if the patient received treatment. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.
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| 45 | 2020-12-31 | headache |
12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 d...
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12/28 Urgent Care HPI - patient is a 45 year old who works for facility. she got a covid vaccine 8 days ago. The site on her left deltoid where she got the shot is warm and read. It also itches. No pain into the rest of left arm. no numbness of tingling at site or distally. no trouble breathing or tingling around mouth/throat. 01/01 - EE notes that her arm was very sore and she had a bad headache. As the days went on, it got redder, hotter, and more swollen. On 12/20, she began to feel bad. On 12/28 while at work, she heard that her supervisor was COVID (+). Throughout the day she felt worse and worse. Was seen at urgent care and COVID was negative. Prescribed Cephalxin and predinose 01/01 -- arm is much better today. Today it is still bruised. She thinks it was bruised previously but that the bruise could not be seen under the redness and swelling
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| 45 | 2020-12-31 | throat swelling |
Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a...
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Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.
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| 45 | 2021-01-02 | fatigue, cold sweat |
After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pul...
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After the shot I sat down and waited for 15 minutes and about 12 minutes a felt flushed and my pulse went night around 119 beats per minute and my blood pressure went high to 150 over 99 .. my sugar jumped to 149 and I got so clammy .. it lasted a good 25 minutes I kept checking my o2 and my pulse finally it went down and I was so tired.. I went home and I was fatigue for 5 days .. I don?t know if I should get the second dose after my heart raced
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| 45 | 2021-01-02 | malaise, headache, weakness, dizziness | Dizziness and Weakness, Headache, Aches, Cold feeling, Nausea, generally feeling unwell. |
| 45 | 2021-01-02 | fatigue, headache |
Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable...
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Severe vertigo began at 3:00 PM on 12/31/2020. Vomiting lasting approx. 9 hours (8 episodes). Unable to open eyes due to vertigo, vasovagal upon standing lasting until approx. 3:00 pm 1/2/2021. Diarrhea began approx. 8:00 pm 1/1/2021 with episodes each time after trying to eat 4 episodes. Headache lasted 3 days. Today on 1/3/2021 I have been able to keep down soup. Eyes feel tired, minimal vertigo upon moving head. No further diarrhea, vomiting.
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| 45 | 2021-01-03 | headache, malaise | 24hr extreme malaise (charley horse left calf) left arm pain 24hr temporal headache 24hr |
| 45 | 2021-01-03 | weakness, fatigue |
After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm a...
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After leaving 15 minute post vaccine period, employee felt pins and needles developing on left arm and leg for 20 minutes but neck and face numbness continued 12/25-12/27. Continued with facial numbness on 12/26. Called Occupational Health on 12/28 and stated that she had thigh numbness, no other Covid symptoms. Sent for testing and was negative. On follow up on 12/29, had fatigue, diarrhea and weakness, and on 1/1 still had thigh numbness and extreme fatigue, no diarrhea. By 1/3/21, had fingertip numbness on left hand, pain on her left arm and chest pressure and burning. Went to ER on 1/3 where she had a full workup for myelitis, MRI, C spine, T spine and brain, CBC, CMP, ESR. Treated with toradol and prednisone in ER and discharged. Currently on 1/4 improved muscle weakness but ongoing fatigue taking four day course of prednisone to follow up with PCP. A second dose of the vaccine scheduled on 1/11/21 will be on hold until PCP clearance. Current diagnosis decompensation of raynauds disease due to vaccine reaction.
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| 45 | 2021-01-03 | somnolence, head discomfort, headache |
Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headach...
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Around 6pm I started with a slight headache and by 8pm i had trouble keeping my eyes open. (headache is not uncommon for me but the extreme drowsiness is). I slept solid through the night (unusual) and the puppy woke me around 5am. (ususal) I felt that i had a heavy? head. My thoughts seemed clear but my head had a fullness to it. Its difficult to describe. I was not stuffy. I had trouble staying awake, to the point I was nodding off at times I should have been able to stay awake. I did not feel safe to work and felt obligated to call in. I slept solidly for the next 5 hours. Later in the day, my affected arm began to have pain radiate from the injection site to my wrist. (probably not unusual). 600mg of Ibuprofen did not seem to help much. By the time I went to bed last night (24+ hrs after receiving the vaccine) I noticed my axillary nymph nodes were extremely tender to the touch and remain so this morning. The pain in my arm still continues to radiate to my wrist but not as intense.
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| 45 | 2021-01-03 | shortness of breath |
High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is...
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High blood pressure 187/95; Heart rate at one time 210 bpm; chest pain; Shortness of breath; This is a spontaneous report from a contactable pharmacist (patient) reported for herself that a 45-years-old female patient received first dose of BNT162B2 (lot number: EH9899), via intramuscular in left arm on 22Dec2020 07:00 AM at single dose for COVID-19 immunization. The patient was not pregnant. No known allergies. No allergies to medications, food, or other products. No other vaccine was received within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination and patient was not tested for COVID-19 since the vaccination. There were no medical history or concomitant medications. The patient experienced high blood pressure 187/95, heart rate at one time 210 bpm, shortness of breath and chest pain on 23Dec2020 10:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for heart rate at one time 210 bpm which included lab works and medication given propranolol to decrease heart rate. The outcome of the event was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events hypertension, heart rate increased, chest pain and dyspnoea cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-01-03 | fatigue | Patient developed fatigue approximately 24 hours after immunization that lasted a couple days. |
| 45 | 2021-01-03 | headache | itching both thighs, mild h/a, sinus pressure |
| 45 | 2021-01-04 | fever | Fevers myalgias arthralgias |
| 45 | 2021-01-04 | skin warm |
Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the tou...
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Notice yesterday, a large round red circle about 2 inches across, raised and swollen, hot to the touch, soreness and tender.
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| 45 | 2021-01-04 | dizziness |
Onset dizziness when turning to the left or going from laying to sitting / standing. Does not occur...
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Onset dizziness when turning to the left or going from laying to sitting / standing. Does not occur sitting to standing; Onset dizziness when turning to the left or going from laying to sitting / standing. Does not occur sitting to standing; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left arm on 26Dec2020 10:00 at SINGLE DOSE as COVID-19 immunization at the hospital. Medical history included psoriasis. Concomitant medications included adalimumab (HUMIRA) and famotidine (FAMOTIDINE). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 17:00, the patient experienced onset dizziness when turning to the left or going from laying to sitting / standing but does not occur sitting to standing. The patient did not receive any treatment for the events. Outcome of the events were not recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-01-04 | shortness of breath | Severe dyspnea, wheezing, heart rate greater than 130 |
| 45 | 2021-01-04 | dizziness |
dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainde...
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dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 45 | 2021-01-05 | cough, fatigue, headache | Coughing, abdominal pain, nausea, vomiting, diarrhea, headache, fatigue |
| 45 | 2021-01-05 | throat irritation, headache, throat pain |
Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), ...
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Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly." Patient also had chest tightness, sore-throat/neck muscles. Patient was given Epi, benadryl IV, decadron IV, and bolus fluid. She was monitored for 4 hours and discharged once stable.
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| 45 | 2021-01-05 | dizziness, throat irritation |
Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No...
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Received Pfizer Covid vaccine at 11:30 am and after 5 min , she experienced dry and itchy throat. No change in voice, no wheezing , able to drink and swallow water without difficulty. Vital signs and O2 saturation /oximetry were normal. After 30 min into observation, she c/o lightheartedness and both eyes were puffy. Vitals: BP 129/75, hr 91, O2 sat 99% at room air . Benadryl 50 mg IM given and client was taken to the Emergency room..
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| 45 | 2021-01-05 | fever, dizziness |
[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative br...
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[1] Lightheadedness: started 1 minute after vaccine, lasted 1-2 minutes. Relieved with meditative breathing; believed it to be anxiety related until seeing CDC produced list of symptoms from vaccine. [2] Mild soreness, mild redness at injection site: started 4 hours after vaccine, lasted 24-36 hours. [3] Felt feverish and flushed, arthralgia: started approximately 18 hours after vaccine (12/31/2020). "Fever" initially managed with Tylenol 650 mg. Later that evening took naproxen 440 mg to address arthralgia, which lasted about 2 days. No medication taken on 1/1/2021.
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| 45 | 2021-01-05 | fatigue | diarrhea, fatigue |
| 45 | 2021-01-05 | dizziness, headache |
next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms star...
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next day with headache, nausea, dizziness, tachycardia up to 170 for about 30 minutes. symptoms started the morning after the vaccine about 24 hours later and then resolved within that next day.
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| 45 | 2021-01-06 | dizziness |
12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartb...
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12/31/2020: Around 2pm, feeling dizzy and rapid heartbeat. 3:30pm, rapid heartbeat. 6pm rapid heartbeat 01/01/2021: 6am, rapid heartbeat. 8pm, rapid heartbeat 01/02/2021: 8am, rapid heartbeat. 2pm, rapid heartbeat 01/03/2021: 1:30pm, rapid heartbeat lasted until around 3pm. 01/04/2021: 7am, rapid heartbeat. around 8pm, rapid heartbeat. 01/05/2021: 10am rapid heartbeat The first two days I experienced the rapid heartbeat, I almost had an anxiety attack but I learned to breath through my nose and I would be okay after that. Today is January 7 and i haven't experienced anything in the last two days.
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| 45 | 2021-01-06 | headache, chills |
At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my...
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At approximately 8 hours post vaccine I began to have Sudden onset bilateral joint pain mostly in my elbows but knees and hips as well. Then my neck started really hurting. I got a headache. Nausea and powerful chills that made my whole body violently shake. My core temperature Dropped to below 96, high 95s. Over a period of two hours I have stabilized my body temperature, the shaking has stopped. However the headache and muscle aches persist. No respiratory symptoms have developed. I feel as if I am recovering, over a period of about four hours.
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| 45 | 2021-01-06 | headache, fever |
Burning sensation. Started in left side of neck went to left shoulder then spread out all over body...
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Burning sensation. Started in left side of neck went to left shoulder then spread out all over body. Headache and fever
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| 45 | 2021-01-06 | cold sweat, shortness of breath |
CLAMMY SKIN , LABORED BREATHING , DRY COUGH, TREATED WITH BENADRLT . SENT TO ER, PLACED ON DECADRON...
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CLAMMY SKIN , LABORED BREATHING , DRY COUGH, TREATED WITH BENADRLT . SENT TO ER, PLACED ON DECADRON.
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| 45 | 2021-01-06 | headache, chills, fever | DIffues hives over chest, abdomen, back, arm |
| 45 | 2021-01-06 | dizziness | Dizziness Little wave of dizziness 100/62 HR62 O2 99%, 100/67 HR 73 Narrative: |
| 45 | 2021-01-06 | fever | Fever and body aches, feels poorly. Stayed home from work |
| 45 | 2021-01-06 | headache | Headache within hour of receiving vaccine, patient took Tylenol |
| 45 | 2021-01-06 | headache | Headache, Myalgia & Angina |
| 45 | 2021-01-06 | fatigue, chills, fever, throat pain, cough |
I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. ...
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I had some aches and pains. I was tired the next morning. I started having chills and became dizzy. My hands started to tingle and remained that way for three days. I developed a cough, sore throat, and fever. The fatigue was really bad for a few days.
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| 45 | 2021-01-06 | malaise |
Immediately after receiving the dose employee didn't feel well. She was monitored (in her vaccinatio...
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Immediately after receiving the dose employee didn't feel well. She was monitored (in her vaccination seat) with a pulse oximeter and heart rate which read 70% and 30 BPM. The vaccination clinic employees administered 1dose of epi and called a rapid response. The rapid response team arrived within 2 minutes and she was brought to the ED
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| 45 | 2021-01-06 | fever, malaise | Low-grade fever, myalgia, general malaise |
| 45 | 2021-01-06 | throat irritation |
Patient complained of having an itchy throat. Patient seen by Resident and examined. Vital signs sta...
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Patient complained of having an itchy throat. Patient seen by Resident and examined. Vital signs stable. Patient given Benadryl for itchy throat.
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| 45 | 2021-01-06 | fever |
Patient presented to clinic stating that she had started to run a fever as high as 102 and pain to l...
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Patient presented to clinic stating that she had started to run a fever as high as 102 and pain to lymph nodes under left axilla and neck
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| 45 | 2021-01-06 | chills | SkinRash chills Narrative: macular rash over the trunk anterior chest, abdomen, back and both arms |
| 45 | 2021-01-06 | nerve pain |
Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but ...
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Soon after the vaccination she began having arm pain that lasted for 3 days. That has resolved, but now she is having nerve pain in her right thumb.
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| 45 | 2021-01-06 | dizziness |
When patient initially received the vaccination, she complained of mild dizziness. She went home aft...
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When patient initially received the vaccination, she complained of mild dizziness. She went home after monitoring and returned to work the PM shift rested. Approximately 45 minutes into the shift, she c/o dizziness. She had elevated BP 209/102 and HR 108 and at one point had a syncopal episode. Emergency services was called and she was transferred to the hospital for further evaluation.
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| 45 | 2021-01-06 | headache, night sweats |
Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and ti...
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Woke up in night sweats, nausea, severe headache with neck and back pain. right shoulder pain and tingling right hand.
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| 45 | 2021-01-06 | dizziness, weakness | around 1500 Vomited x 1; HTN 190's/ 116-118; flush cheeks bilaterally; dizzy; weak; |
| 45 | 2021-01-06 | fatigue, throat irritation |
felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue;...
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felt flushed; itch and felt tightness in her throat; itch and felt tightness in her throat; fatigue; arms and legs feel heavy; This is a spontaneous report from a contactable nurse (patient herself). A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: Ek5730, expiration date: unknown), via an unspecified route of administration on the left arm on 30Dec2020 at 08:00 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included Hashimotos, Celiac, nonalcoholic fatty liver, and known allergies to gluten, eggs whites and eggs yolks, mustard seed, and penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), thyroid (NATURE THROID), and an unspecified women's multivitamin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Dec2020 at 08:15, also reported as within 10 minutes, the patient felt flushed and at 20 minutes, she started to itch and felt tightness in her throat. The patient left after 30 minutes to go home and take diphenhydramine (BENADRYL). The patient worked at night and slept most of the day except to take BENADRYL and call out from work. Also on 30Dec2020, she noticed fatigue when she woke in the afternoon and her arms and legs felt heavy. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of itch and felt tightness in her throat. She had been on BENADRYL 50 mg every 4-6 hours. The itching and throat tightness remained unchanged. She had used an albuterol inhaler 3 times. The patient did not receive treatment for the other events. The patient was not recovered from the events "felt flushed, itch and felt tightness in her throat, fatigue, and arms and legs feel heavy."
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| 45 | 2021-01-07 | dizziness |
06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizz...
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06 Jan 2021 @0810: Patient transported to ED following near syncopal episode at desk. Reported dizziness/lightheaded, intermittent nausea, and heart beating hard. Patient received vaccine at 0645 hours. Provided IV fluids.
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| 45 | 2021-01-07 | headache, discomfort |
After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by ...
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After receiving the vaccine, pt noted a sensation of pressure on the roof of her mouth, followed by a metallic taste. Elevated BP noted. Pt denies SOB and is without rash or angioedema. Pt brough to emergency dept where she reported feeling flushed, nausea, and headache. Given Zofran 4mg ODT and Tylenol 650 mg po. Pt d/c after 2 hours and advised to f/u w/ PCP as needed.
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| 45 | 2021-01-07 | fever, chills, headache | Chills, fever 101.2 (oral), headache, nausea, vomiting, body aches. |
| 45 | 2021-01-07 | chills, headache, fever | Chills, fever, body aches, joint pain, painful lymph nodes in armpit, headache, nausea |
| 45 | 2021-01-07 | headache |
Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse ...
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Diarrhea; Headache; Arm soreness; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 3rd of 6 reports. A 45-year-old female patient received a single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) on 29Dec2020 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After vaccination, on 29Dec2020, the patient had arm soreness and it lasted a few hours. The patient took Tylenol and was fine. She also developed diarrhea and headache, and her symptoms hit her all of a sudden late afternoon on 04Jan2021. No treatment was received. She woke up in the morning of 05Jan2021 and it was all gone. She had a COVID test on 05Jan2021 and it was negative. The patient recovered from the arm soreness on 29Dec2020 and recovered from diarrhea and vomiting on 05Jan2021. The events were considered related to the vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
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| 45 | 2021-01-07 | chills, dizziness, fatigue, fever, headache |
Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, woo...
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Fatigue, fever 100.7, moderate headache, chills, muscle ache, joint pain, restlessness, fatigue, wooziness, mild nausea, mild abdominal pain. No asthma symptoms.
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| 45 | 2021-01-07 | fever, chills, headache, fatigue | Fever 102.5 x 24 hours at this time. Chills, body aches, headache and fatigue. Some chest discomfort |
| 45 | 2021-01-07 | fever, chills | Fever, Chills and generalized body aches . |
| 45 | 2021-01-07 | chills, discomfort, headache, fever | Fever, Headache, Shaking Chills, Discomfort in the body. I am taking Panadol every four hours. |
| 45 | 2021-01-07 | chills, fever | Fever, chills, muscle and joint pain |
| 45 | 2021-01-07 | headache | Headache, Diarrhea with cramping |
| 45 | 2021-01-07 | headache, lethargy |
Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: V...
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Headache, Myalgia, NauseaVomiting, lethargy; injection site soreness, loss of appetite Narrative: Vaccine 12/17 @6:00 pm. On 12/18/2020 - woke up with a headache and "tight" muscles. Progressively that day she felt lethargic. She also had soreness in her arm at the site of the vaccine. Within 24 hours she developed nausea and lost her appetite. She took alleve and went back to sleep. 12/20 - slept all day. 12/21 - woke up feeling much better with a mild headache. 12/22 felt back to normal.
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| 45 | 2021-01-07 | chills, throat pain |
Her period came one week earlier than planned. It's was more painful and heavier.; Her period came o...
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Her period came one week earlier than planned. It's was more painful and heavier.; Her period came one week earlier than planned. It's was more painful and heavier.; Her period came one week earlier than planned. It's was more painful and heavier.; Chills; Sore throat; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included ongoing chronic migraines. Concomitant medications included ascorbic acid (VIT C), and ergocalciferol (VIT D). On 21Dec2020, the patient received the vaccine. After 48 hours (23Dec2020), she had chills, and a sore throat but no fever. It was mentioned that the chills and sore throat just lasted for one day. On 03Jan2021, the patient mentioned that her period came one week earlier than planned. It's was more painful and heavier. She mentioned that she always had a difficult period, but this this one seems more intensified (10 times) and was very painful. It was mentioned that the patient was getting the second one next week. The patient recovered from chills and sore throat on 24Dec2020 while not recovered for the remaining events
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| 45 | 2021-01-07 | cold sweat |
I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitati...
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I started having flushing within a minute of receiving vaccine next I noticed I had heart palpitations I was told my skin was clammy then I had another episode I was taken to ER and decardron was given. I was observed in ER for few hours . Since that day I have heart palpitations every day along with chest pain sometimes I am not able to wean off steroids I also had diarrhea on 1/3 that lasted few days . These side effects are very scary every day heart palpitations I feel my heart would stop
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| 45 | 2021-01-07 | headache |
Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVI...
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Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/7/2021  Date: 1/7/2021  Subjective Patient is a 45 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.  She denied any history of previous adverse reactions to vaccines.  She was given the Pfizer vaccination in the left deltoid muscle.  During her 15 minute waiting period after the injection, the patient began to experience throat tightness and sinus drainage. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.  This provider was notified of patient reaction and she was then assessed in the emergency bay area.  Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting. Pt took allegra this am for allergies.  ALLERGY REVIEW OF SYSTEMS: All other systems negative   Previous Reactions: She states with first shot a few hours after her shot she had a rash on her mid back. and and lower extremities. Pt also had a head ache. Symptoms lasted 5 days.   Objective  Vitals Vitals:  01/07/21 1248 01/07/21 1303 01/07/21 1321 01/07/21 1334 BP: (!) 150/87 130/71 137/87 123/73 Pulse: 94 86 75 76 SpO2: 97% 99% 98% 99%     Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. She is well-developed. HENT: Head: Normocephalic. Jaw: There is normal jaw occlusion. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: Rash (on chest) present. Rash is macular. Comments: Flushing over the cheeks and bridge of the nose. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal.    Assessment/Plan Treatment included: antihistamines. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.Pt told if symptoms worsen or changed she is to be seen in the ER.  Diphenhydramine 25 mg oral given at 12:55pm.  Pt okay to go home with dad driving at 14:22 pm.   Electronically Signed 1/7/2021 2:03 PM   Â
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| 45 | 2021-01-07 | sweating |
PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ...
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PT HAD A VASOVAGAL SYNCOPE EPISODE: ( SWEATING, NAUSEA, AND BLOOD PRESSURE DROPPING). PT WAS LAYED ON THE FLOOR IN A SUSPINE POSITIION WITH FEET ELEVATED. PT WAS PLACED ON A BLOOD PRESSURE MONITORING MACHINE. COLD COMPRESSIONS WERE APPLIED TO THE PATIENT'S BODY. PT WAS GIVEN A FEW CRACKERS AND SODA TO INCREASE BLOOD SUGAR. WITHIN MINUTES THE PT BLOOD PRESSURE BEGAN TO RISE AND PT FELT FINE. PT WANTED TO DRIVE HOME AND WAS ADVISED NOT TO DRIVE. PT CALLED FOR HER PARENTS TO COME AND PICK HER UP.
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| 45 | 2021-01-07 | dizziness, sweating |
Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started...
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Patient was at work and felt nauseous at around 0800 and took a Zofran. Then around 1030 she started to have lower chest (near the lower ribs) pain 9/10 pain and she was diaphoretic. We called 911 as we were concerned about an MI. She was transported via EMS to the hospital. They ran various tests and determined it wasn't cardiac or lung issues and was likely side effects from the COVID vaccine. On 1/8/21, Patient reports that she feels dizzy and is "itching all over." She took antihistamine and that helped the itching symptom.
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| 45 | 2021-01-07 | chills, body temperature increased | chills in evening after vaccination, chills next day in AM then nausea and body aches, temp 102. |
| 45 | 2021-01-07 | dizziness, respiratory tract congestion, cough, fatigue |
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness neg...
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dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness negative Covid test
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| 45 | 2021-01-07 | dizziness, cough, nasal congestion, fatigue |
dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y n...
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dizziness, congestion, cough, heart rate elevated, fatigue, injection site pain, chest heaviness y negative Covid test
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| 45 | 2021-01-07 | chills, malaise, headache | headache, chills, body aches and generalized unwell feeling |
| 45 | 2021-01-07 | fatigue, shortness of breath, dizziness |
typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting...
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typical flu body aches; also had terrible fatigue. I couldn't do normal activity; my arm was getting so sore I couldn't lift it; Within a few hrs I lost the ability to move it at all for a few hrs; overwhelmed with fatigue; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; Every bone hurt and my ribs were so sore I couldn't take deep breaths; nauseous; dizzy; No fever but I felt hot & flushed.; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: Ek9231), via an unspecified route of administration on the right arm on 31Dec2020 09:00 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included lupus.The patient also had allergies to penicillin (PCN). It was also mentioned that the patient COVID twice (Mar2020 until 2020&Nov2020 until 2020). Concomitant medications included lisdexamfetamine mesilate (VYVANSE) and bupropion hydrochloride (WELLBUTRIN). It was reported that the patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient reported that she had a very slight reaction after administration & took diphenhydramine (BENADRYL). She described that approximately at the 11-hour mark (31Dec2020 20:00), her arm was getting so sore and she couldn't lift it. Within a few hours, she lost the ability to move it at all. Also, she was getting overwhelmed with fatigue & she had a feeling that can best be described as the feeling of death entering my bones. Every bone hurt and her ribs were so sore she couldn't take deep breaths. The patient would wake up crying in pain & her pain tolerance was very high. She felt nauseous & dizzy and was the worst night of her life. She took acetaminophen (APAP) 1000mg & meloxicam 15mg that night with no relief. She narrated that she had COVID twice (Mar & Nov) & that night that she experienced; she would rather have COVID 1000 more times than ever have this pain she was in. It was also mentioned that she had no fever, but she felt hot & flushed. At the 23hour mark (01Jan2020 20:00), her symptoms became typical flu body aches which was 100% manageable & was a relief after what she had. It was mentioned that she still had terrible fatigue and couldn't do normal activity (in Jan2021). The patient was not sure if she will take the 2nd shot after this. Outcome of the event of fatigue was not recovered; unknown for "couldn't do normal activity" and recovering for the remaining events.
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| 45 | 2021-01-08 | chills, fever | Diffuse muscle aches Nausea Fever/chills |
| 45 | 2021-01-08 | headache, night sweats, dizziness, chills, body temperature increased |
Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hour...
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Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol
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| 45 | 2021-01-08 | headache, fatigue, fever | Fever, body aches, headaches, tiredness |
| 45 | 2021-01-08 | headache, fever | Headache, Fever & NauseaVomiting |
| 45 | 2021-01-08 | headache |
No major side effects but I have had a headache that is persistent for a couple days. I have taken t...
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No major side effects but I have had a headache that is persistent for a couple days. I have taken tylenol which helps but the headache has been very persistent. It is still on and off on day 3 but getting better.
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| 45 | 2021-01-08 | headache, chills | Severe headache, Chills Gastro intestinal side effects. |
| 45 | 2021-01-08 | body temperature increased |
Sore Arm where injection was given, Temp of 100.2, Hiccups for 2 hours on the morning of 01/09/2021 ...
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Sore Arm where injection was given, Temp of 100.2, Hiccups for 2 hours on the morning of 01/09/2021 (hiccups are not something that I normally get, if I do I only hiccup 3-4 times on average
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| 45 | 2021-01-08 | headache |
Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headach...
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Sore arm and low-grade headache for 3-4 days. Day 1, approx 4 hours after Pfizer dose 1, got headache. Took Aleve, headache gone. Day 2 at 1am, woke up with pretty bad arm pain ("why does my arm hurt so bad? Have I lifted too much weight at the gym?") and headache Did nothing; went back to sleep. Day 3, took Aleve again in the evening; headache gone. Day 4, mild headache. Day 5 and on, feeling fine. On Jan 5, for 4 days straight, I fell asleep at 6 and 7 pm. Normally I go to bed at 9am ( I get up at 4am). Felt fine enough to work, just tired at night more than usual. My 2nd dose is scheduled Jan 15 at noon.
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| 45 | 2021-01-08 | nasal congestion, headache, chills, throat pain |
Swollen tender lymphnodes l. Supraclavicular, L. Axillary, L. Cervical 1 day after 2nd vaccine. H...
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Swollen tender lymphnodes l. Supraclavicular, L. Axillary, L. Cervical 1 day after 2nd vaccine. Headache, chills, sore thrat, nasal congestion started mostly day after, headache day of both tbe first and second vaccine
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| 45 | 2021-01-09 | chills, fatigue, fever, influenza like illness, headache |
18 hours after injection developed maculopapular rash at injection site, muscle pain at sight of inj...
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18 hours after injection developed maculopapular rash at injection site, muscle pain at sight of injection and neck. Subsequently developed flu-like symptoms: headache, fever(101F), chills, myalgias, arthaligias, fatigue that continued daily for several weeks.
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| 45 | 2021-01-09 | fever, chills | Chills Fever 103 NauseA Joint pain |
| 45 | 2021-01-09 | chills, fatigue, fever, headache |
Diarrhea started about 6:30 pm followed by body aches. Within 2 hours I had chills. About 3 am I ha...
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Diarrhea started about 6:30 pm followed by body aches. Within 2 hours I had chills. About 3 am I had a fever of 99.9 degrees F ( normally 97.2 for me). The next day I had a headache and felt fatigue. I had diarhea 3 more times. My spine ached a little when I went to bed about 11pm. No side effects by 1/10/21
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| 45 | 2021-01-09 | headache, fatigue, chills |
Woke up with chills and whole body aches almost 12 hrs. After injection. Chills lasted around 3 hrs....
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Woke up with chills and whole body aches almost 12 hrs. After injection. Chills lasted around 3 hrs. I then had extreme fatigue, nausea and headache for another 10hrs.
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| 45 | 2021-01-09 | dizziness |
on day of injection approx 13 mins after injection RN was called to her car. She reported throat tig...
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on day of injection approx 13 mins after injection RN was called to her car. She reported throat tightness, and dizziness 911 was called and pt was monitored until symptoms improved. Was not transported to ED. 2 days later developed a hive like rash and was seen at walk in clinic was treated with prednisone.
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| 45 | 2021-01-09 | fatigue, headache | slight headache fatigue sore arm |
| 45 | 2021-01-10 | chills, sweating |
45 y.o. female with a hx with asthma, migraine, here for second dose vaccine. C/O feeling shivering,...
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45 y.o. female with a hx with asthma, migraine, here for second dose vaccine. C/O feeling shivering, sweaty, and racing heart beats. Similar feelings with the first dose but much more mild. HR reports up to 120s. Check BP 144/109 HR 110 RR 18 --- > BP 135/91, HR 99-100 on discharge at 12:20 pm. Patient rests comfortably and feels a lot better. She has no respiratory complain or cardiac complain on discharge. Walks away without apparent distress. Symptoms resolved
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| 45 | 2021-01-10 | fever, throat pain, fatigue, headache, chills | About 12 hours after 2nd vaccine high fever >104, chills, headaches, sore throat, fatigue |
| 45 | 2021-01-10 | shortness of breath |
Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, di...
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Approximately 5 minutes after vaccination, patient began reporting flushing, shortness of breath, difficulty swallowing. Presented with elevated BP, pulse, normal O2. Symptoms came in waves with increasing frequency. Nausea also occurred as symptoms continued. Patient was monitored for ~15 minutes before Epi Pen (.03mg) was administered. Patient was transported to hospital by ambulance.
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| 45 | 2021-01-10 | headache |
BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal ...
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BELLS PALSY January 3, 2021- Slight numbness in tongue and food tasted different, pounding frontal headache at night and took Tylenol 500 mg for headache relief. January 4, 2021- The slight numbness in tongue continued and my face started to feel a little different too. I had headaches on and off throughout the day and evening. January 5, 2021- Woke up to get ready for work and noticed that my right eyelid was a little swollen and the right side of my mouth looked different. I arrived at work and my right eye was not closing properly and I was having difficulty blinking. I left work an hour later and went to ER to seek treatment. I was prescribed Prednisone and Valacyclovir for a seven day course. The first time I had Bells Palsy was in 1997 when I was 22 years old.
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| 45 | 2021-01-10 | chills, fatigue, discomfort, weakness |
Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling su...
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Chills with no fever; Cramping in legs; super tired with no energy; Body aches; tiredness/Feeling super tired with no energy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the 45-year-old female patient who receive first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on Saturday (02Jan2021) at single dose (once by injection in the right arm) for covid-19 immunisation. Medical history included ongoing Hypothyroidism from 2008. Concomitant medications included levothyroxine at 75 ug ongoing from 2008 for Hypothyroidism. Medical Professional and told by her work that she could get it because contact with COVID patients. The consumer calls for information about if the side effects she is experiencing after the administration of the COVID-19 vaccine will last for more days. The consumer reported tiredness and other side effects to DSU. A Consumer calls for information about if it would be appropriate the second dose of the COVID-19 vaccine is not administered considering that she had adverse reactions. Consumer calls for information about if the second dose of the COVID-19 vaccine would cause her more side effects than the first one. Received the vaccine on Saturday, 02Jan2021. The day she got it she did not feel anything at all. She was completely fine. She did not even have pain at the injection site. The next day, on Sunday she started feeling super tired with no energy, had body aches, and cramping in legs from 03Jan2021. She has had these for the past 3 days now. She also had chills with no fever from 03Jan2021 to 05Jan2021. She took Tylenol for the first 2 days, but it did not help her at all. She is feeling a little better today, but not much. Her question is, how long will these side effects last? Tylenol: She says it did help a little bit. She think she would just sleep because she was uncomfortable. The Tylenol just did not make her symptoms go away completely. LOT/Batch: AA46487, EXP: Apr2022 UPC: The consumer says the number under the barcode is: 5187536. Feeling super tired and body aches: Has improved about 20%. She says these are all medically significant as she is not able to do what she was able to do before getting the vaccine. She is super tired with no energy and she is confined to her bed most of the time. The consumer confirms this is her first dose of the COVID Vaccine. She thinks she got the standard dose. Vaccine card does not have the expiration date or NDC written on it. Unknown causality. She said that she could be positive for COVID. She is unsure. The outcome of the event Chills with no fever was recovered. The outcome of the event Cramping in legs was not recovered. The outcome of the other events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-10 | throat pain |
First dose of vaccine was received on 12/22/2020. Became COVID test positive on 12/30/2020. Had bod...
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First dose of vaccine was received on 12/22/2020. Became COVID test positive on 12/30/2020. Had bodyaches, sore throat on 12/29/2020. Symptoms improved in 4 days.
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| 45 | 2021-01-10 | headache, dizziness |
HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injecti...
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HA muscle aches, nausea and dizziness improved. Swelling, pain, itchiness and redness at the injection no treatment no improvement.
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| 45 | 2021-01-10 | headache, fatigue | Headache, muscle soreness, diarrhea, fatigue |
| 45 | 2021-01-10 | nasal congestion, head discomfort |
Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms an...
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Left nostril stopped up; Sinus pressure in head; Pressure in head; Burning sensation in both arms and in her left knee/both of her thighs swollen, burning and itching on both knees; Hives on both arms and left knee; both of her thighs swollen, burning and itching on both knees; Burning and itching on both knees; neck feels like someone is sitting on the back of it/Left side neck pressure and throbbing; Left side neck pressure and throbbing; Lower back spasms; This is a spontaneous report received from a contactable consumer. A 45-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, in Dec2020, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the vaccine in Dec2020 (reported as "Thursday"). She began experiencing symptoms on Friday (as reported). Her left nostril stopped up and had sinus pressure in her head. On Saturday and Sunday (as reported), her left nostril was not stopped up but still had pressure in her head. On Monday (as reported), she began to feel burning sensation in both arms and in her left knee. When the patient was de-gowning PPE while at work, she found hives on both arms and left knee. She took BENADRYL and applied cold compress to site. Later Monday (as reported), she woke up to both of her thighs swollen, burning and itching on both knees. Her neck feels like someone is sitting on the back of it. She experienced left side neck pressure and throbbing and lower back spasms. The patient would like to know if these symptoms have been reported and what should she do. The outcome of the event "left nostril stopped up" was recovered on an unspecified date; "sinus pressure in head" and "pressure in head" was not recovered; and the outcome of the remaining events was unknown. Information on lot/batch number for the product has been requested.
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| 45 | 2021-01-10 | chills |
Pfizer-BioNTech COVID-19 Vaccine EUA Onset of chills x 7 hours, significant injection site pain 8/10...
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Pfizer-BioNTech COVID-19 Vaccine EUA Onset of chills x 7 hours, significant injection site pain 8/10, injection site swelling
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| 45 | 2021-01-10 | sweating |
Severe diaphoresis following the immunization. Occurred in waves, about 5 times throughout the day a...
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Severe diaphoresis following the immunization. Occurred in waves, about 5 times throughout the day at work. Face turned red, needed to change her clothes the sweating was so bad.
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| 45 | 2021-01-10 | headache |
Started to have blurry vision with my eyeglasses on then got worst in the afternoon, which I took my...
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Started to have blurry vision with my eyeglasses on then got worst in the afternoon, which I took my glasses off to avoid straining my eye to focus on my computer screen and paperwork. Vision was more blurry without my glasses but could not wear my glasses which made the blurriness worst. Had pressure behind my eyes with a mild headache along with sensitivity to light. The next day 11/05/2021, had my eyes checked by the eye doctor who indicated that everything was normal, eye pressure and response to light. He did put a numbing eye drop in my eye that made the eye pressure relieve for a couple hours but when that wore off, I could feel the pressure behind my eyes. On 11/06/2021, my eye and vision were back to normal
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| 45 | 2021-01-10 | headache |
Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monda...
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Sunday 1/3/21- Numbness in tongue and pounding frontal headache at night. Took tylenol 500 mg. Monday 1/4/21- Started feeling some slight numbness on right side of face and front of tongue, headaches continued on and off throughout the day. Tuesday 1/5/21- Woke up to get ready for work and I noticed my right eyelid was a little swollen and right side of my mouth was numb and smile was slightly crooked. Arrived at work and my right eye was not blinking properly. I went to ER room to seek treatment and was prescribed Prednisone and Valacyclovir. Wednesday 1/6/21- Started with right ear pain that radiated down to right side of neck. This is the second time I've had Bells Palsy. First time was in 1997 when I was age 22.
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| 45 | 2021-01-10 | throat pain, nasopharyngitis |
Tested Positive for Covid on January 7, 2021. Symptoms started that morning with a severe sore throa...
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Tested Positive for Covid on January 7, 2021. Symptoms started that morning with a severe sore throat with no redness or exudate. No fever. Head and chest cold symptoms.
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| 45 | 2021-01-10 | dizziness, somnolence |
While sitting upright I became dizzy. I was assisted to my bed room and remained dizzy throught. W...
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While sitting upright I became dizzy. I was assisted to my bed room and remained dizzy throught. While laying down I was dizzy. I took some tylenol pm and went to sleep. When awakening, I was not dizzy. Occasionally on day two and three, I feel like its going to start again but it has not.
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| 45 | 2021-01-10 | somnolence, headache |
arm soreness and pain with movement, "super sleepy" " I could not speak tomy daughter" headache, t...
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arm soreness and pain with movement, "super sleepy" " I could not speak tomy daughter" headache, throbbing arm pain
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| 45 | 2021-01-11 | nasopharyngitis, fatigue, headache, chills |
A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was ...
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A few hours after the vaccine I got hot. About 2 hours later I got really cold. At night when I was sleeping I had very vivid dreams. I was cold all night. When I woke up my arm was sore to touch , to move and both ankles hurt to walk and I started itching on my face. Started Saturday in the evening( chin, nose) Eyelid and underneath was red and I also had a headache. I had blotches on my cheek. Next day I woke up and no change but I was extremely fatigued.. Monday 10am it started going away. By evening majority of pain was gone. About 98% recovered. I still have some itching and chills.
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| 45 | 2021-01-11 | dizziness, fever |
Around 6 hours after getting the 2nd vaccine at my place of employment (I am a RN) I was very nausea...
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Around 6 hours after getting the 2nd vaccine at my place of employment (I am a RN) I was very nauseated and dizzy. Couldn?t even walk straight. Then at 0200am I woke up with a 102.8 fever, Heart rate of 159 and body aches along with the dizziness and nausea. It is currently 530pm and I still have all symptoms, heart rate is a little better, around 100. I?m controlling my temperature with Advil and tylenol.
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| 45 | 2021-01-11 | dizziness, chills | Chest tightness, dizziness, chills. No reported treatment and symptoms resolved. |
| 45 | 2021-01-11 | dizziness |
Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for hersel...
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Dizzy; flushed after injection; This is a spontaneous report from a contactable Other HCP for herself. A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: EK9231), via an unspecified route of administration in left arm on 03Jan2021 at single dose for covid-19 immunisation. Medical history included mitral valve prolapse. Patient was allergic to some chilis and animals. There were no concomitant medications. The patient experienced dizzy, flushed after injection on 03Jan2021. Prior to vaccination, patient was not diagnosed with COVID-19; Since the vaccination, the patient been not been tested for COVID-19. Outcome of events was recovered in Jan2021.
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| 45 | 2021-01-11 | cold sweat |
Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the ...
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Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; Got very hot and clammy but at the same time had the goosebumps; My whole body was as if I was sun burnt; My heart started to race; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2, (Pfizer COVID Vaccine, lot number: EK9231, expiry date: Apr2021) intramuscular on an unspecified date at single dose on right arm for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included nortriptyline for migraine, botulinum toxin type a (BOTOX) for migraine and birth control medication. The patient stated that, "I was wondering if this was a reaction to the vaccination I had today. So I ended up 3 hours after I received the vaccine, I got very hot and clammy but at the same time had the goosebumps and then my whole body was as if I was sun burnt and my heart started to race. And then my whole body was red as if I had a sunburn. Actually I went to the ER today and they just did lab work because of the way I was feeling. All they gave me in the emergency room is IV fluids." Therapeutic measures taken as a result of the events included IV fluids. The outcome of the events was unknown.
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| 45 | 2021-01-11 | headache, fatigue, chills |
Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility ...
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Had problems with arm mobility and soreness to the touch in the arm; Had problems with arm mobility and soreness to the touch in the arm; Eyes were really heavy; Headache; Chills; Muscle pain; Injection pain; Injection site swelling; Injection site itchiness; Sensation on my face like when eating spicy food. It is a tingling sensation; Tiredness; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 31Dec2020 (15:20) at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing rosacea. There were no concomitant medications. On 31Dec2020, the patient had injection pain; injection site swelling; injection site itchiness; had sensation on the face like when eating spicy food further clarified as a tingling sensation; had tiredness. On 03Jan2021, the patient had chills and muscle pain. On 05Jan2021, the patient had headache, and eyes were really heavy. On an unspecified date, the patient had problems with arm mobility and soreness to the touch in the arm. The patient had received treatment for all the reported events. The outcome of the events was recovered on 31Dec2020 for 'injection pain', 'tiredness'; was recovered on an unspecified date for 'injection site swelling' and 'injection site itchiness', 'problems with arm mobility and soreness to the touch in the arm' and 'problems with arm mobility and soreness to the touch in the arm'; was recovered on 03Jan2021 for 'chills' and 'muscle pain'; was not recovered for 'headache'; and was unknown for 'sensation on the face like when eating spicy food further clarified as a tingling sensation'.
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| 45 | 2021-01-11 | headache, nasopharyngitis |
Have a cold and headache; headache; loss smell/ taste; loss smell/ taste; This is a spontaneous repo...
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Have a cold and headache; headache; loss smell/ taste; loss smell/ taste; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Es1685, expiry date not reported), via an unspecified route of administration on 22Dec2020 at 09:30 AM at single dose for Covid-19 immunization. There were no medical history and no concomitant medications, no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines with 4 weeks prior to COVID vaccine nor any other medications within 2 weeks of vaccination. On 01Jan2021, the patient has a cold and headache, she was sent for Covid test 1/5 loss smell/ taste 1/3. The patient did not receive treatment for the events. The patient underwent lab test on 06Jan2021 which included nasal swab: pending result. Outcome of the events was recovered. The reporter assessed the events as non-serious. Information on Lot/Batch has been requested.
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| 45 | 2021-01-11 | somnolence, headache, fatigue |
Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afterno...
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Right after shot my eyes were feeling dry and my head was slowly hurting (headache). In the afternoon around 4 or 5 got really hot and then in the evening around 9 got really cold and face started to itch. chin was bumpy and face was itching, eyes were still hurting with slight headache. I did have vivid dreams at night and slept not well. in the am my face was itchy red eyelids and under eye, patch like rash on face and itch . Ankles hurt to walk (joints hurt) and arm site was painful and hurt. was cold on and off during day and monday it was hard to wake up, v ery drosy and exhausted. Later that day the face cleared up and i could walk fine and headache was gone . I did feel a little cold monday night. Tuesday everything gone except a slight itch here and there on my face. I feel fine and arm pain is gone as well.
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| 45 | 2021-01-11 | nerve pain |
Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontan...
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Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek5730, expiry date: unknown), intramuscular on the right arm on 16Dec2020 11:00 to at a single dose for an COVID-19 immunization. Medical history included hypertension, obesity, lymphadenopathy, and migraines. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan, clonazepam (KLONOPIN), duloxetine hydrochloride (CYMBALTA), gabapentin (NEURONTIN), ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX), and zinc. The patient experienced right arm soreness, kinda like nerve pain and can't lift her arm up or reach the back on 16Dec2020. Outcome of the events was not recovered. No treatment was received for the events. The patient underwent lab test which included COVID test (nasal swab) on 19Dec2020 and 26Dec2020: both negative. The reporter considered the events non-serious.
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| 45 | 2021-01-11 | dizziness, shortness of breath, headache | SOB, dizziness, nervous, headache Treatment: IV Prednisone, IV Benadryl |
| 45 | 2021-01-11 | headache, chills, fever |
The night of vaccination, pt developed a fever, headache, and chills which continued for three days....
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The night of vaccination, pt developed a fever, headache, and chills which continued for three days. She was tested for COVID on the second day with a negative PCR result.
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| 45 | 2021-01-12 | skin warm |
12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow a...
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12/22/2021-tingling in left arm/fingers, shoulder pain 12/23-12/25/2021-burning pain between elbow and shoulder intermittently 12/26/2021-vomiting and constant severe burning pain in left arm. Applied ice pack 12/27/2021-went to ER for the constant severe pain. Given prescriptions for prednisone 60mg orally x two days and norco. Later that night left arm between elbow and shoulder was bright red and hot to the touch. Took Benadryl liquid and the redness/heat went away in 4 hours. Shoulder, tricep, and bicep have continued to hurt with tingling in fingers. Have seen primary care physician at clinic and Dr. with another facility. Have orders for an MRI and follow up with the other facility
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| 45 | 2021-01-12 | headache, fever |
After receiving the 2nd dose of the Covid-19 vaccine on 1/11/2021 at 8:15 am . On 1/12/2021 at 5:36...
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After receiving the 2nd dose of the Covid-19 vaccine on 1/11/2021 at 8:15 am . On 1/12/2021 at 5:36 am I started to experiencing headaches, slight fever and whole body aches, and both of the back and front of my calf's muscle felt very heavy had a hard time getting out of bed and not able to walk well, I took Ibuprofen every 6 hours. The Ibuprofen helped with the headaches and fever. on 1/13/2021 I woke up feeling better, no fever just very tired and had 3 headaches during the day.
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| 45 | 2021-01-12 | fever, headache |
After receiving the 2nd dose of the Covid-19 vaccine on 1/11/2021 at 8:15 am. on 1/12/2021 at 5:36 ...
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After receiving the 2nd dose of the Covid-19 vaccine on 1/11/2021 at 8:15 am. on 1/12/2021 at 5:36 am waking up I started experiencing slight fever, headaches, whole body aches and both of the back and front of my Calf's muscles felt very heavy. I took Ibuprofen every 6 hour .
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| 45 | 2021-01-12 | fatigue, fever, malaise, chills |
At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck....
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At 9 pm- I exhibited chills labs body aches. At 3 am I had difficulty swallowing and a swollen neck. The next day this continued with a fever of 99-100, malaise, and chest discomfort. At the 48th hour, today?s date, fever still present, body aches are improved, but my head feels hot and now with a stiff neck. I feel very tired and mental status seems ?foggy?
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| 45 | 2021-01-12 | fatigue | Body aches, fatigue. Improving. |
| 45 | 2021-01-12 | fatigue | Fatigue, body aches. Improving. |
| 45 | 2021-01-12 | chills, headache, fever | Fever 100.9 for 5 days. Muscle aches, chills, headache. Arm pain entire left arm. |
| 45 | 2021-01-12 | fatigue, chills, fever, headache |
In the first 12 hours after the vaccine I developed left arm pain. Approximately 12 up to 36 hours a...
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In the first 12 hours after the vaccine I developed left arm pain. Approximately 12 up to 36 hours after the initial vaccine was given, I developed low-grade fevers. headaches, myalgia, chills, and severe fatigue. It?s now about 48 hours later and I still experience mild fevers occasionally.
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| 45 | 2021-01-12 | headache | Intermittent Headache. There is no treatment. |
| 45 | 2021-01-12 | discomfort |
Swelling, redness, itching and burning radiating out from injection site starting two days after, in...
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Swelling, redness, itching and burning radiating out from injection site starting two days after, increasing in severity over time, got to the size of an orange, went to urgent care, treated with steroids and antihistamines. All localized, no other symptoms. Medication started 1/13/2021 but the initial antihistamine helped with discomfort.
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| 45 | 2021-01-12 | throat swelling, throat swelling | Systemic: swelling on her throat, numbing lips; symptoms lasted 0 days |
| 45 | 2021-01-12 | headache, chills, shortness of breath |
The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours a...
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The day after the injection I had a itchy red knot appear at the injection site. Starting 27 hours after injection I had chills, anxiety, slight shortness of breath, headaches, body aches. Today I have had nausea that comes and goes, the red knot is still present on my right arm and the redness has increased a small amount from the marking placed last night. The injection is not in my deltoid muscle or even close and I am wondering if that is at the least what created the redness and the knot.
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| 45 | 2021-01-12 | fatigue, dizziness, malaise |
The day after the second vaccine I had significant arm soreness and some fatigue and malaise. On Sat...
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The day after the second vaccine I had significant arm soreness and some fatigue and malaise. On Saturday two days after the second dose I had significant dizziness which might be considered vertigo. I am now six days past the second vaccine and continue to have dizziness.
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| 45 | 2021-01-12 | malaise, dizziness |
Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:2...
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Vaccine administered at 08:16--08:25 patient c/o feeling unwell and dizzy 87, 143/84, 18, 100%; 08:28: Pt c/o dizzy & chest tightness, appeared pale, monitoring; 08:34: Pt c/o increased chest tightness 130, 144/81, 22, 100% monitoring 08:36: Epinephrine .3mg given IM to R thigh, pt. reported flushing, pounding heart, 911 called; 08:40: Pt flushed.
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| 45 | 2021-01-12 | dizziness, weakness |
after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrin...
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after administration of vaccine, patient felt hot and going to pass out, patient refused epinephrine injection and 911. patient waited around for about an hour after vaccination - patient BP went up, felt weak, signs of weakness, tongue big and throat closing - patient refused epinephrine again, called on call doctor who suggested Benadryl 25mg. Facility gave patient 25mg Benadryl IM. Patient to be monitored at facility
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| 45 | 2021-01-12 | discomfort, cold sweat |
pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 13...
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pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 130's, BP 134/78. c/o feeling pressure in throat. Rapid response called and patient assisted to stretcher and transported to ED.
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| 45 | 2021-01-12 | dizziness, fatigue, fever | severe dizziness, fever, fatigue |
| 45 | 2021-01-13 | dizziness, malaise, sweating, headache, fatigue |
1. Dec. 30, 2020- Headaches for about 24hrs after 1st COVID-19 injection, treated w/ 500 mg of Ibupr...
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1. Dec. 30, 2020- Headaches for about 24hrs after 1st COVID-19 injection, treated w/ 500 mg of Ibuprofen at 1:00 am, reduced/eliminated headaches by Dec. 31, 2020 3:00 p.m. 2. Jan. 01, 2021- Woke up/laying down when the dizziness/room spinning began lasting about 10 seconds. Dizzy/spinning episodes continued from 01/01/2021-01/05/2021 (decreasing in episodes on 01/04/2021- 01/05/2021). The dizzy/spinning episodes would happen randomly when I first woke up, through out the day/night, about 6-7 times a day, and lasting about 10 seconds. A few times I felt like I would faint. Treated with rest, sleep, drinking water, and took off work for 1 week due to the danger of driving or going outside the home. 3. I would randomly wake up with hot sweats and nausea from 01/01/2021-04/01/2021, treated by drinking water, and resting. 4. I experienced the general feeling of being unwell, fatigue, and foggy mind that lasted about a week after the 1st COVID-19 vaccination. Treated with rest and was off work for 1 week.
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| 45 | 2021-01-13 | dizziness |
15 minutes after vaccine administration, patient presented to EC complaining of chest pressure, palp...
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15 minutes after vaccine administration, patient presented to EC complaining of chest pressure, palpitations, lightheadedness and feeling faint. Patient's symptoms resolved by 4:15pm. Patient was prescribed Benadryl 50mg PO and PEPCID 40mg PO. Patient discharged from EC home at 6pm.
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| 45 | 2021-01-13 | malaise |
FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJEC...
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FIVE DAYS OF SYMPTOMS, PAIN INJECTION SITE, TIRED, MUSCULAR PAIN, CHILLS, JOINT PAIN, SWELLING INJECTION SITE, FEELING BAD.
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| 45 | 2021-01-13 | somnolence, chills, fatigue, headache, fever |
Fever @103 average, chills, headache, fatigue for Tuesday 1/12. Upon waking 1/13 low grade fever, w...
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Fever @103 average, chills, headache, fatigue for Tuesday 1/12. Upon waking 1/13 low grade fever, went away before returning in the afternoon 99.8, felt tired, took a nap. Woke up from nap @1600 feeling like nothing ever happened. Today, woke up feeling great. Am actually pleased that I had this reaction. Was told by employer to complete this form. My immune system is working. Actually feel bad for doing this report, because I don't want the anti vaccine community to take this report the wrong way.
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| 45 | 2021-01-13 | chills, fever | Fever, Body aches, Chills. |
| 45 | 2021-01-13 | headache, fatigue, night sweats, dizziness |
Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it...
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Headache, dizziness, fatigue, and night sweats, and slight nausea. I took Aleve for the headache, it did help.
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| 45 | 2021-01-13 | fever, chills, fatigue, headache | Headache, nausea, fever of 103, chills, fatigue |
| 45 | 2021-01-13 | throat irritation, cough |
I received the shot at 2 o?clock. By 2:05 my tongue and the back of my throat started tingling and b...
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I received the shot at 2 o?clock. By 2:05 my tongue and the back of my throat started tingling and burning like it had been scolded. It was reported after 30 minutes. 25 mg of Benadryl was given PO at 2:35. I started to develop a cough and was clearing my throat but had no difficulty breathing. At 3:05 another 25mg of Benadryl po was given. I was monitored until 4:30 PM. I was sent home. By 630 the sensation had started to increase again. I took 25 mg of Benadryl PO again. By 7 PM I was not having any relief so I spoke with my physician and he advised me to take 25 mg of Benadryl PO and the first row of a steroid dose pack. By midnight the symptoms had started to reoccur. I took another 50 mg of Benadryl. I finished the medrol dose pack on Wednesday, January 13th but still have the raw sensation on my tongue.
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| 45 | 2021-01-13 | fatigue, headache, fever, dizziness |
On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nau...
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On 1/13/21 extreme fatigue- sleeping 4 to 5 hours at a time, swollen gland on right side 1/14/21 nausea, headache, dizziness, fever-100.7, muscle ache, swollen gland still
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| 45 | 2021-01-13 | fatigue, dizziness, headache |
Severe dizziness; Mouth breaking out in ulcers; extreme tiredness; headache; This is a spontaneous r...
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Severe dizziness; Mouth breaking out in ulcers; extreme tiredness; headache; This is a spontaneous report from a contactable healthcare professional reporting for self. This 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 04:30 PM at single dose (vaccine location: left arm) for COVID-19 immunisation. The patient previously experienced allergies with penicillin and levofloxacin (LEVOQUIN). Concomitant medications in two weeks included cetirizine hydrochloride (ZYRTEC), colecalciferol (VIATAMIN D) and hormone replacement pellets. Patient did not have other vaccine in four weeks. Patient was not pregnant at the time of vaccination. The patient experienced severe dizziness 36 hours after vaccination, mouth breaking out in ulcers, extreme tiredness and headache on 01Jan2021. No treatment received for events. Patient did not have COVID prior vaccination, and did not have COVID tested post vaccination. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
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| 45 | 2021-01-13 | headache |
Severe headache that did not respond to over the counter medications lasted about 36 hours. After th...
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Severe headache that did not respond to over the counter medications lasted about 36 hours. After that it continued but not nearly as severe and did respond to over the counter medications. Headache still present
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| 45 | 2021-01-13 | headache, fever |
Severe headache, nausea and fever only marginally relieved with Benadryl, Zofran, Tramadol, Pepcid, ...
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Severe headache, nausea and fever only marginally relieved with Benadryl, Zofran, Tramadol, Pepcid, Tylenol. Symptom onset evening of 12.29 and increasing over the next several hours, finally beginning to resolve around noon on 1.1.21. Patient was in contact with her Oncologist who is recommending second dose with additional prophylaxis. Not evaluated in person.
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| 45 | 2021-01-13 | headache | Slight body aches, diarrhea and mild headache |
| 45 | 2021-01-13 | chills, fever |
body aches; Chills; low grade fever; This is a spontaneous report from a contactable consumer. A 45-...
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body aches; Chills; low grade fever; This is a spontaneous report from a contactable consumer. A 45-year-old female patient started to receive bnt162b2 (BNT162B2, lot number EK9231), intramuscular (left deltoid) from 06Jan2021 08:30 to 06Jan2021 08:30 at 0.3 mL, single for covid-19 vaccination. Medical history included ongoing asthma. The patient also received first dose of bnt162b2 on 16Dec2020. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) and salbutamol sulfate (ALBUTEROL); both ongoing given for asthma. It was reported that the patient received the second Pfizer covid19 vaccine dose yesterday around 8:30am. She is calling to report that she experienced body aches, chills, and a low-grade fever which all started around 8pm yesterday (06Jan2021). For the treatment, she is taking Tylenol. The outcome of the events was unknown.
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| 45 | 2021-01-13 | dizziness |
patient reported lightheadedness and leg heaviness. BP 153/102, HR 110-120, O2 100%. Patient was tr...
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patient reported lightheadedness and leg heaviness. BP 153/102, HR 110-120, O2 100%. Patient was transferred to ER via stretcher.
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| 45 | 2021-01-13 | sweating, cough, throat pain, shortness of breath |
shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nau...
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shortness of breath, cough, sore throat, chest pain, myalgia, arm soreness, sweats, hot flashes, nausea, skin burning sensation, facial swelling
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| 45 | 2021-01-14 | dizziness |
About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal an...
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About 10 min after receiving vaccine, patient began to feel lightheaded and paresthesia to distal and upper arm. Vital signs within normal limits. Improved
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| 45 | 2021-01-14 | throat swelling |
After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then...
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After 10 minutes of vaccine, patient started to have tight chest, and numbness on opposite arm. Then she couldn't remember her name and date of birth for 5 minutes. She then felt her throat was swelling. 911 was called and paramedics checked her blood pressure and vitals were within range. She was monitored at the hospital and was doing fine.
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| 45 | 2021-01-14 | headache, fever | Approx 10-12 hours after dose: injection site pain, swelling, headache, fever (temp max 99.5) |
| 45 | 2021-01-14 | influenza like illness |
COVID 19 vaccine - unsure which vaccination Flu like symptoms for 1 day with noted thrombocytopenia...
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COVID 19 vaccine - unsure which vaccination Flu like symptoms for 1 day with noted thrombocytopenia 127 x 10^3 Unclear if thrombocytopenia is from vaccination. No hx of this
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| 45 | 2021-01-14 | sweating |
Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extrem...
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Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1686) via an unspecified route of administration on 06Jan2021 11:00 AM at a single dose in the left arm for Covid vaccine. Medical history included GERD. Concomitant medication included omeprazole (received within 2 weeks of vaccination). The patient had known allergies to erythromycin and hydrocodone bitartrate/paracetamol (VICODIN). The patient was not pregnant at the time of vaccination. She was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine. On 06Jan2021 16:00 (04:00 PM), the patient experienced extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours), it started 5 hours after injection and lasted 48 hours. Treatment was not received for the events. The events were non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 since the vaccination (post vaccination). The outcome of the events was recovered on 08Jan2021 16:00.
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| 45 | 2021-01-14 | headache, chills, fever |
Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second ...
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Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, first dose (lot number: EL0140) on 18Dec2020 at single dose then second dose (lot number: EK9231) on 07Jan2021 18:45 at single dose for COVID-19 vaccination. Medical history included hypertension, depression, osteoarthritis (OA) and known allergies to ACE inhibitors and sulfa eye drops, on unspecified dates. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not have COVID-19 prior to vaccination. Concomitant medications in 2 weeks included losartan, bupropion, fluoxetine hydrochloride (PROZAC), triamcinolone acetonide (NASACORT), naproxen sodium (ALEVE), and colecalciferol (VITAMIN D) from unspecified dates. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient experienced fever 101.2 orally, chills, body aches, headache, nausea, vomiting on 08Jan2021, 5 hrs 15 min onset from last dose on 07Jan2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes paracetamol (TYLENOL), ondansetron (ZOFRAN). Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101.2 (unit unknown) on 08Jan2021, and SARs-CoV-2 test (COVID test) with unknown results on an unspecified date. The outcome of the events was not recovered.
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| 45 | 2021-01-14 | headache, nasal congestion |
Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, n...
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Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; Headache, pain at injection site, nasal congestion, nasal pain.; This is a spontaneous report from a contactable other health care professional. A 45-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose (lot number: EH9899); via an unspecified route of administration on 17Dec2020 14:00 at single dose at arm left; second dose (lot number: EK9231) via an unspecified route of administration on 08Jan2021 00:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic back pain, Allergies to medications, food, or other products: Avocado. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), celecoxib (CELEBREX), pregabalin (LYRICA), triamcinolone acetonide (NASACORT), omeprazole. On 08Jan2021 09:00, the patient experienced Headache, pain at injection site, nasal congestion, nasal pain. The events were assessed as non-serious. There was no treatment received for the events. The outcome of the events was recovering.
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| 45 | 2021-01-14 | dizziness |
Hot flush feeling felt like she was going to pass out started getting wizzy and raspy breathing hasn...
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Hot flush feeling felt like she was going to pass out started getting wizzy and raspy breathing hasn't been great
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| 45 | 2021-01-14 | weakness, headache, malaise, fever, fatigue |
Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fat...
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Increase bowel movements; fever; body ache; injection site pain; intermittent moderate headache; fatigue; weakness; feeling unwell; This is a spontaneous report from a contactable other HCP (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:00 at single dose on arm left for covid-19 immunisation. Medical history reported as none. Pregnant at the time of vaccination: No. Unknown if COVID prior vaccination. No other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced Increase bowel movements, fever, body ache, injection site pain, intermittent moderate headache, extreme fatigue, mild weakness, feeling unwell, all reported from 01Jan2021 07:00 PM (pending clarification). Treatment received for all the events included OTC ibuprofen. Outcome of events was recovering. No COVID tested post vaccination. Information on the lot/batch number has been requested.
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| 45 | 2021-01-14 | dizziness |
Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administrati...
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Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
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| 45 | 2021-01-14 | fatigue, headache |
On Jan 10, 2021 I received the second dose of the Pfizer vaccine into my left upper arm. The followi...
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On Jan 10, 2021 I received the second dose of the Pfizer vaccine into my left upper arm. The following day I woke up with my axillary lymph nodes swollen and extremely painful. I addition I did have headache and fatigue. 90% of swelling has decreased on post day 3. Today at this time I am still having altered sensation and discomfort in left arm.
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| 45 | 2021-01-14 | headache |
Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after inject...
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Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; Patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection; This is a spontaneous report form a contactable physician. A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL0142, expiry date: not reported) intramuscular, on 07Jan2021 07:30 AM on Arm Left at a single dose for COVID-19 immunization. COVID-19 vaccine was administered at a hospital. Medical history was not reported. It was unknown if patient was pregnant at the time of vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. On 08Jan2021 07:30 AM, the patient complained of left arm pain radiating to jaw and temples radiating to neck pain after injection. Treatment was not received for the adverse events. Outcome of the events was unknown.
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| 45 | 2021-01-14 | fatigue, dizziness, fever |
Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with feve...
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Received vaccine 1/13/21 at 10:30 am. Felt fine all day. Woke up next day 1/14/21 at 5 AM with fever 101.0, body aches, dizziness, fatigue enlarged lymph node at left axilla, same side as shot, mild nausea, and a sore left arm. Felt sick for about 12 hours with these symptoms, fever resolved slowly with ibuprofen. Symptoms mostly resolved in 24 hours, except I still have an enlarged lymph node - left axilla with throbbing pain. No fever.
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| 45 | 2021-01-14 | fever |
fever; body aches; severe nausea; This is a spontaneous report from a contactable healthcare profess...
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fever; body aches; severe nausea; This is a spontaneous report from a contactable healthcare professional reporting for self. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Jan2021 at 12:00 PM (Dose 1) as a single dose in the left arm (age at vaccination: 45 years old) for COVID-19 immunization. There was no relevant medical history. She did not have COVID prior to vaccination. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported; there were no other medications taken in the 2 weeks prior. The patient received the COVID vaccine at 12:00 PM on 02Jan2021. Exactly 12 hours later, on 03Jan2021 at 12:00 AM, she began having a fever, body aches, and severe nausea. This had continued all week. The patient was COVID tested post-vaccination on 04Jan2021 via nasal swab with a negative result. "Yesterday" (as of 08Jan2021) she went to immediate care (physician office) and the doctor said that she had a bad reaction to the vaccine and shouldn't be having fevers every day and if they continue she may need to go to the emergency room. She was tested for other illnesses and everything was negative. Therapeutic measures were taken as a result of severe nausea and included ondansetron (ZOFRAN). The outcome of the events fever, body aches, and severe nausea was recovering. She reported the events as non-serious and confirmed there was no hospitalization. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 45 | 2021-01-14 | headache, chills |
significant muscle aches; chills; joint pain; Neck pain with headache that night; Neck pain with hea...
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significant muscle aches; chills; joint pain; Neck pain with headache that night; Neck pain with headache that night; This is a spontaneous report from a non-contactable healthcare professional. A 45-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID 19 vaccine; unknown lot number and expiration date), intramuscular right arm on 06Jan2021 14:00 [02:00 PM] at a single dose for covid-19 vaccination. Medical history included breast cancer and had covid-19 prior vaccination. The patient has no known allergies. Concomitant medication included tamoxifen (TAMOXIFEN). The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her most recent COVID-19 vaccine in a hospital. The patient experienced neck pain with headache that night (06Jan2021 22:00 [10:00 PM]) then next day (07Jan2020), significant muscle aches and chills with joint pain for another day and a half. The events were considered as non-serious. It was unknown if treatment was received. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering. No follow-up attempts are possible; Information about Lot/Batch could not be obtained. No further information is expected.
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| 45 | 2021-01-14 | fatigue | swollen lymph nodes in arm pits and neck area, extreme fatigue |
| 45 | 2021-01-14 | headache |
wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feel...
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wheezing hot flush sensation had to use a breathing treatment arm is really sore headache chest feels tight, almost like she is congested
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| 45 | 2021-01-14 | headache | wheezing tight chest headache had to use a breathing treatment hot flush sensation |
| 45 | 2021-01-15 | dizziness, fatigue, chills |
Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection...
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Bounding heart rate in 150's dizziness confusion/ hallucinations chills body aches fatigue injection site pain
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| 45 | 2021-01-15 | headache, fatigue |
Headache started a couple hours after injection and lasted for days. Muscle pain, neck pain, naus...
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Headache started a couple hours after injection and lasted for days. Muscle pain, neck pain, nausea, fatigue, altered taste bitter,
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| 45 | 2021-01-15 | headache, malaise, fatigue, weakness, fever |
On 1/11/2020 I got my second dose and the same night I started feeling sick it felt tired, I felt fe...
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On 1/11/2020 I got my second dose and the same night I started feeling sick it felt tired, I felt feverish but no fever, achy, headache, weak it felt like I had the flu it lasted 3 days. Telehealth appointment with my doctor 1/12/2020
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| 45 | 2021-01-16 | weakness, somnolence, headache, fatigue, chills |
2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head woul...
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2hr post shot - left arm pain, severe headache- lay flat was moderate- sit up felt like my head would explode- severe left eye pain like my eyeball was going to Pop out 4 hrs post shot- chills no fever temp 97.1 fatigue- took a nap. 12 hrs post shot - severe headache, moderate arm pain and mild swelling at site. SEVERE joint pained tiny joints in ties feet, finger, wrists, neck jaw. Knees were the worst. 16 hours later the joint pain is unbearable . Muscle aching and headache continues at the same time as joint pain. 24 hours post Injection. Chills,moderate painful stomach aching from the inside. Nausea. No vomiting, no energy. Could not work, had to leave. 29 hours post shot- now all symptoms at the same time chills, headache, severe joint pain, stomach pain, nausea, felt like I couldn?t drive home or walk to my car. Got home. Called dr. Went to bed. Slept 14 hours. 48 hours post shot- symptoms decreasing. Headache mild joint pain is the worst. Tired and very cold feeling 72 hours- feeling much better.
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| 45 | 2021-01-16 | chills, malaise, fever, headache |
Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivi...
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Fever as high as 103.1 (after Motrin) Injection site pain Joint pain Headache Chills Skin sensitivity All over feeling unwell Increased heart rate (as high as 135)
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| 45 | 2021-01-16 | fever | Fever, muscle spasms to the point of difficulty walking, severe nausea |
| 45 | 2021-01-16 | dizziness | Vomiting, dizzinesz |
| 45 | 2021-01-17 | dizziness | 5min after vaccine became tachycardic with blurred vision and felt like she was going to pass |
| 45 | 2021-01-17 | headache, fever, chills |
Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) af...
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Facial tingling/numbness to face contralateral to injection site starting 30 minutes (time 1600) after injection and spreading to entire face. Symptoms resolved 4 hours later. Intermittent palpitations starting during this time which have not resolved to this day. Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected supraclavicular lymph node swelling on injection side. Consistent fever of 102 degree fahrenheit starting 12 hours (time 0330) post injection and lasting for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose (0630). Also have continued to have dull headaches since vaccine dose.
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| 45 | 2021-01-17 | shortness of breath |
Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment...
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Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment: epipen, IM Benedryl shot x2, ambulance transport to ER at Hospital for monitoring Outcome- deduced symptoms and eventual absence of symptoms 24 hours later
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| 45 | 2021-01-19 | cough, fatigue, throat irritation |
12/29/20 , left arm soreness, sinus issue, throat issue, which by 12/30/20 sinus/chest congestion w...
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12/29/20 , left arm soreness, sinus issue, throat issue, which by 12/30/20 sinus/chest congestion with cough. HD tested for Covid 19 (negative on 1/1/21) Started aka seltzer cold and flu medicine, seen in respiratory clinic on 12/31 - started new meds codeine with guaifanesin cough syrup, Flovent inhaler, and Mucinex Max strength cold and flu. 1/8/21, felt more fatigued and cough felt more violent. Seen again in respiratory clinic 1/11/21 negative chest X-ray and Covid 19 test, continue same regimen - rest, OTC, inhalers. 1/20/21, first day of feeling overall improvement, still ongoing cough.
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| 45 | 2021-01-19 | fever, chills, fatigue, headache |
1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (...
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1st dose - feverish, all over body ache, HA, run down/ tired/ fatigue. 2nd dose - body ache and HA (both not as severe as 1st dose), two days post injection = painful and swollen right axilla lymphadenopathy and right breast pain...used right deltoid for injection site. Also, noted fatigue and chills w/o known fever.
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| 45 | 2021-01-19 | dizziness |
3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States sh...
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3:35 patient feels shaky, dizzy, tingling. Feels numbness around her face especially lips. States she feels like her heart is racing. HR 109; O2 96%, BP 120/84. Also states she feels like she is breathing fast. BBB CTA per Dr. Opened outside doors for cool air. Continue to observe 3:51 Patient reports feeling better; denies throat swelling. No dyspnea noted, Resp. regular. Still c/o slight dizziness and face feels sl. numb around cheek area. 3:58 - BP 138/p HR 113; O2 sat 99% on r/a 4:03 patient states she does not need an ambulance 4:12 116/82; HR 104; 99% Patient states she feels fine now and left ambulatory to her personal vehicle.
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| 45 | 2021-01-19 | sweating, chills, fatigue, fever, nasal congestion |
Chills, lower back ache within 15 mins of 2nd dose, fever of 102, achy, chills, sweat, joint pain at...
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Chills, lower back ache within 15 mins of 2nd dose, fever of 102, achy, chills, sweat, joint pain at 2am (approx 14 hrs after injection), took 1000mg ibuprofen w water, sleep. Woke up w L eye swelling (have photos), appears L sinus inflamed, more ibuprofen. Effects continued into Sunday, relieved w ibuprofen, swelling of eye went down. Remained tired and achy throughout Monday 01/18 and Tuesday 01/19, woke up Wednesday 01/20 w L sinus stuffiness and "full" feeling, feels like a 1 sided sinus infection.
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| 45 | 2021-01-19 | fatigue, headache |
Fatigue; Headache; Dose number 1: 17Dec2020/dose number 2: 04Jan2021; This is a spontaneous report f...
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Fatigue; Headache; Dose number 1: 17Dec2020/dose number 2: 04Jan2021; This is a spontaneous report from a contactable physician (patient). A 45-years-old female patient received second dose of bnt162b2 (BNT162B2, lot number=EK9231), via an unspecified route of administration on 04Jan2021 on Left arm at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient previously received COVID 19 (Pfizer), lot number=EK5730, administration date=17Dec2020, administration time=04:15 PM, administrator route=Intramuscular, vaccine location=Left arm, dose number=1. The patient received second dose of bnt162b2 on 04Jan2021, experienced fatigue and headache on 04Jan2021 23:00. The patient had no covid prior vaccination, no covid tested post vaccination. No known allergies. The patient did not receive treatment for events. The event outcome of Fatigue and headache was not recovered.
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| 45 | 2021-01-19 | fatigue, weakness | Hives around the waist, weakness/ tired at 0500 1/20 |
| 45 | 2021-01-19 | headache, fever, chills |
Muscle soreness at site, headache, severe body aches, joint pain, chills and fever up to 100.5 lasti...
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Muscle soreness at site, headache, severe body aches, joint pain, chills and fever up to 100.5 lasting less than 12 hours.
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| 45 | 2021-01-19 | dizziness, head discomfort, fatigue | Neck pain Head pressure Dizzy Nauseous Very Fatigue Very sore site (R) arm |
| 45 | 2021-01-19 | chills |
Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nau...
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Patient is a 45 year old female with no significant PMHX who presents today high blood pressure, nausea and chills within 30 min of receiving the 1st dose of the COVID-19 vaccine 4 hours ago Denies rash, shortness of breath, vomiting, diarrhea, trouble swallowing or breathing, swelling of throat, tongue, lips or eyes. No fever. Patient states her BP was taken when she was having the symptoms and it was 170s systolic. Patient is presenting today with report of nausea, chills and elevated BP s/p COVID-19 vaccine. Patient has no evidence of anaphylaxis or severe allergic reaction. . Patient has normal vitals and in no respiratory distress. Will discharge home with close outpatient follow-up.
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| 45 | 2021-01-19 | dizziness, weakness |
Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 11...
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Patient reports sudden onset of dizziness and heart palpitations. Initial vitals BP 224/117, HR 112, RR 28 ,Pox 100% RA (at 1700) Repeat vitals at 1710 BP 217/110, HR 103, RR 32, Pox 97% RA. Symptoms became progressively worse. She was given water. She reports she takes Metoprolol and Nefedipine ( last dose 1/20/21) and HCTZ (last dose 1/19/21. She also began to report feeling weakness as well. Due to persistent symptoms she was transported to the ER at 1715 via wheelchair.
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| 45 | 2021-01-19 | dizziness |
Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the ...
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Rash, dizziness, flushed face, numbness to left side. Occurred approximately 3-5 minutes after the dose. Symptoms completely resolved after diphenhydramine within 75 minutes. Patient signed out against medical advice.
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| 45 | 2021-01-19 | headache, fatigue |
Slight Headache (ibuprofen) Fatigue (sleep) Vomiting Nausea (crackers, peppermint tea) Abdominal pa...
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Slight Headache (ibuprofen) Fatigue (sleep) Vomiting Nausea (crackers, peppermint tea) Abdominal pain after eating and woke up with it 1/20/2021 (still happening) Diaherra (stopped on 1/19/2021)
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| 45 | 2021-01-19 | fever, weakness, fatigue, headache |
Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had n...
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Started with HA/fever/fatigue and body aches on date of vaccine on 1/5/21. Also had shakes,and had numbness loss of feeling to leg leg. Was admitted to Hospital for 5days. Had intermittnet seizure type episodes. Has had labs and imaging tests that have been neg Under the care of the A Neuro Group. MRI scheduled for 1/20/21. As of 1/20/21 feeling better but still weak.
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| 45 | 2021-01-19 | dizziness, headache |
a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, thro...
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a sensation of loss of gravity or floating feeling, increasing dizziness, visual disturbances, throbbing headaches, difficulty operating a vehicle. The dizziness has now gotten bad enough that it is causing nausea.
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| 45 | 2021-01-19 | dizziness |
pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine....
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pt started experiencing tachycardia, dizziness, and itchiness within 2 minutes of receiving vaccine. pt reported symptoms 2 hours after receiving vaccine and was given 25 mg of diphenhydramine. pt was monitored every 60 minutes for changes.
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| 45 | 2021-01-20 | shortness of breath, fatigue |
Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contacta...
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Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular on 18Dec2020 at 20:00 at a single dose at the left arm in the hospital for covid-19 immunization. Medical history included hypertension. Patient was not pregnant at time of report. The patient previously took excedrin [acetylsalicylic acid;caffeine;paracetamol;salicylamide] and experienced allergies. Concomitant medication included Tejocote root. The patient experienced heart above 120s, short of breath, fatigue, and chest pain, all on 21Dec2020 at 13:00. Patient went to a doctor or other healthcare professional office/clinic visit for the events. The patient received treatment which included Tylenol as needed for the events. Tested for Covid twice since the vaccination; Covid test post vaccination - Nasal Swab on 30Dec2020 and on unknown date, both with negative results. Cardiologist consult was pending. Outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.; Sender's Comments: The 45-year-old female patient had medical history included hypertension, and was on concomitant medication. The reported events short of breath and chest pain were more likely due to underlying disease, and less likely causally related to first dose of bnt162b2 (BNT162B2). The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-21 | fever, chills | Fever , severe chills , body aches , abdominal pain , arm pain |
| 45 | 2021-01-21 | fever, cough, headache |
Fever >102.0 F for 7 hours Starting at 19:30 19Jan2021 Fever 100-101.5 F for 29hrs starting 02:30 2...
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Fever >102.0 F for 7 hours Starting at 19:30 19Jan2021 Fever 100-101.5 F for 29hrs starting 02:30 20Jan2021 End date 05:30 21Jan2021 Muscle aches and bone pain start19:30, 19Jan2021 resolved 23:00 20Jan2021 Severe headache starting at 19:30 19Jan2021 resolved 11:00, 21Jan2021 mild cough starting at 19:30 19Jan2021 resolved 01:00 22Jan2021- Only treatment for all symptoms was rest and oral hydration
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| 45 | 2021-01-21 | fever, fatigue, headache | Headache, fever, fatigue |
| 45 | 2021-01-21 | chills, headache, malaise, night sweats |
Headache, muscle pain (extensive), joint pain (extensive), chills and then night sweats. Generalized...
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Headache, muscle pain (extensive), joint pain (extensive), chills and then night sweats. Generalized malaise
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| 45 | 2021-01-21 | headache, chills, fever |
Muscle cramps, fever, nausea, chills, headache , Pain in armpit Treated with Tylenol, ibuprofen ,...
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Muscle cramps, fever, nausea, chills, headache , Pain in armpit Treated with Tylenol, ibuprofen , and mucinex cold and flu
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| 45 | 2021-01-21 | fatigue |
R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Foll...
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R arm pain, fatigue after 1st shot. After second shot sinus pressure, started 1 hr after shot. Following day, r arm sore, fatigue sinus pressure continued. After second day, no more fatigue, sinus pressure but developed vertigo with nausea, vomiting and diarrhea.
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| 45 | 2021-01-24 | discomfort, skin warm |
About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and m...
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About 25 min after receiving the vaccine, I noticed a little tingling on my lips and my cheeks and my face felt heavy. I looked myself in the mirror, my face, cheeks and neck became very red like beet red and warm to the touch. I returned to the vaccine site and they observed me but the symptoms worsened, my eyes started getting puffy/ my cheeks started getting purple instead of red, and they sent me to the ER. At the ER they continued to monitor me and gave me IV Benadryl and IV Pepcid and IV steroids and said I had a delayed case of hives. Once I had all the IV medication the swelling went down and the hives on my arms and my back went away, the redness in my face and neck stayed until next day and I noticed after taking a warm shower the next day the redness returned on other parts of my body. I took a Benadryl. About after 2 days it was all resolved.
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| 45 | 2021-01-24 | throat pain, thirst, somnolence, malaise, headache, weakness, dizziness |
I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm,...
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I took the first dose of the Covid vaccine Saturday, Sunday I woke up with pain in my injection arm, the worse headache ever, feeling nauseous and my body was so sore. Throughout the day I felt weak, sleepy and got light headed and went to bed. I had no appetite but I was very thirsty. I didn?t eat Sunday. Today (Monday) I woke up with those same issues and more. I have a sore throat it feels tight, I?m dizzy and just feel sick all around and still have no appetite but I?m thirsty and my finger tingle.
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| 45 | 2021-01-24 | chills, chills |
She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had bod...
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She had her second vaccine on 1/20/21 in her right arm. She noticed chills but no fever. She had body aches. Swelling in arm pits. Tightness in right chest and back. She did a lot of driving and arm went numb, but gone now she is home. Swelling in arm still there.
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| 45 | 2021-01-24 | fatigue, malaise, headache |
Symptoms started 6-10 hours after receiving my second vaccine dose. Symptoms included, malaise, head...
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Symptoms started 6-10 hours after receiving my second vaccine dose. Symptoms included, malaise, headache, body aches and fatique. Symptoms resolved after approximately 30-36 hours.
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| 45 | 2021-01-24 | body temperature increased, fatigue, somnolence |
Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours...
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Thursday 1st day sore arm, 3pm Friday; my arm hurt, I couldn't stay awake-exhausted, I slept 3 hours and woke with a fever 100.3 treated with Tylenol. Saturday, fever 100.0 most the day and was tired. Sunday felt better. Today better.
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| 45 | 2021-01-25 | fatigue, weakness, sweating |
I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating a...
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I felt mostly fine all day. A little tired and my arm was sore. About 4:45pm, I started sweating and getting really hot. I felt like I might need to use the restroom (soon) and I was at the grocery store. So, I immediately left. My house is 5-7 minutes from the store. During this time, I experienced terrible pains in my stomach and lower abdomen. I barely made it through my door and had to run to my bathroom. I experienced diarrhea like I?ve never experienced in my life. It was painful and explosive. This lasted about 30 minutes on and off. Mostly on. Once I cleaned myself up, I was very tired and weak. I felt nauseous this entire night but have not had any other episodes. I also have not invested anything except water since this happened.
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| 45 | 2021-01-25 | dizziness |
Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out...
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Immediately after 2nd injection, mouth tingling, felt cold like she might pass out. Never passed out. Felt better minutes later. Reports rash to body 2 weeks after 1st injection.
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| 45 | 2021-01-25 | dizziness, chills |
Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for...
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Patient received her first dose of the Pfizer vaccine and appeared well. Patient was told to sit for 30 min to monitor for reaction. After 5 min, patient reported feeling dizzy, tongue feeling slightly swollen, chills, slight difficulty swallowing her own saliva. She denied difficulty breathing, racing heart. NP on site notified, who performed a focused assessment and administered 50 mg IV Benadryl IM. Patient was reassessed and monitored by NP and two RN. Patient reported instant symptom relief within 2-4 min, that her chills went away and no issues swallowing and felt "90%" better. After 15 mins patient reported she was feeling symptoms again come back. Patient was escorted to the ED with NP and RN immediately.
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| 45 | 2021-01-26 | body temperature increased, headache | Extreme headache, 101 temp. Reactive lymphadenopathy at clavicle on side of injection. |
| 45 | 2021-01-26 | weakness, fatigue, fever, headache | Fever ranging from 102-104, headache, fatigued, weak, body aches |
| 45 | 2021-01-26 | weakness, migraine, chills, fever |
I'd heard about these side effects, was more than I expected, couldn't go to work that day since I w...
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I'd heard about these side effects, was more than I expected, couldn't go to work that day since I was in bed with side effects. Felt like more than any vaccine I'd received in my life, so decided to report just since this is a new vaccine. About 10 hours after vaccine, chills and fever started, fever up to 101, body weakness, lack of appetite, headache/migraine. Insomnia that night, up all night due to symptoms. . All symptoms except migraine resolved over the next 24 hours. Migraine continued so I took 50 mg imitrex x 3 over the course of the next 36 hours until that finally resolved . So all symptoms gone after around 2.5=3 days.
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| 45 | 2021-01-26 | dizziness |
Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR ...
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Reported feeling dizzy, lightheadedness adn tingle and thick in the throat. BP 135/65 SP02100%, HR 66 bpm. Given apple juice and didn't feel lightheadeness or tnling. Then expressed waves of episodes reported by the patient. Monitored for 117 minutes. PRovider called 1 hour after monitoring symptoms that were not worsening. Still felt shakey. Given option to go to ED or be transported by ambulance. Went via ambulance to ED. Did not receive any additional treatment in the ED. ED noted that it did not appear to be anaphylactic reaction.
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| 45 | 2021-01-26 | fatigue | Systemic: Exhaustion-Medium, Systemic: Fainting-Medium |
| 45 | 2021-01-26 | dizziness, fatigue, headache, influenza like illness |
headache; aches all over my body similar to how you feel with the flu; aches all over my body simila...
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headache; aches all over my body similar to how you feel with the flu; aches all over my body similar to how you feel with the flu; very tired for 2 days; One week after the second shot I felt dizzy on two occasions; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose on the left arm for COVID-19 immunization. The patient's medical history included hypertension, anxiety, degenerative arthritis and allergies: sulfa. The patient's concomitant medications were none. The patient previously took the first dose of BNT162B2 on 22Dec2020 09:30 at right arm for COVID-19 immunization and experienced headache and mild arm soreness. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After the second shot by 12:00, patient had a headache, in the middle of the night on 05Jan2021 patient started with aches all over her body similar to how you feel with the flu. The aches lasted for 2 days. Patient was also very tired for 2 days. One week after the second shot she felt dizzy on two occasions. No treatment received. Outcome of the events was recovered in Jan2021. Information about lot/batch has been requested.
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| 45 | 2021-01-26 | dizziness, sweating, headache |
intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; p...
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intermittent dizziness; felt a "closing in" sensation/brain fog; pulse and blood pressure went up; pulse and blood pressure went up; severe headache; hot flushing; chest tightness; started getting pale; sweating; peripheral perfusion worsened; palpitations; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), intramuscular in left arm on 31Dec2020 at 08:15 AM at a single dose for COVID-19 immunization in a workplace clinic. Medical history included mild asthma and known allergies to bee stings. There were no concomitant medications. Within a few minutes of the vaccine on 31Dec2020, the patient felt a "closing in" sensation and then her pulse and blood pressure went up. She developed a severe headache and hot flushing with chest tightness. The medical team gave her epinephrine in right thigh and she felt a bit better. Then she started getting pale, sweating, and peripheral perfusion worsened so she was given a second dose of epi. She started feeling better, but had a headache, palpitations and "brain fog" for about 5 days after and she still having intermittent dizziness (unspecified date). The patient received epinephrine IM and benadryl IV push for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient recovered from the events with lasting effects. The patient had not yet recovered from the event dizziness, while the patient recovered with sequelae for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: The reported events were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | fever, shortness of breath |
joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irrita...
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joint pain/still having joint pain and muscle aches in her knees and lower legs; It is mainly irritating; still having joint pain and muscle aches in her knees and lower legs; body aches; a fever for about 3 days; feeling heaviness in her chest; She was chocking it up to anxiety; This is a spontaneous report from the contactable nurses (one is the patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration, on the right deltoid, on 04Jan2021 at a single dose as she wanted added protection (Covid-19 immunization). The patient medical history was not reported. The patient has no heart issues but has a family history of heart disease. The patient's concomitant medications were not reported. The patient was asking if it is okay to take second dose after experiencing side effects of fever, body ache, joint pain, probably anxiety, chest heaviness 8-10h after (not wheezing, 98% O2 saturation) which returned next day and subsided. On 04Jan2021, the patient got her first dose of the Pfizer COVID Vaccine, she was one of the lucky people who had joint pain, body aches, and a fever for about 3 days. She noticed about 8-10 hours after she got the vaccine that she started feeling heaviness in her chest, chest felt tight and heavy; not shortness of breath, harder to take a deep breath. She had no wheezing. In Jan2021, her oxygen level was 98%. She was chocking it up to anxiety in Jan2021. It went away. She had it the same day and the next day intermittently. It was short and passing. She is still having joint pain and muscle aches in her knees and lower legs. It is intermittent and mainly at night. She is supposed to get the second dose next Friday and asking should she go ahead and get the second dose. The joint pain had went away intermittently on Tuesday, then hit her harder on Wednesday. Thursday she felt okay but the Friday again was having the pain. It is still occurring. It is mainly at night. In the day she feels okay. It is when she lays down to relax that it kicks in. It is mainly irritating but she would say it is medically significant as it has lasted for a while, almost 2 weeks now and she is still having issues. She takes 1000mg of acetaminophen (TYLENOL) to knock it out. The heaviness in her chest lasted about 1.5 hours the first day, and then went into Tuesday intermittently. The patient recovered from anxiety in Jan2021, body aches and fever on 07Jan2021, heaviness in her chest recovered on 05Jan2021, while other events were not recovered. The reporter assessed the events of Joint pain and muscle aches in her knees and lower legs, and irritating as medically significant. The reporter causality of the events for joint pain and muscle aches in her knees and lower legs, body aches, fever and heaviness in her chest were related to the suspect drug, causality for other events was not reported. Information about lot number/batch number was requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of events of Joint pain and muscle aches in her knees and lower legs and irritating. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | discomfort |
lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on ...
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lymph node swelling in axillary area on the injection side; lymph node swelling in axillary area on the injection side and it's painful; This is a spontaneous report from a contactable nurse and other hcp (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number: EL1283, expiry date: unknown), via an unspecified route of administration on 11Jan2021 09:00 at single dose (left deltoid) for COVID-19 immunization. There were no medical history and concomitant medications. On 12Jan2021, patient had lymph node swelling on the same arm as the injection site. It got worse on the 13th. She described her experience as uncomfortable. She was asking how long it is expected to last. It was further reported that the patient received first Covid-19 vaccine on 11Jan2021 and is doing well, but had lymph node swelling in axillary area on the injection side and it's painful on 12Jan2021. She wanted to know how long it will be like that and if it doesn't go away when should she seek medical attention. Received the vaccine on the 11th and a couple days later had the lymph node swelling. She then clarified lymph node swelling started the 12th. Mentioned it got worse yesterday and it's staying about the same today with the swelling and is very uncomfortable (Jan2021) and is persisting. Causality not provided. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in the past. Vaccination Facility Type was Clinic. The outcome of the events was not recovered. Events reported as medically significant.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events swollen lymph nodes and lymph node pain. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-26 | headache |
mild arm soreness that lasted a few days; headache; This is a spontaneous report from a contactable ...
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mild arm soreness that lasted a few days; headache; This is a spontaneous report from a contactable nurse (patient). This 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 22Dec2020 09:30 at single dose on the right arm for COVID-19 immunization. The patient's medical history included hypertension, anxiety, degenerative arthritis and allergies: sulfa. The patient's concomitant medications were none. No other vaccine received in four weeks. Facility type vaccine was workplace clinic. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After first shot given at 09:30 by 12:00, patient had a headache and mild arm soreness that lasted a few days. No treatment received. Outcome of the events was recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-01-27 | body temperature increased, fatigue, dizziness |
5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphad...
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5 days after the first shot(12/24/2020), I started feeling extremely fatigued. I had axilla lymphadenopathy, dizziness, nausea, joint pain, muscle pain and periods of tachycardia when standing. This lasted for 7 days. The lymphadenopathy was diagnosed in a routine mammogram/ultrasound screening 9 days after the vaccine. I finally started feeling better the week I was scheduled to receive my second shot. I got my second shot on 1/14/2021. Within 12 hours, I had a 101 fever and muscle aches. I also had axilla lymphadenopathy. Within 3 days, I was feeling better, however about 8 days post vaccine, I started to experience bouts of tachycardia and dizziness again. As time progresses, these symptoms are slowly improving.
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| 45 | 2021-01-27 | fever, headache, dizziness, cough, chills, shortness of breath |
COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patie...
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COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK570), via an unspecified route of administration in the left upper arm on 21Dec2020 at a single dose for COVID-19 immunization. Medical history was none and there were no concomitant medications. The patient stated that she felt yucky afterwards on 23Dec2020, experienced shortness of breath on exertion and coughing on 26Dec2020; chills, dizziness, headache, muscle pain, body aches, fever on 28Dec2020; loss of taste, loss of smell and COVID-19 pneumonia on 07Jan2021. All the events were reported as being medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 29Dec2020. Therapeutic measures were taken as a result of COVID-19 pneumonia and included: started on bronchodilator, cough elixir, steroids and azithromycin (ZITHROMAX). The outcome of muscle pain, body aches and COVID-19 pneumonia was recovering and of loss of taste and loss of smell was not recovered. The causality of the suspect vaccine to the events was reported as related.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
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| 45 | 2021-01-28 | headache, chills |
26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th...
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26th January 2021-after the injection-she became foggy funny headed for about an hour-her words 27th January 2021-Chills, nauseated 28th January 2021-Body aches, left deltoid area extra tender, nauseated, HA, she has a history of migraines 29th January 2921-A lot better today she took Tylenol for her symptoms-told to go to the ER if her symptoms get worse, PCM if she needs to
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| 45 | 2021-01-28 | throat irritation, dizziness | feeling of throat closing/HTN/drop in O2 sat, itchy throat dizziness |
| 45 | 2021-01-28 | fatigue, headache |
severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report f...
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severe muscle weakness; tremors all over the body; fatigue; headache; This is a spontaneous report from a contactable Other HCP reporting for herself. A 45-year-old female patient who was not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: WHO142), via an unspecified route of administration on 05Jan2021 11:30 at single dose in Left arm at the hospital for COVID-19 immunisation. Medical history included Wolff-Parkinson-White (WPW) syndrome from an unknown date. There were no known allergies. Concomitant medication included Multi Vitamin in two weeks. The patient did not receive other vaccine in four weeks. The patient had a mild headache within 2 hours on 05Jan2021. She started next day with headache and fatigue, on 06Jan2021. 3 days later (on 08Jan2021) severe muscle weakness and tremors all over the body. The adverse events (AEs) were resulted in Emergency room/department or urgent care, Hospitalization, the patient was hospitalized for AEs for 5 days. This was day 11 and she was still having the systems. She was released and now seeing a Nuero at (facility name) for additional treatment. The patient underwent lab tests and procedures which included COVID test type post vaccination=Nasal Swab: negative on 09Jan2021. The patient was not recovered from reported AEs.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events headache, fatigue, muscle weakness and tremor. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-01-31 | fever, headache, fatigue | nausea, emesis, syncope, as well as extended tiredness, headache, joint pain, fever |
| 45 | 2021-01-31 | fever, headache |
nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling an...
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nausea; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; left upper arm/underarm/breast swelling and pain; headache; body aches at the slightest touch; fever; loss of appetite lasting 4 days; left upper arm/underarm/breast swelling and pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiration date not provided), intramuscular in the left arm on 14Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and hypothyroidism. The patient is not pregnant. The patient has no know allergies. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 02:45, the patient experienced nausea, left upper arm/underarm/breast swelling and pain, headache nothing would take away, body aches at the slightest touch, fever, loss of appetite lasting 4 days and still with nausea, loss of appetite and headache. Treatment was not provided in response to the events. The outcome of the events was recovered with sequelae on an unspecified date in Jan2021. The patient has not been tested for COVID post vaccination.
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| 45 | 2021-02-02 | headache, weakness, fever, influenza like illness, fatigue |
Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in...
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Flu like symptoms: started getting week and tired. Went to bed about 11pm and could barely get up in the morning at 4:30 am. Headache, low grade fever of 99.7, achy all over, a bit of nausea.
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| 45 | 2021-02-02 | dizziness |
Patient refers that He started to feel dizziness and loss of consciousness, was evaluated for parame...
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Patient refers that He started to feel dizziness and loss of consciousness, was evaluated for paramedics who took her blood pressure having 80/50, Patient recovered, felt better and didn't wanted to go to the hospital.
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| 45 | 2021-02-03 | headache, fatigue |
Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; St...
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Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; Stage 3 kidney failure; High/Increased blood pressure; Outbreak of genital herpes; Hip pain bilateral; Extreme fatigue; on and off headaches/Intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history ongoing included sickle cell trait (diagnosed as a child, sickly as a child, found out in 2016. It was reported that patient has the sickle cell that mimics the disease), ongoing high blood pressure, and ongoing genital herpes, and pre-diabetes, all diagnosed prior to vaccination, and 'blood pressure'. Concomitant medication included chlorthalidone from 2018 and ongoing for 'blood pressure'. It was reported that patient got her first dose of Covid vaccine on 04Jan2021. Patient stated that she has been experiencing some effects, started maybe 2 days after, she began experiencing fatigue (06Jan2021). Patient also stated that she has genital herpes diagnosed before the vaccine, and stated that she usually doesn't have an outbreak unless there is extreme stress on body. On 08Jan2021, patient clarified she experienced a genital herpes outbreak and thought that it may associated. Patient stated that she treated it with valaciclovir (VALTREX) and some cream and it went away. States that she had another outbreak after, treated it again, and it went away and now she is struggling with another outbreak of genital herpes. Patient also reported that she has on and off headaches (also reported as intermittent headaches) on 04Jan2021, states this could be due to her high/increased blood pressure which she first experienced on 14Jan2021 (as reported). Patient mentioned that her blood pressure has been higher than it ever has been after the vaccine. Patient also stated that she noticed that after the vaccine it was out of control, that she got a blood pressure cuff and it was 149/103, she contacted her nephrologist, stated she is treating it with her usual diuretic and the doctor just prescribed her amlodipine (NORVASC). Patient further stated that she is still struggling to get the diastolic blood pressure in the 90s, stated this is abnormal for her. Also is experiencing severe hip pain bilateral on 08Jan2021 after the vaccine. Patient further reported that she was a little over weight - usually about 150 sometimes 162 around this time she was 162. Patient clarified that her current weight is 159.2 and stated that she was diagnosed with sickle cell trait and stated that she has the kind that mimics the disease and will have a lot of side effects of sickle cell disease. Patient further added that she also has stage 3 kidney failure on 18Jan2021 due to either her high blood pressure or sickle cell trait and is also pre-diabetic. Patient also thought that the outbreak was associated with stress on body. Patient wanted to know if she refuses the second vaccine, if the first vaccine will do anything. Outcome of the events 'Stage 3 kidney failure', 'High/Increased blood pressure', 'Outbreak of genital herpes', and 'on and off headaches/Intermittent headache' was not recovered, outcome of the event 'extreme fatigue' was recovered on 06Jan2021, outcome of the event 'hip pain bilateral' was recovering, outcome of the remaining events was unknown.; Sender's Comments: The reported stage 3 kidney failure was due to either the pre-existing high blood pressure or sickle cell trait or prediabetic condition, and was unrelated to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).
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| 45 | 2021-02-03 | dizziness |
impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more...
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impairing her from driving/ bothering her while driving; panic; nauseous; increasingly more and more dizziness with visual disturbances; increasingly more and more dizziness with visual disturbances/She feels things are moving that aren't; This is a spontaneous report from a contactable physician, the patient. A 45-year-old female physician received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK9231, Expiry: Apr 2021), intramuscularly in the left deltoid on 30Dec2020 at 16:30 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included heartburn. Concomitant medications included (dexlansoprazole) DEXILANT for heartburn from an unspecified date (reported as a year and a half). The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced dizziness with visual disturbances. She was having increasingly more and more dizziness with visual disturbances where today (20Jan2021) she felt nauseous from that. It was impairing her from driving because she felt things were moving that weren't and made her panic on the interstate, as of an unspecified date. It. Initially it was bothering her while driving, but now she noticed it while sitting at her desk or when she ate. It was all the time now. The reporter assessed the events "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" as being between disabling and medically significant. The patient did not visit the emergency room or a physician's office, although stated it probably did require it. The patient queried whether to receive the second dose today as her symptoms were worsening. The clinical outcome of "increasingly more and more dizziness with visual disturbances/she feels things are moving that aren't" was not resolved, and of nauseous, "impairing her from driving/ bothering her while driving" and panic were unknown.; Sender's Comments: Based on a compatible temporal relationship causality between events dizziness with visual disturbances and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-02-03 | fatigue | sore arm, fatigue, body aches Narrative: |
| 45 | 2021-02-04 | head discomfort |
In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicate...
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In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some "pressure in her head" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.
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| 45 | 2021-02-04 | dizziness, headache |
Patient states that her physician advised against second dose. She states she had a severe headache ...
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Patient states that her physician advised against second dose. She states she had a severe headache for days following vaccine, she collapsed at work and was hospitalized for a few days. She also reports ongoing dizziness. All information was left in a private message sent to the health departments social media page. Further requests for information have been unsuccessful thus far.
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| 45 | 2021-02-07 | dizziness |
Monitor 9RN) checked on pt at 15 min check. Pt stated to RN that she was feeling warm, lightheaded ...
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Monitor 9RN) checked on pt at 15 min check. Pt stated to RN that she was feeling warm, lightheaded and slightly dizzy. POD leader + supervisor was informed. Supervisor informed EMS staff of current situation. Pt was monitored for 15 min more at that time water was given + vitals were taken. BP 140/75, HR 105,SPO2 94% RA & 20 respirations. 09:15 Pt reassessed by (RN) & (EMS), pt showed no changes, and stated that she felt the same. Pt was removed to a private area to be further evaluated and await until squad arrived. Pt. also stated to staff that she typically experiences these symptoms whenever she takes in any form of nuts. Pt stated she does have an epipen injection. 0922 squad arrived. BP 148/90, HR 83, SPO2 99% RA, RR 20. Pt lung sounds were clear stated by EMS staff. Pt refused to be rescue by squad/ EMS but instead taken by her husband. Pt was informed that if anything went wrong on her way to TCH to call 911 right away. Pt agreed and was discharged at 0921AM.
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| 45 | 2021-02-07 | chills, malaise, headache, fatigue |
Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headac...
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Pfizer-BioNTech COVID19 Vaccine Severe symptoms following day: injection site pain, fatigue, headache, whole body muscle pain, chills, nausea, malaise. 2nd and 3rd day symptoms: left underarm swollen lymph nodes, injection site pain, headache, tiredness, slight nausea, slight muscle pain. Missed work 1 day, unable to drive 2 days.
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| 45 | 2021-02-08 | chills, fever, dizziness |
faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arriva...
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faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE). The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM. Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-09 | cough | Throat right and coughing a lot |
| 45 | 2021-02-09 | body temperature increased, weakness | tremors temp of 104.9 rash pain all over and little zings weak shaking immune system issues |
| 45 | 2021-02-10 | fever, respiratory tract congestion, cough, fatigue, headache |
Fever, cough, congestion, nausea, fatigue, headache, MS flare, hospitalized for MS flare, received h...
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Fever, cough, congestion, nausea, fatigue, headache, MS flare, hospitalized for MS flare, received high dose steroids for MS flare (4 days)
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| 45 | 2021-02-10 | fatigue, fever |
Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is...
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Mental fog; Soreness at injection site; Fatigue; Fever ( low grade: 1-2 degrees over basal); This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN 5318), via an unspecified route of administration on the left arm on 27Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included esomeprazole magnesium (NEXIUM), ibuprofen (ADVIL), beclometasone dipropionate (QNASL), diphenhydramine hydrochloride (BENADRYL) and doxylamine succinate (UNISOM). The patient previously took naproxen (ANAPROX) and experienced allergy. The patient experienced mental fog, soreness at injection site, fatigue and fever ( low grade: 1-2 degrees over basal) on 27Jan2021 18:00. No treatment and hospitalization was caused by the events. The outcome of the events was not recovered.
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| 45 | 2021-02-14 | chills, headache, nasopharyngitis, fever, fatigue, discomfort |
passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of ba...
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passing out; vomiting; tingling; severe pain shoulders; tingling/severe pain shoulders and all of back/torso, legs ached; tingling/severe pain shoulders and all of back/torso, legs ached; pain all over/torso; slight head ache; chills/cold; chills/cold; turned to temp 99.9; very warm/uncomfortable; fatigue; This is a spontaneous report from a non-contactable nurse (patient). This 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3249), via an unspecified route of administration on 29Jan2021 09:30 at single dose in the left arm for COVID-19 immunization. The patient's medical history was none. No known allergies. The patient's concomitant medications included naproxen (occasional) in two weeks. The patient previously took first dose of bnt162b2 (Lot number: EK9231), on 07Jan2021 at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine received in four weeks. Patient got vaccine at 9:30am. Woke up morning (30Jan2021) after the vaccine about 9:30am with tingling/severe pain shoulders and all of back/torso, legs ached. During shower at that time, very close to vomiting/passing out. Took NSAID and slept. Then paracetamol (TYLENOL) mid day. That evening had fatigue and pain all over, slight head ache, chills/cold and then turned to temp 99.9, very warm/uncomfortable. Paracetamol again that night before bed. Woke on Sunday better just fatigue and achy. No treatment received. No COVID prior vaccination. No COVID tested post vaccination. Outcome of the events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
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| 45 | 2021-02-16 | shortness of breath |
Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a co...
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Fainting; shortness of breath; hand spasms; nausea; vomiting; This is a spontaneous report from a contactable other health care professional (HCP) reporting for herself. A 45-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 45-year-old) on 13Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included penicillin allergy. Patient did not receive any other medications within two weeks prior to the vaccination. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On 16Jan2021 at 06:00 PM patient experienced nausea, vomiting, shortness of breath, fainting and hand spasms. Events resulted in Emergency room/department or urgent care. Patient was treated at emergency room (ER) with diphenhydramine hydrochloride (BENADRYL), Steroid and Anti nausea. Patient was not tested for Covid post vaccination. Patient recovered on unknown date in 2021 from the reported events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-16 | shortness of breath, fatigue |
injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (flutt...
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injection site pain; chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); chest discomfort (fluttering, thud feeling, tightness); shortness of breath; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. This 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247 and expiry date unknown) on 16Jan2021 at 11:00 via an unspecified route of administration into right arm at a single dose for COVID-19 immunization. The patient had known allergies to penicillin, erythromycin, garlic. Other medical history included asthma. She was not pregnant. The patient had not had COVID prior to the vaccination. Nasal Swab (for COVID) tested on 19Jan2021 was negative. Concomitant medications in two weeks included venlafaxine and ceirizine hydrochloride (ZYRTEC). No other vaccine received in four weeks. The patient experienced chest discomfort (fluttering, thud feeling, tightness), shortness of breath, fatigue since 17Jan2021 11:00, and injection site pain since 01Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and formoterol fumarate;mometasone furoate (DULERA) as treatment for the adverse events. The patient had not recovered from the events.
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| 45 | 2021-02-17 | shortness of breath |
First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; U...
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First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; This is a spontaneous report from a contactable healthcare professional (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283, expiration date not reported), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication included cefalexin monohydrate (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY), and triamcinolone. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5760, on right arm, on 19Dec2020, and experienced urticaria and folliculitis with severe exacerbation after both vaccination. It was reported that on Jan2021, the patient was under successful treatment for urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; experience of rash and dyspnea on Jan2021 required steroids and epipen. Treatment included Prednisone course, epipen, and H2 blockers. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. It was also reported that the patient had first dose administration on 19Dec2020 and second dose administration on 12Jan2021. The patient was recovering from all events, except for "First dose administration on 19Dec2020 and second dose administration on 12Jan2021" with outcome of unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-17 | chills |
Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood oc...
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Nearly passed out; Postural Orthostatic Tachycardia Syndrome; icy like pulsation through my blood occurred; fell to the ground; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (not pregnant) received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Lot number: EL9261, via an unspecified route of administration on 06Feb2021 12:30 at single dose in Left arm for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history included anaemia, no known allergies. Patient had COVID-19 starting on 06Jan2021 and persisting through 16Jan. Her COVID symptoms were crushing chest pain, no fever, blood oxygen level never dropped below 98%. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. Patient was experiencing Postural Orthostatic Tachycardia Syndrome. Nearly passed out going to the toilet when she first awoke. An icy like pulsation through her blood occurred first thing this AM, day after the vaccine. She fell to the ground and called for her husband to help her. He gave her 500mg acetaminophen and aspirin. She slept. Same thing happened with pulse 140+, he measured, as she showered. They stopped the shower, she laid down and recovered. When she got up immediately the pulse rises to 120+. Adverse events started from 07Feb2021 08:30 AM. Therapeutic measures were taken in response to the events. The outcome of the events was not recovered. Covid was not tested post vaccination.
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| 45 | 2021-02-18 | throat irritation, cough |
Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlyi...
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Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.
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| 45 | 2021-02-21 | throat swelling |
1.5 hour post-vaccine throat swelling. Seen at anther hospital, tryptase drawn >2 hours after vaccin...
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1.5 hour post-vaccine throat swelling. Seen at anther hospital, tryptase drawn >2 hours after vaccine - results unavailable. Has not confirmed anything else after that.
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| 45 | 2021-02-21 | sweating, fatigue, fever, body temperature increased |
Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), ...
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Elevated temperature, feeling as though I was outside of my body during fever (quasi-dissociative), sweating and heat episodes (heat feels like it's emanating from from my neck/shoulder area). Additional SE's: pain at injection site, fatigue. Quasi-dissociative feeling resolved after fever stopped. At this writing, still having sweating episodes, pain diminished considerably, fatigue waxing and waning.
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| 45 | 2021-02-21 | chills, dizziness, fatigue |
Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-da...
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Sore arm, swollen arm pit lymph nodes -day 2 and now. Fatigue-day 2 til now. Nausea and dizziness-day 3. Chills-day 4.
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| 45 | 2021-02-22 | headache, chills, fever | fever, chills, joint pain, nausea, headache, overall pain, insomnia |
| 45 | 2021-02-23 | fatigue, dizziness, chills, fever, headache |
3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood ...
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3:30 am 2/19- Extreme body ache, headache; 8:00 am couldn't stand up, fever, chills, elevated blood pressure & heart rate, dizziness, complete fatigue and meltdowns and very high blood glucose . This lasted till 2/20 until around 5:30 pm
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| 45 | 2021-02-23 | dizziness, chills, body temperature increased |
Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated bloo...
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Waves of extreme nausea; chills; dizziness; Shakiness; Vomiting; elevated temperature; Elevated blood pressure; heavy burning sensation in my chest; extreme body aches; so dizzy I can barely stand; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 01Feb2021 15:00 at single dose for COVID-19 immunization. The COVID-19 vaccine was administered at Workplace clinic. Medical history included Migraine, anxiety. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), thyroid, naltrexone hydrochloride (NALTREXON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had Allergies to Erythromycin, morphine. The patient received the first dose of BNT162B2 via an unspecified route of administration at right arm on 08Jan2021 02:30 PM for COVID-19 immunization. The patient experienced Waves of extreme nausea, chills and dizziness, Shakiness, Vomiting and elevated temperature. Elevated blood pressure on 02Feb2021 15:15, After a week and a half in Feb2021, the patient had heavy burning sensation in her chest, extreme body aches, so dizzy she can barely stand. Events were assessed as serious with seriousness criteria-Disabling/Incapacitating. Adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Blood tests, electrocardiogram (EKG), chest X-ray on an unknown date in Feb2021 with unknown results, Nasal Swab Covid test on 02Nov2020: Negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 45 | 2021-02-23 | shortness of breath |
dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (bot...
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dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek5760, via an unspecified route of administration in the right arm, on 19Dec2020 17:00 at SINGLE DOSE for covid-19 immunization. The patient's medical history included urticaria and folliculitis: patient was under successful treatment for urticaria and folliculitis with near resolution. Concomitant medication included cefalexin (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC) and triamcinolone. The patient received BNT162B2 on 19Dec2020. Then on 29Dec2020, 12:00, severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); experienced rash and dyspnea requiring steroids and epipen. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. The patient was recovering from all events. Treatment for the events included Prednisone course, epipen, and H2 blockers. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between rash, dyspnea and suspect product cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 45 | 2021-02-28 | chills, headache, fatigue, dizziness |
Fatigue; chills; severe aches; headache; nausea; dizziness; This is a spontaneous report from a cont...
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Fatigue; chills; severe aches; headache; nausea; dizziness; This is a spontaneous report from a contactable other healthcare professional. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: El9262, via an unspecified route of administration on 26Jan2021 15:00 at single dose in the left arm for COVID-19 immunization. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: En1686 on 05Jan2021 15:15 in the left arm. Medical history included allergy to bacteria. Concomitant medication included hydrochlorothiazide, triamterene (MAXZIDE), bupropion, escitalopram oxalate (LEXAPRO), lorazepam and paracetamol (TYLENOL). The patient previously took erythromycin and experienced drug allergies. The patient experienced fatigue, chills, severe aches, everywhere, headache, nausea, dizziness on 26Jan2021 at 22:00. No treatment received for the events. The patient had no prior vaccinations and has not tested for COVID post vaccination. The outcome of the events was not recovered.
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| 45 | 2021-02-28 | headache |
Headache; Muscle fatigue; Lymph node pain; Left armpit; This is a spontaneous report from a contacta...
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Headache; Muscle fatigue; Lymph node pain; Left armpit; This is a spontaneous report from a contactable nurse (patient). A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: GL92113), intramuscular on 22Jan2021 at 14:15 at a single dose on left arm for COVID-19 immunisation. Medical history included depression, mitral valve regurgitation and hypercholesterolaemia from an unknown date and unknown if ongoing. The patient previously took guaifenesin;phenylephrine hydrochloride (ENTEX) and NOVICAINE and experienced allergies. The patient experienced headache, muscle fatigue, lymph node pain and left armpit on 22Jan2021. Treatment received for the adverse event was reported as No. The outcome of the events was not recovered.
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| 45 | 2021-03-01 | weakness, shortness of breath |
Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to s...
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Low oxygen SaO2 of 79-86% with exertion and during sleep leading to extreme weakness, inability to sleep and shortness of breath. In addition, swollen and painful lymph glands under both arms but worse in injection arm.
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| 45 | 2021-03-02 | dizziness |
dizziness; achiness behind my eyes for 16 days; This is a spontaneous report from a contactable heal...
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dizziness; achiness behind my eyes for 16 days; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration at the left arm on 14Jan2021 at 12:30 PM at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included penicillin allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK5730) on 26Dec2020 at 03:30 PM (at the age of 45 years old) at the left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. On 16Jan2021 at 09:00 AM, the patient experienced dizziness and achiness behind her eyes for 16 days. The patient did not receive treatment for the events. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 which included Nasal Swab: Negative on 31Jan2021. The outcome of the events was not recovered.
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| 45 | 2021-03-02 | chills |
had mild symptoms chills; body ache; This is a spontaneous report from a contactable nurse (patient)...
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had mild symptoms chills; body ache; This is a spontaneous report from a contactable nurse (patient). This 45-year-old patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route on 29Jan2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in April2020 and a positive COVID-19 test on 28Jan2021. Concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced mild symptoms, chills and body aches. On Saturday (30Jan2021) the patient didn't go to work. The patient was concerned because she found out after receiving the vaccine that she had COVID-19 when she received the vaccine. She wanted to know if there were any issues regarding her health with being positive and having gotten the vaccine. The outcome of mild symptoms, chills, and body aches was recovered on Sunday (31Jan2021). The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 45 | 2021-03-02 | chills, fever |
severe abdominal pain; low grade fever; body chills; had an appendectomy at the ER; This is a sponta...
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severe abdominal pain; low grade fever; body chills; had an appendectomy at the ER; This is a spontaneous report from a contactable consumer (patient). This 45-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EN5318), via an unspecified route of administration on 11Feb2021 15:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included magnesium, cannabidiol (CBD) and docusate sodium (COLACE) received within 2 weeks of vaccination. The patient previously took the first dose of bnt162b2 (lot number=EL1283) on 21Jan2021 15:00 in the left arm for COVID-19 immunization and experienced extreme muscle cramps in both legs. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. On 13Feb2021 19:00, patient experienced severe abdominal pain with a low grade fever and body chills. Patient visited her primary doctor the following day, and then went to the ER on day four of the onset of her symptoms. Patient had an appendectomy in Feb2021 at the ER. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for the adverse event included surgery to remove appendix. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab (post vaccination): Negative on 15Feb2021 and 16Feb2021. Outcome of the events was recovering. The report was assessed as serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021183649 same patient, different AE/dose
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| 45 | 2021-03-04 | night sweats, fever, chills, headache |
Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats a...
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Fainted; Fainted/aggravated it; chills; fever; Headache; body aches; All night woke up with sweats and burning; All night woke up with sweats and burning; All night woke up with sweats and burning; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in left arm on 20Feb2021 08:30 at single dose for covid-19 immunization. Medical history included Vasovagal synchope, allergy to Sulfa drugs. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), metoprolol. The patient previously allergy to cipro and levaquin. The patient previously received the first dose of bnt162b2 (Lot number unknown), at the age of 45-year-old, via an unspecified route of administration in left arm on 28Jan2021 15:30 at single dose for covid-19 immunization. About 11 hours after 2nd dose (20Feb2021 19: 30), the patient got extreme chills and fever, headache and body aches. All night woke up with sweats and burning. Fainted around 21Feb2021 06:00 (patient had vasovagal synchope so maybe aggravated it). No treatment received. The patient was no pregnant. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 45 | 2021-03-04 | shortness of breath |
chest pain; Shortness of breath; This is a spontaneous report from a contactable other health profes...
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chest pain; Shortness of breath; This is a spontaneous report from a contactable other health professional (patient herself). A 45-year-old female patient (non-pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Jan2021 (at the age of 45-years-old) in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient had no chronic illnesses and no allergies. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Other medications in two weeks was none. The patient previously took the first dose of bnt162b2 (Pfizer) on 21Dec2021 12:00 PM via intramuscular in left arm for COVID-19 immunization. The patient experienced chest pain and shortness of breath on 15Feb2021 01:00 (as reported). Clinical course: She took her second vaccine on 10Jan2021. Two weeks after the vaccine she was admitted to the hospital with chest pain and shortness of breath x2, one on 19Feb2021 (as reported) and the second time was 24Feb2021. On an unspecified date, all the blood works and CT (computerised tomogram) scan came back negative. She was a healthy individual until she took this vaccine. She also did Echocardiogram which came back negative. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). No treatment was received for events. Outcome of events were unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, chest pain and shortness of breath occurred 2 weeks following the second vaccine are more likely associated with coincidental medical conditions unlikely related to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 45 | 2021-03-04 | fever, dizziness |
rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This ...
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rash; Shingles; intense burning; intense dizziness; body aches; fever of 102.7; left ear pain; This is a spontaneous report from a contactable other health professional (patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3249), via an unspecified route of administration in the left arm, on 25Jan2021 at 15:30 (at the age of 45-years-old) at a single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib), tachycardia, and allergy to proton pump inhibitors. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included metoprolol tartrate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231) on 04Jan2021 at 11:00 (at the age of 45-years-old) in the left arm for COVID-19 immunization. The patient experienced body aches and fever of 102.7 on 26Jan2021, left ear pain in Jan2021, intense burning and intense dizziness on 01Feb2021, and rash and shingles on 02Feb2021. The events were reported as non-serious. The clinical course was reported as follows: The day after the vaccination, 26Jan2021, the patient had body aches intermittently (reported as: not bad) and then spiked a fever of 102.7 the evening of 26Jan2021. The pain (per family recollection: complains of left ear pain) started about 28Jan2021 or 29Jan2021, but intense burning, pain, and intense dizziness started on 01Feb2021 with diagnosis of rash and shingles on 02Feb2021. Therapeutic measures were taken as a result of all of the events, which included valacyclovir (MANUFACTURER UNKNOWN) and prednisone (MANUFACTURER UNKNOWN). The clinical outcome of body aches, fever, left ear pain, intense burning, intense dizziness, rash, and shingles was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 45 | 2021-03-07 | chills, fatigue, headache, fever |
arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is ...
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arm hurt worse than ever; extremely exhausted; headache; controllable chills; fever of 101; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 02Feb2021 10:30, at single dose, for COVID-19 immunization, at a school or student health clinic. Medical history included COVID-19 (prior to vaccination) and arm hurt, both on an unknown date. The patient was not pregnant at the time of vaccination and has no allergy to medications, food, or other products. Concomitant medication included ibuprofen and vitamins. It was reported that on 02Feb2021 at 14:30, about 4 hours after getting the vaccine, the patient's arm hurt worse than ever and she was extremely exhausted. On 02Feb2021, in the middle of the night, the patient experienced headache, controllable chills and had a fever of 101. No treatment was given for the events. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was not resolved. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.
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| 45 | 2021-03-07 | headache, chills, sweating, somnolence, fatigue |
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have verti...
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groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
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| 45 | 2021-03-07 | cough, throat irritation |
thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; S...
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thought she was going to die/She could have died; she couldn't speak/unable to speak very clearly; She lost her voice completely; coughing; itchy throat; very hoarse voice/her voice goes and comes; she got very dark in her face; She had an allergic reaction from the Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer (patient's mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on the right arm on 17Feb2021 10:46 at a single dose for covid-19 immunization. The patient medical history included renal failure which she has had since 17Feb2020 and she was on dialysis which started on 04Dec2020. She had had a prior renal transplant before which was on 12Aug2004. Concomitant medications included prednisone, nifedipine (PROCARDIA [NIFEDIPINE]), clonidine, sevelamer, tacrolimus, carvedilol and repaglinide; all were taken from an unspecified date for an unspecified indication. She was on current medication for that for the renal failure. However, at the time of the vaccine her regular medication was on hold, she did not take it because she wanted to do the vaccine. The patient's mother reported that on 17Feb2021 her daughter has been having a lot of difficulty, she couldn't speak, she can't speak properly, unable to speak very clearly. She lost her voice completely/loss of voice, coughing, itchy throat, very hoarse voice, her voice goes and comes, and she got very dark in her face. The patient's mother thought that her daughter was having a stroke. The patient's mother also thought that the patient was going to die. She added that her daughter went to the ER and she still has problems and she could have died. She had an allergic reaction from the Pfizer COVID vaccine. She took the Pfizer vaccine at 10:46 AM. She can't speak now if she does it strains her voice then she was more hoarse. She said after the vaccine this occurred about 30 or 45 minutes. The patient was terrified, she was frightened because she wasn't able to speak. She had coughing, itchy throat, unable to speak clearly. The patient stated that she was dying. They had to get her to the hospital and she stayed over night for observation. She was discharged the next day, she stayed over night because they gave her medications they had to watch and take her vitals and blood work and they came back normal it was just the hoarseness but she had a bad allergic reaction. They gave her a lot of medications to go home on. She said that on 17Feb2021 she went to the hospital and she was discharged home 18 Feb2021. They were doing an EKG, a chest Xray, blood work, those test were being done to make sure her respiratory was okay. She had no swelling, no enlargement or they would have admitted her but all of that was normal and she was discharged home on 18Feb2021 on Solumedrol, Albuterol, Pepcid, Benadryl, Claritin. She had a terrible allergy. She said she was not admitted to the hospital they kept her for observation and she stayed in the emergency room for observation. They gave her an EpiPen. They discharged her home with an EpiPen and Prednisone 40 mg for 4 days. She said that the doctor said if you have an allergy, go to the nearest hospital and that was all being done. She asked what happens now because the patient was supposed to get a second dose but the patient's mother doesn't think so since the patient was terrified. The patient's mother said the vaccine was causing a lot of big allergies up there. She confirmed that it was her daughter experienced. Coughing itchy throat, loss of voice, unable to speak very clearly, and her face was very dark. She said hopefully someone will get back to her. She said the loss of voice after so many days, it has been 7 days now and her voice that way frightens the patient's mother. The outcome of the events was unknown.
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| 45 | 2021-03-14 | somnolence, fever, fatigue |
being sleepy; tired; Body aches; low grade temperature; This is a spontaneous report from a contacta...
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being sleepy; tired; Body aches; low grade temperature; This is a spontaneous report from a contactable consumer reporting for herself. A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 25Jan2021 at 13:30 (at the age of 45 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 05Jan2021 at 12:00 (at the age of 44 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient did not experience any adverse events to previous vaccinations. Relevant medical history and concomitant medication were none. On 26Jan2021 in the evening, the patient experienced low grade temperature and body aches. On 28Jan2021, the patient experienced being sleepy and tired than normal. She said the sleepiness and tiredness has not lifted since she got the shot. She also said she gets tired anyway. The events did not result in an ER or physician's office visit. The outcome of the events low grade temperature, body aches, being sleepy and tired was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 45 | 2021-04-04 | fever, cough, headache, chills | Fever, muscle pain, chills, cough, headache |
| 46 | 2020-12-31 | shortness of breath |
Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated b...
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Pt endorses onset of 2.5 hours ago. Endorses associated rash, numbness, palpitations, and elevated blood pressure. She reports getting the COVID-19 vaccine this morning, and after having been given the vaccine developed elevated blood pressure, palpitations described as "her heart feels hot", shortness of breath, a diffuse rash, and some generalized numbness. Patient called EMS after her symptoms did not resolve on their own, who gave her 50mg of IV Benadryl and transported her to the ED. Received solumedrol and famotidine IV in ED. Erythema noted on neck Â
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| 46 | 2021-01-01 | chills, weakness, dizziness, headache |
Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driv...
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Acute onset of reactogenicity reaction as patient was leaving grocery store. Almost crashed car driving due to violent rigors. Single episode explosive diarrhea upon arrival home. Patient incapacitated on couch for 3.5 hours due to shaking chills, dizziness, headache, profound weakness, near syncope when attempting to get up. Patient unable to reach phone to summon help for over an hour. (phone was only 2 feet from patient).
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| 46 | 2021-01-01 | dizziness, throat swelling |
Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/1...
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Experienced dizziness, lightheadedness 1 hour post vaccine. Started to feel throat swelling on 12/18/20. Went to ED on 12/20/20. Not reported as serious adverse effect, but medical record labeled with moderate reaction. Diagnosis: vasovagal episode. Discharged stable.
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| 46 | 2021-01-02 | malaise, headache |
Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/20...
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Malaise and Unable to perform ADL, Hot flashes, Muscular pain, headache, Insomnia from 12/31-1/2/2021, peripheral tingling or numbness on 1/2/2021. Took 800 mg Ibuprofen BID to help with symptoms,
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| 46 | 2021-01-02 | headache, cough |
Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for obs...
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Started to lose voice and clearing throat- took benedryl as suggested , stayed an extra hour for observation, left on my own. Noticed face was swollen and red after showering- took photo. Cough and clearing throat like when I eat something I?m allergic to. Took another benedryl four hours later as well as Tylenol for headache. Ate dinner went back to sleep notice arm hurts a bit. Next morning 9 am face no longer swollen but arm hurting to the slightest touch. 4:30 pm still resting arm very painful . Headache and facial swelling under control. At no time did I have trouble breathing, slight itching
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| 46 | 2021-01-03 | fatigue, shortness of breath, headache |
Patient states she was advised by nurse that because it was intermuscular (triceps), it may be becau...
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Patient states she was advised by nurse that because it was intermuscular (triceps), it may be because she is experiencing a headache that lasted 36 hours, also fatigue for 5 days, also joint stiffness for 7 days and she states she felt very sore and stiff and had a hard time walking up and down stairs without feeling shortness of breath. Said she felt "run down". On day 8 (12/31) she felt a lump like a mosquito bite. Day 9 the injection site became red and became very hot to touch. No fever reported. She was advised to see a nurse and was advised it could be hypersensitivity and to report this. This happened on 01/02/2021
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| 46 | 2021-01-03 | dizziness |
Patient was feeling faint and placed on a cot with feet elevated above heart, vital signs were taken...
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Patient was feeling faint and placed on a cot with feet elevated above heart, vital signs were taken. Vital signs were as follows: BP was 109/74, Pulse 61. Provided cool wet cloth and water. Vitals were taken again: BP 120/84 and Pulse 73. Patient was placed in sitting position for 5 minutes, patient fully recovered and released.
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| 46 | 2021-01-03 | throat swelling | Throat swelling, urticaria |
| 46 | 2021-01-04 | shortness of breath, dizziness |
Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of...
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Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
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| 46 | 2021-01-04 | shortness of breath, throat swelling, headache, dizziness |
Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ...
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Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.
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| 46 | 2021-01-04 | fatigue, fever |
At 2pm, I felt very tired like I hadn't slept all night with warm rosy cheeks-low fever. I took an ...
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At 2pm, I felt very tired like I hadn't slept all night with warm rosy cheeks-low fever. I took an 800mg and went to bed, woke up the next morning feeling great with no reactions.
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| 46 | 2021-01-04 | fever, chills, headache |
At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen an...
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At about 10pm the injection site pain had radiated to my armpit and breast area. I took ibuprofen and tried to go to sleep. I was unable to sleep on my left side as normal. Around 12:30am I woke up cold, shivering violently, with a fever of 103.°3. My feet were also burning. I woke up around 2:30am. Fever was down to about 102.4°, feet were still burning and my face and eyes were swollen. I took more ibuprofen and put used cold compress on my eyes. Around 4:30am I woke up with abdominal pain and pain in my hips. Fever was lower, eyes were better but face still swollen and feet still burning. I called off work at that time. By about 8am fever broke and have just had an intense headache.
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| 46 | 2021-01-04 | headache, fatigue |
Began with headache in late evening on the 4th. Woke up with extreme nausea, headache, fatigue. Ha...
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Began with headache in late evening on the 4th. Woke up with extreme nausea, headache, fatigue. Has continued through the day of 5th.
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| 46 | 2021-01-04 | dizziness, shortness of breath |
Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; Thi...
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Dizziness; Shortness of breath; Tightness in throat; Blurred vision; Tingling in hands and face; This is a spontaneous report from a contactable consumer who reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 22Dec2020 at 06:40 (at the age of 46-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history and family medical history were both reported as none. Concomitant medications were reported as none. It was reported that history of all previous immunizations was unknown and that the patient had no previous adverse events following prior vaccinations. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any additional vaccines on the same date as BNT162B2. On 22Dec2020 the patient experienced "dizziness", "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face". The adverse events required a visit to the Emergency Room; however, the patient was not admitted to the hospital and was discharged from the Emergency Room. The patient stated that she had a reaction to the COVID-19 vaccine. She reported that she was in the Emergency Room and was still feeling dizzy after being released. The clinical course was reported as follows: "Started off with dizziness, shortness of breath, and then tightness in her throat. Also had blurred vision, and tingling in hands and face. Occurred 25 to 30 minutes after receiving the COVID-19 vaccine. Continuing to experience dizziness that comes in waves after being released from emergency room." The patient stated that she received the vaccine to protect herself and her family. She called to inquire what she could expect, and what her next steps were in terms of the dizziness. She was advised to follow-up with her healthcare provider. It was reported that there were no relevant tests. The clinical outcome of the event "dizziness" was not recovered/not resolved, while the clinical outcomes of the events "shortness of breath", "tightness in throat", "blurred vision" and "tingling in hands and face" were all unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 46 | 2021-01-04 | fatigue |
I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I start...
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I experienced Fatigue, chest tightness, and increased blood pressure the first 2 days. Day 5 I started having pain in my upper back, left side. The next day had increased discomfort and developed a rash. Today, it is extremely painful and spread from the upper back to across my left breast. My PCP agrees that it is Shingles. I am beginning a course of Valtex today, to lesson the severity of symptoms.
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| 46 | 2021-01-04 | fever, weakness |
Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no brea...
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Never pregnant, swelling and redness at injection site, Nausea in the morning, slight fever, no breathing difficulties, and weakness. Tylenol helped.
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| 46 | 2021-01-04 | fever, sweating |
Thyroiditis with hyperthyroidism: 5 days after vaccine developed sweats, 10 days after the vaccine (...
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Thyroiditis with hyperthyroidism: 5 days after vaccine developed sweats, 10 days after the vaccine (1/1/21)developed fevers and right sided neck pain, tachycardia, myalgia
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| 46 | 2021-01-04 | chills, headache |
chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report...
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chills; bad headache; body aches; She felt cold; Her arm felt so heavy; This is a spontaneous report from a contactable other health professional reporting for herself. A 46-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), intramuscular in arm right, on 28Dec2020 morning, at single dose, for COVID-19 immunisation. Medical history included COVID-19 from the end of May2020 to unknown date in 2020 (not ongoing) and ongoing hypertension. Concomitant medication included losartan (LOSARTAN) from an unspecified date and ongoing, for hypertension. On 28Dec2020 evening, around 08:00 or 09:00 PM, the patient experienced chills with outcome of recovering, bad headache with outcome of not recovered, body aches with outcome of recovering, she felt cold with outcome of recovering, her arm felt so heavy with outcome of recovered in Dec2020. Therapeutic measures were taken as a result of bad headache and included laying down, ice on her back and neck. The second dose is scheduled on 18Jan2020.
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| 46 | 2021-01-04 | dizziness |
feeling like motion sickness, light headed/unbalanced which is causing nausea, when in sitting posit...
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feeling like motion sickness, light headed/unbalanced which is causing nausea, when in sitting position on couch i feel fine. too much movement gets me nausea and feeling light headed
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| 46 | 2021-01-04 | fever, chills, fatigue | fever, body aches, chills, fatigue |
| 46 | 2021-01-04 | dizziness |
flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (pa...
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flushing; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female (not pregnant) patient received BNT162B2 (lot number EH 9899) first dose intramuscularly on right arm on 30Dec2020 09:30 AM at single dose for COVID-19 immunization. Medical history included HTN/GERD, allergies to pineapple and sulfa. Concomitant medications in two weeks included diltiazem (CARDIZEM), valsartan (DIOVAN), omeprazole (PROTONIX), meloxicam (MOBIC), docusate and bupropion hydrochloride (WELLBUTRIN). No other vaccine in four weeks. Patient experienced flushing, chest pressure and lightheadedness on 30Dec2020 09:30 AM, resulted in: Emergency room/department or urgent care and received treatment as ER evaluation. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovered in Dec2020. The seriousness was reported as no.
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| 46 | 2021-01-04 | headache |
ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient...
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ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of bnt162b2 (Batch/lot number: EH9899), via an unspecified route of administration (reported as one injection to left arm) on 16Dec2020 at a single dose for COVID-19 vaccination. Medical history included allergy. Concomitant medication included prednisolone acetate (PREDNISOLONE ACETATE, Manufacturer: Pacific Pharma. NDC: 60758119-05, Lot: E88990, Exp. date: Feb2023) 1%, four eyedrops a day until she is out, 7 days at most or a week for allergy. The nurse called as a patient about the Pfizer COVID-19 vaccine, which she received on 16Dec and had a headache - only a slight headache, the day after and ringing in her ears that has not gone away. She says it was her first injection of the vaccine. The patient says she was given the vaccine through her work, and says she had a headache that evening and then a slight headache the next day. She says that the ringing in the ear, she noticed the next day in the morning. She says it is hard to tell if the ringing is just one ear or not, the ringing is staying about the same, and is more in her right ear. She says she has not had treatment for either the headache or the ringing in her ears, and the headache improved on its own. She had no new medications and didn't receive any other vaccines when she got this one. She says that she went to the eye doctor in the past week and he started her on eye drops, she has never been on prednisone for allergies, and for her eyes he gave her prednisone drops and allergy drops. She says she started that medication on the evening she got it, Monday 21Dec. She would like to know if there could be some type of allergy, she doesn't know if she should take the second dose of the vaccine. She says she doesn't know if there is something she should do for the ringing in her ears, like a common treatment or anything, or if others have been reporting this. She says she saw on the website that one side effect said ringing in ears, but she isn't sure if the website was either of those provided by call handler for further information. The outcome of the events slight headache was resolving while ringing in the ears had not resolved.
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| 46 | 2021-01-04 | malaise, headache |
severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injec...
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severe intractable headache; photo sensitivity; generalised body malaise; pain & tenderness in injection site; nausea; This is a spontaneous report from a contactable physician. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 23Dec2020 01:00AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. The patient medical history was not reported. Concomitant medication included folic acid, ascorbic acid (VIT C), tocopherol (VITAMIN E), Multivitamins. The patient previously took metronidazole and experienced drug allergy, NTG and experienced drug allergy. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe intractable headache, photo sensitivity, generalised body malaise, pain & tenderness in injection site, nausea on 23Dec2020 12:00 PM. Patient received Tylenol, neurofen and rest as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The events were reported as non-serious.
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| 46 | 2021-01-04 | nasal congestion |
tested positive COVID; tested positive COVID; nasal congestion; loss of smell; This is a spontaneous...
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tested positive COVID; tested positive COVID; nasal congestion; loss of smell; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Expiration Date Mar2021), via an unspecified route of administration in her right deltoid on 19Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing Crohn's disease from 2007/ diagnosed at 33 years old. There were no other concomitant drugs. The doctor who received the COVID vaccine stated that she must had been exposed to the virus prior to receiving the vaccine because she became symptomatic 48 hours after getting the vaccine. She noted that on Pfizer website recommended that a person not get the vaccine until 6 weeks after active infection but she of course did not know she had been exposed and when her second dose was due, she would not be 6 weeks after active infections. The vaccine was received on 19Dec2020 and she tested positive on 22Dec2020. The only symptoms she had experienced after testing positive are nasal congestion and loss of smell and they started on 21Dec2020 in the morning. She had had no worsening of her Crohn's disease. The only testing she had had done was the PCR testing for COVID. No treatments for the symptoms at this point. The outcome of the events tested positive COVID was not recovered, while for other events was unknown.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination therapy and the event onset.
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| 46 | 2021-01-04 | influenza like illness, throat pain, nasal congestion, weakness, malaise |
tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-lik...
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tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included polycystic ovarian diseases from an unknown date. Concomitant medication included metformin, omeprazole, apremilast (OTEZLA). Patient stated she got the vaccine on the 18th. She took the vaccine on 20Dec2020. Yesterday (25Dec2020) she started to feeling sick and today (26Dec2020) patient got tested and she have Covid. She reported to have tested positive for COVID today (26Dec2020) with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms yesterday at around 4:00pm. This was the first time she has taken the Covid test. The physician stated she didn't know the causality between the event and vaccine. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive test for COVID based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 46 | 2021-01-05 | chills, runny nose, fever, cough |
12/23: developed soreness 12/30: developed runny nose, congestion, cough 12/31: fever 100 deg F and ...
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12/23: developed soreness 12/30: developed runny nose, congestion, cough 12/31: fever 100 deg F and chills
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| 46 | 2021-01-05 | dizziness |
24 hours after receiving COVID vaccine I began having symptoms of vertigo and dizziness in my L ear....
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24 hours after receiving COVID vaccine I began having symptoms of vertigo and dizziness in my L ear. Vaccination was given in the L deltoid.
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| 46 | 2021-01-05 | body temperature increased, chills, fever |
About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever a...
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About 3 hours after I received the vaccine, my arm started to hurt. Then I started running a fever and some chills, along with body aches. I felt nauseous. I started feeling cramping in my stomach. Yesterday, my temp was just 99.4, face was really red. Felt over heated all day long. When they gave me the shot, after 20 mins I could feel my right nostril burning, and like I could taste a metal taste and taste the actual shot. At 9am, my temp was 100. I took a tylenol.
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| 46 | 2021-01-05 | dizziness | Dizziness, flushing |
| 46 | 2021-01-05 | sweating, chills, dizziness, fatigue |
Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of ...
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Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription. Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.
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| 46 | 2021-01-05 | fatigue | Extreme fatigue and nausea. |
| 46 | 2021-01-05 | chills, dizziness, fatigue, headache, sweating |
Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not ...
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Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
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| 46 | 2021-01-05 | fever, chills | FEVER , ACHINESS CHILLS SEVERE JOINT PAIN |
| 46 | 2021-01-05 | chills, headache | Headache, Myalgia, Arthralgia, NauseaVomiting, chills/ pain inj site |
| 46 | 2021-01-05 | fatigue, chills, malaise, fever |
Injection site pain, redness at injection site, then followed by chills and fever. Injection site sw...
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Injection site pain, redness at injection site, then followed by chills and fever. Injection site swelling about 2" with fever and redness at injection site - lasted about 5 days. Also was feeling unwell, tiredness & muscle pain for a few days.
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| 46 | 2021-01-05 | shortness of breath, sweating |
Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms...
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Ongoing heart palpitations, breathlessness, tremulous hands, jittery feeling, sweating, PMS symptoms earlier and worse than usual. EKG showed PVCs.
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| 46 | 2021-01-05 | dizziness |
Patient received COVID-19 Vaccine 12/19/2020 at 7:30 am. Did well during the 15 minute observation ...
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Patient received COVID-19 Vaccine 12/19/2020 at 7:30 am. Did well during the 15 minute observation period. Upon returning home started to experience dizziness. Patient has history of (Persistent Postural Perceptual Dizziness (PPPD and Vestibular migraine.
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| 46 | 2021-01-05 | headache |
Received vaccination on right arm, the next morning felt radiating pain up to the neck and behind th...
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Received vaccination on right arm, the next morning felt radiating pain up to the neck and behind the ear. Was temporarily resolved with APAP and Advil
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| 46 | 2021-01-05 | fatigue | SkinRash, Rash, sevdere fatigue and facial hives |
| 46 | 2021-01-05 | dizziness |
c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to even...
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c/o l122/67, c/o lighted, itchy eyes, warm. She took Benadryl 50 mg at 0700 - 2 hours prior to event. 0900 - bp 126/70, hr 107, rr 20, sats 100 0905 - bp 122/67, hr 90, rr, 18, sats 100 0910 - bp 113/66, hr 81, rr 20, sats 100 - lightedness no longer present, she c/o of being cold, 0915 - dry throat that water helped. denied throat itching, states breathing wnl. 0915 - bp 120/80, hr 88, rr 20, sats 100 Pt reports that she feels better. She is off work today, but she will stay in the rt office with staff for 30 minutes before going home.
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| 46 | 2021-01-05 | fever | faver 102, body aches, joint pain after first dose |
| 46 | 2021-01-05 | dizziness, fatigue, weakness, headache |
muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; he...
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muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus. Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.
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| 46 | 2021-01-05 | shortness of breath |
rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician rep...
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rapid heart rate; shortness of breath; This is a spontaneous report from a contactable physician reported for herself. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date unknown) intramuscular at left arm on 27Dec2020 09:45 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroidism. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medications included levothyroxine from unspecified date for unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 27Dec2020 less than 5 minutes after receiving the vaccine, the patient developed rapid heart rate and shortness of breath. The patient has not been tested for Covid-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events rapid heart rate and shortness of breath was recovered in Dec2020. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
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| 46 | 2021-01-06 | chills, fever, headache, dizziness, weakness |
12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to inj...
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12 hours after vaccine I felt chills, headache, fever, dizziness, weakness, pain and swelling to injection site, body aches, lymph node swelling. 36 hours after, still have piercing headache, fever, body aches, lymph node swelling, weakness, on and off chills and dizziness.
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| 46 | 2021-01-06 | chills, fever |
Chills, fever, extreme body aches, nausea Ibuprofen 400mg taken every 4-6 hours. Fever broke after ...
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Chills, fever, extreme body aches, nausea Ibuprofen 400mg taken every 4-6 hours. Fever broke after 15 hours but returned within 4-6 hours. Easier to manage on second day with ibuprofen. Loss of appetite and nausea. Compazine taken forever nausea. Currently 50 hours post vaccination, had to miss work due to symptoms. Fever free for 12 hours , co tinge to have loss of appetite and body aches
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| 46 | 2021-01-06 | chills, headache, fever |
Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & nec...
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Day 1: strong ache in all joints, mild nausea, headache Day 2: swollen lymph nodes in left arm & neck, severe back ache low temp 99-100.3 Day 3: @ 0300 fever 101.5, chills (rigors 3hrs), very bad headache, neck pain, joints and lymph swelling. Had both regular and Rapid covid test and rapid was negative. Awaiting FLU swab and regular Covid test. Day 4: continued fevers 99-100.9, back and neck pain, milder headache.
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| 46 | 2021-01-06 | dizziness | Dizziness Left leg tingling intermittingly, BP163/107 HR 75, BP110/119 HR79 O2 98% |
| 46 | 2021-01-06 | sweating |
Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; Thi...
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Fainting; Red Palms; blotching; sweating profusely; heart palpitations; Chest pain; Elevated BP; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left arm (Lot number: ek9231) for COVID-19 immunisation. Medical history included asthma, bronchitis, mitral valve regurgitation, herpes, depression, ADHD. COVID prior vaccination: Yes. Known allergies: tramadol, milk products. No other vaccine in four weeks. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion, and, losartan/hydrochlorothiazide. The patient experienced red palms/blotching, sweating profusely, heart palpitations, chest pain and fainting, elevated BP, all on 28Dec2020 09:15. All these events required Emergency room visit. Therapeutic measures were taken as a result of the events included 50 mg of Benadryl, 60 mg of Prednisone, omepresol. No COVID tested post vaccination. Outcome of events was recovered with sequelae.
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| 46 | 2021-01-06 | fever, fatigue, headache | Fatigue, extreme headache, mild fever |
| 46 | 2021-01-06 | headache, chills, fever | Fever 36-48 hours Headache Chills Nausea Aches/ sore muscles |
| 46 | 2021-01-06 | chills, headache, fever | Headaches, body aches, fever, chills, x3 days |
| 46 | 2021-01-06 | fever, chills |
I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on...
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I had abdominal cramps, generalized that lasted for two days. On the second day, went to ER. Then on the 3rd and 4th day, I had chest pain radiating to left arm and jaw. Fever and chills reported 100.2 in fever. Severe right arm pain. I have difficulty lifting objects. I have recovered from the chest pain and abdominal pain but the arm pain is still bothersome and continues to be hurtful.
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| 46 | 2021-01-06 | headache, dizziness |
Patient c/o dizziness about 5 minutes post-vaccination. Denies SOB or CP. Transported to ED by drit...
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Patient c/o dizziness about 5 minutes post-vaccination. Denies SOB or CP. Transported to ED by dritical care transport team where she started to c/o headache upon arrival.
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| 46 | 2021-01-06 | shortness of breath |
Patient while waiting after receiving her second COVID Vaccine dose started to feel short of breath,...
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Patient while waiting after receiving her second COVID Vaccine dose started to feel short of breath, anxious and shaky. She was taken to the ED, where they took a set of vitals, listened to her lungs (clear) and completed an EKG.
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| 46 | 2021-01-06 | shortness of breath, dizziness, headache |
Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortnes...
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Pfizer vaccine 12/19. Reports intermittent dizziness, brain fog, severe headaches, nausea, shortness of breath, left axillary lymphadenopathy, elevated blood pressure which onset on 12/31. COVID-flu negative, normal labs, CT thorax and brain MRI negative. Has been to ED and is returning today due to continued symptoms. Reported symptoms to VSafe
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| 46 | 2021-01-06 | chills, dizziness |
Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antie...
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Presented to ER 12/23/2020 with Lightheadedness, chills, nausea, vomiting, rash. Iv fluids and antiemetics administered, pt reported feeling better. RX for Medrol Dosepak given.
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| 46 | 2021-01-06 | runny nose, chills | Received covid shot 1-4-21. Has chills, body aches and runny nose. |
| 46 | 2021-01-06 | respiratory tract congestion, cough, malaise, nasopharyngitis |
Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had...
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Received the Vaccine on a Monday morning, Next day started with a bad cold. By Tuesday night I had to use my inhaler, take cold/cough medicine to help me stop coughing. By Wednesday Had a bad cough, tightness in the chest, and lots of congestion. Left arm was very sore. Called work who told me to go to the ER for covid test. Tried to get into my doctor's office who would not see me and told me to get a covid test. Tried to get into Facility who told me I would require two appointments. One to see a doctor and another to get a Covid test. Also, it would be a three to four-hour wait. Felt so sick that I took myself to an ER in order to be seen. Mysaturation was good in the ER but HR was in the 120s. They did an EKG, gave me an albuterol inhaler, IV fluids, IV steroids, and a chest X-ray. They did a Covid test which was negative as well as other bloodwork. Then sent me home. My husband also started with a cold the Sunday night before my vaccine so I do not know if that might have been where I got sick?
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| 46 | 2021-01-06 | discomfort |
Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right ar...
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Shingles outbreak 5-7 days after infection in C6-C7 dermatome of left arm (injection was in right arm) limiting the use of this arm and causing excruciating pain and discomfort.
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| 46 | 2021-01-06 | fatigue, dizziness | Sore arm- lasted 3 days. Moderate intensity Fatigue- 24 hours Nausea and dizziness-2 hours |
| 46 | 2021-01-06 | shortness of breath, dizziness, weakness |
Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body a...
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Tingling in arm, vision was blurry, Dizziness, difficulty breathing, head spinning. Weakness, body aches, fast heartbeat. Speech slurred, jaw locking. Taken to ER where she works.
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| 46 | 2021-01-06 | sweating, malaise, dizziness |
Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin ...
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Within 30-45 minutes after injection, became ill with extreme dizziness, facial/neck swelling, skin pale, diaphoretic, c/o nausea with vomiting x1. Taken to ED. Treated with Benadryl 50mg IV, Zofran 4mg SL, meclizine 25mg PO, and 1 liter of 0.9% Normal Saline IV. Symptoms improved, discharged to home at 6pm.
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| 46 | 2021-01-06 | fever | fever 100.3, lymph pain, body aches |
| 46 | 2021-01-06 | headache, chills, fever | nausea, fever, body chills,headache, tx with Motrin |
| 46 | 2021-01-07 | runny nose, headache, cough | Chest tightness, headache, runny nose, mild cough. |
| 46 | 2021-01-07 | fever, headache |
Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Fa...
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Fine rash (almost petechiae appearance) upper body appeared 18 hrs post-injection - still present Facial flushing accompanying rash Severe body and joint aches appeared 18 hrs post-injection - responsive to ibuprofen-still present Severe headache appeared 16 hrs post-injection - responsive to Excedrin/Tylenol - still present Low-grade fever 100.1F (taken 3 hrs post ibuprofen)
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| 46 | 2021-01-07 | fatigue, headache | Headache, Fatigue- on day 2 Bels Palsy- Day 4 |
| 46 | 2021-01-07 | fever, headache, fatigue, chills | Headache, Myalgia, Fever, chills, fatigue Narrative: |
| 46 | 2021-01-07 | chills, headache | Injection site pain. Muscle pain. Joint pain. Chills. Headache. Eyes pain |
| 46 | 2021-01-07 | dizziness |
Pt began feeling lightheaded after receiving the vaccine. 1146: 100% 91 132/88 Pt was given water an...
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Pt began feeling lightheaded after receiving the vaccine. 1146: 100% 91 132/88 Pt was given water and asked to drink the whole bottle. Symptoms resolved. 1148 98% 70. 1150 126/84 96% 74
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| 46 | 2021-01-07 | fever | Reported temp.101F Resolved with Tylenol (99.9F) |
| 46 | 2021-01-07 | shortness of breath |
Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feelin...
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Shortly after receiving vaccination, patient experienced chest pressure, shortness of breath, feeling jittery and shaky. Oxygen saturation remained normal. Vital signs normal.
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| 46 | 2021-01-07 | fatigue, headache |
With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I co...
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With in my arm got soar. About four hours later I started getting a head ache and feeling cold, I couldn't get warm, I felt very tired. About the next thirty hours I had body ache and head ache my arm got very heavy and hurt, I did not run a fever but felt very restless and achy. I was very tired and didn't work the following day, didn't have much of an appetite. I had some mild itching on my arm.
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| 46 | 2021-01-07 | shortness of breath |
difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in ...
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difficulty breathing/swallowing; difficulty breathing/swallowing; Hives/hives all over including in her mouth; This is a spontaneous report from a contactable consumer (spouse). A 46-year-old female patient (wife) received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, lot number: EH9899) via unspecified route of administration at arm right on 29Dec2020 at single dose for Covid-19 vaccine. Medical history included ongoing anxiety diagnosed 22 years ago. Concomitant medications were not none. Patient received the vaccine and was one big hive (01Jan2021). She went to the ER on sat and will have to go back. Caller is asking where she should go. patient went through the VAERS report 3 times. She did not have any sides effects. patient is a frontline worker. On 29Dec2020 she got the Covid vaccine. On Sat 02Jan2021 she went the ER with hives all over including in her mouth, stated she had difficulty breathing/swallowing, was given medication to take home and discharged. She was readmitted yesterday 05Jan2020 with worsening symptoms and needed to be given a prednisone nebulizer. they had two ER visits. No Investigation Assessment. patient was not recovered from the event hives/hives all over including in her mouth, the final outcome of other events was unknown.
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| 46 | 2021-01-07 | fatigue, headache |
left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, sli...
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left arm pain and swollen lymph nodes in left arm pit generalized muscle aches, slight headache, slight fatigue started 12 hours after my second Pfizer dose, better with ibuprofen.
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| 46 | 2021-01-07 | fever, throat pain |
muscle aches, joint aches, sore throat, low grade fever; muscle aches, joint aches, sore throat, low...
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muscle aches, joint aches, sore throat, low grade fever; muscle aches, joint aches, sore throat, low grade fever; muscle aches, joint aches, sore throat, low grade fever; muscle aches, joint aches, sore throat, low grade fever; This is a spontaneous report from a contactable other hcp. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 29Dec2020 10:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included anxiety and food allergy from cashews from an unknown date and unknown if ongoing. Concomitant medication included paroxetine (PAROXETINE), cetirizine (CETIRIZINE), iron (IRON), vitamin d3 (VITAMIN D3) and magnesium (MAGNESIUM). The patient experienced muscle aches, joint aches, sore throat and low grade fever (non-serious) on 29Dec2020 18:00. The patient underwent lab tests and procedures which included body temperature: low grade fever on 29Dec2020. The outcome of event was recovered with sequelae. Information about lot/batch number has been requested.
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| 46 | 2021-01-07 | shortness of breath, throat swelling, throat irritation |
she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratc...
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she received vaccine at 8:30 am. At approximately 11:00 am she developed sudden onset hives, scratchy throat, swelling sensation of the throat, hoarse voice, difficulty breathing. Presented to the ED. Received IM Epi, IV Benadryl and Solumedrol.
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| 46 | 2021-01-08 | headache, chills, dizziness, fatigue, sweating, fever |
01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marath...
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01/07/2021 8:30PM-1st chills- Uncontrollable shaking for 2-3 hours.(felt like I was running a marathon in bed) Temp 99.5 9:30PM-Temp of 101 then it went to 102 within an hour. Headache. 10:30 took Tylenol 11:30 Temp 101.5 stopped shaking but still have a temp and muscle aches- probably from the shaking. 12:30 (01/08/2021) Temp 101. Fell asleep 4:30 Temp 100 8:30 Temp 99.5 Still have a headache and muscle pain, and upper back pain Tired, but probably just from roller coaster ride. 01/08/2021 Most of the day and night had low grade fever 99.5-100.7 , headache and sweats 01/09/2021 No Fever, but still have the occasional seats and dizziness
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| 46 | 2021-01-08 | dizziness | 1st Day- Arm Neck Pain 12/31/2020 Loss of Appetite, Dizzy-current |
| 46 | 2021-01-08 | headache, chills, fever | Chills, Headache, Nausea, and Fever |
| 46 | 2021-01-08 | dizziness |
Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizzi...
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Dizziness, NauseaVomiting, right arm mild soreness Narrative: 12/29 employee reports onset of dizziness and nausea about 2 hours after the vaccine. Her right arm is slightly sore. 12/30 - symptoms have improved and are very slight today. 12/21 resolution of all symptoms.
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| 46 | 2021-01-08 | fever, chills, headache, night sweats | Fever, chills, night sweats, swollen glands under arm, swollen injection site, body aches, headache |
| 46 | 2021-01-08 | headache | Headache aches, peeling fingertips Narrative: |
| 46 | 2021-01-08 | chills, headache |
Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating ...
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Headache, left arm numbness, mild left arm pain Injection site, moderate Myalgia, severe migrating joint pain, chills leading to rigors. No fever. Incapacitating.
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| 46 | 2021-01-08 | fatigue |
Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids,...
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Myalgia, NauseaVomiting, Left Arm pain, fatigue, sharp muscle pain, nausea Narrative: Rest, fluids, Tylenol and Motrin at home
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| 46 | 2021-01-08 | chills, headache, fatigue, fever |
Pfizer-BioNTech COVID-19 Vaccine EUA Fever (Tmax 101.3), generalized myalgia, chills, headache, fati...
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Pfizer-BioNTech COVID-19 Vaccine EUA Fever (Tmax 101.3), generalized myalgia, chills, headache, fatigue - these symptoms began to occur about 18 hours after the 2nd injection in the series and last about 18 hours. Treated successfully with ibuprofen. Feeling much better by the following morning with only fatigue.
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| 46 | 2021-01-09 | dizziness |
15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could fe...
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15 minutes and 21 seconds after shot was given, I felt suddenly very hot, lightheaded and I could feel my pulse escalating. Nurse in the post-shot monitoring tent took vitals to confirm pulse at 95, when typically 68. I was laid down and BP dropped to 110/78. Chest tightness that I am familiar with from asthma started to develop and my neck and throat and upper shoulders felt very tight and constricted. I had some trouble swallowing water as though my throat was constricted and my breathing felt shallow. Nurses provided care and I was asked to get up and sit in a chair again. Within a minute, I felt dizzy and disoriented again and heart rate went up. The tightness in my chest and throat and shallow breathing continued along with my voice becoming hoarse. The doctor on call asked if I?d had these symptoms before and I said I had after eating shrimp years ago. He decided to transfer me to the ER for monitoring . I stayed at the ER for about an hour and a half and was monitored. The constricted throat and asthma chest tightness did not subside but did not get worse. Doctor recommended Benadryl every 6 hours as symptoms persisted. Within a half hour of taking 25 mg of Benadryl, I started to feel improved breathing and less throat constriction and easier swallowing. After the second dose of Benadryl, symptoms were much 70% gone, except for hoarse voice abs very slight tightness with swallowing. I had informed the injection staff prior to receiving my vaccine that I am a person with a history of anaphylaxis (not to a vaccine) that required and epi pen and overnight hospital stay in the past .
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| 46 | 2021-01-09 | fever, fatigue | Arm soreness, myalgia, fever, fatigue |
| 46 | 2021-01-09 | fatigue, chills, headache, fever | Chills, feverish, headaches, muscle pain, joint pain severely fatigue lasted ~ 12 hours . |
| 46 | 2021-01-09 | nerve pain |
Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injectio...
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Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injection), radiates to the right neck and fingertips. Neuropathic, worse at night. Improves to a 3/10 with ibuprofen. No weakness/sensory loss.
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| 46 | 2021-01-09 | chills |
Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway con...
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Tightness, tenderness in thyroid area across the throat/lowest part of front of neck (not airway constriction but on the outside). Severe heartburn, burping and reflux, anxiety, slightly elevated heart rate about 30 mins after injection, lasting about 30 mins. 5 hours after injection, after eating a small snack, repeat of heartburn, burping and reflux. Felt hot but temperature 97.7, then chills briefly. Anxiety and related fast heart beat and shallow breathing for about 1 hour. Took benadryl, no change.
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| 46 | 2021-01-10 | headache, fever |
01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vacci...
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01/09 shortly after vaccine for right arm soreness and right eye swelling, about 6 hours after vaccine 01/09 body aches, headache couldn?t move neck due to stiffness; 01/10 left arm soreness, armpit pulsation, fever range 102 F,; 01/11 vomiting. seasonal allergy eye drops for right eye swelling (went away), Benadryl 50 mg.; ibuprofen and Tylenol around the clock starting 01/09 to present day, 01/11/2021
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| 46 | 2021-01-10 | cold sweat, sweating, headache, dizziness, fatigue |
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: lik...
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About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff and finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to. I left event center at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine. The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
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| 46 | 2021-01-10 | cough, fatigue, headache |
Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain...
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Diagnosed with COVID 19, Cough, Fatigue, Aguesia, Anosmia, Diarrhea, Headache, phonophobia, leg pain. Patient now knows she was exposed before receiving vaccine.
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| 46 | 2021-01-10 | fever, chills, headache | Fever, chills, nausea, headache |
| 46 | 2021-01-10 | fatigue, dizziness, malaise, headache, weakness, chills | Headache, malaise, fatigue, dizziness, weakness, chills and hot flashes |
| 46 | 2021-01-10 | chills, fatigue, weakness, malaise, migraine | Migraines, body ache, malaise, fatigue, weakness, chills, hot flashes |
| 46 | 2021-01-10 | body temperature increased, fever |
Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on...
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Patient is a 46 yo I female with no sig PMH who reports the onset of fever, body aches and chills on Saturday 1/9 after receiving dose#2 of the Pfizer COVID Vaccine on 1/8 24 hours prior. Her temp went up to 100.4. She took Tylenol and motrin with subsequent resolution of symptoms except some slight body aches and the onset yesterday of bilateral stocking like paresthesia in LE's. As the body aches improved, she noticed the paresthesias more although they have lessened somewhat today. No prior history of COVID. Allgergies: NKA Meds: as above SH: Tob: none. ASSESSMENT Vaccine Reaction to COVID. PLAN Follow up with OMS tomorrow or prn.
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| 46 | 2021-01-10 | migraine, fever, weakness, headache |
Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the v...
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Pfizer COVID-19 Vaccine A couple hours after the vaccination the patient experienced pain in the vaccine arm, headache, and feeling ache. Day 1 post vaccination patient experienced sore arm, headache, low grade fever, feeling ache, and GI symptoms with diarrhea. Day 2 post vaccination patient experienced sore arm, Migraine, and diarrhea. Day 3 post vaccine patient woke up with chest pain that radiated into her left arm and some weakness. Patient's blood sugar was >500 and was admitted to hospital for DKA.
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| 46 | 2021-01-10 | headache | Rash and headache |
| 46 | 2021-01-10 | chills, fever | Severe rigors, chills, arthralgia Fever 104 extreme pain |
| 46 | 2021-01-10 | lethargy, fatigue | exhaustion, lethargy |
| 46 | 2021-01-10 | fever | muscle ache, fever, can barely move. called in sick to work. |
| 46 | 2021-01-11 | fatigue, throat irritation, headache |
#2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue,...
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#2 vaccine on 1/4. She had side effects beginning that night, started with HA, body aches, fatigue, scratchy throat. Over next 2 days pain back of legs, which then evolved into burning and then numbness of palms of hands, soles of feet. Reported to me on 1/8. Over last 3 days, she has had slow improvement with slight tingling and numbness fingers. Over weekend, I had her get tested for COVID - both rapid and PCR neg. She went to ED for testing, and they also ran CT head and labs -- negative. She made appt with neurologist today and will follow up with her PCP. Testing for COVID was to rule out as cause for peripheral neuropathy. Might be due to vaccine vs some other undiagnosed condition including autoimmune. Due to the unique nature of this complaint, may be considered Adverse Reaction
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| 46 | 2021-01-11 | fever, fatigue, headache, chills |
1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-t...
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1/6/2021, 5hrs and 20 min post vaccine: pounding headache, nausea, abd pain, tingly/itchy all over-took tylenol and benadryl 1/7/2021, 6:30 AM, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore, called into work 1/7/2021, 10:20 am, pounding headache, very fatigue, itchy/tingling all over, slight upset stomach, felt feverish, left arm very sore-took benadryl and tylenol 1/7/2021, 1:15 PM, very fatigue, fever, body aches, upset stomach, right ear throbbing, fever 100.6-employee health notified, was advised to self monitor for 48 hrs and if no improvement to be tested for COVID on 1/9/2021 1/7/2021, 7:27 PM, completely exhausted, on going headaches, chills off and on, body aches, decreased appetite-tylenol taken 1/8/2021, 10:02 AM, headache, body aches, arm swollen and very painful, the pain traveled to the armpit, felt about 60 % better this day, but still fatigue Symptoms remain the same for the day of 1/8/2021 1/9/2021, 9:38 AM, lingering headache, arm and armpit sore; otherwise, feel much better 1/10/2021, 7:27 PM, Felt much better this day, just little fatigue and arm soreness; otherwise not further symptoms.
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| 46 | 2021-01-11 | fever, chills, shortness of breath | Body aches, chills, feverish feeling, mild shortness of breath, dry mouth |
| 46 | 2021-01-11 | fever, headache, chills, fatigue, cough |
Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is...
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Chills; tingling under her lip and chin area; tingling under her lip and chin area; said that she is really cold; Caller is continuously coughing during the call.; Fever; Headache; joint and muscle achiness all over; joint and muscle achiness all over; Tiredness; joint and muscle achiness all over, it started in her right arm where she received the injection; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), intramuscularly in right arm on 05Jan2021 around 1315-1320 at single dose for covid-19 prophylaxis in hospital and vaccine was not administered at Military Facility. Medical history included ongoing asthma diagnosed as a child, leaky valve closed up in her heart from 2020 to an unknown date. Family medical history included her mother had Covid over around May2020 and the mother was positive for quite sometime and had to take 3-4 tests, her son had tested positive for Covid and the patient had been around him a little bit. Prior Vaccinations (within 4 weeks) were none and adverse events following prior vaccinations were none. Concomitant medication included fluticasone furoate, vilanterol trifenatate (BRIO INHALER) at 200/25 once a day by inhalation, nebulizer by inhalation every 4 hours as needed, salbutamol sulfate (PROAIR) at 2 puffs every 4 hours when needed, montelukast at 10mg every evening by mouth, all ongoing for asthma. The patient received the Covid-19 vaccine yesterday 05Jan2021 and reported that on 05Jan2021 she has had tiredness, headache, joint and muscle achiness all over. On 06Jan2021, she had fever and chills. She said that she was really cold. She also had a little tingling under her lip and chin area, but it is resolved. She stated that this was this morning 06Jan2021. She said that she did not have the physician details to provide at this time. She said that she had only seen this doctor once on a virtual appointment. She said that tiredness started around 1830-1900 05Jan2021. Headache started 05Jan2021 around when she got off of work at 1500. For event fever, she took her temperature 3 different times, it was at 101.2, then she had a temperature of 102. She last checked it about a half an hour ago on 06Jan2020. For event joint and muscle achiness all over, it was noticed the achiness around 9-10 pm 05Jan2021, she said that it started in her right arm where she received the injection, then moved down to her legs and her back. She stated that it was worse and when she went outside. For chills it started this morning on 06Jan2020 when she was still in bed before she got up at about 0500. She said that she called out of work. This was her first dose of the vaccine. Her next dose is supposed to be on 26Jan2021. The patient was continuously coughing during the call on 06Jan2020. The fever, joint and muscle achiness all over were worsened. The adverse events did not require a visit to emergency room or physician office. The outcome of tiredness, headache, fever, chill, joint and muscle achiness all over, it started in her right arm where she received the injection, were not resolved, outcome of the tingling under her lip and chin area were resolved on 06Jan2021, outcome of she was really cold and cough were unknown.
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| 46 | 2021-01-11 | fatigue |
Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral ...
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Day 1 After vaccination fatigue, Day two fatigue, nausea vomiting, afternoon started with bilateral foot pain. Day three moderate bilateral foot pain, all joints have pain, hands and feet the worst. Day four: fatigue (decreased), all over joint pain mild to moderate (went home from work) fatigue. Day Five (today) continued bilateral feet and hand joints mild pain that increases with pressure (walking holding or opening anything causes increase in pain from mild to moderate.
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| 46 | 2021-01-11 | headache, chills, fatigue, fever |
Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest u...
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Headache, body aches, fever over 100, fatigue, chills, sharp pain occasional in same area of chest upper left side. when i would shift to laying flat, pain would go away.
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| 46 | 2021-01-11 | headache, migraine |
Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headach...
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Initially just had mild muscle soreness at injection site. At 1000 on 1/8/21 began having a headache that worsened to a severe migraine throughout the day. Also that afternoon, developed sores/ulcers inside of mouth. Next day developed worsening sores in mouth and then my tongue began to swell and then noted sores on my tongue as well. This improved with Benadryl over the next 36 hrs.
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| 46 | 2021-01-11 | fever | Pain and numbness in her arm, fever |
| 46 | 2021-01-11 | weakness |
Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse e...
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Pain, numbness, weakness in arm opposite site of injection. Time line regarding possible adverse event from COVID 10 Vaccine Dec 21, received COVID-19 Vaccine #1 in right arm lot #EH9899 Dec 23- mild pain in left shoulder, did not do anything that I could pinpoint as the cause of this, no injuries, falls or accidents Dec 24, pain intensified Dec 28, 2020- went to primary MD for exam, gave several medications and ordered an MRI of C-spine which was completed on this day. Dec 29- pain has continued to intensify, now shoulder, and entire left arm. Fingers on left hand intermittently numb except for pointer finger that stays numb, and hand is colder than right hand Dec 29, 2020- results of C-Spine showed no significant issues. Small herniation in one of the disks. Per MD, ?more suspicious of a muscular issue or something external to spine pinching that nerve?. Pain has continued despite medications ordered. Dec 30, 2020 MD referred me to a Neuroversion for pain control. I did not want to go here yet, I wanted to know what was causing the issue, not just treat the pain, decided to wait to make this appointment and instead get an appointment with a Neurologist on Monday due to offices being closed on New Year?s Eve. January 4, 2021 pain, numbness and now weakness have persisted all weekend, appointment with Neurologist scheduled for Tuesday January 5, 2021. January 5, 2021, appointment with Neurologist, suspecting Parsonage-Turner Syndrome. Parsonage Turner syndrome (PTS) is characterized by the sudden onset of shoulder and upper arm pain followed by progressive (worsening over time) weakness and/or atrophy of the affected area. The pain is felt along the path of one or more nerves and often has no obvious physical cause. The network of nerves involved in this syndrome is called the brachial plexus and it controls movement and sensation in the shoulders and arms. The cause is still unknown (idiopathic). However, researchers believe that most cases are due to an autoimmune response following exposure to an illness or environmental factor. Suspected triggers include viral and bacterial infections, surgery, vaccinations, injury, childbirth, strenuous exercise, certain medical procedures, and various health conditions. Treatment is symptomatic and may include pain relievers, corticosteroids and physical therapy.[1][2] January 6, 2021- MRI of left shoulder completed January 8 2021- Follow up of MRI with neurologist. No abnormalities seen on MRI, ruled out any other tumors, or anatomical issues causing pain. Diagnosis Parsonage-Turner Syndrome. Increased dosages of current medications and added another to control nerve pain. January 9, 2021- pain seems to be lessening, numbness and weakness continues January 10, 2021- significant pain returned, numbness and weakness continues. I did get the 2nd dose of the COVID-19 lot # EJ1685 in R arm vaccine today, as MD did not advice against it and I still believe that the vaccine is important.
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| 46 | 2021-01-11 | fatigue, chills, throat pain | Sore throat Chills. Myalgias. Fatigue |
| 46 | 2021-01-11 | malaise, dizziness, fatigue |
Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizzin...
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Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; Soreness in my arm, dizziness, tiredness and over all not feeling well; This is a spontaneous report from a contactable healthcare professional, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 31Dec2020 at 15:30 as a single dose for COVID-19 immunization. Medical history included allergy to tomatoes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Dec2020 at 21:00, the patient experienced soreness in my arm, dizziness, tiredness and overall not feeling well. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the soreness in my arm, dizziness, tiredness and overall not feeling well were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 46 | 2021-01-12 | fever, sweating, chills, shortness of breath, fatigue, headache |
1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache,...
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1/9/21 at 1030pm began with chest pain, chills, sweats, fever 101, body aches, joint pain, headache, fatigue. Took tylenol and slept. Next morning, 1/10/21,w oke up at 10am, fever 102, continued with chills, sweats, body aches, joint pain, headache, fatigue and began with intermittent SOB. Took tylenol and slept most of the day and night. Next day, 1/11/21, temp 100.8, continued with chills, sweats, body aches, joint pain, headache, fatigue, intermittent SOB and chest pain. Continued to take tylenol and alternated with ibuprofen. Rested most of the day in bed. 1/12/21, no fever, intermittent SOB with activity, continue with headache and joint pain. 1/13/21 better today. Continue with intermittent SOB with activity and feel fatigue. No fever.
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| 46 | 2021-01-12 | chills, malaise, sweating |
Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very wa...
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Around 11:30pm on 1/12/2021, began having pretty serious chills (fever not measured but felt very warm). At about 1:45am on 1/13/2021, was feeling very achy and uncomfortable, so I went downstairs to get some Tylenol. Rapid heart rate and sweating, so much I had to sit down in the kitchen for a few minutes. Eventually took the Tylenol, and as I was heading back upstairs, I passed out (I don't remember going down to the floor) and dropped the cup of water I was taking with me. Was out for less than 30 seconds. A couple episodes of heaving/vomiting small amounts of liquid while on the floor. Made it back to bed and was starting to feel improved around 4:00am.
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| 46 | 2021-01-12 | sweating, chills |
Around 11:30pm, I woke up with incredible chills and had them for about 1.5 hours. Around 1:45am/2:0...
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Around 11:30pm, I woke up with incredible chills and had them for about 1.5 hours. Around 1:45am/2:00am on 1/13/2021, aches began, so I went downstairs to take acetaminophen. Increased heart rate and sweating while in the kitchen (had to sit down on the floor), eventually took Tylenol, and as I was heading back upstairs with cup of water, I passed out (less than 30 seconds) dropping the cup of water. Heaved/vomited small amount of liquid two or three times. Made it back to bed and began to feel better around 4:00am 1/13/2021.
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| 46 | 2021-01-12 | headache, chills, dizziness | Body aches, joint pain, headache, feeling light headed, intestinal cramping, chills |
| 46 | 2021-01-12 | fever | Fever 102.9F |
| 46 | 2021-01-12 | fever, chills |
Got vaccine at 10:30 am, took took Tylenol 500 mg with Benadryl 25mg 2 tabs at 11:30 as prophylaxis ...
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Got vaccine at 10:30 am, took took Tylenol 500 mg with Benadryl 25mg 2 tabs at 11:30 as prophylaxis Around 02:00 am injection site feels sore, chills, Temp 99.9 degrees F, applied warm compress to sore arm 06:00 T=102 degrees, took Tylenol with Benadryl again at 08:30 am, no further fever after, arm still sore but bearable.
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| 46 | 2021-01-12 | fatigue, fever, cough, throat pain, headache |
Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for ...
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Headache fever fatigue severe pain cough earache sore throat sore arm. Sore arm day after shot for 3 days. Fatigue day after for 5 days all other sxs started day 5 and still continue
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| 46 | 2021-01-12 | fever, headache, fatigue, chills | Headache, fatigue, swollen lymph nodes, chills, fever |
| 46 | 2021-01-12 | headache | Muscle ache Joint pain Injection site pain Headache |
| 46 | 2021-01-12 | dizziness |
Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactab...
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Palpitations; Chest pressure; Lightheadedness; Nausea; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:15 at left arm, at single dose for covid-19 immunization. Medical history included history of seizure, known allergies: topical Sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included (ascorbic acid) (VITAMIN C), (sambucus nigra) (ELDERBERRY), (linum usitatissimum seed oil) (FLAXSEED OIL), (allium sativum) (GARLIC). The patient previously took lamotrigine (LAMICTAL) and known allergies: LAMICTAL. The patient was not pregnant at the time of vaccination. The patient experienced palpitations, chest pressure, lightheadedness and nausea on 23Dec2020 14:15. The patient received Zofran and Meclizine given. Event resulted in: Emergency room. The outcome of the events was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information on the lot/batch number has been requested.
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| 46 | 2021-01-12 | throat irritation, dizziness |
Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a sho...
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Right after I received the vaccine, like 2 minutes latter, I started feeling dizzy, then I had a shocking sensation around my throat then I had some palpitation.I better about 20 minutes latter. I had prednisone at home, so I took 40mg and Benadryl and PepciI felt I had some sensation of throat tightness the day after that but it went away after few hours.
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| 46 | 2021-01-12 | fever, chills, fatigue |
Saturday evening the day of the shot I become extremely fatigued, Sunday morning woke up with extrem...
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Saturday evening the day of the shot I become extremely fatigued, Sunday morning woke up with extreme muscle aches, Sunday after noon developed the chills and fever. When fever reached 101.1 started taking Advil but fever continued to rise started alternating every 2 hours with Tylenol fever finally stopped increasing around 1 am on Monday highest it went was 102.3. Monday and Tuesday continued to have a fever ranging from 99.5 to 100.9 did not take anything to treat this. Felt fine otherwise. Today feel fine and fever free
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| 46 | 2021-01-12 | fatigue | Systemic: Exhaustion-Mild, Systemic: Generalized Body Aches -Mild; symptoms lasted for 0 days |
| 46 | 2021-01-12 | dizziness | Systemic: dizziness, tinnitus, blood pressure 220/112 |
| 46 | 2021-01-12 | cough, dizziness | TIGHTNESS OF CHESS, FEELS LIKE I AM GOING TO GET AN ASTHMA ATTACK. SOME COUGHING DIZZINESS |
| 46 | 2021-01-12 | fatigue |
The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also ha...
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The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also had a muscle pain in the arm and I felt tired during the day and in the evening. My pulse rate continues to be high. My pulse rate was 100 on the second day and for number of days it is around 95. Today it was 95 most of the day. I have not been regularly checking my pulse rate before, but based on what I found in some information in my medical record, it is most likely around 75. I notice the higher pulse rate through pulsation in the chest and temples. I have a hard time concentrating on work and reading things on the screen.
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| 46 | 2021-01-12 | headache | headache nausea syncope |
| 46 | 2021-01-13 | chills, fever |
Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday ar...
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Achy joints and bones, low grade fever 99.9, chills, feeling of needles pricking my skin- Tuesday around 1130am- went home from work and took ibuprofen. stayed home from work Wednesday- started to taper off pre immunization medication of benedryl, Pepcid, and prednisone on Wednesday afternoon. Wednesday night noticed using my inhaler. Little more- I took Half dose of prednisone. Had to do nebulizer treatment later that night. Thursday morning woke up wheezing took another prednisone and used rescue inhaler. Went to work and wheezing didn?t get any better, but didn?t get any worse. Took another prednisone and sent home to do nebulizer. Continued to rest and monitor asthma- Notified PCP of what was going on- advised to continue Pepcid, benedryl and prednisone for a few more days and advise of any issues.
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| 46 | 2021-01-13 | chills | Chills, muscle aches. Resolved |
| 46 | 2021-01-13 | fever, fatigue, headache | Fever, fatigue, headache |
| 46 | 2021-01-13 | fever, chills |
Fever; chills; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female...
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Fever; chills; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscular on 24Dec2020 14:30 (reported as "02:30 PM") at single dose on left arm as COVID vaccine. Patient was not pregnant. Medical history included asthma and hypothyoridism. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), reported as "Other medications in twoweeks: synthroid, Breo". The patient previously took cefalexin (KEFLEX) and experienced allergies. The patient experienced fever and chills on 25Dec2020 at "08:00PM". The events were assessed as non-serious. No treatment was given. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date.
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| 46 | 2021-01-13 | fatigue, headache |
Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contac...
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Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on her left arm on 28Dec2020 at 12:45 at a single dose for COVID-19 immunization. Medical history included hypertension, migraine, polycystic ovaries (PCOS) and allergies to wasp venom and dust mites. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 28Dec2020 at 15:45, the patient experienced mild left arm pain near injection site that lasted a few hours, severe fatigue which started 3 hours post injection and lasted for 4 hours; and moderate headache which started on 29Dec2020 (duration 3 days). The patient did not receive treatment for the adverse events. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-01-13 | headache, fatigue | Headaches, extreme fatigue |
| 46 | 2021-01-13 | migraine, fever |
Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever...
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Received vaccine 1/13 at noon. Woke up with a migraine level headache about 3am along with a fever of 101.6. My right arm is very sore/tender. I have generalized aches.
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| 46 | 2021-01-13 | migraine |
Severe, intractable daily migraine headaches that escalate throughout the day; This is a spontaneous...
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Severe, intractable daily migraine headaches that escalate throughout the day; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received bnt162b2 (BNT162B2) lot no: RH 9899, via an unspecified route of administration in left arm on 16Dec2020 at a single dose for Covid-19 immunization in hospital. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Concomitant medication included vilazodone hydrochloride (VIIBRYD), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lamotrigine (LAMICTAL), trazodone, and lorazepam (ATIVAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 17Dec2020 06:00, the patient experienced severe, intractable daily migraine headaches that escalate throughout the day and do not respond to any treatment, medicinal or non medicinal (unspecified). The event was reported as non-serious. The event resulted in doctor or other healthcare professional office/clinic visit. The patient had not recovered from the event. The patient received another bnt162b2 dose (lot no: EK 4176) on 06Jan2021 in left arm. Information on the batch number has been requested.
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| 46 | 2021-01-13 | fatigue, fever, headache |
Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101,...
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Symptoms started at 0100 (11hr post vaccination) Severe headache, myalgias, arthralgias, fever 101, fatigue, facial swelling (eyes and nose), blurred vision Symptoms lasted for 48 hours and did not respond to IBU, Toradol, or Tylenol. Headache was the worst that I have ever experienced- missed 2 days of work Symptoms resolved in the morning on 01/14/2020
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| 46 | 2021-01-13 | chills | Systemic: Chills-Severe, Systemic: chills led to hyperventilation-Severe; symptoms lasted 0 days |
| 46 | 2021-01-13 | shortness of breath | Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath |
| 46 | 2021-01-13 | fever |
Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all ...
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Systemic: Rash (other than injection site)-Medium, Systemic: Fever-Medium, Systemic: Felt itchy all over body, no visible hives, flushed-Medium; symptoms lasted 0 days
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| 46 | 2021-01-13 | shortness of breath | dyspnea for 3 hours occurring 24 hours subsequent to vaccine |
| 46 | 2021-01-13 | dizziness, headache, fever |
fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizzi...
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fever above 100, Bone muscle pain on a scale 7/10, injection site pain and burning 9/10, dizziness, slight headache and decreased appetite
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| 46 | 2021-01-13 | throat irritation |
flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, thr...
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flush, rash to face, trunk, and generalized to bilateral lower extremities , intense itchiness, throat itchiness and was given Benadryl 25mg IM and took 20 -30 minutes to relieves the itching and hives subsided gradually
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| 46 | 2021-01-13 | discomfort |
following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflamm...
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following initial vaccine 12/28, got extremely bloated with joint tightness, fluid overload, inflammation, overall discomfort, back pain which radiated to the front of the chest lasting x3 days, took Tylenol. now resolved
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| 46 | 2021-01-13 | chills | swelling of arm vaccine administered in, redness at injection site, chills |
| 46 | 2021-01-13 | throat swelling |
throat is swelled; hard for me to swallow; This is a spontaneous report from a contactable consumer ...
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throat is swelled; hard for me to swallow; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the Pfizer vaccine for the COVID-19 on 29Dec2020. She reported that it was hard for her to swallow on an unspecified date. It was not when she was eating or drinking, just sitting down. She was having trouble swallowing on an unspecified date. It felt like something in her throat swelled. She was having trouble swallowing. She works as a lab assistant. As for the treatment, she said that she has a doctor appointment on Monday (unspecified date). She had been taking diphenhydramine hcl (BENADRYL) as treatment. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 46 | 2021-01-14 | weakness | Body ache , feeling weak |
| 46 | 2021-01-14 | fever, throat swelling, fatigue, chills, weakness, thirst, runny nose |
Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird meta...
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Flu symptoms,; fever; chills; achy body; dry mouth with weird metal taste; dry mouth with weird metal taste; very thirsty at times; throat seemed swollen; Still feeling tired and weak; Still feeling tired and weak; running nose and draining in the back of my throat; running nose and draining in the back of my throat; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received first dose of BNT162B2 (Lot# EK9231), via an unspecified route of administration, in left arm, on 07Jan2021 14:30 at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Medical history included migraines, depression and allergy: latex. The patient's concomitant medications were not reported. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced flu symptoms, fever, chills, achy body, dry mouth with weird metal taste, very thirsty at times, throat seemed swollen, all symptoms started Thursday, the evening of getting the vaccine and lasting until Saturday morning. Still feeling tired and weak. Now have running nose and draining in the back of my throat. The start date of all the events was 07Jan2021. No treatment was received for the events. The outcome of the events was not recovered.
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| 46 | 2021-01-14 | chills, dehydration, fatigue, sweating, fever |
I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by ...
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I had body aches, knee joints were hurting, temp 100F, chills, shaking, exhausted like I was hit by a truck. Later that evening my temp went to 102F, after that I was sleeping 10 hours a day, no appetite, nausea, vomiting, diarrhea, 9lbs in 9 days, back was killing me, alternated hot and cold compress. One morning I woke up and my tongue was like a rock, I was so dehydrated. Fever for 5 days, took Tylenol and it would just break it down to 100F. Went to COVID and flu on the 12/29 got positive for COVID on 12/31/20. Yesterday I felt hot and flushed and was sweating profusely, other than that no other symptoms. ( I received the second dose on 01/13/21)
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| 46 | 2021-01-14 | somnolence, dizziness, weakness |
Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and ...
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Left arm went total numb for over 72 hours; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Red and swollen all the way up to the shoulder; Tighten in chest; Weakness; dizziness; Slept for over 24 hours; Nausea; vomiting; This is a spontaneous report from a contactable other Health Professional (HCP) (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek9231), via an unspecified route of administration on 07Jan2021 14:30 at single dose in her left arm for covid-19 immunization. Medical history included dermatitis contact and asthma. The patient had allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) at single dose in her left arm on 17Dec2020 14:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced feft arm went total numb for over 72 hours, red and swollen all the way up to the shoulder, tighten in chest, weakness and dizziness, slept for over 24 hours, nausea and vomiting on 08Jan2021 04:30. The events result in doctor or other healthcare professional office/clinic visit. The patient received prednisone 100 mg to treat these events. The outcome of the events was recovered in Jan2021.
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| 46 | 2021-01-14 | dizziness, shortness of breath | Lightheaded, dizzy, nausea, dry mouth, shortness of breath |
| 46 | 2021-01-14 | shortness of breath, headache, fatigue, fever |
Low grade fever, muscle aches, fatigue, nausea, headache hours 17 - 29 post vaccine. Still continui...
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Low grade fever, muscle aches, fatigue, nausea, headache hours 17 - 29 post vaccine. Still continuing to have headache, as well as fatigue and shortness of breath with activity.
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| 46 | 2021-01-14 | cough |
Mild cough after 1 week of vaccine; This is a spontaneous report from a non-contactable nurse. A 46-...
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Mild cough after 1 week of vaccine; This is a spontaneous report from a non-contactable nurse. A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscular (anatomical location: arm right) from 17Dec2020 07:45 to 17Dec2020 07:45, single dose for covid-19 immunisation. Medical history was reported as none. Concomitant medication included ergocalciferol (VIT D). On 23Dec2020 at 08:00, The patient experienced mild cough after 1 week of vaccine. The patient did not received any treatment for the event. Outcome of the event was recovering. No follow up attempts are possible. No further information is expected.
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| 46 | 2021-01-14 | runny nose |
Significant sneezing and rhinorrhea (allergy-type symptoms) that lasted approximately 12 hours. Did ...
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Significant sneezing and rhinorrhea (allergy-type symptoms) that lasted approximately 12 hours. Did not respond to Sudafed.
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| 46 | 2021-01-14 | headache, body temperature increased, weakness | Temature, body aches, headache, weak and vomiting |
| 46 | 2021-01-14 | cough, body temperature increased, headache, chills |
Woke up 1:30 with chills and bad H/A. Then work up again at 5:45 for work with 100.5 temp. 101.5, H/...
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Woke up 1:30 with chills and bad H/A. Then work up again at 5:45 for work with 100.5 temp. 101.5, H/A, back pain, with cough. Was seen by doc. and was given Benvonatate.
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| 46 | 2021-01-14 | headache, fatigue | achy, chills, swollen lymph node, tired, headache |
| 46 | 2021-01-14 | fever, headache |
arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold ...
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arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at 13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water. They kept her for 30 minutes on observation. She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00. She took Motrin 600mg and it helped out. The outcome of the events was recovered. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.
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| 46 | 2021-01-14 | influenza like illness, chills, fever, headache, sweating |
chills; body aches; fever; flu like symptoms; headache; was drenched in sweat; This is a spontaneous...
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chills; body aches; fever; flu like symptoms; headache; was drenched in sweat; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162b2 (lot: EL1283), via an unspecified route of administration in left deltoid on 09Jan2021 15:30 at single dose for covid-19 immunization. Medical history included asthma from Dec2019 and ongoing, insomnia, hypertension. Concomitant medication included ongoing hydrochlorothiazide, metoprolol tartrate (LOPRESSOR HCT) for Hypertension. The patient previously took lopressor and experienced edema. The patient previously received the first dose of BNT162b2 (Lot number: EK5730), intramuscularly in right deltoid at single dose on 19Dec2020 for covid-19 immunization. The patient experienced fever, chills, flu like symptoms, headache all day long on 10Jan2021. The above events were reported as serious as medical significant. No nausea or diarrhea. She had chills and was drenched in sweat on 10Jan2021. She woke up at 10:30 am with chills, body aches on 10Jan2021. Last night at 10 pm she finally fell asleep. She woke up this morning (11Jan2021) and felt fine. The outcome of the event sweating was unknown, other events was recovered on 11Jan2021.; Sender's Comments: Based on a close temporal relationship there is a reasonable possibility of an association between the events and the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-14 | headache | headache, nausea, pain in upper stomach area |
| 46 | 2021-01-14 | chills, headache |
headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); ...
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headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); some GI Symptoms (nausea and diarrhea); injections site soreness; This is a spontaneous report from a contactable pharmacist reported for self. This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. She experienced injections site soreness on the day 07Jan2021 then resolved. The next day (08Jan2021) experienced headache, chills, muscle & joint pain, and some GI Symptoms (nausea and diarrhea). Outcome of the event injections site soreness was recovered. Outcome of other events was unknown. Information on batch/lot number was requested.
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| 46 | 2021-01-14 | body temperature increased, headache, fatigue, chills |
her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain...
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her whole body is achy; Chills; Temperature of 99.7; Tired all over; Headache; muscle and joint pain; muscle and joint pain; GI Issues; having soreness of her left arm where she got the injection; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 at single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 on 18Dec2020. The patient received her second dose. After getting the second dose she is having soreness of her left arm where she got the injection, it is painful and she expected that. It is not depriving her of moving or anything. Now (08Jan2021) her whole body is achy, has chills, she has a temperature of 99.7, she is tired all over. She is calling to see if it safe to take acetaminophen or something else OTC around the clock to pass the symptoms or will it cause a delay in anything with the vaccine? She mentioned she heard there was a time frame where could not take anything because it would cause a delay. She is wondering if she should be worried she has COVID and get tested since it came back? She doesn't want to report she is doing it online. The side effects she is experiencing are headache, chills, muscle, and joint pain. Also, last night she had GI issues. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 46 | 2021-01-14 | skin warm, shortness of breath, lethargy, fatigue, headache |
severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; i...
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severe aches; voice very raspy; headache/lingering headache; wiped out /fatigued/tired; lethargic; it took a minute for her to catch her breath; flushed; itchy; muscle aches; something that look like hives on the arm/hives on the lower right arm; skin felt really hot to touch; fire engine red on the right upper arm; pain at the injection site; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), via an unspecified route of administration on 06Jan2021 11:00 in deltoid left at single dose for covid-19 immunization. There were no medical history and concomitant medications. Family medical history relevant to event was none. Relevant tests were none. Patient reported she received the Pfizer COVID-19 vaccine on 06Jan2021 and had pain at the injection site. On 07Jan21 she started having muscle aches and got something that look like hives on the arm and her skin felt really hot to touch, it was fire engine red on the right upper arm. On 08Jan2021, she woke up and felt like she got hit by a tractor trailer, has severe aches, voice very raspy, and very wiped out with headaches. Patient mentioned injection site arm was bright red and warm to touch after injection, but has improved. When waking up this morning on 08Jan2021 even walking this morning from the bedroom to the bathroom she was fatigued and it has gotten better with her walking around, but she still felt wiped out. The muscle aches was very short lived. She went to do something at work and it took a minute for her to catch her breath and that and the muscle aches went away and that was it. An hour later she felt very flushed and itchy and coworkers joked with her about what she ate for lunch, which was nothing different. On the opposite arm from injection arm she had hives on the lower right arm. They were there about 15-20 minutes and it turned completely fire engine red and that lasted about half an hour. She showed the doctor she worked with and they recommended diphenhydramine hydrochloride (BENADRYL), which she didn't take, it was weird. All this subsided and she felt fine afterwards. Last night she felt very fatigued when walking around the house. This morning when she woke up she felt very, very, very fatigued. Walking took a lot of effort out of her. It is hard to explain, but people say this was how they felt when they had Covid. She felt very lethargic and very tired. Patient still had a lingering headache, but nothing like she felt earlier this morning. It's not terrible, but it wasn't pleasant for a couple of hours. Patient was unable to provide seriousness for today's events (08Jan2021), and stated it wasn't really life threatening, but more significant than yesterday. Patient denied having any other vaccines the same day or 4 weeks prior. No history of problems or adverse events with vaccines in past. Pfizer Covid-19 vaccine with events were reported as related. Events did not require a visit to emergency room or physician office. Outcome of severe aches, voice very raspy, headache/lingering headache, wiped out /fatigued/tired were not recovered; outcome of lethargic, it took a minute for her to catch her breath, flushed and itchy was unknown, and outcome of other events were recovering.
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| 46 | 2021-01-14 | somnolence, fever, headache |
sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a s...
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sleeping all day; pain at the injection site to left arm; Fever; Headache; legs hurting; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration in the left arm on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 (reported as three weeks ago from 07Jan2021) for COVID-19 immunization and she was fine. The patient got the second COVID vaccine on 07Jan2021 afternoon. The pain at the injection site to left arm started on 07Jan2021 20:00. On 07Jan2021, in the middle of the night, the fever, headache, and legs hurting started. She has been sleeping all day on 08Jan2021 and she does not do this normally. Outcome of the sleeping all day was unknown, of the headache was recovering, of the pain at the injection site to left arm was recovered on 07Jan2021, of the legs hurting and fever was recovered on 08Jan2021.
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| 46 | 2021-01-15 | chills, dizziness, fatigue |
12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. ...
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12:30 pm legs shaking, fatigue, dizziness, freezing under a couple of blankets, chills, brain fog. 2:30 -5 Skin on face feels like it is burning from the inside out & fatigue. Brainfog. 2:30 thru evening Face and neck puffy, red, hives & fatigue.
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| 46 | 2021-01-15 | headache | Injection site pain, headache, body aches, joint pain |
| 46 | 2021-01-15 | skin warm |
Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred ...
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Previously reported when first started: report # 219108 on 1-3-21 Additional symptoms that occurred since then: extremely itchy blotchy rash that attacked underarms, under bra area, stomach, lower back, legs. Skin was hot to the touch, felt like a mild sunburn, sensitive to the touch, difficulty wearing clothes. Pain in muscles/joints in hands, and knees .
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| 46 | 2021-01-15 | dizziness |
Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swo...
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Starting approximately 15 minutes after injection started with tingling in lips and lips feeling swollen, developed minor tightness in throat and feeling tongue swollen along with tremors and lightheadedness. BP 140/102, HR low 100s. Took Benadryl 50mg with bottle of water. Symptoms resolved over next 30 minutes. Developed numbness in left 4th and 5th digit which resolved at approximately 1 hour. About 1 1/2 hours after injection some abdominal cramping and 1 episode of diarrhea. BP and HR back to normal at about 1 hour after event.
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| 46 | 2021-01-15 | respiratory tract congestion, fatigue, headache | headache, myalgia, fatigue and arthralgia-- stuffyand congested |
| 46 | 2021-01-16 | chills, fatigue, headache |
24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The h...
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24 hours after 2nd dose my heart rate was elevated at an abnormal rate for more than 24 hours. The highest I recorded was 104 at resting. My normal is 74. I felt tired but wired and started recording it on my smart watch. After 48 hours it returned to more of a normal rate but still continues to be more elevated than before. I will follow up with my PCP this week. I had other symptoms that seemed normal-headache, chills, exhausted, sore arm, etc.
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| 46 | 2021-01-16 | chills, fatigue, headache, fever |
Began with chills - shaking in bed for 2 hours, 11 hours after getting vaccine. Woke in middle of n...
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Began with chills - shaking in bed for 2 hours, 11 hours after getting vaccine. Woke in middle of night with 103 fever which lasted 36 hours. SEVERE headache began on Day 2 which I wondered if I should go to urgent care. Unable to tolerate walking or being "up" for more than 3-5 minutes at a time. Notable fatigue. A week later now, still having daily headaches which are moderate in nature.
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| 46 | 2021-01-16 | malaise, chills |
Besides soreness on the injection site on both times, a day after received the second dose of Covid-...
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Besides soreness on the injection site on both times, a day after received the second dose of Covid-19 vaccine I have experienced left-arm site soreness, aches all over my body i.e back pain and muscle pain, malaise, chills, and numbness on the fingers on my left arm.
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| 46 | 2021-01-16 | headache | Rapid onset facial & neck numbness, headache |
| 46 | 2021-01-16 | shortness of breath |
Sudden, intense pain in the mid sternum just to the left side. She recalls some dull vague pain ove...
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Sudden, intense pain in the mid sternum just to the left side. She recalls some dull vague pain over the past night, but the sudden pain developed about 3 minutes before I came into her office. Pain was a 10/10 in severity and made it difficult to breathe and talk. She was able to tolerate snow blowing this morning without notable difficulty. Pain is not clearly exertional in nature.
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| 46 | 2021-01-16 | fever, chills |
Vaccine was administered Friday and Saturday I had body aches, chills, neck pain, and fever. Sunday ...
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Vaccine was administered Friday and Saturday I had body aches, chills, neck pain, and fever. Sunday I woke up with a severely swollen armpit and anterior chest
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| 46 | 2021-01-17 | fatigue, headache, cough, nasal congestion, runny nose | 1/6/21 Cough, loss of taste and smell, congestion, runny nose, HA, fatigue, wheesing |
| 46 | 2021-01-17 | headache, chills |
18 hours post injection I started with body aches and chills. No fever. Body aches continued for 12 ...
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18 hours post injection I started with body aches and chills. No fever. Body aches continued for 12 hours. Tylenol and Advil taken with some help. Headache continued off and on for a week.
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| 46 | 2021-01-17 | headache |
Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe h...
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Vaccination at at 12 noon - on 16/01/2021 - at 4 pm tingling of the face - at midnight felt severe headache, no breathing difficulty, no rash, no swelling of tongue or throat, was able to walk, now feeling much better- after 2 days.
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| 46 | 2021-01-17 | malaise |
arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contact...
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arm really hurt; stomach cramping; didn't feel well; This is a spontaneous report from a non-contactable Nurse anesthetist reporting for herself via Pfizer employee (friend). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at 08:00 at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) received via an unspecified route of administration on 18Dec2020 at 08:00 at single dose. The patient was taking COVID-19 vaccine since is front line healthcare worker. The patient was vaccinated at hospital. Age at vaccination was 46 years. The patient's medical history and concomitant medications were not reported. The patient reported she had no problems with the first dose but after the second dose that night (08Jan2021) her arm really hurted and she had stomach cramping. She didn't feel well at all. The patient took two Advil and the next day (09Jan2021) she was fine and is still fine. The Pfizer employee stated her friend looked fine as she was exercising. Onset date of the events was also reported as 09Jan2021 with recovery date 10Jan2021. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
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| 46 | 2021-01-19 | headache, chills, fatigue, fever | 100.5-101 Fever x 15 hrs thus far, chills, body aches, headache, fatigue-Ongoing |
| 46 | 2021-01-19 | throat irritation, skin warm |
A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. ...
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A few minutes after injection, I experienced itching in the mouth and throat and heat in right ear. Right ear was flushed red. No symtoms in left ear. No tongue swelling. Symptoms eventually resolved after approximately 1 hour.
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| 46 | 2021-01-19 | cough, headache |
About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of ch...
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About 10 minutes after injection - extreme sedation, flushing, hives and itching on right side of chest, and continuous cough. Was administered one dose of epi-pen injection, steroid injection, and oral benedryl by doctor on site. 20 minutes later flushing, headache, and extreme nausea. Was given second dose of epi-pen and sent to the hospital in an ambulance for monitoring.
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| 46 | 2021-01-19 | chills, fever | Fever, chills, body aches |
| 46 | 2021-01-19 | headache | Headache for approximately 10 days, sore neck for 2 weeks. |
| 46 | 2021-01-19 | fatigue, sweating, chills, headache |
Hello, When I received my second Covid vaccine, I was asked to report my side effects to this emai...
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Hello, When I received my second Covid vaccine, I was asked to report my side effects to this email address. They are as follows: After Vaccine 1 (12/22/20): I had the vaccine at around 1:30pm. I only had arm-stiffness at first. Approx. 24 hours after however (1:30pm the next day), I started having chills and feeling like I had a fever. My entire body ached but I did not have a headache. These side effects lasted through the night for approx. 14 hours. The following day I woke up with a surge of energy and felt very much like I had been given a shot of adrenalin. I?m not sure that I have ever felt as good. After Vaccine 2 (01/11/21): I had much more severe side effects after the second vaccine. I had this vaccine at approx. 1:30 pm and within a couple of hours I started to feel a bit tired. At approx. midnight that night, I started having body aches and a headache that woke me up. I had chills and was oscillating between feeling very cold and feeling very hot. Through the night I had to change my clothing several times due to sweating. These symptoms lasted for the entire following day. The second day after the vaccine I felt much better but still a little tired. Of greatest concern is that I have a lingering pain deep within my left arm (the arm into which the shots were given). Having a hard time extending my arm and doesn;t seems to be going away. Sometimes it feels tingly and I sometimes have loss of grip and/or weakness in the entire arm. Hope this helps you in compiling the side effects. Thank you.
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| 46 | 2021-01-19 | chills |
I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visibl...
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I began itching at the nape of my neck then all over my trunk and arms. I became hoarse, had visible muscle spasms, and my teeth began to chatter uncontrollably.
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| 46 | 2021-01-19 | headache |
I have had a headache since injection was given on the day of I did have. Diarrhea the day of. And a...
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I have had a headache since injection was given on the day of I did have. Diarrhea the day of. And also neck stiffness for three days after vaccine
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| 46 | 2021-01-19 | fatigue |
Staff reporting that 1st vaccine she doesn't have any reaction. 2nd vaccine on 01/11/2021 1pm. On ...
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Staff reporting that 1st vaccine she doesn't have any reaction. 2nd vaccine on 01/11/2021 1pm. On 01/13/2021 noon time she started to feel extremely exhausted which last for 3 days. Staff was so tired that she didn't want to open her eyes. Staff said she is fine now. Denies COVID exposure.
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| 46 | 2021-01-19 | fever, chills, headache |
Tmax (max temperature) 102; chills; muscle aches; headache; sharp shooting jaw pain; shooting into e...
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Tmax (max temperature) 102; chills; muscle aches; headache; sharp shooting jaw pain; shooting into ears; This is a spontaneous report from a contactable nurse who reported for herself. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK 9231) second dose, via an unspecified route of administration on 07Jan2021 10:00 at single dose on right arm for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not have prior vaccination. Patient did not test COVID post vaccination. Patient had no known allergies. Historical vaccine included first dose of bnt162b2 (lot number EC 0140) on 21Dec2020 11:45 AM at single dose on right arm for COVID-19 immunisation. Patient experienced side effects included Tmax (max temperature) 102, chills, muscle aches, headache, sharp shooting jaw pain, shooting into ears, all on 07Jan2021 20:00 with outcome not resolved. It was unknown if patient received treatment for the events or not.
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| 46 | 2021-01-19 | headache, throat pain, fever, fatigue |
about 10 hours after receiving the vaccine, a lymph node under my arm swelled up. it was the arm tha...
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about 10 hours after receiving the vaccine, a lymph node under my arm swelled up. it was the arm that i received the vaccine in. then i became tired and developed a headache, fever and sore throat. that lasted a few days and has since resolved. i was tested for covid after to make sure i did not contract the virus at my place of employment. it was negative.
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| 46 | 2021-01-20 | chills |
COVID test/ tested positive; COVID test/ tested positive; This is a spontaneous report from a contac...
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COVID test/ tested positive; COVID test/ tested positive; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received first dose of bnt162b2 (Lot Number: EL1284), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced COVID test/ tested positive on 29Dec2020, chills, body aches on 25Dec2020. She was supposed to get the second dose of the COVID Vaccine at the time of this report. She got the first dose on 23Dec2020 and after 2 days got chills and body aches. She took a COVID test swab on 29Dec2020. Then she tested positive on 31Dec2020. She was asymptomatic besides chills and body aches. She was in Isolation for 14 days and is done. She was wondering if she could take the second dose. Caller was a nursing assistant. The patient underwent lab tests and procedures which included COVID test swab: positive on 29Dec2020. The outcome of events was unknown.; Sender's Comments: The association between the event lack of effect (COVID test swab positive) with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-01-20 | headache, fever, fatigue |
Severe debilitating headache/severe headache; Fever 103 lasting 24 hours, coming down to 100 after t...
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Severe debilitating headache/severe headache; Fever 103 lasting 24 hours, coming down to 100 after that; fatigue; Lump in left armpit area; second dose on 08Jan2021/first dose on 22Dec2020; second dose on 08Jan2021/first dose on 22Dec2020; This is a spontaneous report from a contactable Other HCP (patient). A 46-year-old female patient received the second dose of BNT162b2 (Lot number: EL1284), via an unspecified route of administration in left arm on 08Jan2021 09:30 at single dose for covid-19 immunization. Medical history included thyroid condition. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously received the first dose of BNT162b2 (Lot number: EL1284), at the age of 46-year-old, via an unspecified route of administration in left arm at single dose on 22Dec2020 15:30 for covid-19 immunization. The patient experienced severe debilitating headache that she wondered if she should go to ER for. Fever 103 lasting 24 hours, coming down to 100 after that. Unable to get out of bed for 24 hours due to fatigue, fever and severe headache. Lump in left armpit area. The above events were occurred at 20:30 on 08Jan2021. The patient did not receive the treatment for the above events. The patient received the first dose on 22Dec2020, second dose on 08Jan2021. The patient was not pregnant. The patient underwent lab tests and procedures which included body temperature: 103 on 08Jan2021, 100 in Jan2021. The outcome of the events headache, fever, fatigue, Axillary lump was recovering.
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| 46 | 2021-01-21 | throat irritation |
1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well ...
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1320: arrived in 30 minute observation. 1350 notified she had waited 30 minutes and if feeling well she could leave. Patient stated she had had some left lateral hand numbness since just after the injection that now is feeling more like tightness than numbness, a new tickle in the throat and tongue which felt "puffy" like "taking up some more space than normal. Denied any other symptoms. 1400: VS 135/90, pO2 98-99%, HT regular at 84, stated throat tickle dissipating, tongue puffiness resolving and left had less tight. 1410: Patient asked to go to BR and returned without complaint. 1420: Patient drank small bottle of water without difficulty, "felt normal to swallow." Patient stated her symptoms had resolved and there were no new symptoms. Patient stated she felt normal and comfortable to drive home.
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| 46 | 2021-01-21 | chills, fever, fatigue |
Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fe...
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Chills, myalgia and fatigue starting around 12 hours after vaccine dose. Nausea, photophobia and fever starting around 24 hours after vaccine dose, subsiding with medication after about 8 hours. Diarrhea and blanching red rash at chest, shoulders and back starting 48 hours after vaccine dose.
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| 46 | 2021-01-21 | chills, fatigue, headache, fever | Fatigue; muscle pain at injection site; joint pain; headache; low grade fever; chills. |
| 46 | 2021-01-21 | cold sweat, sweating, dizziness |
Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but ...
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Feeling dizzy like I just got off a cruise ship with nausea and hot flashes on and off no fever but felt intermittently clammy/sweaty started on the 20th and resolved midday on the 21st until the morning of the 22nd, the dizzy/nausea returned and occasional sweaty/clammy feeling. Called OHS and they recommended calling pcp. PCP called in script for zofran and instructed me to take that and dramamine and call if not improved by Monday the 25th
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| 46 | 2021-01-21 | dizziness |
Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered set...
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Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; Full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting; This is a spontaneous report from a contactable Other HCP. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscularly on 28Dec2020 10:30 at single dose for covid-19 immunisation. Vaccine location: Left arm, dose number: 1, facility type vaccine: hospital. Medical history included viral asthma, hypertension, mild depression, anaphylaxis to Bee Stings, vertebral artery dissection with brainstem injury and covid-19 (If covid prior vaccination: Yes). Concomitant medication included acetylsalicylic acid (ASPRIN), metoprolol (METOPROLOL), omeprazole (PROTONIX [OMEPRAZOLE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity and fentanyl and experienced drug hypersensitivity. On 11Jan2021 02:00 the patient developed "full body numbness, able to feel pressure, no pain. Dizziness, burning rush sensations scattered settled in right side of head neck chest arm and back, feel of passing out with standing up or sitting up". The patient was taken to emergency room (ER) /department or urgent care. In the ER all labs and CT with and without contrast clear, but was unable to find any other reason for the event. No treatment received. The events outcome is recovering. The action taken was not applicable.
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| 46 | 2021-01-21 | chills |
Hypothermia 95.7 - 96.1F; chills; This is a spontaneous report from a contactable physician. A 46-ye...
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Hypothermia 95.7 - 96.1F; chills; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EJ1685/expiration date) via an unspecified route of administration on 11Jan2021 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included negative PCR nasal swab on 15Dec2020. Concomitant medications were not reported. The patient received the vaccine in a hospital. She did not receive other vaccines within 4 weeks prior to COVID vaccine. She was not diagnosed with COVID-19 prior vaccination and was tested for COVID-19 since vaccination (PCR, unknown result). The patient experienced Hypothermia 95.7 - 96.1F and chills on 12Jan2021. No treatment was received for the events. The outcome of the event was recovered. The reporter assessed the events as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of hypothermia and chills due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 46 | 2021-01-21 | fatigue, headache |
I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to...
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I received the second dose of the vaccine on Tuesday morning, and took 800 mg ibuprofen afterward to ward off arm soreness. I had quite a bit of pain at the injection site with this vaccine, more severe than the initial dose. I felt the same mild fatigue and headache as with the first dose, but yesterday (Thursday (01/20/21) afternoon, around 3-4pm), I noticed soreness in my right axillary area, and found lymphadenopathy with palpation. I took additional ibuprofen and tylenol, and the pain has lessened somewhat today (Friday 01/22/21, noon)
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| 46 | 2021-01-21 | fever |
Shortly after the vaccination I got a burning warming sensation up and down my left leg which still ...
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Shortly after the vaccination I got a burning warming sensation up and down my left leg which still presist today. I had a fever for one day but had diarrhea for about a week.
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| 46 | 2021-01-21 | body temperature increased |
Temp of 102 took Tylenol stated to go down them Spikes again 24 hours later back to 102 took more Ty...
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Temp of 102 took Tylenol stated to go down them Spikes again 24 hours later back to 102 took more Tylenol and has finally gone below 100 Hives on chest back behind knees back of legs and bottom of feet. Stated in one spot and progresses thought out the day and night. Took Benadryl and put Benadryl cream on has calmed down after several doses of Benadryl
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| 46 | 2021-01-21 | malaise |
allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well ...
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allergic reaction; patient was experiencing being flushed; fast heart rate; she wasn't feeling well a few minutes after receiving it; her throat felt thick; had trouble swallowing; This is a spontaneous report from a contactable other HCP and pharmacist. A 46-year-old female patient received the first dose of BNT162b2 (lot: EL3247, Expiry Date: May2021), via an unspecified route of administration in left arm on 15Jan2021 at 0.3 mL, single for covid-19 immunization. Medical history included food allergic. The patient's concomitant medications were not reported. The patient experienced allergic reaction on 15Jan2021. The patient alerted she wasn't feeling well a few minutes after receiving vaccine. The patient was experiencing being flushed, had a fast heart rate, and her heart rate kept increasing over time, despite two benadryl, the patient had allergic reactions in the past due to food, so the patient knew what it felt like, so could expect it, so the patient spoke up soon, and the Epipen was given 28-30 minutes later, and after that, the patient said her throat felt thick and she had trouble swallowing, so was taken to the hospital. The patient seemed to be getting worse, after time, after the Epipen. The patient was most likely admitted to the hospital. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-24 | sweating, dizziness |
Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous...
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Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous, and not feeling right. She was tachycardic and bradycardic soon after. She was transported to the ED for evaluation. She endorsed lightheadedness, chest pain, and trouble swallowing upon ED triage. She was given diphenydramine 25mg PO x 1 dose and observed for ~2.5 hours prior to discharge.
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| 46 | 2021-01-24 | fatigue, headache, chills | Chills lasting approximately 1-2 hours, headache and fatigue last approximately 12 hours |
| 46 | 2021-01-24 | fever, dizziness, headache |
I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes we...
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I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes were hurting and burning really bad.
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| 46 | 2021-01-24 | headache |
Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25m...
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Itching bilateral hands, feeling warm for 2-3mins, anxiety, flushed ,Headache received Benadryl 25mg orally and chest tightness and heaviness received 2nd dose Benadryl 25mg . EMS /cardiac monitored and was transferred to a Hospital.
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| 46 | 2021-01-24 | headache, fever, fatigue, chills |
chills; extreme fatigue; fever of 102.9 for 12 hours; body aches; headache; This is a spontaneous re...
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chills; extreme fatigue; fever of 102.9 for 12 hours; body aches; headache; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Lot EL1284) intramuscular in Left arm on 11Jan2021 at 18:00 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, endometriosis, polycystic ovarian syndrome (PCOS). Known allergies to latex, and past drug allergy to levothyroxine and armour thyroid. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EH9899) on 21Dec2020 at 18:00 intramuscular in Left arm at single dose for COVID-19 immunization.The patient's concomitant medications were not reported. On 12Jan2021, within 24 hours of her second COVID-19 vaccination, the patient started with chills, then fever of 102.9 for 12 hours, extreme fatigue and body aches, when fever broke the headache started. She was feeling better by the following morning, so it was approximately 24 hours of symptoms that started approximately 24 hours after the 2nd vaccine. The final outcome of the events was reported as recovered on 13Jan2021, without treatment administration.
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| 46 | 2021-01-24 | chills, fatigue, headache, malaise, fever, cough |
fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive he...
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fever/had a 100.1 degree fever/temperature over 100.1; Sore ARM/Injection site; Headaches/massive headache; eye pressure/Pressure in eyes; Body aches; Muscle spasms/Cramping; tired/tiredness/fatigue/feeling rundown; hot and cold chills; tremors; coughing; chest pain; swelling; unable to work; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via intramuscular on 06Jan2021 09:45 at single dose on left arm for COVID-19 immunization. The patient's medical history included asthma, arthritis and COVID-19. No known allergies. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EH9899) on 16Dec2020 09:45 at single dose for COVID-19 immunization. Facility type vaccine was workplace clinic. Patient was not pregnant. No other vaccine received in four weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was a PCT Patient Care Technician. Patient had not been feeling well/sick on 06Jan2021 since receiving her second vaccine dose. Patient said she was unable to work, and was still feeling sick. Patient experienced massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/tiredness/fatigue/feeling rundown, hot and cold/chills on 06Jan2021 11:00. These adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient stated she had reactions coughing, chest pain, swelling, tremors in Jan2021. Patient said she couldn't bend without having a muscle spam. Patient clarified if she tries to wipe herself after she goes to the bathroom, she has muscle cramping. Patient clarified if she tries to turnover in bed, she has charley horses everywhere. Patient reported walking hurts from having so many charley horses. Patient said the headache seemed like it was progressing. Patient was feeling rundown and tired. Patient reported she had hot and cold chills over the weekend. Something didn't feel right on 11Jan2021, so she took her temperature and she had a 100.1 degree fever. Patient clarified she did not check her temperature prior to 11Jan2021. Patient reported she has been taking ibuprofen 800mg to maintain herself as treatment. She said she took some of the ibuprofen 800mg over the weekend, and then decided to take her temperature on 11Jan2021, and that was when she discovered she had a fever. Reported the ibuprofen 800mg was a prescription from her doctor and was dispensed in an amber pharmacy bottle. Patient stated she had lab work for, because of COVID her lungs has been messed up but before she had the shot she was doing pretty good. So, she would be getting tested periodically for her lungs and all that because she had COVID at one time. Patient stated the doctors gave her prednisone and antibiotics as treatment. For antibiotics name, Patient stated amoxycillin she believed it was and the doctors gave her another pill start with a M for swelling. Patient stated her doctor did said it had nothing to do with concomitant medication and other medication conditions. The doctor said it had to do with having the shot. Treatment for adverse events (headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms, cramping, tired, fatigue, temperature over 100.1, hot and cold/chills) included penicillin, amoxicillin, prednisone. Outcome of massive headaches, pressure in eyes, body aches, sore arm/injection site, muscle spasms/cramping, tired/fatigue, temperature over 100.1, hot and cold/chills were not recovered, outcome of other events was unknown.
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| 46 | 2021-01-24 | headache |
on Jan 9-11 experienced significant muscle fatigue Jan 12-17 body aches, headache requiring over the...
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on Jan 9-11 experienced significant muscle fatigue Jan 12-17 body aches, headache requiring over the counter NSAID for some relief Jan. 18 to present, mild symptoms of headache, muscle fatigue persist although not as severe
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| 46 | 2021-01-25 | headache |
Extreme body achees; Severe headache; lymphadenopathy in the armpit.; This is a spontaneous report f...
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Extreme body achees; Severe headache; lymphadenopathy in the armpit.; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 10:30 on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 on an unspecified date. The patient experienced extreme body achees, severe headache, lymphadenopathy in the armpit, all at 21:30 on 11Jan2021. Adverse reactions did not result any serious consequences. Facility type vaccine was hospital. No need treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. Other medical history was none. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 46 | 2021-01-25 | fever, throat pain, malaise, lethargy, sweating, headache, chills, weakness |
Fever; Chills; Aches and Pains; Lethargic; shaking; weakness; Sweats; joint pain; headache; pain in ...
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Fever; Chills; Aches and Pains; Lethargic; shaking; weakness; Sweats; joint pain; headache; pain in the armpit of the injection arm; severe sore throat; generally feeling ill; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246; expiry date: unknown), intramuscular in the left arm on 08Jan2021 at 08:30, at a single dose, for COVID-19 immunisation. Medical history included autoimmune disease. The patient has no know allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown), intramuscular in the left arm on 18Dec2020 at 08:00 AM for COVID-19 immunisation. On 08Jan2021, at 15:00, the patient experienced fever, chills, aches and pains, lethargic, shaking, weakness, sweats, joint pain, headache, pain in the armpit of the injection arm, severe sore throat, and generally feeling ill. The patient did not receive treatment for the events. Outcome of the events was recovered. The patient underwent nasal swab on 10Jan2021 with a negative result.
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| 46 | 2021-01-25 | shortness of breath |
PVCs started after the first COVID19 Pfizer vaccine. They were frequent, had associated symptoms of ...
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PVCs started after the first COVID19 Pfizer vaccine. They were frequent, had associated symptoms of chest discomfort and breathlessness, and I went to the doctor. Their frequency/severity trended toward improving, but after the 2nd vaccine I was back to their original intensity/frequency. I do not have a history of similar. They are affecting my daily life. I've been referred to a Cardiologist.
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| 46 | 2021-01-25 | fatigue, weakness, cold sweat, dizziness, headache, sweating, night sweats |
Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at i...
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Saturday, 01/09/21 1300-received 2nd vaccine Sunday, 01/10/21 0500 -severe left arm pain, began at injection site, radiated: up and across L shoulder blade area, up neck and into head, down to L fingertips 0600 -all above continued, R knee joint pain (sharp/stabbing) 1400 -all above continued except R knee joint pain; spinal pain and intercostal pain began 1900 -all above continued; TMJ, jaw, and 'tooth' pain began Monday, 1/11/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Tuesday, 1/12/21 TMJ, jaw, and 'tooth' pain, nausea, fatigue, night sweat Went to dentist (scheduled appointment on Monday) for cleaning and thorough exam...exam was normal Wednesday, 1/13/21 continuation of symptoms from 1/12/21, but pain worse, ear pain Thursday, 1/14/21 0630 had eaten a full can of chicken noodle soup. Was sitting and working on CEs for work, had taken medications for the day, but added in hydrocodone, half of a 7.5/325mg tablet and ibuprofen 200mg. Felt a severe wave of nausea. Laid my head down on my arms on the table. Do not remember getting up, but remember walking through the kitchen in front of the refrigerator, reaching up to feel my pulse, felt two beats which were too far apart and thought to myself, "I'm going to faint". Apparently I was able to walk about 6 feet further, but I don't remember it. I don't know what time I fainted, but I think I must have fallen. I woke up sometime after 7, disoriented and my head hurt, lying on the kitchen floor. My husband came to my side after I called out to him about 5 times. I was drenched in sweat and very weak. When firefighters arrived they said my heart rate was 'all over the place', from 46 to I don't know what (did not hear). Ambulance arrived around 0730. Glucose was normal. Was taken for evaluation. Was given IV NS (I think 1000mls). Labwork was drawn. CXR, CT, and EKG. ER Dr recommended I follow up with my cardiologist, as she noted mitral valve regurgitation and thought a Holter monitor would be advisable. CXR and CT normal. EKG normal sinus rhythm, but showed anteroseptal infarct of unknown age, confirmed by cardiologist who read the EKG. Also seen by my PCP at 1430, he checked my ears, as they had been hurting as well, said they were clear. Advised alternating tylenol and ibuprofen Q4-6H. Friday and Sunday 1/15 and 1/16 night sweat, TMJ pain, nauseated, headache, neckache, fatigue, shoulders sore, eyes sore, inner ear pain Sunday, 1/17 0500 woke up, lying in bed, dizzy, clammy palms, chest pain (mid-clavicular, just below left breast, stabbing), night sweat, TMJ pain, nauseated, headache, neckache, fatigue, L & R flank pain, BP 115/70, HR 54 Monday 1/18, Tuesday, 1/19, Wednesday 1/20, Thursday 1/21, Friday 1/22, and Saturday 1/23 varying degrees of: fatigue, nausea, dizziness, TMJ, jaw, and 'tooth' pain, palpitations, and ear pain. TMJ and jaw pain worsens with activity.
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| 46 | 2021-01-25 | throat pain, cough |
Sore Throat immediately tasted alcohol and immediately started with a dry cough and sour throat, be...
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Sore Throat immediately tasted alcohol and immediately started with a dry cough and sour throat, before the shot she had no sore throat or Cough
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| 46 | 2021-01-25 | headache |
cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a cont...
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cramping; Diarrhea; body aches; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient) and another consumer. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: 30Apr2021), intramuscular (right arm) on 11Jan2021 (around 1:10-1:30pm) at single dose for Covid-19 immunization. The patient received the first dose of COVID Vaccine (BNT162B2, lot number: EK5730, expiration date: 31Mar2021) on 21Dec2020, intramuscular (right arm) for Covid-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021, the patient experienced nausea, some vomiting which has subsided, diarrhea, headache and body aches. The patient also stated that she woke up at 3 a.m. this morning (12Jan2021) vomiting. She vomited for about an hour and half. The vomiting has subsided and now she is just nauseated. The diarrhea initially began about 7:30 a.m. She had 3 bowel movements and she hasn't had a movement since about 8:30. She still has cramping but nothing else. The body aches started within last half hour or so. The headache has been the entire time since 3 a.m., starting when the vomiting occurred. The vomiting was more important at that moment, but she knows her head hurting at the time. The patient verified it was her second COVID vaccine. She received the vaccine yesterday (11Jan2021), between 1:10-1:30p.m. The patient reported that she did have bloodwork, but not in regard to the COVID vaccine. She had bloodwork done Monday, 04Jan2021. The outcome of vomiting was recovering; outcome of event cramping was unknown; while the outcome of other events was not recovered.
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| 46 | 2021-01-25 | headache, fever, chills |
low grade fever; rigors; myalgias; headache; skin hurt; unable to stand without feeling like passing...
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low grade fever; rigors; myalgias; headache; skin hurt; unable to stand without feeling like passing out; This is a spontaneous report from a contactable other hcp. A 46-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the right arm on 11Jan2021 17:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included lichen sclerosus from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), caffeine, paracetamol (EXCEDRIN [CAFFEINE;PARACETAMOL]). The patient previously had the first dose of BNT162B2 on 21Dec2020. The patient experienced low grade fever, rigors, myalgias, headache, skin hurt, unable to stand without feeling like passing out on 11Jan2021 18:00. The patient underwent lab tests and procedures which included body temperature: low grade on 11Jan2021. No treatment were received for the events. The outcome of events was recovering. Information of lot/batch number has been requested.
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| 46 | 2021-01-26 | chills, headache |
Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; bac...
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Cold chills; Body aches; Nausea; Right arm sore/site of injection started to get sore; Headache; back is hurting a little more, and she is more achy; joints are starting to get tight; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration into right arm on 12Jan2021 12:15 at a single dose for covid-19 immunisation. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity; Hashimotos Disease diagnosed 10 years ago; pre-diabetic diagnosed 5 years ago (she does not have to take insulin or take blood sugars daily). Concomitant medication included metformin for Pre-diabetic. The patient had no previous history of immunization. No additional vaccines administered on same date of the Pfizer covid vaccine. The patient experienced headache on 12Jan2021 13:30 with outcome of not recovered; right arm sore further described as site of injection started to get sore on 12Jan2021 19:00 with outcome of not recovered; cold chills on 13Jan2021 02:00 with outcome of not recovered; body aches on 13Jan2021 02:00 with outcome of not recovered; nausea on 13Jan2021 02:00 with outcome of recovering. The patient also reported on unspecified date in Jan2021, her back is hurting a little more, and she is more achy, joints are starting to get tight. No ER or physician's office required yet. No prior vaccinations within 4 weeks. Therapeutic measures were taken as a result of headache and cold chills as TYLENOL extra strength. Outcome of events back pain and tight stiffness was unknown.
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| 46 | 2021-01-26 | fever, fatigue, chills, headache |
Fatigue within a few hours of receiving vaccine. Extreme fatigue the next day, as well as body aches...
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Fatigue within a few hours of receiving vaccine. Extreme fatigue the next day, as well as body aches and headache. That evening fever onset and chills.
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| 46 | 2021-01-26 | fatigue, chills, headache |
Fatigue; Chills; Brain fog; Headache; This is a spontaneous report from a contactable consumer (pati...
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Fatigue; Chills; Brain fog; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (left arm) on 13Jan2021 16:15 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. On 13Jan2021 17:45, the patient experienced Fatigue, chills, brain fog, headache. No treatment was given for the events. The outcome of the events was recovering. The patient has no Covid prior vaccination and was not tested post vaccination. Information on the Batch/Lot number has been requested.
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| 46 | 2021-01-26 | headache |
Muscle pain; Joint pain; Headache; This is a spontaneous report from a non-contactable other health ...
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Muscle pain; Joint pain; Headache; This is a spontaneous report from a non-contactable other health care professional. A 46-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), via an unspecified route of administration on 11Jan2021 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID19 vaccine bnt162b2 for COVID-19 immunization on 21Dec2020; lot number: EL0140 on left arm at 46 years old. On 12Jan2021, the patient experienced muscle pain, joint pain, and headache. The patient did not receive treatment for the events. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
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| 46 | 2021-01-26 | chills, night sweats, fatigue | Severe muscle aches and fatigue, chills, night sweats, hypersensitivity of skin (prickly sensation0 |
| 46 | 2021-01-26 | headache | Systemic: Rash (other than injection site)-Severe, Systemic: Headache-Severe |
| 46 | 2021-01-26 | fatigue, headache, fever |
Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day ...
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Took second dose COVID vaccine on 1/18/21, had fever, fatigue, headache that lasted through the day of 1/19, only took 1g dose of Tylenol that evening mostly due to headache. I woke up feeling fine on 1/20 but then developed some shakiness that evening. On 1/21, I had fatigue/tiredness, and other than food/bathroom, stayed in bed resting. On 1/22 continued to feel fatigued and dizzy, finally checked my BP, the readings were 93/67 (did not write down HR - heart rate) and 89/68, HR87. I videoconferenced the Methodist urgent line, spoke to NP, recommended continued check BP and increase fluid intake. Still feeling slightly dizzy and tired, but better overall, just feel slightly "off", especially with exertion. BP: 1/23 - 98/76 HR84 , 104/83, HR77; 1/24 - 102/82, HR87; 1/25 - 109/75, HR68, 104/67, HR58, 98/79,HR104, 96/74, HR93; 1/26 - 94/69, HR81, 95/72, HR74, 98/64, HR80; 1/27 - 121/84, HR81 (during MD video visit), 114/80, HR75, 96/74, HR82. Spoke to my doctor today. She asked if I'd filled out this form so decided to fill out. She recommended I continue to monitor BP, increase fluid intake, restart vitamins, add electrolyte drink, add caffeinated drink (for intermittent headache) and follow-up next week if not resolved.
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| 46 | 2021-01-26 | dizziness |
tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizzine...
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tunnel vision; 2 minutes after injection Heart rate went to 138/Hr 110/elevated heart rate.; dizziness; This is a spontaneous report from a contactable nurse reporting for herself. A 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number Ek9231, via an unspecified route of administration in left arm on 28Dec2020 at 11:45, at 46 years of age, at single dose for COVID-19 immunization. The patient was not pregnant when she was vaccinated and received the vaccine in Hospital. She didn't receive any other vaccine in the previous 4 weeks. Medical history included Meniere's disease with sudden hearing loss in left ear from an unknown date, gastrooesophageal reflux disease from an unknown date and allergy to penicillin and sulfa drugs. Concomitant medication included famotidine (PEPCID), paracetamol (TYLENOL), ergocalciferol (VITAMIN D) supplements and cetirizine hydrochloride (ZYRTEC). On 28Dec2020, 2 minutes after vaccine injection, the patient experienced tunnel vision, assessed as medically significant, her heart rate went to 138 and she experienced dizziness. The same happened again "at the 8 min mark": heart rate at 110 and dizziness. The events resolved on their own. Dizziness and elevated heart rate happened again later that evening. At the time of the report the reported events had resolved without any treatment.; Sender's Comments: Based on the compatible time association, the events tunnel vision, heart rate increased and dizziness are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-01-27 | chills, fatigue |
Nausea; Vomiting; Muscle pain; Fatigue; Chills; This is a spontaneous report from a contactable heal...
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Nausea; Vomiting; Muscle pain; Fatigue; Chills; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), intramuscular in left arm, on 11Jan2021 at 14:15, at a single dose, for COVID-19 immunization. The patient's medical history included hypertension, Hashimoto's, and allergies to sulfa. The patient had unspecified concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EK5730) on 19Dec2020 at 08:00 AM (intramuscular in left arm) for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 12Jan2021 at 10:30 PM, the patient experienced nausea, vomiting, muscle pain, fatigue, and chills. No treatment was administered for the events. The patient had not been tested for COVID-19 post-vaccination. The patient was recovering from the events.
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| 46 | 2021-01-28 | fever | Fever, body aches |
| 46 | 2021-01-28 | dizziness |
Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated...
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Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated to minor dizziness within 15 minute wait; Pain in shoulder to neck; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date unknown), via an unspecified route of administration (left arm) on 13Jan2021 at 10:45 at a single dose for COVID-19 immunization. Medical history included Polycystic Ovarian Syndrome (PCOS), allergies, excessing calcification of veins and arteries, high blood pressure (BP), and known allergies to trees, grass and weeds. Concomitant medications included metformin (METFORMIN), rosuvastatin (ROSUVASTATIN), levothyroxine (LEVOTHYROXINE), and liothyronine (LIOTHYRONINE). The patient had no other vaccine in four weeks. On 13Jan2021, the patient experienced pain traveled up shoulder to ear, strong dizziness that dissipated to minor dizziness within 15-minute wait and pain in shoulder to neck has lessened 48 hours later, but still present. The patient had no COVID prior vaccination and had no COVID test post-vaccination. No treatment administered for the events. The events were resolving at the time of the report.
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| 46 | 2021-01-28 | dizziness |
pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff ...
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pulsing squeezes/pulsing feeling periodically; I felt tingly; lightheaded; a little hot; felt stiff in neck; a little aching in shoulder/chest area; a little aching in shoulder/chest area; This is a spontaneous report from a contactable healthcare professional reporting for self. This 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3247) on 14Jan2021 03:30 PM at single dose (vaccine location=Left arm) for COVID-19 immunisation. Medical history included known allergies: penicillin, erythromycin, seasonal allergies, can't really say food allergies but she had had reactions to random items on 2 occasions. Generally a very healthy person, no chronic health conditions. Patient was not pregnant. No other vaccine in four weeks. Did not have COVID prior vaccination. Concomitant medications in two weeks included lactobacillus acidophilus (FLORAJEN), vitamin D3. It was reported that on 14Jan2021 03:30 PM, within approximately 2 mins of getting the vaccination, she felt tingly, lightheaded and a little hot. That lasted a few minutes then started to subside. Also felt stiff in neck and a little aching in shoulder/chest area. Sat in observation for 20 mins to make sure she was ok. About 10 minutes after she left the facility (30 minutes after the shot), she felt the aching in upper left chest that turned into what felt like pulsing squeezes. She also got lightheaded again. Lasted several minutes. It was incredibly scary. Later that night and next 2 days she had felt the same achy/pulsing feeling periodically. No treatment received for events. The patient did not test COVID post vaccination. The outcome of events was unknown. No follow-up attempts are possible, No further information expected.
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| 46 | 2021-01-31 | headache |
Injection site pain; Headache; Body aches; Joint pain; This is a spontaneous report from a contactab...
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Injection site pain; Headache; Body aches; Joint pain; This is a spontaneous report from a contactable consumer, reporting for herself. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ek9213), via an unspecified route of administration at the left arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Vaccination was done in a health clinic. Medical history included diabetes, psoriasis, asthma and Covid (prior vaccination), all from an unknown date and unknown if ongoing. The patient was not pregnant. The patient had no known allergies. The patient's concomitant medications were not reported. On 16Jan2021 07:00, the patient experienced injection site pain, headache, body aches and joint pain. No treatment was received. There was no other vaccine in four weeks. The patient has not had covid tested post vaccination. The outcome of the events was recovering.
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| 46 | 2021-01-31 | headache, fever |
severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; blee...
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severe headache; severe neck pain; severe arm pain; fever at 103 degrees F; Swollen lymph node; bleeding gums; small hematomas on legs; extremely hot diarrheas; horrible burning sensation; This is a spontaneous report from a contactable nurse (patient herself). A 46-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EJ1686, expiration date was unknown), via an unspecified route of administration on the left arm on 08Jan2021 at 14:15 at a single dose for COVID-19 immunization administered at the hospital. She received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number; EK5730, expiration date was unknown) via an unspecified route of administration on the left arm on 18Dec2020. Relevant medical history included known allergies to shellfish. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. On 09Jan2021 at 12:00 AM, the patient experienced severe headache, severe neck pain, severe arm pain, fever at 103 degrees Fahrenheit (F), swollen lymph node, bleeding gums, small hematomas on legs, and extremely hot diarrheas that she had this horrible burning sensation. The patient did not receive any treatment for the adverse events (AE). The patient underwent further lab tests and procedures, which included COVID test via nasal swab post vaccination on 13Jan2021, which resulted negative. The patient was recovering from all the events.
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| 46 | 2021-02-02 | headache | Had a severe headache that has never gone away. Jan 1st went to ER |
| 46 | 2021-02-03 | chills, throat pain, cough |
Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site te...
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Reports symptoms began one hour after the 2nd COVID-19 vaccine. Symptoms were cough, chills, site tenderness, sinus pressure, sore throat, eye pain (R), burning sensation and tingling. Seen at ED on 1/12/21.
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| 46 | 2021-02-04 | shortness of breath, headache |
Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we att...
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Within a few minutes of vaccine, I got a severe piercing headache and nausea / vomiting which we attributed to nerves and I went to go home without reporting. During the drive the headache and nausea got worse and my extremities and face began to tingle. My chest felt tight. My body was shaking. My colleague noted weak pulses and pale complexion. I am a doctor and gave myself epinephrine 0.3 mg IM and within 60 to 90 seconds the symptoms improved dramatically. I had my husband pick me up at the office and went home. The headache and nausea worsened on the drive but then settled down significantly. I rested for a few hours, then took oral pred 20 mg at about 2:45. I noticed that my headache was back and very intense at about 3:15 pm. No nausea this time, but my left eye began itching and it was very tight / hard to breathe. My extremities began tingling and I had spasms / tremors of my muscles. I injected another 0.3 mg epi into my thigh and followed with dex sodium phosphate 4 mg IM. Symptoms resolved within about 2 to 3 minutes. I took 40mg more of oral pred. I also took 10 mg of pepcid PO. I am still feeling well now with no headaches or other symptoms at this writing (7:30 pm), but I have another doctor with me and we are 2 minutes from the ER if needed. I am marking unknown below since it has only been a few hours without symptoms.
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| 46 | 2021-02-08 | shortness of breath |
One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and w...
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One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
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| 46 | 2021-02-08 | headache |
headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist...
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headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist. A 46-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home. Medical history included latex allergy, mushrooms allergy. The patient has no covid prior vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 first dose at the right arm on unspecified date for Covid-19 immunization. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced headache with hives and was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events headache with hives was unknown.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of headache with hives cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-02-18 | weakness |
Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spo...
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Tongue swelling; difficulty swallowing; raised blood pressure; body weakness; redness; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: not available), via an unspecified route of administration on left arm on 01Feb2021 16:00 at single dose for COVID-19 immunization. Age at vaccination was 46 years. The patient was not pregnant at the time of vaccination. Medical history included food irritations. Concomitant medications included unspecified vitamins (received within 2 weeks of vaccination). The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient experienced tongue swelling, difficulty swallowing, raised blood pressure, redness, body weakness on 01Feb2021 at 16:30. The events resulted in emergency room visit/ department or urgent care visit. The patient received breathing treatments and unspecified IV medication for the events. The events were assessed as non-serious by the reporter. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.
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| 46 | 2021-02-19 | malaise, headache, fever |
24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 ...
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24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 days after vaccine), woke up with vertigo, visual changes, severe nausea, diagnosed with cerebrovascular accident
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| 46 | 2021-02-21 | migraine, fever, fatigue |
- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC...
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- Fever 105 + for over 24 hours, from Friday night to Sunday morning. I kept it down to 105 with OTC meds. Sometimes too high for thermometer to read. - Swelling at injection site (and halfway to elbow), soreness. By Monday this was down to about a golf ball, and it resolved in a week. - Fatigue, slept all weekend and was tired but functioning the following week. - Severe joint pain and muscle aches Saturday and Sunday. I took OTC pain relievers. Went to bed. - Blindingly bad migraine Friday night, worse Saturday, and resolving some on Sunday, somewhat responsive to Naratryptin.
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| 46 | 2021-02-21 | headache, dizziness |
Approximately 45 minutes after receiving the vaccine, patient returned reporting sharp back pain and...
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Approximately 45 minutes after receiving the vaccine, patient returned reporting sharp back pain and headache. Patient denied difficulty breathing or swallowing. Denied chest pain or palpitations. Patient reports dizziness began 3 weeks ago. Glucose was 167.
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| 46 | 2021-02-21 | chills, fatigue, headache, shortness of breath, malaise, nasopharyngitis, throat pain, dizziness, fever |
Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) ...
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Fever; Chills; I feel very tired; I can hardly walk; Sore throat; I have a cold; The (most serious) issue is my throat, I feel like I have something (stuck) in my throat; I feel like I can't breathe normally; I can't speak; I do not feel well/I feel terrible/I feel isolated; I have pain in my body; I could hardly stand up/I did not got to work; Feel an itch, like an allergy, it was not a rash, just an urge to scratch me; Feeling dizzy; Nauseous; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 01Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she received the COVID-19 vaccine at a hospital, patients were allowed to stay for 30 minutes, then they were released. After she left the hospital she started to feel an itch, like an allergy, it was not a rash, just an urge to scratch herself. She started feeling dizzy, nauseous, and a headache. Yesterday (02Feb2021), she could hardly stand up. Today (03Feb2021) she did not got to work, she do not feel well, she have pain in her body, fever and chills. The (most serious) issue was her throat, she feel like she have something (stuck) in her throat, she can't speak, she feel like she can't breathe normally. She haven't felt well at all, today is the 3rd day after receiving the vaccine and she couldn't go to work, she was nervous because she was fine (before receiving the vaccine). She does not want to go out because she feel very tired and dizzy, she was afraid of falling down in the street and getting hurt, she can hardly walk and she feel tired, experienced fatigue and sore throat. She have a cold, she feel terrible. she feel isolated and afraid. She will have to go to the hospital, if she cannot breathe well. Outcome of the events was unknown. Information about Lot/batch no has been requested.
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| 46 | 2021-02-22 | dizziness |
C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight...
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C/o right am numbness from injection site down back of arm. Full ROM of R. arm. Felt dizzy, slight redness below injection site. BP taken was elevated, sent to ED for additional monitoring
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| 46 | 2021-02-22 | headache |
Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, aff...
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Daily headaches lasted for 7 days. Arm soreness lastes for 3 days. Needed to take daily Tylenol, affected work.
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| 46 | 2021-02-22 | headache, fever, fatigue, chills |
Day 2-3: fever, chills, body aches, joint and muscle pain, headache, nausea, fatigue and vomiting Da...
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Day 2-3: fever, chills, body aches, joint and muscle pain, headache, nausea, fatigue and vomiting Day 4-5: felt completely fine Day 5-6: that evening, all of the same symptoms returned, including fever of 102 Day 7-9: felt completely fine Day 10-11: all symptoms returned, including fever of 101 Day 12: today, feel completely fine
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| 46 | 2021-02-22 | headache |
Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches...
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Excessive tremors, inability to walk due to shaking uncontrollably. Delayed speech. Severe headaches, body aches, and muscle pain.
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| 46 | 2021-02-22 | headache, throat pain, nasal congestion | Pain in arm, upper body aches, back, neck, shoulder, headache sore throat, congestion. |
| 46 | 2021-02-22 | headache |
Patient complained of worsening of a headache she experienced since 2/8/2021 after receiving the vac...
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Patient complained of worsening of a headache she experienced since 2/8/2021 after receiving the vaccine. Reported the headache was 8/10 on pain scale. She also reported she has hx of migraine headaches 2-3 times weekly. Was taken to ER via ambulance. She was given medications to control B/P and pain, then discharged to home after six hours.
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| 46 | 2021-02-22 | fatigue, throat irritation |
Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 ho...
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Severe hives outbreak. Hives began on legs about 18 hours after second dose shot. After about 4 hours, all limbs covered in hives and throat felt irritated. Took a 5mg Claritin at that point (fearing hives would worsen during night). Awoke with no reaction next day or thereafter. No hives reaction after first dose. After both doses had typical sore arm for 48 hours; fatigue after second dose only.
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| 46 | 2021-02-22 | shortness of breath |
While Pt was sitting in the waiting area she began to has partial upper body "seizure" also breathi...
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While Pt was sitting in the waiting area she began to has partial upper body "seizure" also breathing problem that included tightness in her throat, husband alerted staff who then alerted EMS, upon arrival to the Pt she was saying under her breath "EPI" Pt quickly moved to the back of the tent to the EMS area where EPI .3 administered in the left thigh, lung sounds where having wheezes in both sides. within minutes she stated she felt much better. As we obtained Pt demographic she again stated her throat was feeling tight, second dose of EPI .3 given, within minutes it happened again a total of three EPI .3 given and 50mg of Benadryl given, ambulance arrived to transport.
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| 46 | 2021-02-28 | fatigue, headache |
Mental fog; Massive head consuming headache; Extreme fatigue; This is a spontaneous report from a co...
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Mental fog; Massive head consuming headache; Extreme fatigue; This is a spontaneous report from a contactable other hcp. A 46-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration arm right single dose on 05Feb2021 for COVID-19 immunisation. First dose lot#EL8982, arm right (IM) was received on 15Jan2021, 10:00. Medical history included drug hypersensitivity (to sulfa drugs) from an unknown date. The patient's concomitant medications were not reported. The patient experienced mental fog on 05Feb2021 15:00, massive head consuming headache on 05Feb2021 15:00, extreme fatigue on 05Feb2021 15:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 12Feb2021. The events outcome was recovered in Feb2021 No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a causal relationship between event "mental fog" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 46 | 2021-02-28 | fever, headache |
headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest an...
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headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back.; This is a spontaneous report from a contactable Consumer (patient). A 46-years-old female patient received bnt162b2 (BNT162B2, Lot number: EM5318) second dose, via an unspecified route of administration on 28Jan2021 at left arm at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Sulfa from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on 08Jan2021 (vaccine location=Left arm; lot number=EK41, administration time=01:45 PM). Concomitant medication included levothyroxine sodium (SYNTHROID), calcium (CALCIUM), hibiscus tea and green tea. The patient experienced headache, muscle pain, fever, mild injection site pain, swollen lymph nodes in left armpit, chest and back on 28Jan2021 16:00 with outcome of recovering. No treatment received for events. No covid prior vaccination. No covid tested post vaccination.
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| 46 | 2021-02-28 | fever, fatigue, headache, malaise, chills |
injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of ap...
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injection site is painful; chills; fever with temperature of 99.7 F; headache; tiredness; loss of appetite; joint pain; feeling unwell; received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the left arm on 22Jan2021 13:15 (lot number: EL3302; expiration date: unknown) at a single dose for covid-19 immunization. Medical history included mental disease, seasonal allergy in spring and allergies to sulfa antibiotics. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included aripiprazole (ABILIFY). The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at the vaccination age of 46-year-old via an unspecified route of administration in the right arm on 05Jan2021 13: 45 (lot number: EJ1685) at a single dose for covid-19 immunization. The patient received the first dose of Pfizer Covid 19 vaccine on 05Jan2021 and the second dose on 22Jan2021. On 23Jan2021 02:00 AM, she had chills, fever with temperature of 99.7 F, headache, tiredness, loss of appetite, joint pain and feeling unwell for 2 days post vaccination. She also mentioned that the injection site was painful on 25Jan2021 for 4 days post vaccination. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the events was unknown.
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| 46 | 2021-03-01 | sweating, cough, shortness of breath, fever, headache |
sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h...
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sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.
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| 46 | 2021-03-02 | fever, influenza like illness, headache |
Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid...
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Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); Covid vaccine first dose--flu like symptoms (body aches, headache, muscle aches, light fever); This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and expiration date not reported), intramuscular administered to left arm on 04Jan2021 14:00 for COVID-19 immunization. Vaccination Facility Type: Hospital. Medical history included migraine. Patient had medication for them, but has not had any migraines in a long time. The patient's concomitant medications were not reported. There were no other vaccines given the same day. Patient had no problems with vaccines in past. The patient had questions about the side effects of the Covid vaccine. On 04Jan2021 when she got the first dose, later that day (a few hours after the shot) the patient experienced flu like symptoms (body aches, headache, muscle aches, and light fever). Had the headache for about 4 days with the first dose. All this lasted about 4 days. They cleared up and she was fine. The patient wanted to know if anyone reported any of this or prolonged symptoms. Patient was unable to provide seriousness criteria when queried, only states that it was very frustrating, it's not life threatening, but she was at home versus being at work. No investigation assessment/relevant tests performed. The patient recovered from the events on an unspecified date in Jan2021. The reporter considered the events as related to the Covid vaccine. Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
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| 46 | 2021-03-02 | dizziness, fatigue |
Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received fro...
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Gait issue; involuntary lips movement; dizziness; fatigue; This is a spontaneous report received from a contactable pharmacist (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included levothyroxine and gabapentin. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 24Dec2020, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 13Jan2021, the patient experienced gait issue, involuntary lips movement, dizziness and fatigue. No treatment was given for the events. The outcome of the events was not recovered. Information about lot/batch no. has been requested.
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| 46 | 2021-03-02 | sweating, chills, fatigue, headache, lethargy |
body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight ...
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body aches/body aches and especially the throbbing in head became much worse by midday/achy; slight throbbing in head/throbbing in head became much worse by midday; very tired; body chills and hot sweats on and off; body chills and hot sweats on and off; still lethargic and achy but improving; slept all day, and all night; eye pain which was triggered by light and eye movements; eye pain which was triggered by light and eye movements; This is a spontaneous report received from a contactable nurse (who is also the patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: unknown), via an unspecified route of administration on the left arm, on 29Jan2021 11:15, at single dose, for COVID-19 immunization, at an urgent care center. There was no medical history. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included probiotics. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: unknown) received at age 46 years, via an unspecified route of administration on the left arm, on 08Jan2021 11:15, for COVID-19 immunization. On 30Jan2021 at 07:00, the patient experienced body aches and slight throbbing in head which became worse by midday; was very tired; returned to bed within 30 minutes and slept all day, and all night; had eye pain which was triggered by light and eye movements; body chills and hot sweats of and off. The patient reported that although she never had a fever according to her non contact forehead thermometer, she had body chills and hot sweats on and off. 48 hours later, she was still lethargic and achy but improving. Treatment for the events included ibuprofen 600 mg every 4-5 hours which helped but did not completely relieve the discomforts. The patient was recovering from the events.
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| 46 | 2021-03-02 | fever, migraine, headache |
migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fe...
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migraine; face numb and tingling sensation; face numb and tingling sensation; vomiting; diarrhea; fever; body aches and muscle aches; body aches and muscle aches; really sick; She had the horrible headaches; Nausea; Upset stomach; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), intramuscular in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 for COVID-19 immunization and experienced flu like symptoms, body aches, headache, muscle aches and light fever. No additional vaccines administered on the same date of the Pfizer suspect. The patient had questions about the side effects of COVID vaccine. The patient experienced migraine, face numb and tingling sensation, vomiting, diarrhea, fever, body aches and muscle aches, and has been really sick the night after that second vaccine on an unspecified date in Jan2021. It is slowly getting better and now it had been a Monday a week later from the second dose and she still has the body aches, fever that comes and goes, and headaches that have just been ongoing. She wanted to know if anyone reported any of this or prolonged symptoms. She also mentioned horrible headaches, nausea, vomiting, numbness and tingling in face on an unspecified date in Jan2021. She mentioned again the nausea and upset stomach, body and muscle aches and fever she still has a little of on an unspecified date in Jan2021. The biggest thing was the headaches. The body and muscle aches and fever comes and goes. Thought she was over the fever and it started back again yesterday. She was unable to provide seriousness criteria when queried, only stated that it was very frustrating, it's not life threatening, but she is at home versus being at work. The events migraines, fever off and on, body and muscle aches, diarrhea, vomiting, numbness and tingling in face, really sick required a visit to the Physician office. The outcome of the events migraine, Tingling, Numbness in face, Vomiting, Diarrhea, Fever, Generalized aching, Muscle ache and sickness was not recovered while the outcome of the events headache, nausea and upset stomach was unknown.
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| 46 | 2021-03-04 | chills, fatigue |
body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-conta...
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body aches; chills; pain at injection site; tiredness; This is a spontaneous report from a non-contactable consumer who reported for herself. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 01Feb2021 01:15 PM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination and patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3248, via an unspecified route of administration in the left arm on 12Jan2021 03:15 PM for COVID-19 immunization. On an unspecified date, the patient experienced body aches, chills, pain at injection site and tiredness. No treatment was received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 46 | 2021-03-09 | throat pain, fever |
Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found t...
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Patient presented to BIDMC on 02/23/21 with ~5d of sore throat and intractable fever and was found to have fulminant myocarditis. She required ICU stay with VA ECMO and Impella circulatory support from 02/25/21-03/03/21. She received a course of hydrocortisone. Cause of myocarditis was unclear but felt to be viral or post-viral versus inflammatory. As of this submission she has been transferred to the cardiac floor and seems to be recovering. Symptoms started ~14d after 1st dose COVID vaccine. She also had self limited COVID infection in early January, 2021.
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| 46 | 2021-03-09 | shortness of breath |
got vaccine - about a week later - she sent us a message saying "I have been having right calf pain ...
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got vaccine - about a week later - she sent us a message saying "I have been having right calf pain for about a week or more. I have more increased SOB and chest pain." was able to get ddimer which was elevated - and was admitted to the hospital for this since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.
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| 46 | 2021-03-14 | sweating, throat swelling, chills |
Throat swelling; severe allergic reaction to the Pfizer vaccine; chills; sweats; nausea; This is a s...
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Throat swelling; severe allergic reaction to the Pfizer vaccine; chills; sweats; nausea; This is a spontaneous report from two contactable physicians. A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267), via an unspecified route of administration on 13Feb2021 at a single dose in left arm for COVID-19 immunization. Medical history included herpes Simplex I, back pain, SI joint dysfunction, difficulty sleeping and allergy to raw tomatoes. The patient's concomitant medications were not reported. On 13Feb2021, the patient experienced throat swelling, severe allergic reaction to the Pfizer vaccine, chills, sweats, nausea, the seriousness of throat swelling, severe allergic reaction was reported as hospitalization, seriousness of the other events was reported as medically significant. Under anaphylaxis that the patient has EpiPen at home for raw tomatoes Clinical course: she had a severe reaction to the first shot presenting the following side effects: chills, sweats and nausea within 5 minutes and then developed throat swelling within 10 minutes, the patient was administered with an EpiPen, Benadryl and was sent to the ER where she received Benadryl IV monitored, eventually her symptoms diminished from 10 of 10 to a 6 in a scale of 10, the patient also received Prednisone 40 mg everyday for 4 days. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. She had a virtual visit with a patient who apparently had a severe reaction after the first vaccine. It was set up in physical therapy office. HCP wants to know if it is safe for the patient to receive the second dose of the vaccine. HCP mentioned that this is her first patient who has a severe allergic reaction to the Pfizer vaccine. She was feeling better. She was told to call her doctor about getting the second shot. The bottom line is if they acted as severely as they did she would think the answer would be not to get the second. She was better. She felt fine. She has an allergy to raw tomatoes. She knows she is not supposed to have raw tomatoes. A couple of days ago she had a dressing that must have had raw tomatoes in it because she had throat swelling. The patient said what happened with Pfizer was more. She knew it when it was happening because it has happened before. She had no hypoxia. The patient reported that her pulse ox was checked and was in the high 90's. The patient was able to swallow. No drooling. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. On 23Nov2020, the patient weighed 150 pounds and her height was 66 inches. The outcome of events was recovering. There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling. There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling.; Sender's Comments: Based on known safety profile and temporal association, the contribution of the suspect drug to the onset of events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-03-15 | dizziness |
First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat cl...
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First dizziness and nausea; First dizziness and nausea; Then itching; Then tongue swelling/throat closing; throat closing; This is a spontaneous report from a contactable consumer (Patient herself). A 46-Year-Old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration at Left arm on 16Feb2021 17:45 (at age of 46 years old) at single dose for COVID-19 immunisation. Relevant medical history included: Athsma-lasting trouble breathing after allergic reaction, Ehlers-Danlos Syndrome, PCOS (Polycystic ovarian syndrome), Hypothyroid. Known allergies was Cashews, pistachios, cat dander. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination. The patient experienced first dizziness and nausea Then itching Then tongue swelling/throat closing, all Adverse events started on 16Feb2021 17:45. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included COVID test type post vaccination was Nasal Swab, COVID test name post vaccination=PCR on 21Feb2021 with result Negative. Treatment (Epipen, IV Benadryl, Pepcid, Prednisone) received for all AE. The outcome of the events was recovered in 2021.
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| 46 | 2021-03-18 | headache, chills, fever, fatigue |
Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting to...
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Vomiting fainting took a nop as the day went on the pain on my R leg got worse; Vomiting fainting took a nop as the day went on the pain on my R leg got worse; vomiting fainting took a nop as the day went on the pain on my R leg got worse; Symptoms of fatigue; Pain on my R knee; Went to fever 102.2 then; Chills, into the entire night/Shivers and shakes; Headache; Into the morning could not walk on my R leg/Can not walk on either foot; Numbness to my face; Found a cyst on the back of my knee; Shivers and shakes; Damage to my ligaments; This is a spontaneous report from a contactable other HCP (patient). A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular in the left arm on 04Feb2021 at single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history was none, and concomitant medications were not reported. The patient was not sure about allergies. The Patient not received other vaccine in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via intramuscular Left arm on 14Jan2021 04:30 PM at single dose for COVID-19 immunization (at the age of 46-years). The patient stated, "on 12Feb2021 at 03:30 PM, (as reported: one week after the second dose) after the second dose of vaccination. I started having symptoms of fatigue, pain on my R knee, went to fever 102.2 then, chills, into the entire night, headache, into the morning could not walk on my R leg, numbness to my face, vomiting fainting took a nop as the day went on the pain on my R leg got worse. Went to the ER (emergency room) x ray and ultrasound was done, found a cyst on the back of my knee not sure if it was from the shivers and shakes caused damage to my ligaments, 2 hours later my right foot was in a lot of pain, two bumps onto of my L foot lots of pain went back to the ER on Sunday morning (14Feb2021), x ray was done only no broken bones foot was red turned purplish, this started Friday 12th (12Feb2021) and her Monday the 16th Tuesday missed work and still in a lot of pain cannot walk on either foot very far without my boot or crushes." No covid prior vaccination. The patient underwent lab tests and procedures which included post vaccination sars-cov-2 test Nasal Swab: negative on 23Dec2020; body temperature: 102.2 on an unknown date; ultrasound scan and X-ray: cyst on the back of my knee on 12Feb2021, x-ray: no broken bones foot on 14Feb2021. Took the following treatment measures, shot for pain, cortisone shot, naproxen 500. The adverse events resulted in doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relation, the association between the event syncope and the vaccination with BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 46 | 2021-03-21 | cough, fever |
severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; card...
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severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; cardiogenic shock; myocarditis; hypoxic respiratory failure; mural thrombus; hypotensive despite pressors; fever; cough; myalgias; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), intramuscularly on 05Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included hyperlipidemia and COVID-19 pneumonia from an unspecified date in Jan2021 to an unspecified date in Jan2021 (the patient was diagnosed with COVID-19 pneumonia prior to the vaccination. Recovered. Returned to work on 25Jan2021). Concomitant medications included atorvastatin orally at 10 mg, once a day, acetylsalicylic acid (ASPIRIN) orally at 81 mg, once a day, colecalciferol (VITAMIN D); all the drugs were received within two weeks. The patient previously took clindamycin and experienced known allergies: Clindamycin. The patient did not receive other vaccine in four weeks. The patient developed fever, cough, myalgias on 19Feb2021 at 12:00 AM. She developed peripheral swelling in hands/feet on 24Feb2021, she was evaluated in the ER; admitted to (hospital name withheld) on 24Feb2021 with cardiogenic shock, myocarditis, hypoxic respiratory failure. The patient was started on IV vancomycin and Unasyn. TTE (transthoracic echocardiogram) demonstrated LVEF (left ventricular ejection fraction) 35%; reduced biventricular function; mural thrombus on 24Feb2021. Remained hypotensive despite pressors on 24Feb2021. Patient had elevated PCW with preserved cardiac index. Patient underwent VA ECMO (veno-arterial extracorporeal membrane oxygenation) and Impella placement on 25Feb2021. COVID-19 PCR was negative. Blood cultures were no growth. She developed severe thrombocytopenia and developed bleeding at Impella insertion site on 25Feb2021; required multiple, PRBC transfusions. Evaluated for HLH; Soluble IL2 receptor on 26Feb2021 elevated at 7232 pg/mL; ferritin 3054; CRP > 300. ECMO stopped 03Mar2021. The patient was treated with IV antibiotics, mechanical ventilation, pressor support, underwent VA ECMO and Impella placement. The patient was hospitalized from 24Feb2021 to 16Mar2021. Number of days of hospitalization was 20 days. The patient tested COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure: hypotensive despite pressors, LVEF: 35 %, nasal swab: Negative on 24Feb2021, blood cultures: No growth, nasal swab: Negative on 25Feb2021, ferritin: 3054, HLH: Evaluated, Soluble IL2 receptor: 7232 pg/mL (elevated at 7232 pg/mL), CRP: > 300 on 26Feb2021, nasal swab: Negative on 11Mar2021, nasal swab: Negative on 14Mar2021. The events were considered as serious (hospitalization and life threatening) by the physician. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: the events being serious, life threatening and hospitalisation ,medical intervention required are assessed as possibly related to the suspect drug __BNT162B2____ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.
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| 47 | 2020-12-31 | headache |
Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then ...
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Ever since I got the vaccine I have headaches which increased to near migraine level on 12/29, then yesterday 12/31 at 330pm while painting my left face became paralyzed and numb. Went to ER Had CT/CTA of head EKG, chest Xray and multiple labs including Lyme test which will not be resulted for 5-7 days. ER started me on taper prednisone and doxycycline. Diagnose with significant Bell's Palsy
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| 47 | 2020-12-31 | shortness of breath |
Extreme and worsening right upper hip pain, spreading to center lower back. Making it extremely diff...
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Extreme and worsening right upper hip pain, spreading to center lower back. Making it extremely difficult to take full breath. Unable to bend, sit up. Extreme pain while laying in any position and needing help to stand. Pain lvl 9.5
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| 47 | 2020-12-31 | fatigue, somnolence, headache, respiratory tract congestion |
Significant fatigue 24 hours after injection. Brain fog, need to sleep. Next am felt better Left arm...
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Significant fatigue 24 hours after injection. Brain fog, need to sleep. Next am felt better Left arm discomfort for week Day 4 after vaccine- nausea, mild congestion no fever Day 6 after vaccine mild congestion and significant headache
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| 47 | 2021-01-01 | malaise, fatigue |
Received covid-19 vaccine on 12/17/2020. On 12/23/2020, noticed small rash bumps on back of both ha...
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Received covid-19 vaccine on 12/17/2020. On 12/23/2020, noticed small rash bumps on back of both hands. On 12/26/2020, noticed rash on shoulders and middle back. Noted fatigue and malaise. No fever. On 12/28/2020, rash appeared on upper legs and back of both knees. Noted fatigue and malaise. No fever. On 12/29/2020, rash appeared on both lower legs and on arms. Noted fatigue and malaise. No fever. On 12/30/2020, attempted to make an appointment with primary care provider and was unable to be seen before Jan 6, 2021. On 1/1/2021, went to Urgent Care for evaluation and treatment of full body rash. The only part of my body not affected by the rash is my face. Was prescribed a methylprednisolone dose pack.
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| 47 | 2021-01-02 | shortness of breath, dizziness |
BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST...
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BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST INJECTION. BEENADRY 100MG TAKEN, 4 DOSES OF TWO PUFF OF PROAIR HFA TAKEN. BREATHING NORMALIZED. ITCHING REMAINED, LIGHTHEADED SUBSIDED. GENERALIZED TOTAL BODY ITCHING CONTINUED THROUGH THE 3RD TODAY, LESSENDED YESTERDAT THE 2ND. BREATHING DIFFICULTY SOB AND TIGHTNESS RESUMED TODAY 1/3/2021 FOR ABOUT 2 HOURS BENADRYL 150 MG TAKEN , PEPCID 40 MG TAKEN, CLARATIN TAKEN PROAIR PUFFS TAKEN X 5 . CHEST TIGHTNESS CONTINUES, ITCHING CONTINUES AND BENADRYL CONTUNES TO BE USED WITH PUFFS FOR RELIEF. NORMAL MEDS TAKEN AS WELL XYZAL AND SIGULAR
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| 47 | 2021-01-02 | weakness, headache, dizziness | dizziness weakness headache neck pain |
| 47 | 2021-01-03 | dizziness |
12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out m...
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12/23 within 2 mins after the vaccine I felt light headed and I felt like I was going to pass out my heart was beating really hard, it started to mellow out and my face swelled up about an hour after. I was told to go to the ER and I took oral Benadryl and it went away and did not return
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| 47 | 2021-01-03 | cough, shortness of breath |
Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breat...
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Didn't feel "right", felt like her throat was closing, couldn't swallow, shortness of breathe, breathing got worse, called 911, 1 Epipen given, she started to cough and talk to us, then couldn't breathe again, couldn't talk, paramedics arrived.
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| 47 | 2021-01-03 | runny nose, nasal congestion, malaise, fatigue, dizziness, respiratory tract congestion |
Friday 7 AM - Extreme Dizziness, fell over 2x Extreme fatigue, general malaise, Nausea 5 pm more awa...
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Friday 7 AM - Extreme Dizziness, fell over 2x Extreme fatigue, general malaise, Nausea 5 pm more awake, dizziness subsiding Sat 10am Dizziness Subsiding, general malaise, Nausea Sun Dizziness gone, Runny Nose, Stuffiness, full/congested feeling Mon 99.5, Nausea, Drainage
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| 47 | 2021-01-03 | dizziness, migraine |
Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise ar...
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Migraine with nausea and dizziness preceded by visual aura, severe left arm pain (could not raise arm without significant pain), left wrist pain
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| 47 | 2021-01-03 | fatigue, fever | Severe fatigue, abdominal cramping, fever 102.7 |
| 47 | 2021-01-03 | malaise, headache | Temp, diarrhea for 4 hrs, malaise, bad headache , insomnia |
| 47 | 2021-01-03 | fever, malaise |
have COVID; have COVID; bone-crushing-pain; fever; This is a spontaneous report from a contactable c...
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have COVID; have COVID; bone-crushing-pain; fever; This is a spontaneous report from a contactable consumer reporting for a patient (nurse). A 47-year-old female patient received first single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 20Dec2020 for immunization. The patient's medical history concomitant medications were not reported (unknown). Patient was an ER Nurse and took first dose of vaccine and then described mild/moderate symptoms on day one only. On 23Dec2020, patient posted they have COVID (positive COVID test). Contracted from spouse who got it from work. She further described it as "hit by a truck." On Day 4 she describes her COVID symptoms: bone-crushing-pain when fever rises. Symptoms were COVID symptoms, not directly related to vaccine. The events/symptoms started on 20Dec2020. Patient had no Covid prior vaccination. The patient was COVID tested post vaccination. The patient considered the events as non-serious. The outcome of events was not recovered. Information on Lot/Batch number has been requested.
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| 47 | 2021-01-03 | shortness of breath, headache, fatigue |
short of breath; Intense headache; tiredness; body aches; This is a spontaneous report from a contac...
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short of breath; Intense headache; tiredness; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO124), via an unspecified route of administration on 23Dec2020 at 14:30 on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included Rheumatoid arthritis, lupus. No known allergy, no allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included baricitinib (OLUMIANT), hydroxychloroquine, prednisone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intense headache, tiredness, body aches, short of breath on 24Dec2020; events were resulted in: Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had been tested for COVID-19 on 27Dec2020: Nasal Swab, result was unknown. No treatment was received for the events. The outcome of the events was not recovered.
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| 47 | 2021-01-04 | chills, fatigue, runny nose |
12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled musc...
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12/28 - 2 hours after injection - terrible arm pain. Could not raise arm and felt like a pulled muscle from my neck all the way down arm. This went on for 4 days. The pain woke me up at night for 2 nights. Just took Ibuprofen. This pain has resolved. 12/29 - body aches, chills, joint pain, fatigue, SOB on exertion, runny nose, and sneezing. These symptoms went on for 5 days. Mostly resolved - still some fatigue and SOB on exertion, runny nose, and sneezing. Again, treated with ibuprofen and rest. 1/31 - Extreme nausea, aggitatation, and fatigue. Took Zofran and went to bed at 7pm and slept until 9am. Felt much better. 1/2 - Completed a virtual visit. Advised to come in to clinic for covid test only. Not seen by physician. Negative results, and no F/U from a provider. 1/5 - All symptoms resolved except some fatigue and SOB on exertion, runny nose, and sneezing.
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| 47 | 2021-01-04 | headache, fever |
All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My ...
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All of sudden I started feeling bad, I mean it just hit me; Fever; Headache; I am very nauseous; My left arm started swelling, it started in fore arm and it started getting marks on it; pain in arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in her right arm on 21Dec2020 at single dose for covid-19 immunization. Medical history included Blood pressure high, Attention deficit hyperactivity disorder (ADD), depression and cancer four years ago and she didn't have any left node in left arm. Concomitant medications included losartan (LOSARTAN) for Blood pressure high, venlafaxine hydrochloride (EFFEXOR) as antidepressant, tamoxifen (TAMOXIFEN) for her cancer and it was hormone blocker, lisdexamfetamine mesilate (VYVANSE) for ADD. The patient received the vaccine last this last Monday on 21Dec2020, in her right arm, she was fine, on Thursday on 24Dec2020 like all of sudden she started feeling bad, she mean it just hit her. She had fever, she was very nauseous and her arm, her left arm started swelling, it started in forearm and it started getting marks on it. Anyway she went go and got tested for Covid yesterday 26Dec2020 because in middle of night, that night I felt so bad. She have got just headache on 24Dec2020, its most of that before then. Anyways she had just got her results back that was negative but so she didn't know that her arm, it was the opposite arm. The patient still experiencing pain in arm, she haven't had fever in last night and she haven't checked it today. She took Tylenol and she called her doctor yesterday and they made of me some antibiotics for her arms, probably the 7mg and the patient guess it is every 8 hours. The outcome of the event pain in arm was not recovered and the outcome of the other events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-04 | dizziness |
Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light hea...
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Approximately 20-25 min. post vaccination, employee reported chest tightness, flushing and light headed. She was alert and oriented x 3. V/S: 120/72; pulse 140; resp 22; O2 sat 99% on RA; pupils equal and reactive; skin pink. Dr was notified and assessed the employee. Dr. ordered Benadryl 25mg PO which was administered at 1050. 1120 - o2 sat was 98% on RA; pulse 85; employee reported that chest tightness resolved and light headedness impoved, but not resolved; she continued to be flushed. Symptoms continud to improve. Employee remained in the observation area and was instructed to seek emergency treatment if symptoms returned, worsen or new symptoms occured. She verbalized understanding.
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| 47 | 2021-01-04 | dizziness | DIZZINESS |
| 47 | 2021-01-04 | fever, fatigue | Felt tired and cold Fever |
| 47 | 2021-01-04 | chills, sweating, fever | Fever, chills, myalgia, sweats |
| 47 | 2021-01-04 | fatigue, fever, weakness, dizziness |
Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip p...
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Fever; feels weak; tired; lightheaded; pain at the injection site; back and hip pain; back and hip pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included sick with coronavirus infection from 11Aug2020. There were no concomitant medications. The patient was experiencing the expected side effects fever, feels weak, tired, lightheaded, pain at the injection site in the right deltoid, hip and back joint pain on Dec2020. She does not know exactly when these events started but that she noticed them when she was trying to sleep last night. Outcome of the events was not recovered. The events were considered serious due to being medically significant.; Sender's Comments: Based on temporal association, the causal relationship between BNT162b2 and the events pyrexia, asthenia, fatigue, dizziness, vaccination site pain, back pain and arthralgia cannot be excluded.
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| 47 | 2021-01-04 | headache, chills, fever, malaise |
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling fever headache joint pain spe...
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Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain and swelling fever headache joint pain specifically in hands wrists and neck chills muscle pain nausea feeling unwell
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| 47 | 2021-01-05 | chills, fever | CHILLS , FEVER , BODY ACHES, JOINT PAIN |
| 47 | 2021-01-05 | weakness, sweating, fever, chills, fatigue | Chills, fever, general weakness & fatigue, sweating |
| 47 | 2021-01-05 | headache, dizziness |
Dizziness, Headache, Lightheadedness; Injection site pain Narrative: Dizzy and lightheaded 14 minut...
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Dizziness, Headache, Lightheadedness; Injection site pain Narrative: Dizzy and lightheaded 14 minutes after injection. Headache and injection site pain for 2 days after injection.
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| 47 | 2021-01-05 | fever, chills, fatigue, headache |
Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous re...
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Fever; fatigue; uncontrolled headache; eye pain; chill; joint pain; nausea; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 02Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included COVID on an unspecified date. The patient's concomitant medications were not reported. The patient stated, "fever, fatigue, uncontrolled headache, eye pain, chill, joint pain. nausea. Get more worst and worst". The patient received treatment. The outcome of the events was not recovered.
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| 47 | 2021-01-05 | headache, throat pain |
Headache; Sore throat; This is a spontaneous report from a contactable nurse (patient). A 47-year-ol...
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Headache; Sore throat; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had a vaccine received this afternoon on 30Dec2020, 4 to 5 hours after, she was having a headache and had sore throat as well. The patient wanted to know if it was okay to take Tylenol. The outcome of events was unknown. No follow-up attempts are possible; Information on Lot/Batch Number cannot be obtained.
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| 47 | 2021-01-05 | fever, body temperature increased |
Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents w...
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Pfizer-BioNTech COVID-19 Vaccine: Emergency Department Visit 01/07/21: 47 y.o. female who presents with complaints of fever, rapid heart rate and body aches that began around 1 PM this afternoon. Patient states that she received her second Covid vaccination yesterday and began developing symptoms today. States she had a temperature of 102. She is a nurse here in the rehabilitation center. She denies any cough, sore throat, abdominal pain that is new, vomiting, diarrhea or bloody stools. She has had no urinary symptoms. She denies any leg swelling or pain. No history of DVT or pulmonary embolism. No recent travel, immobilizations, surgeries, bedrest or history of malignancy. No hemoptysis. Again, no cough. Patient is taken no medications for the symptoms other than Tylenol which she states has not improved her symptoms. ROS negative. No pertinent history - Ovarian cyst, Spontaneous abortion, Uterine fibroid. She is given a liter normal saline 1 ibuprofen as she has allergies and side effects to multiple medications including pain medication and the patient did refuse any pain medications other than ibuprofen. Symptoms are consistent with side effects of the Covid vaccine. She does not appear ill appearing. She has no fever at this time. She does state that her symptoms are somewhat improved. Chest x-ray and labs are otherwise unremarkable. Encouraged the patient to get rest, drink plenty fluids and take ibuprofen and follow-up with her primary physician or return if symptoms worsen. This is the patient's second dose of vaccine for Covid.
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| 47 | 2021-01-05 | fever, fatigue, weakness |
Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous ...
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Weakness; Tingling in arm that was vaccine was given; Fever; Extreme fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC1284), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced extreme fatigue, tingling in arm that was vaccine was given, fever, and weakness on 30Dec2020. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
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| 47 | 2021-01-05 | chills, headache | soreness and swelling at injection site in small area, chills, and headache. |
| 47 | 2021-01-06 | dizziness | Dizziness, UrticariaPruritus, HYPERtension, facial flushing, face felt warm |
| 47 | 2021-01-06 | headache, throat swelling, sweating, shortness of breath |
During 15 minute observation period post vaccine: Patient develop tightness in the throat and had tr...
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During 15 minute observation period post vaccine: Patient develop tightness in the throat and had trouble breathing. Reported head pounding, throat swelling and sweaty feet. BP of the patient was taken by Nurse faculty at the facility and recorded at 201/110. Heart Rate was recorded at 180. Benadryl was given to the patient.(50mg total) Patient was taken to hospital by staff at facility at 11:02am. Confirmed check-in at 11:25am.
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| 47 | 2021-01-06 | headache, fever, malaise |
Fatigue, malaise, body aches, mild headache starting 12 hours after vaccination Fever of 101.3 24 h...
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Fatigue, malaise, body aches, mild headache starting 12 hours after vaccination Fever of 101.3 24 hours after vaccination
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| 47 | 2021-01-06 | headache, fatigue |
Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work a...
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Headache, Arthralgia, Diarrhea, NauseaVomiting, fatigue, injection site pain Narrative: left work at noon on 12/31/20
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| 47 | 2021-01-06 | headache | Headache, Myalgia & NauseaVomiting |
| 47 | 2021-01-06 | fever, headache, chills | Headache, Myalgia, Fever, UrticariaPruritus, NauseaVomiting, temp 101.0 then 99.5 Chills Narrative: |
| 47 | 2021-01-06 | fever, headache | Headache, Myalgia, NauseaVomiting, fever T 99.5 F |
| 47 | 2021-01-06 | fatigue, headache, fever, chills, malaise |
Headache, fever, muscle pain, joint pain, chills, fatigue, pain at injection site, overall not feeli...
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Headache, fever, muscle pain, joint pain, chills, fatigue, pain at injection site, overall not feeling well
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| 47 | 2021-01-06 | throat swelling | Mild throat swell, nausea, blurred vision |
| 47 | 2021-01-06 | fever | Myalgia, Arthralgia & Fever |
| 47 | 2021-01-06 | headache |
Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 ...
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Patient presented to clinic with complaints of generalized itching, status post COVID vaccination 2 days ago on 12/22. Patient also reporting flushing, intermittent tachycardia, and headache x2 days. Vitals were taken and follow: blood pressure 108/117, heart rate 111, spO2: 100%. Injection site observed to be red and tender. Patient reports history of allergies to tetracaine. Patient did not take medication OTC prior to coming in to clinic. Patient was transferred and admitted to the emergency department. In the emergency department was given benadryl and monitored for symptom improvement. Was discharged on the same day.
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| 47 | 2021-01-06 | dizziness |
Pt received vaccine felt light headed lowered to floor 96HR 99% no respiratory distress, no allergic...
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Pt received vaccine felt light headed lowered to floor 96HR 99% no respiratory distress, no allergic rx, no loc. EMS called pt declined transport vs wnl FSBG 93 EMS left and pt lightheaded again lowered to floor MD/EMS called and pt taken to the hospital
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| 47 | 2021-01-06 | chills | Shaking chills, myalgia and bone pain |
| 47 | 2021-01-06 | headache |
Sudden severe headache followed by severe joint pain (elbows, knees, neck and back) and axillary and...
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Sudden severe headache followed by severe joint pain (elbows, knees, neck and back) and axillary and left arm lymphedema and left breast swelling.
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| 47 | 2021-01-07 | throat irritation, malaise, throat swelling, malaise |
12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling li...
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12 minutes, first vaccine reported tingling to the tongue, cheeks flushed, progression to feeling like throat was swelling. Patient was taken to ED via wheelchair. Monitoring and BP @7:40 135/83 HR 72 Resp. 18. Under oBS at hospital, not admitted. *Initial dose reported symptoms of feeling sick with dose 1 but not to extent of second dose
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| 47 | 2021-01-07 | shortness of breath |
After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER...
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After 15 mins I felt like I couldn't breath. On the way home hour later hard to breath. I went to ER gave me Steroids and Pepcid. Since then I have taken Benadryl. On 12/30 at 10am I was exp reaction again went back to the ER. They provided me with breathing treatment and was sent home on Prednisone. I contacted my PCP to inform her that I have to continue taking Benadryl to help with sob and my voice changes. It seems like my lungs are affected due to taking the vaccine. I'm currently off and not able to receive comp due to the vaccine being voluntary.
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| 47 | 2021-01-07 | chills |
Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontan...
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Allergic reaction; Hives on back; Flushed; Chills; Swollen tongue; Burning tongue; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 07:00 at single dose on left arm for COVID-19 vaccination. There were no medical history and concomitant medications. The patient previously took flu shot. Vaccination Facility Type was hospital. Patient did not receive any other vaccines at time COVID-19 vaccine given and no vaccines given 4 weeks prior. Patient got the Pfizer COVID-19 vaccine on 29Dec2020 and had an allergic reaction to it. Had hives on her back, was flushed, had chills, and swollen tongue on 29Dec2020. There was swelling on either side of tongue not in the center. Swelling seemed to bounce around sides of tongue. Patient mentioned she also had burning sensation of tongue first on 29Dec2020 and then the swelling was after that. Adverse events hives, flushed, chills, burning sensation of tongue and swelling of tongue required a visit to emergency room. Patient was seen in the emergency room and given diphenhydramine hydrochloride (BENADRYL) and an Epi-pen to take home. This all happened after receiving the vaccine on 29Dec2020. Patient wasn't getting any better/feeling better and went back to the emergency room on 30Dec2020. Patient was treated with dexamethasone and told her to take diphenhydramine hydrochloride every 4 hours, her last dose was at 2pm 31Dec2020. Patient said all events still persisting, but there maybe a little more swelling of the tongue, but not much. Patient had had a flu shot before, but never had anything to happen like this. Outcome of allergic reaction, hives, flushed, chills and burning tongue was not recovered, outcome of swollen tongue was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | malaise, headache, chills, fatigue | Chills, body & joint aches, headache, fatigue, malaise |
| 47 | 2021-01-07 | fatigue, malaise |
Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating j...
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Cp initially that resolved in seconds. Then severe muscle aches, fatigue, temp 1 week,excruciating joint pain continues now. Malaise.
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| 47 | 2021-01-07 | dizziness | Dizziness resolved after about an hour |
| 47 | 2021-01-07 | fever, headache | Headache, Myalgia, Fever & NauseaVomiting Narrative: |
| 47 | 2021-01-07 | headache |
Patient developed headache almost immediately after vaccine administration that persisted with sligh...
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Patient developed headache almost immediately after vaccine administration that persisted with slight worsening. Her BP was found to be elevated 4 hours later to 180s/100s; on manual recheck, was 172/96. Given signs and symptoms consistent with hypertensive urgency, she was sent to the emergency room. She has a history of well-controlled HTN and has been adherent to her medications (including the day of vaccine administration); she has had no recent episodes of uncontrolled BP.
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| 47 | 2021-01-07 | dizziness, sweating | Pfizer-BioNTech COVID-19 Vaccine EUA. Sweating, lightheaded |
| 47 | 2021-01-07 | cough, runny nose |
Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous repor...
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Rash on both legs; nausea; diarrhea; runny nose; epigastric pain; cough; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number ej1685) on 20Dec2020 13:15 at single dose intramuscularly in the left arm for COVID-19 immunization. Relevant medical history included unspecified allergies (known allergies: Yes. Allergies to medications, food, or other products: yes). There were concomitant medications. The patient experienced rash on both legs, nausea, diarrhea, runny nose, cough, epigastric pain on 20Dec2020 20:00, which resulted in emergency room/department visit or urgent care. The reporter (patient) considered the events were non-serious. It's unknown if any treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020, the patient was tested for COVID-19 (Nasal Swab) and the result was negative. The patient recovered with lasting effects.
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| 47 | 2021-01-07 | throat irritation |
Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over b...
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Reported itchy throat, tongue, face apprx 10 mins after vaccine. Later that night she had all over body itching with no rash and mouth swelling, eye swelling. No SOB, or difficulty swallowing.
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| 47 | 2021-01-07 | fatigue, headache |
Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontan...
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Severe headache, severe body aches, skin sensitivity, fatigue and diarrhea for 18 hours then spontaneously resolved
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| 47 | 2021-01-07 | headache, malaise |
Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; He...
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Soreness at injection site and entire upper arm; Soreness at injection site and entire upper arm; Headache; Feeling sluggish and unwell; Feeling sluggish and unwell; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at right arm on 28Dec2020 10:00 at single dose for COVID-19 immunization. Medical history included none. No known allergies. Concomitant medication included Alive multivitamin which received within 2 weeks of vaccination. The patient experienced soreness at injection site and entire upper arm, headache, feeling sluggish and unwell, all on 28Dec2020 16:00. No treatment received. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. This is a non-serious report. The outcome of the events was recovered on an unspecified date.
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| 47 | 2021-01-07 | head discomfort, dizziness, fatigue, headache |
Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hou...
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Terrible headache for 19 hours which started 1 hour after shot. Headache again with heaviness 25 hours after shot including dizziness with bending. 35 hours after dose, had dull pain on the inside prominence of my right elbow (arm I got my shot). This pain lasted for 8 hours. Also accompanied with fatigue.
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| 47 | 2021-01-07 | productive cough | Throat flem, body tingles, EMS screened, increased observation time, resloved in 15 min |
| 47 | 2021-01-07 | shortness of breath, somnolence, throat irritation |
Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside m...
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Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat. Then I began to have difficulty swallowing my saliva. And then the lump inside my throat started to feel larger and larger. By this time Dr had already injected me with Epipen and the pharmacist injected me with Solumedrol and I still felt as if I was having difficulty breathing and then I was taken to ER and I really can't remember too much after that. I was very groggy and then I was discharged from ED about 9:30 pm.
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| 47 | 2021-01-07 | skin warm |
Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I r...
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Within 45 minutes, my neck and face became hot and red. No issues with breathing, 6 hours later, I received a rash over the arm in which I had the injection. Since the shot Monday, I have continued to have redness on neck and face and along with felling hot. I have been taking Benadryl since Monday and finally went to UC on Thursday 01/07/2021. At the appointment, I received a Decadron injection, which helped, but today I am back to red face/neck and warmth.
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| 47 | 2021-01-07 | dizziness |
dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 h...
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dizziness; tongue and lip tingling; welt on bottom lip; chest tightness; SOB with activity for 2-4 hours; itching; burning; diarrhea; redness traveling up arm into chest; This is a spontaneous report from a contactable nurse reporting for herself. A 47-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 29Dec2020 03:30 at single dose for COVID-19 immunization. Medical history included breast cancer, allergy to peanuts, dogs, cats, the outdoors. Concomitant medication included tamoxifen (unknown manufacturer). On 29Dec2020 04:00 the patient experienced dizziness, tongue and lip tingling, welt on bottom lip, chest tightness, SOB with activity for 2-4 hours, itching immediately after injection (as reported), then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. The outcome of the events was recovered. The patient received famotidine (PEPCID) and Cetirizine as treatment for the event. No other vaccine was administered in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | throat pain, fatigue, fever |
excessive sleeping; Extreme fatigue; temp 100; sore throat; loss of balance; Muscle weakness; This i...
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excessive sleeping; Extreme fatigue; temp 100; sore throat; loss of balance; Muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration in the left arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. The patient's medical history included COVID-diagnosis from Mar2020 that resulted in blood clots and pneumonia both on 2020, and allergies to shellfish, eggs, peanuts. The patient was not pregnant. Concomitant medications included acyclovir [aciclovir], levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS), escitalopram oxalate (LEXAPRO), and bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020 06:00, the patient experienced extreme fatigue, temperature of 100, sore throat, loss of balance, muscle weakness, and excessive sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent other lab tests and procedures which included COVID test nasal swab was negative on 28Dec2020. Outcome of the events was not recovered. The events were considered non-serious by the reporter.
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| 47 | 2021-01-07 | shortness of breath, headache |
noticed an itch around that area (site of vaccine); heart started beating very fast; could not breat...
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noticed an itch around that area (site of vaccine); heart started beating very fast; could not breathe/difficulty breathing; light headaches; some soreness on the vaccine site; swelling on the area where she was vaccinated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration in left arm on 30Dec2020 at single dose for Covid-19 immunisation. Medical history included high cholesterol (it was under control. Diagnosed a couple years ago). There were no concomitant medications. She did her first dose of Pfizer COVID vaccine on 30Dec2020, and she had a little experience, she didn't tell the nurse at that time, but she went through her paperwork and decided to call Pfizer. When she got the shot, she was told to go to the next room to sit down for 15 minutes. When she went to the next room, 1 minute later, her heart started beating very fast, then she started to feel like she could not breathe/difficulty breathing for that moment. So, she tried to calm herself down and she focused on her phone to play games and to not think about it. After a couple minutes, it had gone. it was probably gone maybe about 10 minutes later. After 15 minutes, she went back to her office, everything was ok. Her heart was beating but not that fast, it was calmer than before, and she had a light headache, then some soreness on the vaccine site, on the left side, 'she thinks that is normal, right?' Clarifies soreness as swelling and painful on the area where she was vaccinated. She wanted to know, was she able to go back for the second shot, she was scheduled for 20Jan2021. Regarding light headache, she took some paracetamol (Extra Strength Tylenol, strength: 500mg, expiration date: Jun2024, lot number: SJC214). Soreness outcome: It went away, maybe the third day (02Jan2021), it was completely gone. The third day it was ok to completely sleep and lean on that side. She has recovered completely. The third day (02Jan2021), she noticed an itch around that area (site of vaccine), but she was not scratching it. The itching had gone, she had recovered completely. The outcome of heart started beating very fast and could not breathe was recovered on 30Dec2020, light headache was not recovered, soreness at vaccine site was recovered on 02Jan2021, itching at vaccine site was recovered on an unspecified date of Jan2021, and swelling on the area where she was vaccinated was unknown.
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| 47 | 2021-01-07 | fever, chills, headache |
sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injecti...
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sore left arm swelling at injection site; 15 hours after injection:Sore left arm swelling at injection site; Nausea; joint pain; specifically hands wrists and neck; muscle pain; headache; fever between 102.8 and 101.3; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 11:45 am at single dose at left arm for covid-19 immunization. The patient medical history was not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took codeine and zolpidem and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. 15 hours after injection, patient experienced sore left arm swelling at injection site, nausea, joint pain, specifically hands wrists and neck, muscle pain, headache, fever between 102.8 and 101.3, chills on 05Jan2021 03:00 AM. Patient took covid test /Nasal Swab on 04Jan2021 and on 05Jan2021 with unknown results. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Outcome of events was not recovered. The report is considered non-serious. Information on the lot/batch number has been requested.
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| 47 | 2021-01-07 | chills, headache |
swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is...
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swollen supraclavicular lymph node; headache; chills; soreness to injection site for 2 days; This is a spontaneous report from a contactable nurse, reporting for a patient. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1685, via intramuscular on 22Dec2020 at 14:45 (at the age of 47 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma, celiacs, and hypertension from an unknown date. The patient had known allergies to shellfish, latex, sulfa, Levaquin, Morphine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydrochlorothiazide, zyrtec, dicyclomine, ibuprofen, benadryl, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 23Dec2020, the patient experienced soreness to injection site for 2 days (23Dec2020 and 24Dec2020). On 26Dec2020 at 16:00, she started having chills and headache. On 27Dec2020 chills were to the point where she couldn't get warm. Shivering chills. She remained afebrile just bad chills for 2 days. On 28Dec2020, she noticed swollen supraclavicular lymph node to left clavicle area which was painful to touch and approximately quarter in size. It was not as painful today and swelling was starting to subside. The patient did not receive treatment for the events. The clinical outcome of soreness to injection site for 2 days was recovered on 25Dec2020. The clinical outcome for headache, chills, and swollen supraclavicular lymph node was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 47 | 2021-01-08 | sweating, headache, nasal congestion, fatigue |
1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left...
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1 of 2, Pfizer-BioNTech COVID-19 Vaccine EUA received 1/7/21. Got hot flashes/sweaty, headache, left chest/breast pain, fatigue, stuffy nose.
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| 47 | 2021-01-08 | fatigue, fever |
About 1 hour after injection, I started getting very itchy so I took a benadryl. This morning I woke...
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About 1 hour after injection, I started getting very itchy so I took a benadryl. This morning I woke you with body pain everywhere, especially to arm of injection. Running fever of 101.4 and higher, all over body rash that is extremely itchy. Very fatigued feeling.
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| 47 | 2021-01-08 | dizziness, fatigue |
About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did...
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About 36 hours after vaccination, I experienced incredible "brain" fatigue/fog. My physical body did not seem affected by the fatigue but my brain/head felt very "fuzzy". I had a hard time getting words out. Similar feeling to etoh intoxication. I was a bit off balance and dizzy. I remember shaking my head to try to clear it. I also had a very"plastic" taste in my mouth and felt nauseous. At the 48 hour mark (almost exactly) I felt better. At 60 hour mark brain/head symptoms completely resolved. Only experienced a very slight nauseated feeling.
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| 47 | 2021-01-08 | throat swelling |
Arms started tingling immediately after injection but did not think it was a significant response. A...
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Arms started tingling immediately after injection but did not think it was a significant response. As I was driving home my throat began to swell, my heart was racing, my chest got red and I was very shaky - this occured appx 50 minutes post injection.
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| 47 | 2021-01-08 | fever, chills, fatigue |
Chills, low grade fever to start at 98.1, full body aches, fatigue, temperature rose to 101.1 then a...
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Chills, low grade fever to start at 98.1, full body aches, fatigue, temperature rose to 101.1 then about 9:00 pm fever broke and back down to 98.0 and felt fine ever since.
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| 47 | 2021-01-08 | dizziness | Dizziness & Angina Narrative: |
| 47 | 2021-01-08 | thirst, throat swelling, fever |
Dryness in mouth immediately as vaccine was being administered. Within 2-3 minutes mouth, tongue and...
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Dryness in mouth immediately as vaccine was being administered. Within 2-3 minutes mouth, tongue and throat started to swell. 50 mg of Benadryl was given. Started to feel better but 45 minutes later swelling started back up. Dryness in mouth still there and water couldn?t quench my thirst. Escorted to Emergency department. Epinephrine shot given 40mg of prednisone, 20 mg of Pepcid and 10 mg of Zyrtec given. Given another 20mg of prednisone, 10 mg of Pepcid and 10 mg of Zyrtec 1.5 hours later. Release after 4.5 hours. Given 3 days of medicine previously given. Swelling started back up 6 hours later so I took 50 mg of Benadryl. Swelling continued every 6-8 hours. Mouth was still really dry but as long as I drank 100 oz of water a day I was ok. Tuesday I had a small fever and very achy. Went to doctor and he prescribed 20 mg of prednisone twice daily tapering off for 11 days, 10 mg of Pepcid and Zyrtec twice daily for 11 more days. Finished my medicine Saturday January 2nd. I have been feeling better but still have swelling occasionally.
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| 47 | 2021-01-08 | headache |
Headache & NauseaVomiting Narrative: Developed headache and nausea following administration of covi...
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Headache & NauseaVomiting Narrative: Developed headache and nausea following administration of covid vaccine. Resolved by 1/3/21.
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| 47 | 2021-01-08 | runny nose, fever, chills |
Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with B...
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Myalgia, Fever, UrticariaPruritus, Anorexia, SOA, rhinorrhea, chills, Narrative: Self treated with Benadryl and motrin
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| 47 | 2021-01-08 | headache |
She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes...
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She initially developed and numbness of her face (both sides). This started in about 15 - 30 minutes after the vaccine and lasted about 2 hours. She had no facial muscle issues. She then developed intense vertigo and nausea. I question possible vestibular neuritis. This lasted about 5 days and was more severe the first 3-4 days. At day 7 she was almost back to normal. She also had a frontal tension style headache
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| 47 | 2021-01-08 | somnolence |
employee received the vaccine 12/31/2020. 15 minutes later she stated she felt very sleepy. Stated i...
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employee received the vaccine 12/31/2020. 15 minutes later she stated she felt very sleepy. Stated it was hard to keep her eyes open. She was observed for 30 minutes and sent home. Telephone calls to her during the day indicate she felt sleepy until late afternoon. She stated she felt sleepy for the rest of the afternoon. She stated she woke next day feeling fine.
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| 47 | 2021-01-09 | chills, headache, malaise, body temperature increased |
At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection sit...
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At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection site, body aches, chills, headache. Still feeling poorly on January 10th.
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| 47 | 2021-01-09 | fever, headache | Fever (101.9), myalgias, nausea, anorexia, headache x24 hours |
| 47 | 2021-01-09 | headache, chills, fever, malaise | Headache, body aches, malaise, chills, fever |
| 47 | 2021-01-09 | headache | Location site pain X1 day and headache X2 days |
| 47 | 2021-01-10 | fever, chills |
01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and thro...
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01:45 I woke with severe soreness and ache over my entire body (8/10), chills, fever 101.5, and throbbing excruriating pain in the left arm (10/10). I was barely able to move the left arm, and I could not bend it due to severe pain in the elbow joint. At approximately 0800, I started having diarrhea that lasted for no more than an hour. By noon the soreness and aching had reduced to a moderate pain (5/10). I was able to bend my left arm, but the arm remained sore at the elbow joint until 01/10/2021. By the morning of 01/10/2021, all the symptoms were gone.
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| 47 | 2021-01-10 | chills, fatigue, headache |
72 hours of extreme fatigue. 48 hours of nausea and vomiting. 48 hours chills, aches. Ongoing headac...
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72 hours of extreme fatigue. 48 hours of nausea and vomiting. 48 hours chills, aches. Ongoing headache x5 days.
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| 47 | 2021-01-10 | throat swelling |
? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to...
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? cold feeling in chest ? itchy tongue, mouth and throat ? swelling in throat ? tongue progressed to becoming numb ? elevated BP
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| 47 | 2021-01-10 | throat irritation |
At 4:43pm while in observation refers to itching in throat and bad taste in the mouth. Dr is notifie...
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At 4:43pm while in observation refers to itching in throat and bad taste in the mouth. Dr is notified who shows up immediately and evaluates, BP150/80mmhg Pulse 72/minute, Breaths 18/minute, afebrile, Communicative and alert in time place and space, not complications, is placed oxygen by nasal cannula at 3lt/min at 5:05pm by medical order be administered Benadryl 50mg IM in right deltoid under aseptic techniques and kept under observation, at 5:45pm goes out walking and in stable condition by medical order to her home in company co-workers, oriented at notifying any other event, verbalize understanding
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| 47 | 2021-01-10 | fatigue | Axillary lymphadenopathy, severe fatigue for two days |
| 47 | 2021-01-10 | headache, fatigue, chills |
Bodyache , chills, Diarrhea , headache , fatigue , was tested for Covid on the 28th and was confirm...
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Bodyache , chills, Diarrhea , headache , fatigue , was tested for Covid on the 28th and was confirmed positive
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| 47 | 2021-01-10 | headache, malaise, chills |
Five hours after vaccination developed Left scapula pain, chills, headache, body ache , general mala...
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Five hours after vaccination developed Left scapula pain, chills, headache, body ache , general malaise end left axillary pain
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| 47 | 2021-01-10 | weakness |
I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccina...
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I experienced numbness, tingling sensations and weakness in my arm starting on the day of my vaccination (01/04/2021). It is especially troublesome on my left hand/fingers. It is worse in the morning when I wake up, but it gets better with movement of my arm/hand to complete my normal day activities.
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| 47 | 2021-01-10 | headache | Mucular pain Achy Joint pain Headache Injection site pain that radiated whole right arm |
| 47 | 2021-01-10 | headache, sweating |
Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her head...
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Patient had headache, diaphoresis, low blood pressure and seizure. Patient got Tylenol for her headache and was observed for a few minutes. She was offered Benadryl but patient was allergic to Benadryl. She exhibited grand mal seizure twice. The ambulance was called after the second grand mal seizure.
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| 47 | 2021-01-10 | headache, malaise |
Persistent headache and malaise with intermittent nausea and muscle/joint aches - began 1/4/21 and o...
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Persistent headache and malaise with intermittent nausea and muscle/joint aches - began 1/4/21 and ongoing
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| 47 | 2021-01-10 | fatigue, weakness |
Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of...
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Received doe #1- left deltoid on 1/8/2021-within 10 minutes of receiving the vaccine had a "wave of warmth" come over my body and my heart rate suddenly increased to the 140's. Began to feel fullness in my throat and extremely tremulous. Nurse monitored my BP- elevated 140/101 with no hx of HTN. HR remained elevated for ~ 10 minutes than began to normalize. BP slowly began to decrease to more normal range. Tremors continued along with tingling sensation to extremities. Monitored by nurse for ~ 1 hour. Symptoms improved. Drove home. Extremely fatigued. Took dose of Benadryl. Fitful sleep with sporadic episodes of tachycardia on day #1. Following day 1/9- extreme fatigue, arm soreness, "spacey" feeling, weakness and nausea. Took additional doses of Benadryl. Slept 12 hours. Awoke on the following day ( 1/10), with persistent fatigue and nausea. Had insomnia that night and was restless, Awoke on 1/11 again with nausea, fatigue, arm soreness resolved but itchiness injection site.
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| 47 | 2021-01-10 | nerve pain |
ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consume...
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ball palsy, facial dropping; painful shingles; This is spontaneous report from a contactable consumer reported for herself. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: EK5730; dosage form: injection) via an unspecified route of administration as injection to left arm on 24Dec2020 at 7:30 am at a single dose for COVID-19 immunization. Relevant medical history and concurrent conditions included slight hypertension from Jul2020 and ongoing. Concomitant medications included lisinopril from Jul2020 and ongoing for slight hypertension. The patient developed ball palsy, facial dropping which did not lasted long but she still had the painful shingles on 27Dec2020, after the first dose. She wanted to know the recommendations for taking the second dose which is due in 10 days. The patient wanted to know if she should receive the shingles vaccine. This caller was a lab tech who works in the healthcare industry and manages a medical office; but clarified she did not call on behalf of a healthcare professional. She was the patient who received her first dose of Pfizer SARS-CoV-2 Vaccine on 24Dec2020. She reported onset of what the Urgent Care Physician believed was Shingles on 27Dec2020. She called to ask if she should or should not receive the second dose of Pfizer SARS-CoV-2 Vaccine on 14Jan2021 as scheduled due to the Shingles. The Urgent Care Physician advised her to still get the second dose, as there was about a 1:10,000 chance of developing shingles with the vaccine. She reported shingles as a reaction subsequent to the Pfizer SARS-CoV-2 Vaccine. Initially on 27Dec2020 she developed sites of what she thought were canker sores or fever blisters in her mouth which had gotten pretty large and stopped her from being able to eat on 29Dec2020. Then on 30Dec2020 she developed sites on her face which have gotten scarily large; and was causing some deep nerve pain going to her eye and down her chin; the sites felt like lesions on her face with roots. The sites in her mouth were now completely gone; but the sites on her face are ongoing. Now it has kind of taken over her face. She saw the Urgent Care Physician regarding this who believed the sites to be shingles. She had never had fever blisters or shingles before this event. She was still kind of reeling. The report was reported as non-serious. The outcome of event ball palsy/facial dropping was resolved and of shingles was unknown.
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| 47 | 2021-01-10 | chills, fatigue, headache, fever | fatigue body aches chills fever headache |
| 47 | 2021-01-10 | chills, fatigue, headache | fatigue,nausea, body aches, head ache, chills |
| 47 | 2021-01-10 | fever, headache | headache, body aches, fever |
| 47 | 2021-01-10 | fever, headache | headache, fever, palpitations |
| 47 | 2021-01-10 | weakness |
vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can o...
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vaccine reaction started 12/27/2020 muscle aches on left side of body, both left arm and leg, can only say it is what I would imagine restless leg syndrome might feel like, weak and achy that disrupted sleep all night. 12/28/20 noticed enlarged lymph node on left side near clavicle tender to touch
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| 47 | 2021-01-11 | shortness of breath, headache, dizziness, sweating |
Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes...
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Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-01-11 | weakness | Arm pain and weakness for 10 (ten) days. 600 and 800 mg doses of ibuprofen |
| 47 | 2021-01-11 | throat irritation |
At 4:43pm while in observation refers to itching in throat and bad taste in the mouth, Dr. is notifi...
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At 4:43pm while in observation refers to itching in throat and bad taste in the mouth, Dr. is notified who shows up immediately and evaluates, BP 150/50mmhg, Pulse 71/minute, Breaths 18/minute, afebrile, Communicate and alert in time, place and space, not complications, is placed oxygen by nasal cannula at 3lt/min, at 5:05pm by medical order be administered Benadryl 50mg IM in right deltoid under aseptic techniques and kept under observation, at 5:45pm goes out walking and in stable condition by medical order to her home in company co-workers, oriented at notifying any other event, verbalize understanding.
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| 47 | 2021-01-11 | chills |
Chills and joint pain in hips and shoulders with severe body aches occurred about 10 hours after bei...
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Chills and joint pain in hips and shoulders with severe body aches occurred about 10 hours after being vaccinated and continued to get worse over a period of 6 hours. Nausea and stomach pain also present. Diarrhea started 19 hours after being vaccinated. Body aches and diarrhea continued for a total of around 20 hours of symptoms.
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| 47 | 2021-01-11 | throat pain, fatigue, headache, malaise |
Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of...
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Day of vaccination, arm tender, 7 hours after vaccination, Extreme Fatigue and Sore throat - loss of voice. Day after vaccination, Severe body pain - back, shoulders, hips, abdomen with Muscle aches, Headache, Mild Discomfort in chest and ribs when breathing, and General feeling of being unwell
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| 47 | 2021-01-11 | respiratory tract congestion, fatigue |
Fatigue; tested positive after receiving Covid-19 vaccine; tested positive after receiving Covid-19 ...
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Fatigue; tested positive after receiving Covid-19 vaccine; tested positive after receiving Covid-19 vaccine; severely congested; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported that a 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, Expiry Date: Mar2021) via an unspecified route of administration at right deltoid on 20Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing severe asthmatic diagnosed as a child. There were no concomitant medications. Patient (a front line worker) is Grief Counselor. She tested positive after receiving BNT162B2 on 29Dec2020. She was supposed to get the second dose on 10Jan2021. She was having fatigue since 01Jan2021 and was severely congested since 26Dec2020. She was asking if she should get the second dose. The outcome of the events severely congested and fatigue was recovering, of the other events was unknown.
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| 47 | 2021-01-11 | headache, fever | Fever, nausea, HA, abdominal cramping |
| 47 | 2021-01-11 | headache | Headache, Sore Arm |
| 47 | 2021-01-11 | fatigue, headache |
Headache; fatigue and feeling run down; developed a clicking sensation in her right ear/ persistent ...
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Headache; fatigue and feeling run down; developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization, also reported as "for work." The patient has no medical history and there were no concomitant medications. The patient received the first dose of the COVID 19 vaccine on 22Dec2020. She was scheduled to receive the second on 12Jan2021, Tuesday. Since receiving the vaccine, the night of receiving it, she developed a clicking sensation in her right ear. It hasn't gone away. It was kind of like "when you have water in your ear." It is not popping like on an airplane. She can trigger it if she hums or makes her vocal cords vibrate. She can make it happen. It is not painful. She notices it a lot at night. It might be a eustachian tube thing. At first, she was wondering if it could be coincidental. She hasn't experience it before though. It could be related to a sinus thing. But she hasn't realized a sinus issue. She thought, by now it would have gone away. No one has looked in her ear though. She works in healthcare. She doesn't have a prescribing doctor. She got the vaccine at work. She noticed the clicking in the middle of night so she can't say an exact time of onset. She thought it might have been improving, but she thinks she is just getting used to it. She is less aware of it now. The patient asked if she should be seen by her HCP or have her ears checked out. She asked if the clicking sound that developed in her ear after getting the first dose of the vaccine was normal? It is persistent like "if you have water in your ear." It happens mostly at night but is happening right now. The patient further reported having the expected side effects of headache, fatigue and feeling run down since an unknown date. The patient has not recovered from the event "developed a clicking sensation in her right ear/ persistent like "if you have water in your ear"/ notices it a lot at night/ happens mostly at night but is happening right now." Outcome of the events "headache" and "fatigue and feeling run down" was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-11 | discomfort |
Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increase...
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Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; Mild arthritis joint pain in my hands, and feet/The pain and inflammation has significantly increased; pain and inflammation has significantly increased; feels very sharp especially in my hands in my back near my scapula, and my knee joints; My muscles also feel tight in these areas; The pain and discomfort are significantly greater than normal; This is a spontaneous report from a contactable other hcp. This 47-year-old female other HCP (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 30Dec2020 09:00 at single dose on right arm for COVID-19 immunisation. The patient was mostly healthy, no chronic health conditions. No known allergies. Her family had a lot of auto immune disease history. Concomitant medication included paracetamol (TYLENOL), ibuprofen. The patient had mild arthritis joint pain in her hands, and feet that were usually resolved with OTC pain medications. The pain and inflammation has significantly increased since the COVID-19 vaccine injection and felt very sharp especially in her hands, in her back near mhery scapula, and her knee joints. Her muscles also feel tight in these areas. The pain and discomfort are significantly greater than normal. Symptoms were the worst 2-5 days Post injection and have not resolved. All of the events were on 31Dec2020 09:00 and no treatment was received, all considered as non-serious. No COVID tested post vaccination. The outcome of the events was not recovered. Information on the Lot/Batch number has been requested.
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| 47 | 2021-01-11 | chills, somnolence, headache |
Morning after vaccine was sleepy with a slight headache. Went home about 16:30. Felt nauseated wi...
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Morning after vaccine was sleepy with a slight headache. Went home about 16:30. Felt nauseated with chills. Took a nap. Woke with significant chills and proceeded to dry heave for about 5 minutes. Advised to take 25mg Benadryl and also took 1 tab Advil. Symptoms resolved after about one hour. Went to bed. Following morning had stomach pain. Assumed from dry heaving, but took another 25mg Benadryl and 325mg Tylenol. Slept all day / night. Following day had diarrhea but otherwise fine.
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| 47 | 2021-01-11 | chills | Nausea, Chills, Body Aches |
| 47 | 2021-01-11 | weakness, cough, shortness of breath, fatigue, headache |
Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later...
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Patient had a headache the next morning 1/8/20 after reving the 2nd dose on 1/2/21. On 1/7/21, later in the morning, she began to have axilla pain that radiated to her chest on the site she rcvd. the vaccine. On 1/9/21 she had symptoms of weakness, cough & a great deal of fatigue. By Sunday, 1/10/21 she was feeling fine. Patient also had shortness of breath on 1/8 that resolved.
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| 47 | 2021-01-11 | fever, headache, chills, cough, fatigue |
Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 ...
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Vaccine administered at 2pm. 1/8/21 @ ~ 4pm LEFT arm soreness (which persisted all evening) 1/9/21 @ ~ 1am I awoke from sleep with worsening LEFT Arm soreness, headache (bad) and body aches 1/9/21 @ ~ 11am Feeling more fatigued, chills, low grade fever 99.9 1/9/21 @ ~ 2 pm, continue to have body aches, fatigue, itchy nose/post nasal drip, chills fever 100.7 1/9/21 @ 8pm continued w/ prior symptoms, developed mild cough ( at this point I felt symptoms may be outside vaccine side effects, honestly wasn't sure if it was seasonal allergies w/ vaccine side effects) 1/10/21 ~ 10 am Awoke feeling better, remained fatigued and with mild intermittent cough but body aches/headaches resolved, opted to go for testing 1/12/21 informed of Covid + test (PCR), was advised by my hospital employee health to complete this form It should be noted I underwent mandated employee testing on 1/5/21 which was negative.
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| 47 | 2021-01-11 | chills |
Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued t...
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Woke up 1/9/21 with pain in my L axilla and swelling. Improved with ice and ibuprofen. Continued to get better of the course of 3 days. No fever but felt ache all over and chills starting 1/8/21 about 8PM, pain in L arm 1/8/21 starting about 2 hours after injection. resolved 1/10/21
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| 47 | 2021-01-11 | dizziness |
body aches/aches all over her body like a fever; nausea; Pfizer COVID 19 vaccine; first dose 17Dec20...
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body aches/aches all over her body like a fever; nausea; Pfizer COVID 19 vaccine; first dose 17Dec2020; second dose 05Jan2021; dizziness; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration in the right arm on 05Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included heart attack three years ago which predates treatment with the Pfizer COVID 19 vaccine. The patient's concomitant medications were not reported. The patient previous received the first dose of the Pfizer COVID 19 vaccine (first dose lot= EH9899) on 17Dec2020 at 17:30 PM in the right arm and reported no reactions to the vaccine. The patient experienced dizziness on 05Jan2021, body aches/aches all over her body like a fever, nausea on 06Jan2021. Consumer calling regarding the Pfizer COVID 19 vaccine. States she never had side effects with the first shot but the second was killing her. Clarified she received the first dose of the Pfizer COVID 19 vaccine 17Dec2020 at 17:30 PM in the right arm. She didn't have any effects after that dose. Reports she received the second dose of the Pfizer COVID 19 vaccine 05Jan2021 at 17:30 PM in the right arm. She noticed about 20 minutes after the injection on the way home, she felt dizzy had to pull over. The next morning, she continued to experience a little dizziness with nausea but states she never threw up and she had aches all over her whole body, like a really bad fever but she didn't have a fever. She was still feeling the body aches but when she gets up and walks it gets worse, like if she went to work so she stayed home today and she can still feel it a little but it is less since she is relaxing. From her vaccine card she provides the lot number for the first dose and the lot number for the second dose EK9231; does not see NDC or expiration date. The outcome of events for dizziness, nausea was resolved on 06Jan2021, for body aches/aches all over her body like a fever was not resolved. The adverse event didn't require a visit to physician office nor emergency room. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks). Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to adverse event was none. Relevant tests were none. Vaccination Facility Type: Hospital. Vaccine Administered at Facility: No.
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| 47 | 2021-01-11 | headache, fever, chills |
chills/rigors; Fever of 103; muscle pain; headache; This is a spontaneous report from a contactable ...
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chills/rigors; Fever of 103; muscle pain; headache; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the left arm on 05Jan2021 08:30 at a single for COVID-19 immunization at a hospital. Medical history included hypothyroidism. Patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO), and calcitriol. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via unspecified route of administration at the left arm on 15Dec2020 16:00 at a single dose for COVID-19 immunization. The patient experienced fever of 103, rigors, muscle pain, headache, and chills, lasted 12 hours on 6Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the events. The patient was recovering from the events.
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| 47 | 2021-01-11 | weakness, headache |
patient developed occipital headache, backache, flushed sensation, and weakness; has known history o...
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patient developed occipital headache, backache, flushed sensation, and weakness; has known history of "MS". pt. given a water, vitals signs taken, and 1st response team called to transport to ED.
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| 47 | 2021-01-11 | fatigue, chills, headache, malaise, fever |
she had COVID symptoms; she had COVID symptoms; chills; low grade fever; muscle joint pain; muscle j...
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she had COVID symptoms; she had COVID symptoms; chills; low grade fever; muscle joint pain; muscle joint pain; exhausted with a headache/ She doesn't want to get up she is tired; exhausted with a headache/slight headache; muscle joint pain which is a stabbing pain all over her body; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, manufacturer: Pfizer), via an unspecified route of administration on 04Jan2021 14:00 at single dose for Covid-19 immunization. Medical history included ongoing childhood asthma, COVID 19 positive from 07Dec2020 to an unknown date. There were no concomitant medications. The patient felt like she had covid symptoms, chills, low grade fever, muscle joint pain, exhausted with a headache/ she doesn't want to get up she was tired, muscle joint pain, which was a stabbing pain all over her body, feeling unwell, all on 05Jan2021 05:00. The events were reported as non-serious. Caller had Sars-COV-2 infection diagnosed 07Dec2020. Received first dose of vaccine 04Jan2021 at 14:00. She was experiencing chills, low grade fever, muscle joint pain, exhausted with a headache. Asking for information on efficacy of second dose. She didn't have any side effects or anything initially. Then, 12 hours later at 5- 6 am she felt like she had COVID symptoms. She already had COVID so she known what it feels like. She was wondering how long would last. It was almost like having real COVID. She didn't have a prescribing doctor. She had COVID 07Dec2020. She was currently experiencing Chills, fever low grade, muscle joint pain which was a stabbing pain all over her body, and she was feeling unwell. She didn't want to get up she was tired. She has a slight headache. This all started at 5 am on 05Jan2021. Even with medication. She has been taking paracetamol (TYLENOL) and excedrin. She cannot work if she wanted to, but these effects are not serious. Her fever has went down. The chills have stayed the same. She was diagnosed with childhood asthma. Caller asked about interval information between the SARS-COV-2 infection diagnosed 07Dec2020 and her first dose of vaccine 04Jan2021 at 14:00. The outcome of events for felt like she had covid symptoms was unknown, for low grade fever was resolving, for other events was not resolved.; Sender's Comments: There is not a reasonable possibility that event suspected COVID-19 is related to BNT162B2. There is no test done to confirm whether patient got COVID-19 or not. And symptoms that were suspected by reporter as due to COVID-19 occurred one after the vaccination, when vaccine was not expected to achieve the effect.
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| 47 | 2021-01-11 | fatigue, headache |
tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her a...
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tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
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| 47 | 2021-01-11 | dizziness |
tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole f...
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tongue was thick; numbness on face/started on the left side but now her whole face was numb; whole face/swelling; dizzy; felt like she was floating/felt like she could get a nosebleed; teeth hurt; hands were swelling and it's hard to write; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. It was reported that received vaccine today, 06Jan2021, at 11:00. The patient's tongue was thick, she had numbness on face that started on the left side but now her whole face was numb and swelling. She was dizzy and felt like she was floating, her teeth hurt, her hands were swelling and it's hard to write, and felt like she could get a nosebleed. She took two Benadryl at 12:06 that expired in 2013 and then 2 more Benadryl at 1:08 that do not expire until 2022. She inquired if should she seek medical attention or ride this out and if should she follow through with her second dose of the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 47 | 2021-01-12 | dizziness |
1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79...
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1327: received injection - patient said it hurt much more than 1st injection 1337: Felt dizzy, HR 79, 125/78, O2 Sat 100%, placed supine position 1343: Felt shakey like low BG - got cookies, water, 80 HR, 128/88, 100% O2 1348: Felt like she wanted to sit up. 66 HR, 107/72, 100%, wave of dizziness and nausea 1349: HR 82, 123/86, 100% applied O2 8L Mask 1353: 92 HR 128/84, 100%, nauseated - coolw ash clothes applied - needed to transfer to a better chair that would lay back 1400: HR 72, 120/80, 100%, 36.7 - Felt warm but cool, wanted warm blankets - said she feels like she is sinking into the chair. HR 73, 118/78, 100% feeling better. 1409: 70 HR, 115/76, 100%, orthostatics taken. 1411: 69 HR 118/77, 100%, sat up 1414: 79 HR 123/87 99% took O2 off - felt ok. 1419 67 HR 121/83 100% standing felt okay, not dizzy.
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| 47 | 2021-01-12 | headache, chills | Chills, headache and body ache that started approx 12 hours after vaccine admin |
| 47 | 2021-01-12 | chills, headache | Chills, headache, arm pain, nausea, body aches and pain |
| 47 | 2021-01-12 | headache |
Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart ra...
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Metal taste immediately after injection. 8:20 felt hot and flushed. blood pressure 118/78 heart rate 100. 8:32 b\p 130/80 Heart rate 100 discomfort in neck back and headache. Reported she had a headache with the first dose. 8:50 states she is better and ready to go home. b\p 128/88 heart rate 90 Advised to seek medical help if symptoms worsen.
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| 47 | 2021-01-12 | fatigue |
Reported fatigue, muscle aches, and chest pain.Followed up with her PCP for the chest pain. EKG unr...
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Reported fatigue, muscle aches, and chest pain.Followed up with her PCP for the chest pain. EKG unremarkable. Cardiologist to follow up.
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| 47 | 2021-01-12 | fatigue, headache |
Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and tod...
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Shortly after injection, pain at site; continued pain in arm today. Some fatigue yesterday and today. Major headache today, not all day just part of day.
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| 47 | 2021-01-12 | weakness, headache |
feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my ...
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feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown. Information about Lot/batch number has been requested.
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| 47 | 2021-01-12 | malaise | nausea, malaise, GI upset, diarrhea; redness, swelling, warmth, pain at injection site |
| 47 | 2021-01-13 | headache, discomfort, fever, fatigue |
12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and...
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12 hours after receiving the vaccine (at 11:00pm on Saturday), I woke with nausea, stomach pains and the chills. I was up the remainder of the night. By morning I had a bad headache and terrible body/muscle aches. I was unable to report to work that day. By midafternoon, the nausea and stomach pains subsided, all other symptoms remained along with then getting a 100.5 fever. I was taking Tylenol every 4 hours since 1am and keeping hydrated. By midnight I was exhausted and was finally able to sleep. I woke the following morning with a dull headache and just felt achy. I felt much better by that evening (now Monday). Tuesday morning I woke with discomfort to my left armpit and clavicle area. I then noticed swelling, the areas felt ?lumpy? and were very tender to touch. That lasted about 2 days.
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| 47 | 2021-01-13 | headache, chills | Chills, nausea, vomiting, headache, neck pain. Improving. |
| 47 | 2021-01-13 | dizziness, headache, migraine, fever, chills |
Fever, chills, dizziness, headache. Fever on and off from 1/9/21 through 1/14/21. Fever, chills, mus...
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Fever, chills, dizziness, headache. Fever on and off from 1/9/21 through 1/14/21. Fever, chills, muscle ache 1/9/21 through 1/14/21. Severe headache/migraine from 1/11/21 to present (still have).
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| 47 | 2021-01-13 | fatigue, chills, fever |
Fever; Chills; muscle soreness; joint soreness; fatigue; injection site pain; received the first dos...
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Fever; Chills; muscle soreness; joint soreness; fatigue; injection site pain; received the first dose of bnt162b2 on 21Dec2020, received the second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left arm on 07Jan2021 at a single dose for COVID-19 immunization. Vaccination was done in hospital. There were no relevant medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 21Dec2020 12:00 via intramuscular route in left arm at a single dose for COVID-19 immunization. The patient experienced fever, chills, muscle soreness, joint soreness, fatigue, injection site pain on 07Jan2021 14:00 with outcome of not recovered. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The events was considered non serious by the reporter. Information about lot/batch number has been requested.
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| 47 | 2021-01-13 | cough |
PATIENT WITH KNOWN HISTORY OF SEVERE ALLERGIES PRESENTED TO RECIEVE COVID-19 VACCINE AFTER RECIEVING...
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PATIENT WITH KNOWN HISTORY OF SEVERE ALLERGIES PRESENTED TO RECIEVE COVID-19 VACCINE AFTER RECIEVING CLEARANCE FROM HER PCP. DUE TO HISTORY OF ANAPHYLAXIS PATIENT MONITORED BY PROVIDER AFTER ADMINSITRATION OF VACCINE. WITHIN 20-30 MINS OF ADMINISTERING VACCINE PATIENT DEVELOPED COUGH AND COLOR CHANGE IN EXTREMETIES. PATIENT TRANSPORTED DOWN TO ED FOR FURTHER EVALUATION.
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| 47 | 2021-01-13 | chills, fever | Patient describes fever, chills, bone pain and body ache |
| 47 | 2021-01-13 | shortness of breath, headache, dizziness |
Patient developed tachycardia to 170s and BP 160/100, headache, lightheaded, some difficulty breathi...
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Patient developed tachycardia to 170s and BP 160/100, headache, lightheaded, some difficulty breathing/shortness of breath but pt states it may be associated with the mask.
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| 47 | 2021-01-13 | fever, headache, fatigue |
Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in lef...
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Received 2nd dose on Friday, did not experience any issues until Monday. Began with tinnitus in left ear, severe sound sensitivity, headache, then myalgia, fatigue, brain fog and disorientation, low grade fever of 99.6. Was sent home from work. Had COVID-19 testing and was negative. Worked from home the next day and still had myalgia and then had gastric issues of nausea and diarrhea, low grade fever.
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| 47 | 2021-01-13 | chills |
Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after takin...
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Systemic: Chills-Severe, Systemic: Chills/numbness lead to hyperventilating, felt better after taking benadryl and is back to normal-Severe; symptoms lasted 0 days
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| 47 | 2021-01-13 | dizziness | Systemic: Lightheadness for 30 mins felt better after resting-Medium; symptoms lasted 0 days |
| 47 | 2021-01-13 | shortness of breath, dizziness |
Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; sy...
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Systemic: Nausea-Medium, Systemic: light headed, high blood pressure, shortness of breath-Medium; symptoms lasted 1 day
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| 47 | 2021-01-13 | fatigue, chills, headache, fever |
THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVE...
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THREE DAYS WITH SINTOMES , PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN,CHILLES,PAIN JOINTS,FEVER,SWELLING INJECTION SITE,NAUSIAS GANGLIOR INFLAMATION.PAIN ALL HER BODY.
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| 47 | 2021-01-13 | nasal congestion, fever, headache, cough, chills, malaise |
a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued a...
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a weird rash on her left shoulder area; not feeling quite well; Fever of 99.5/ her fever continued at 99.7 and her symptoms were 10 fold; Left arm soreness; Increased dry cough; Nasal congestion; Chills; Headache; Unable to sleep- tossing and turning; This is a spontaneous report from a contactable nurse reporting for self. This 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: Apr2021) on 04Jan2021 around 10:30 AM at 0.3 mL single by injection in the left arm for COVID-19 immunisation. Medical history and concomitant medications were none. Prior to getting the vaccine patient had her temperature taken on unspecified date, which was 97.4. She had the injection in her left arm on 04Jan2021 around 10:30 AM. After she felt perfectly fine that day. She felt nothing. Then around 8 PM her side effects started. That night her left arm got sore, she had increased dry cough (reported as feels like a bronchial spasm that an asthmatic would have), nasal congestion, chills, and a headache. She went to bed unable to sleep- tossing and turning. She woke up around 2 AM or so. The next morning, 05Jan2021, she felt somewhat okay. She went to work. She had a normal temperature that morning at work. Then around 10 AM, her arm was still sore, she was not feeling quite well, she started to feel chills again, and had a fever of 99.5, along with a headache still. They sent her home. The next day, 06Jan2021, her fever continued at 99.7 and her symptoms were 10 fold. Then her fever broke around 10 AM. On 05Jan2021, she took a shower from all the sweating with her fever, and she did not notice any rash. She took another shower this morning (07Jan2021) and she noticed a weird rash on her left shoulder area. It does not itch, it is just there. She took a picture of it so she could monitor it. It is blotchy. For left arm soreness, she can now move it without feeling it, but then you touch it, it is sore and tender. The event fever broke yesterday around 10 AM. This morning (07Jan2021) her temperature was 98.6. Chills would come and go with the fever off and on. Treatment for all events included over the counter medications. Lab data included COVID test was negative on 28Dec2020 and 04Jan2021. Outcome of left arm soreness, increased dry cough, nasal congestion was recovering, outcome of chills, headache, unable to sleep- tossing and turning was recovered on 06Jan2021, fever was recovered on 06Jan2021 10 AM, outcome of rash was not recovered, outcome of other event was unknown. Relatedness of product to all events was reported as related, the reporter considered all events as non-serious.
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| 47 | 2021-01-13 | fatigue, headache |
intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of...
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intense itching on back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of Benadryl. via IV in right arm. I went home and slept for 3 hours. Woke up Right hand swollen and painful, muscle aches, headache, itching
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| 47 | 2021-01-13 | fever, headache, cough |
tested positive for covid/headache, ever, cough, diarrhea; tested positive for covid/headache, ever,...
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tested positive for covid/headache, ever, cough, diarrhea; tested positive for covid/headache, ever, cough, diarrhea; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, expiration date: 20Mar2021), via an unspecified route of administration on 19Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history included hysterectomy in 2010, pulmonary Embolism in 2010, gallbladder removed on an unknown date. There were no concomitant medications. The patient received 1st dose 19Dec2020, she was supposed to get her second dose, but tested positive for covid. She thought she had side effects after vaccine, she began with a headache, fever a week later and thought they were from the vaccine, but then her sister-in-law was positive for COVID, her sister-in-law passed away from covid virus. Then the patient, her mom, and husband tested positive for COVID. She tested positive for COVID on 27Dec2020. She developed symptoms of COVID on 27Dec2020. It was exactly one week after receiving the first dose. It was also reported that she got tested on the 30th (as reported) and received results on 31Dec2020 that she was positive. After she got sick she has taken Mucinex. Day eleven, she is doing ok, but has a little cough. No more fever. Sometimes she has diarrhea but today no diarrhea. The patient asked if she can get her second dose of the covid vaccine on day 24. The outcome of the events was recovering.
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| 47 | 2021-01-14 | fever, headache, chills |
24 hours after 2nd vaccine, I had one day oh fever to 104; headache; myalgia; chills; This is a spon...
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24 hours after 2nd vaccine, I had one day oh fever to 104; headache; myalgia; chills; This is a spontaneous report from a contactable physician. A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 08:00 at a SINGLE DOSE and second dose via an unspecified route of administration on the left arm on 07Jan2021 04:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. 24 hours after 2nd vaccine, the patient had one day of fever to 104, headache, myalgia and chills on 08Jan2021. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 47 | 2021-01-14 | fever, chills, fatigue |
6pm- fatigue 9pm myalgia and joint pain 12am- fever 101.3, rigors, myalgia. took tylenol 6am- fatig...
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6pm- fatigue 9pm myalgia and joint pain 12am- fever 101.3, rigors, myalgia. took tylenol 6am- fatigue, fever 100.5 took tylenol
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| 47 | 2021-01-14 | fever, chills |
I had fever and chill the whole day on the next day of the vaccination (01/12/2021). It started in ...
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I had fever and chill the whole day on the next day of the vaccination (01/12/2021). It started in the early morning. I took 500mg of Tylenol twice on that day to stop the fever. I had upset stomach on the following day(01/13/2021). I didn't take anything for that, just drank more water. I had back shoulder pain on the next day after the stomach upset(01/14/2021). I tried warm pack and pain patch. One symptom a day and it was last the whole day. It took three days for the symptoms to go away.
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| 47 | 2021-01-14 | headache, fatigue, throat pain | Intense headache, stomach upset, tired, sore throat |
| 47 | 2021-01-14 | dizziness |
Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old fema...
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Lightheaded; flushed; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 (Batch/lot number: EJ1685) at a single dose on left arm, and received the second dose, intramuscular on 08Jan2021 (Batch/lot number: EK9231) at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded and flushed on an unspecified date. Treatment not received for the adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 47 | 2021-01-14 | dizziness |
Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. ...
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Pt experienced tachycardia and severe dizziness and associated nausea. BP 133/78, HR 94, sat 100. Symptoms passed after 10 minutes of observation. Sent patient home per her request.
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| 47 | 2021-01-14 | fatigue, chills |
The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I f...
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The first night of the shot I had severe pain in both arms and could not sleep. The first 3 days I felt tired and chilled, without fever. After the third day, symptoms subsided and I was back to normal activity. On the 7th day following the vaccine, I began having pain in the armpit of the left side. It was painful to have pressure on the area and to raise the arm overhead. It progressed on the the 8th day with increased pain and tenderness to touch. On the 9th day, I had severe pain with palpation and could feel a lump in the armpit. I have no redness, heat, or rash in the area. I went to my physician with concern because I have had a double mastectomy two years ago.
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| 47 | 2021-01-14 | throat irritation, somnolence, shortness of breath |
Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then i...
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Within 15 minutes, I began feeling dry throat; Within 15 minutes, I began feeling dry throat, then itching, then it felt like I had a lump inside my throat.; it felt like I had a lump inside my throat.; Then I began to have difficulty swallowing my saliva.; difficulty breathing; very groggy; This is a spontaneous report from a contactable pharmacist. A 47-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), intramuscular in left arm on 20Dec2020 at a single dose for COVID-19 immunization. Vaccination was administered in a hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included hypertension, overweight, and known allergies to bee stings and hair dye. The patient's concomitant medication included multivitamins. On 20Dec2020, within 15 minutes, the patient began feeling dry throat, then itching, then it felt like she had a lump inside her throat. Then she began to have difficulty swallowing her saliva. And then the lump inside her throat started to feel larger and larger. By this time, the doctor had already injected the patient with Epipen and the pharmacist injected her with Solumedrol and she still felt as if she was having difficulty breathing and then she was taken to ER and she really can't remember too much after that. The patient was very groggy and then was discharged from ED about 9:30 pm. The outcome of the events was recovered on an unknown date. Treatment for the events included epinephrine, methylprednisolone, diphenhydramine. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling dry throat, itching, felt like having lump inside her throat, having difficulty swallowing saliva, difficulty breathing and very groggy cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-01-14 | shortness of breath |
approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to t...
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approx 20-30 minutes after injection: tingling lips & tongue, which then turned numb. Inability to take deep breath. Severe difficulty swallowing. Difficulty getting words out, then slurring of words/poor pronouncing of words. Foggy head. Poor balance.
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| 47 | 2021-01-15 | headache, chills, dizziness, influenza like illness |
1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near sync...
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1st dose only side effect was sore injection site - 2nd dose- 14 minutes after injection near syncope episode with severe dizziness, nausea, tachycardia, high blood pressure. Benadryl 50 mg was administered. 45 minutes after Benadryl administration driven home and severe dizziness was present until next morning. 17 hrs post injection had severe flu like symptoms (chills, severe headache, muscle/body aches/no fever). Took Advil 800mg. At 48hrs no symptoms remain. At 69 hrs post injection had severe dizziness that is still present at 72.5 hrs post injection.
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| 47 | 2021-01-15 | headache, fever, chills |
Beginning 4 hours after second injection: body aches and chills that lasted 48 hours. These were not...
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Beginning 4 hours after second injection: body aches and chills that lasted 48 hours. These were not responsive to Tylenol or ibuprofen. On day two fever that got as high as 101 degrees was observed. Severe headaches lasted from 4 hours after second injection until 48 hours after second injection. Beginning at about 48 hours post second injection painful tender lymphadenopathy observed in axillary area of left arm. I am now 96 hours post second injection and the lymph nodes in that left arm are still swollen and tender and painful.
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| 47 | 2021-01-15 | head discomfort, dizziness, fatigue, headache |
Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has s...
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Current as of day eleven: exhausted; face and hands numb; arms, legs, and head heavy; numbness has spread through shoulders and upper back; challenges in arms and legs?very little control, hard to even lift arm to eat, to type?like heavy weight pressing down on arms and shoulders, like filled with lead and extreme stiffness; still have floating feeling off and on; still have tingling in face, arms, and hands; dizziness; mental fog; headaches; heart palpitations; hands swelling--difficult to use. This has been ongoing for eleven days now. Other symptoms can be found in report made to Pfizer site: (1/12/2021 at 2:27 pm)
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| 47 | 2021-01-15 | malaise, nasal congestion, fever, shortness of breath |
Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anor...
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Day 1, Paresthesias in my feet, weakness in legs. Day 4, nasal congestion, feverish, malaise, anorexia, intermittent paresthesias, SOB, Chest Discomfort for 14 days straight, slightly better today.
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| 47 | 2021-01-15 | dizziness |
Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness contin...
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Increased Heart Rate and Tingling in the Arm and Dizzyness right after the vaccine. Dizzyness continuted through out the day Increased Heart Rate had continued off and on, went to ER and have seen Cardiologist
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| 47 | 2021-01-16 | chills, sweating, fatigue |
Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscle...
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Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscles aches through mid back and chills Day 3 - Exhausted and achy, nauseous, chills, sweats Day 4- Adverse reactions gone.
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| 47 | 2021-01-16 | fatigue, fever, chills |
Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left ...
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Fever 102, hr 120, decreased spo2 94, nausea, vomiting, fatigue, chills, body/joint ache, sore left shoulder. Most symptoms lasted 36 hrs, nausea and fatuge lasted 48 hrs
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| 47 | 2021-01-16 | chills |
severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine d...
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severe muscle, spine cord and joint pain, chills, lymphodenopathy started 12 hrs after 2nd vaccine dose, extreme pain in right arm, leg, neck, and right side of the stomach started on day 2 - phone appointment with doctor , rash started on day 3 - urgent care visit, diagnosed with shingles after dermatology consult
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| 47 | 2021-01-17 | headache, weakness, dizziness, throat swelling |
I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my...
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I was vaccinated at 3:30pm . At 5:27pm while driving home i felt a cold sensation in the back of my neck and back of my throat which began spreading to the back of my head . My heart felt as if I was startled by something. I looked at my smart watch and my heart rate was 145. I began trembling and having abdominal cramping . The back of my head felt like I had swelling or collection of fluid. I opened my windows and began taking slow deep breaths to bring down my heart rate . It took quite a while to get it below 100. I felt as if I was going to pass out. After deep breathing for what felt like atleasr 15 to 20 minutes , my pulse came down and I closed my windows . As soon as my body warmed back up in the car , the symptoms returned and my heart rate went back up to 130s , 140s . I had to keep my windows down and deep breathe the entire way home which took an hour . My body was trembling. When I got home I felt as if I was too week to get out of the car . I still felt that startled feeling in my heart and was afraid of what could happen next . My lips and face were swollen. My lips were also slightly itchy. I called 911 for help . By the time they arrived my vital signs had stabilized but I still had swelling in my face and lips . My EKG , vital signs and oxygen levels checked out normal so I did not go to the ER. That night I took benadryl and Tylenol. Day 2 post vaccine the collection of fluid or swelling in the back of my head had now spread to the top . That night I had the feeling that my throat was swelling do I took benadryl and Tylenol and my face and lips were still slightly swollen . Day 3 post vaccine I woke up with slightly blurry vision. The swelling in my head now feels like it has encompassed my entire head and have a slight headache. I went to the urgent care requesting an MRI of the head and an epi pen . I was given Medrol dose pack , an RX for epi pen for emergencies and advised to continue benadryl and Tylenol. Day 4 post vaccine, slight headache continues. Slightly blurry vision
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| 47 | 2021-01-18 | shortness of breath, headache, weakness, chills, dizziness, fever | Tachycardia, Shortness of breath, headache, dizzyness, weakness, chills, nausea, fever |
| 47 | 2021-01-19 | headache, dizziness | Bad headache, stomach cramps, nausea, dizziness for 24 hours |
| 47 | 2021-01-19 | chills, lethargy | Chills, lethargy, body aches |
| 47 | 2021-01-19 | fever, throat pain, headache, cough, chills, weakness | Fever of 103, severe chills, body aches, joint pain, weakness, cough, headache, sore throat |
| 47 | 2021-01-19 | headache, chills | HEADACHE,CHILLS AND SWELLING INJECTION SITE. |
| 47 | 2021-01-19 | headache, head discomfort, fatigue |
Having severe headaches that is more severe from when I had the first dose. Currently feel heaviness...
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Having severe headaches that is more severe from when I had the first dose. Currently feel heaviness in my head that is affecting my activity performance. I am also experiencing more tiredness than in first dose that is worsening instead of getting better. I have been talking Tylenol with no relieve that I couldn?t sleep.
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| 47 | 2021-01-19 | dizziness |
I received the vaccine in the afternoon of Jan 6th. Approximately 45 minutes to an hour later I felt...
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I received the vaccine in the afternoon of Jan 6th. Approximately 45 minutes to an hour later I felt lightheaded and like I was going to pass out. After a bit I felt a little better but remained dizzy and lightheaded. On the 7th I continued to feel dizzy and lightheaded throughout the day. I was sitting down on a call in the afternoon when my Apple watch vibrated and indicated my heart rate was below 50 for 10 minutes. I checked my heart rate and it was 38 - 48 BPM. On the morning of the 8th I reported my persistent symptoms to Dr. and an EKG was done showing a heart block. I have had bradycardia for the past year and likely the heart block but was not symptomatic until after I took the vaccine. See next pg
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| 47 | 2021-01-19 | night sweats, headache, fatigue, weakness |
Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cra...
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Mild headache; Weakness; Loose stools/diarrhea; it was hard for me to walk; stomach ache/stomach cramping; Fatigue; Some sweating in the middle of the night; some pain behind her eyes; Shoulder area is sore; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK4176), via an unspecified route of administration on 09Jan2021 11:00 in left arm at single dose for COVID-19 immunization. Patient take medications for mood and sleep with were very low doses. But she didn't have any medical problem. She took 10 mg of fluoxetine hydrochloride (PROZAC), 150 mg of bupropion hydrochloride (WELLBUTRIN) and 10 mg of doxepin for sleep. Yesterday after the vaccination towards the end of the day (09Jan2021 approximately 11 o' clock am), she developed a stomach ache about 5 pm and it went on throughout the night and she normally didn't have issues with her stomach. Maybe it was because she was hungry because she went ice skating with her son where they wore mask in the afternoon yesterday and she was feeling perfectly fine. But when she came home, she noticed her stomach started hurting at 5 pm and she wondered maybe it is because she was hungry. And after she ate it was still bothering her and then it got progressively worst in the middle of the night where it would wake her up periodically. But she was so fatigue that she was able to sleep still. But she noticed in the middle of the night that her stomach would wake her up because it was aching and cramping in the middle of the night. And then she also had some sweating in the middle of the night as well as some pain behind her eyes. And today (10Jan2021) she had some fatigue which she noticed was not usual, she had mild headache which she saw was a common side effect. And then in the morning (10Jan2021) some fatigue and weakness like when she walked to the bathroom it was hard for her to walk. And when she went to use the bathroom she had some loose stools which was not common for her unless at all she was sick or have eaten something that makes her stomach really sick which was very unusual for her. Her stomach was still hurting her, if she walked it will start getting cramped so she was sitting down. The only thing she toon this morning was 2 acetaminophen medicine tablets because she was having pain behind her eyes when she woke up. She was just going to say she had influenza type A and type B on several occasions. And these symptoms are similar to when she had type B influenza, which was not as difficult as type A. So this is, they seemed to be like a mild version of type B influenza which she had terrible stomach issues, diarrhea and fatigue and pain behind the eyes from type B influenza. She had not any sickness because she work from home and she had limited field contact. So, she hadn't had illness from past year now. Because she worked from home. She provided mental health counselling remotely. So, she didn't think it could be attributed from anything else. The left on arm which was up toward like shoulder area and it was sore but it was tolerable in Jan2021. Outcome of stomach ache/stomach cramping was not recovered, and outcome of other events were unknown.
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| 47 | 2021-01-19 | body temperature increased, fatigue |
Morning following vaccination T. 100.5. Around noon started having diarrhea. Diarrhea was severe, un...
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Morning following vaccination T. 100.5. Around noon started having diarrhea. Diarrhea was severe, unrelieved with OTC intervention. Continued for 34 hours. Temp continued thru 12/27/20. Aching, severe fatigue. Diarrhea stopped after 34 hours. Has been intermittent nearly daily since. Only occasional 24 hour periods without it. When diarrhea resumed following the 34 hour stretch, MD prescribed Lomotil. Lomotil was taken x4 days, then diarrhea stopped x2 days, then resumed again. Diarrhea continues at this time along with pain in upper stomach area, intermittent lower abdominal cramps that occur prior to episodes. Remains unable to eat normal foods r/t stomach pain and diarrhea
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| 47 | 2021-01-19 | throat irritation |
Pt had vaccine at 1143, hives started at 1200, c/o itching throat at 1210 which progressed to diffic...
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Pt had vaccine at 1143, hives started at 1200, c/o itching throat at 1210 which progressed to difficulty swallowing. Epi given and pt transferred to ED
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| 47 | 2021-01-19 | headache, fatigue |
Severe headache that doesn?t go away with ibuprofen or acetaminophen. Very tired. Muscle pain for 1 ...
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Severe headache that doesn?t go away with ibuprofen or acetaminophen. Very tired. Muscle pain for 1 of the past 3 days.
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| 47 | 2021-01-19 | fever, fatigue |
Sore arm- could not raise arm above shoulder, 106 fever, muscle/joint/body aches for 3 days, seen in...
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Sore arm- could not raise arm above shoulder, 106 fever, muscle/joint/body aches for 3 days, seen in ER after 24 hours of symptoms. Fatigue for 1 week post vaccination.
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| 47 | 2021-01-19 | headache |
Started having body aches at 1800 the day of administration. Continues to have mild headache and bo...
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Started having body aches at 1800 the day of administration. Continues to have mild headache and body aches.
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| 47 | 2021-01-19 | throat irritation | Tingle in tongue Fullness in throat |
| 47 | 2021-01-19 | weakness, chills, headache, fever |
Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with...
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Woke up at 1am with fever of 103 and unable to get out of bed due to muscle weakness. Continued with fever and chills until 7pm. Had a throbbing headache from 2pm until midnight. Severe muscle weakness and bone pain. No appetite at all. Next day still weak and sore but fever gone and about 75% better.
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| 47 | 2021-01-19 | sweating, headache, shortness of breath, fever |
fever, sweats, body aches, headache, watery eyes fever sweats started at 3:30 am. Body aches 5:00am ...
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fever, sweats, body aches, headache, watery eyes fever sweats started at 3:30 am. Body aches 5:00am along with headache and constant watery eyes. Difficulty taking deep breaths due to muscle soreness in back and ribs
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| 47 | 2021-01-19 | fatigue |
pain at injection site joint pain in bilateral hips, knees and wrists fatigue onset within 2 hours o...
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pain at injection site joint pain in bilateral hips, knees and wrists fatigue onset within 2 hours of vaccine, treated with otc naproxen 220 mg q12 hours prn pain continued next day, continued otc naproxen 220 mg 2 12 hours
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| 47 | 2021-01-19 | malaise, dizziness |
pt c/o dizziness 15-20 after vaccine. B/P 154/104 HR63 O2 sat 100%. states no history of hyperten...
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pt c/o dizziness 15-20 after vaccine. B/P 154/104 HR63 O2 sat 100%. states no history of hypertension. C/o having a busy day at work. B/P recheck 3 mins later 154/85. Vaccine given at 454pm. Pt not feeling better at 6:40pm. Sent pt to ER. Still with dizziness. Able to walk but unable to drive per pt. Gave juice and cookies to pt starting at 5:15pm. did not improve her status
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| 47 | 2021-01-21 | chills | CHILLS, BODY ACHES |
| 47 | 2021-01-21 | chills, fever | Fever, chills, nausea, vomited, body aches, |
| 47 | 2021-01-21 | migraine |
Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull o...
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Migraine- the worse I?ve ever experienced. Shooting pain up the left side of neck to base of skull on the same side where I got the shot in my left shoulder
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| 47 | 2021-01-21 | migraine, headache |
Migraine- worse I ever had, with shooting pain on the left side of my neck up to base of skull on th...
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Migraine- worse I ever had, with shooting pain on the left side of my neck up to base of skull on the same sideI received the shot in my shoulder
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| 47 | 2021-01-21 | cough, chills, runny nose, fever, headache |
vaccine was given at 6:40am and by midnight I had headache, chills and fever. By 7 am I had severe j...
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vaccine was given at 6:40am and by midnight I had headache, chills and fever. By 7 am I had severe joint pain, muscle aches and my left arm pit was painful, swollen lymph node in my left arm pit and left neck. Fever and joint pain were gone by sunday. Then on monday night I came down with a bad chest cold, runny nose and cough and chills but no fever. Chest cold symptoms still present today 1/22/21.
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| 47 | 2021-01-24 | fatigue, dizziness, headache |
2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upp...
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2030 arm became quite sore/remaining symptom slight soreness at injection site; 1700 achiness in upper back and neck; 1700 achiness in upper back and neck; 1200 extreme fatigue/tiredness became more pronounced; On day of 2nd shot:1100 dizziness and slight headache; On day of 2nd shot:1100 dizziness and slight headache; This is a spontaneous report from a contactable Healthcare Professional reporting for herself. A 47-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot # EL3246, via an unspecified route of administration on 12Jan2021 at 08:30, at 47-years of age, at single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Lot # EL0140) in left arm on 22Dec2020 at 08:30 am; medical history included food allergy including fish, shellfish, seafood of all types and corn, gastrooesophageal reflux disease, an unspecified neoplasm malignant, Vertical Sleeve gastrectomy (VSG) and neuropathy peripheral, all from an unknown date. Concomitant medication included amlodipine, pantoprazole, cetirizine hydrochloride (ZYRTEC), zinc and magnesium. The patient was vaccinated in Hospital and she was not pregnant when she received the vaccine. On 12Jan2021, day of 2nd vaccine shot, at 11:00 the patient experienced dizziness and slight headache, at 12:00 she experienced extreme fatigue, at 17:00 she suffered from achiness in upper back and neck, at 20:30 her arm became quite sore; on 13Jan2021 all symptoms continued and tiredness became more pronounced and, on 14Jan2021, the only remaining symptoms were slight soreness at injection site and some achiness in upper back. All other symptoms had resolved. No treatment was received for the reported events. The patient has not been tested for COVID-19 after vaccination. At the time of the report the events dizziness, slight headache, extreme fatigue/tiredness became more pronounced had resolved and the events soreness at injection site and achiness in upper back were recovering.
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| 47 | 2021-01-24 | dizziness | Dizziness and Chest pain-- > ER |
| 47 | 2021-01-24 | chills, dizziness, headache, fever, fatigue |
On night on vaccination (01/22/2021), experienced headache, fever, chills, nausea, and vomiting. On ...
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On night on vaccination (01/22/2021), experienced headache, fever, chills, nausea, and vomiting. On 01/23/2021, experienced same symptoms plus dizziness and muscle aches. Vomiting subsided on 01/24/2021 at 3:00pm. Muscle aches subsided on 01/25/2021 at 10:00am. Other symptoms persist. Nausea, fatigue, and dizziness are severe.
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| 47 | 2021-01-24 | nasal congestion, runny nose, throat irritation |
right eye shut/she couldn't open the right eye, it was glued shut completely; right eye red/ right E...
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right eye shut/she couldn't open the right eye, it was glued shut completely; right eye red/ right Eye being Red; mucus from throat, clear mucus; Right eye weeping; Right eye pink; She was super congested/she couldn't breathe through the nose; barely being able to sleep; Right eye itching/Left eye itching; red and swollen eyes/right eye swollen; itchy throat/itching of the throat/scratching in the throat; runny nose, clear mucous (post nasal drip); This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Left arm, via an unspecified route of administration on 07Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Sinus infection, Kidney stones, pink eye when she was a kid. The patient's concomitant medications were not reported. She reports the following side effects: itchy, red and swollen eyes, itchy throat, runny nose, clear mucous (post nasal drip). The patient experienced Right eye itching, red and swollen eyes/right eye swollen, Right eye pink on 08Jan2021 with outcome recovering, right eye shut on 09Jan2021 with outcome of received on 09Jan2021, itching throat, mucus from throat, clear mucus, Right eye weeping on 08Jan2021 with outcome of recovered/resolved with sequel on 11Jan2021, Left eye itching on 08Jan2021 with outcome of recovered on 09Jan2021, runny nose, clear mucous (post nasal drip) on 08Jan2021 with outcome of recovered on 11Jan2021, right eye red/ right Eye being Red on 09Jan2021 with outcome of recovered on 09Jan2021. The patient got her First shot on Thursday morning at 7:30AM, then on Friday night 08Jan2021 at 7 in the evening her right eye was itching and weeping, it felt like something was in the eye but there wasn't. The right eye was swelling as well on Friday. On Friday the itching of the throat started. She is also having scratchiness in the throat. Her eye is scratchy also. When she woke up Saturday 09Jan2021 she couldn't open the right eye, it was glued shut completely and red. When she was a kid, in the past she has had pink eye, and there was green stuff coming out the eye but this was not like previously. She had to pull the eye lids apart, maybe this is viral. With her throat, she has had sinus infection in the past before in which she couldn't breath out of the nose, but with this she is experiencing Mucus that is clear and thin from the throat. Her left eye itching started Friday night, but it was only slight itchiness and by Saturday the left eye was normal. She is purely doing this report to help, in case other people have this happen. Early today, she did use a Neti pot and it did help a little, she has had horrible sinus infections in the past but this is not it. In the past, once you get a sinus infection you are prone to getting them, thankfully she has not had one in a few years, she would get thick crap in the sinuses, in this case her eye was draining going into her nose, therefore making her have a runny nose, and she also had scratching in the throat. She is breathing clearly through the nose. Itching in the right eye was ongoing but less intense. Right Eye Swollen: She was looking at mirror hates looking at herself but the eyelid was back to normal, however the white part of eye is still swollen. Right eye being Shut: It is open now, that was a one day occurrence. Itching in the throat: She noticed that today at noon around 1 is when she last had it, it is 5% still there where she feels something. Mucus from Throat: She used the Neti pot a couple hours ago, at about 1:30 PM. Since then she has had some drainage but it is 95% better. Her Right Eye ball is still pink looking like as if she was hung over. The Left eyeball is white. Right Eye Weeping: She left work because her right eye was weeping so much, going into her nose, and she is running at work, she has glasses, goggles, face shield, and so she cant wipe the liquid. She came home and iced her eye which helped. Right Eye Pink: On Saturday the right eye was red. Right now it is pink, like an eye lash is in the eye. The right Eye being Red was only for Saturday, like sclerosis, it was red and swollen. The left eye was swollen, but it is better now from this morning. She was super congested on Friday (08Jan2021), barely being able to sleep, she couldn't breathe through the nose. Weird, she barely slept but it wasn't a sinus infection. She couldn't sleep because of nose running and the eye running then Saturday into Sunday she was able to sleep with eye running. The runny nose got better with the neti pot. She is schedule for the 2nd dose on 28Jan2021. The outcome of other events was unknown. Information on the lot/ batch number has been requested.
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| 47 | 2021-01-25 | shortness of breath |
Felt a little "weird" right after vaccine, after an hour she felt like she was suffocating. Went to...
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Felt a little "weird" right after vaccine, after an hour she felt like she was suffocating. Went to ED for SOB, felt like throat was closing. Given prednisone, benadryl. Questionable if she was given epinephrine in ED. Will follow up with allergist before second dose. HX of allergy to cats and grass. No hx of anaphylaxis.
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| 47 | 2021-01-25 | headache, fever |
High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot...
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High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot size of softball where injection given; This is a spontaneous report from a contactable other health care professional reported that a 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection); first dose (lot number: eh9899) via an unspecified route of administration on 18Dec2020 09:00 at SINGLE DOSE at right arm, and second dose (lot number: EL1284) via an unspecified route of administration on 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included depression, anxiety, and migraine. The patient has Known allergies with lisinopril, morphine, vancomycin, albuterol. On 09Jan2021 12:00, the patient experienced High fever, nausea, diarrhea, muscle/body aches, horrid headaches, large red spot size of softball where injection given. The outcome of the events was recovering. The patient did not receive treatment for the events.
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| 47 | 2021-01-25 | headache | Hypertension and headache within minutes of vaccination; symptoms resolved by 20-30 minutes |
| 47 | 2021-01-25 | chills, fever |
Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was ab...
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Low grade temp chills muscle aches sore arm and lacey rash on chest for about 36 hours. Onset was about 14 hours after injection
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| 47 | 2021-01-25 | cold sweat, sweating, body temperature increased | Tachycardia, sweating, uncontrollable shaking, clamy hands and vomitimg |
| 47 | 2021-01-25 | body temperature increased, migraine |
Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pa...
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Temperature 100.5-102. Swelling of all Lymph nods throughout entire body within 48 hours. EXTREME pain with swelling. 72 hours into time left side of body was swollen to point that clothing and jewelry do not fit. Left under arm and Breast are extra swollen *approximately triple size of right side. Migraine at 30 hours. Stomach pain in right side at 28 hours, also nausea and diarrhea.
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| 47 | 2021-01-25 | fatigue, malaise, throat pain |
nausea; sore throat/ throat hurt; feeling unwell; fatigue/extra tired; This is a spontaneous report ...
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nausea; sore throat/ throat hurt; feeling unwell; fatigue/extra tired; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EI1686; expiry date: unknown) intramuscular in the right arm, on 04Jan2021 at 12:00 at a single dose, for COVID-19 immunization. Medical history included diabetic/ diabetes diagnosed in 2015, high blood pressure, and high cholesterol, all prior vaccination. The patient has no relevant family history. The patient has no concomitant medications. Patient has no previous immunization with the Pfizer vaccine. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient received the first shot of the vaccine 04Jan2021 at 12:00, and she started feeling unwell during the weekend (Saturday; 09Jan2021). She's still experiencing these symptoms: fatigue, nausea, sore throat, and she's feeling worse. She called the COVID hotline because she was having fatigue and nausea. They told her to call her PCP and call Pfizer to report. After first dose on 04Jan2021, she felt ok over the weekend. She was just fatigued last night and had nausea and her throat hurts. She wanted to know about getting her second shot that is scheduled for 26Jan2021, if it is recommended or not. There was no prescriber. She received the vaccine through work clinic. She was extra tired this weekend, so Saturday would have been the start for that. She went to bed early and that was when the nausea started. It woke her up. Her throat hurt off and on through winter. But last night, it was worse than it has been. It comes and goes without any medication or anything. She was sure it was given in the muscle. NO emergency room (ER) or physician's office required. She called COVID hotline and they are making her go to the doctor before she can return to work. She has not gone yet. Outcome of the events was not recovered.
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| 47 | 2021-01-25 | chills, headache |
severe body aches; joint pain; chills; headache; nausea; diarrhea; This is spontaneous report from a...
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severe body aches; joint pain; chills; headache; nausea; diarrhea; This is spontaneous report from a contactable nurse (patient). A 47-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL3249), via an unspecified route of administration on 09Jan2021 11:15 at single dose at right arm for covid-19 immunization. Medical history included mild asthma, known allergies: latex, peanuts from an unknown date and unknown if ongoing, and the patient was diagnosed with COVID-19 prior to vaccination. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient's concomitant medications were not reported. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EH9899) at single dose at right arm on 19Dec2020 11:15 am for covid-19 immunization. About 12 hours after the vaccination patient had severe body aches, joint pain, chills, headache, nausea, diarrhea on 09Jan2021 09:00 PM. All symptoms lasted from 12-16 hours, except the diarrhea lasted about 20 hours. Outcome of all events was recovered on 10Jan2021. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.
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| 47 | 2021-01-26 | chills, fever | chills and fever of 101.4, body aches, sore arm at injection site |
| 47 | 2021-01-28 | dizziness | DIZZINESS |
| 47 | 2021-01-28 | headache, chills, fever | Fever as high as 103, muscle aches, joint pain, nausea, change in smell and taste, headache, chills |
| 47 | 2021-01-28 | chills |
ears have been burning; she checked her temperature and it is lower than normal, her temperature is ...
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ears have been burning; she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit; feels like her ears are hot; low iron; it feels like someone is pouring ice on her back/ she finds herself so cold; chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231, expiration date not reported) intramuscular on 30Dec2020 at, single for COVID. The patient had no medical history. There were no concomitant medications. The patient said that calling she was having a side effect that is not on the list of side effect. She does not know if it was from the chills but her ears have been burning ever since had the shot. She feels like her ears were hot. Can the vaccine cause this to happen? She clarified she was not having chills, it doesn't feel like chills, she said on the second day after the vaccine she had chills but right now it felt like someone was pouring ice on her back and she checked her temperature and it is lower than normal, her temperature is usually 96 and she just checked it and it was 91 degrees Fahrenheit. Her ears have been burning. Her first dose was given 30Dec2020. That was another reason she was calling should she get the second dose if she was feeling this way. She said her ears began burning sometime last week and it has not stopped. Sometimes it will go away and come back but she find herself so cold she has to get under the covers and it takes forever to warm up. Today she put a hat and a scarf around her ears to warm up in doors. She has low iron. She doesn't know with her having low iron all her life and she has never experienced this before. Outcome of the event ears have been burning was not recovered while unknown for the other events.
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| 47 | 2021-01-28 | dizziness, weakness, malaise |
she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so ...
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she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; she was supposed to get her second dose on the 12Jan2021 but she was still not feeling very well so now they are telling her to go this weekend; tested positive for COVID; tested positive for COVID; not feeling very well; feeling dizzy and weak; feeling dizzy and weak; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included Diabetes which was diagnosed in Apr2020. There were no concomitant medications. The patient received the first dose of the vaccine on 22Dec2020. She tested positive for COVID19 on 08Jan2021. The second dose of vaccine on 12Jan2021 was deferred as the patient was not feeling well on an unspecified date in Jan2021. She asked for guidance/information about receiving the second dose after testing positive. She stated that she was still feeling dizzy and weak on an unspecified date in Jan2021. She said that she heard the people were not feeling too well after the second dose and she will get it as long as it will not kill her. She asked what will happen if she does not take the second dose and will she need to get the series again. She wanted to know if she can take the second dose of vaccine. She clarified that she was supposed to get her second dose on 12Jan2021 but she was not feeling very well so now they were telling her to go on the weekend. She does not feel fine. She asked if it was safe for her to take the second dose or should she wait. She wanted to know if the effect of the first dose is null since she has now delayed it so long. She is the supervisor of ultrasound department. She started having COVID symptoms of 04Jan2021, she was tested on 05Jan2021 and got a positive result on 08Jan2021. The outcome of the events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive for COVID19 based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 47 | 2021-02-01 | throat swelling |
throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from...
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throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "throat closing" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-03 | dizziness, weakness, headache |
Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with ...
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Profound weakness; severe muscle and bone pain; severe muscle and bone pain; crushing headache with severe ocular pressure; palpitations; dizziness; Tingling and numbness to hands and feet; Tingling and numbness to hands and feet; Vein engorgement and swelling of left leg; Vein engorgement and swelling of left leg; right abdominal and flank pain; right abdominal and flank pain; crushing headache with severe ocular pressure; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 47-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: El3249), via an unspecified route of administration in the left arm on 19Jan2021 at 15:30 as a single dose, for COVID-19 vaccination. The vaccine was administered in a Nursing Home/Senior Living Facility. Medical history included asthma and known allergies (details not provided). Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 19Jan2021 at 15:30, the patient experienced Profound weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure. The events resulted in an emergency room visit and physician office visit. No treatment was given for the events. The clinical outcome of weakness, dizziness, palpitations, severe muscle and bone pain, tingling and numbness to hands and feet, vein engorgement and swelling of left leg, right abdominal and flank pain, crushing headache with severe ocular pressure was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-03 | headache, fatigue, malaise |
She got tested with the COVID saliva test on 09Jan2021 and tested positive; She got tested with the ...
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She got tested with the COVID saliva test on 09Jan2021 and tested positive; She got tested with the COVID saliva test on 09Jan2021 and tested positive; headache; not feeling well; fell super run down; This is a spontaneous report from a contactable consumer. A 47-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899) via an unspecified route of administration at single dose arm left on 06Jan2021 16:45 for covid-19 immunisation. Medical history included allergy induced asthma, neoplasm malignant since 2011 (reported as 10 years ago), ongoing white blood cell count decreased. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT) for allergy induced asthma, cetirizine hydrochloride (ZYRTEC) for allergy. No other vaccine was received in four weeks. Patient had headache on 09Jan2021, not feeling well on 09Jan2021, fell super run down on 09Jan2021. The patient got tested with the covid saliva test on 09Jan2021 and was positive. Patient just wanted to know if she can go forward to 2nd dose. The outcome of headache was not recovered, of fell super run down was recovering, of the other events was unknown.
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| 47 | 2021-02-06 | fatigue, cold sweat, dizziness, headache, weakness, chills, shortness of breath |
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w...
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2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
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| 47 | 2021-02-08 | headache, fever, chills |
Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spont...
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Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), intramuscularly on 25Jan2021 at 10:00 AM in Left arm at single dose for COVID-19 immunization. The patient medical history included Hypothyroidism and COVID prior vaccination. No known allergies, no allergies to medications, food, or other products. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek4176), on 07Jan2021 in Left Arm at single dose for COVID-19 immunization at age of 47-year-old. The patient experienced fever, strong muscle pain, chills, headache and muscle weakness on 26Jan2021 at 03:00 AM; Cellulitis in the arm on 27Jan2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events fever, strong muscle pain, chills, headache and muscle weakness included Acetaminophen, ibuprofen; no treatment was received for the event Cellulitis in the arm. The outcome of the events was not recovered. The report was reported as non-serious for event "Cellulitis in the arm", with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 47 | 2021-02-10 | cough, chills, fever, fatigue, malaise |
her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; f...
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her face feels swollen; her legs are really achy; Chills; skin burns/ skin burning, sore to touch; fever; her right carotid on her neck felt swollen; right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt; tired and achy; tired and achy; feeling sick; muscle and joint pain; muscle and joint pain; cough; the back of her ribs hurt; Nausea; she is having shooting pains in different spots; This is a spontaneous report from a contactable nurse reporting for self. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot Number EL3249, via an unspecified route of administration from 25Jan2021 14:00 (at the age of 47 years old), Dose 2, as a single dose in the left arm for COVID-19 immunization. Medical history included she had her tonsils out on an unknown date. She was a nurse that works with COVID patients; she got tested twice last week (Jan2021), both were negative. She had no pre-existing medical conditions. She has never had a problem with vaccines. There were no concomitant medications. The patient previously received dose 1 of BNT162B2 on 04Jan2021 (Lot # EX9231) and experienced no reaction then. The patient had the second dose of the Pfizer vaccine around 2 PM yesterday (25Jan2021) and she kept moving around in bed and feeling sick last night. That night she was just tired and achy but she thought that could just be from working. She went to bed early and she woke up around 1:50 or 2 AM with chills so she went and got a thermometer. She woke up at about 2 AM (26Jan2021) with a 103 fever and chills and her right carotid on her neck felt swollen and her face felt swollen, but her right carotid hurt. Her skin just burns; she went to take a shower. With the skin burning she knew it was sore to touch but when she got in the shower, that was when she noticed it hurt. She was really achy; her legs were aching and she was having shooting pains in different spots. She commented that she called out today (26Jan2021), she never calls out; all she wanted to do was take a shower and she wondered if she needed to go to the doctor. Her skin burns even when she was showering; every part her skin burns. She was also having muscle and joint pain and cough and the back of her ribs hurt (Jan2021). The other thing was nausea (Jan2021). The fever and chills were persisting and were about the same. She was hoping for it to go down so she could go to work to tomorrow (27Jan2021). The clinical outcome of the fever, chills, and her right carotid on her neck felt swollen and hurt was not recovered. The clinical outcome of feeling sick, tired and achy, face feels swollen, skin burning, muscle and joint pain, cough, back of her ribs hurt, nausea, and shooting pains in different spots was unknown. The reporter states she thinks what she is reporting was directly related to the product.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-14 | fever, dizziness, fatigue, chills, headache |
syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours...
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syncopal episode; Swollen lymph nodes in left neck and left arm pit; Nausea within a couple of hours of vaccine /continued nausea; Fatigue; fever; chills; headache; dizziness; This is a spontaneous report from a contactable other health professional (patient). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), via an unspecified route of administration in left arm on 27Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included very infrequent anxiety and headaches, only after illness. Concomitant medication included sertraline, ethinylestradiol, norethisterone acetate (JUNEL), fluticasone propionate (FLONASE). The patient previously took prochlorperazine maleate (COMPAZINE) and experienced allergies to Compazine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140), via an unspecified route of administration at the age of 47-year-old in left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. The patient experienced nausea within a couple of hours of vaccine. The patient experienced fatigue, fever, chills, headache, continued nausea, dizziness with 1x syncopal episode, swollen lymph nodes in left neck and left arm pit, mostly resolved after 3 days. She had still with headache. All events occurred on 27Jan2021 14:30. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The patient did not receive any other vaccines in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the event headache was not recovered and the outcome of the other events was recovering.; Sender's Comments: Based on a compatible temporal relationship causality between event syncopal episode and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-21 | chills, fatigue, headache, nasal congestion, dizziness |
48 hours after the second dose of Pfizer COVID19 vaccine I started feeling very dizzy. I also felt v...
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48 hours after the second dose of Pfizer COVID19 vaccine I started feeling very dizzy. I also felt very tired and sleepy, kind of getting a cold, with weird head ache. I almost never have head aches. I also experienced chills. Oddly, my husband got all the same symptoms very same day, as if I had 'infected' him with the vaccine. The feeling sick symptoms passed in about 2-3 days, but the weird stuffiness and some sort of pressure in my brain has stayed, and is annoying. I have not had this kind of head sensation before, and it is not going away. I have since had 2 negative covid RT-PCR tests.
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| 47 | 2021-02-21 | dizziness, headache |
Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache an...
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Developed itchiness on face and mild palpitation 20 minutes after injection Developed headache and injection site soreness 12 hours after injection Developed dizziness about 20 hours after injection Developed itchiness, redness, and welt below the injection site 3 days after injection and lasted for about 5-7 days
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| 47 | 2021-02-21 | headache | Headache Muscle aches |
| 47 | 2021-02-21 | body temperature increased | Loss of smell, high temperature of 104 degrees. |
| 47 | 2021-02-21 | fatigue |
Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest p...
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Received 2nd vaccine on 2/19/21 and started having fatigue the next day that progressed into Chest pain that radiates into shoulders.
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| 47 | 2021-02-21 | chills, fever |
~13 hours post vaccination, symptoms consistent with acute intermittent porphyria exacerbation (atta...
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~13 hours post vaccination, symptoms consistent with acute intermittent porphyria exacerbation (attack) developed: severe abdominal pain, nausea, brain fog. Porphyria symptoms responded to porphyria-specific treatment (IV infusion with hemin (Panhematin) on both 2/10/21 and 2/11/21; analgesics). Porphyria symptoms lasted until 2/12/21. -On 2/10/21 also typical COVID-19-vaccine side effects: muscle and joint pain, fever (101.2F), chills. These resolved within one day. Previous mild COVID-19 (8 months prior to vaccination). Infection is a known trigger of porphyria attacks. Vaccination does not usually trigger porphyria symptoms.
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| 47 | 2021-02-22 | dizziness | Dizziness |
| 47 | 2021-02-22 | respiratory tract congestion, fatigue, headache, malaise, fever | Tachycardia,fever,malaise,fatiuge,headache,congestion, inflamed thyroid |
| 47 | 2021-02-22 | fatigue, chills, headache, fever | fever, chills, muscle ache, fatigue, headache that lasted 12 hours. Negative covid test. |
| 47 | 2021-02-23 | fever, chills |
Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelli...
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Little bit of arm soreness; 8 days after vaccine I experienced swollen lymph nodes under arm; Swelling and pain of injection site; Swelling and pain of injection site; Fever; Chills; 3 by 5 inch red circle and swelling around injection site/arm turned red; This is a spontaneous report from a contactable other healthcare professional (medical receptionist -patient). A 47-years-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EL3246, expiration date unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 17:30 at the age of 47 years old at a single dose for COVID- 19 immunisation in the hospital. Medical history included mitral valve prolapse, gallstones , hypertension and crab allergy. Concomitant medications included lisinopril and hydrochlorothiazide. The patient did not receive vaccines in four weeks. On 28Jan2021 at 07:00 AM, the patient had a little bit of arm soreness initially. The patient experienced swollen lymph nodes under arm, swelling and pain of injection site, fever and chills. On the 9th day after vaccine (29Jan2021), patient had a 3 by 5 inch red circle and swelling around injection site. It was also reported that the arm and lymph nodes swelled. The patient had fever and chills. Then her arm turned red. As of 05Feb2021, the swollen mark which is about 5x4 inches is swelling again. The patient's next dose is scheduled for 10Feb2021. She is really concerned about getting the second dose. The events were assessed as non-serious by the reporter. It was unknown if the patient received a treatment in response to the events. The patient was not diagnosed with COVID-19 prior t vaccination and was not tested for COVID-19 post vaccination. The outcome of the event was unknown.
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| 47 | 2021-02-25 | chills |
Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a p...
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Rigors and severe back pain; Rigors and severe back pain; syncope; prolonged PT; Loss of work as a physician for 2.5 weeks; This is a spontaneous report from a contactable physician (patient) A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jan2021 12:30 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease and allergies. The patient was not pregnant. Concomitant medication included lansoprazole (PREVACID). The patient experienced rigors and severe back pain, syncope, prolonged pt and loss of work as a physician for 2.5 weeks on 12Jan2021 with outcome of recovered with sequelae in Feb2021. The events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized due to the events for 2 days. The patient received steroids, pain meds, muscle relaxers as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship and known product safety profile causality between event chills and syncope and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be excluded. The events prolonged PT and loss of work as a physician for 2.5 weeks are attributed to intercurrent conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 47 | 2021-02-25 | sweating, migraine |
sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit,...
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sweating; nauseated; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea; really bad migraine migraine/always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was more diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261 and expiry date: May2021), via intramuscular route of administration on 26Jan2021 at 11:30 at 0.3 mL, single on the left arm for COVID-19 immunization. Medical history included ongoing migraine and vomiting. Concomitant medications included ongoing sumatriptan succinate (IMITREX) for migraine, ongoing nadolol for migraine, ongoing sertraline for migraine, and ongoing ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). On 26Jan2021 at 13:00, the patient experienced really bad migraine. The patient always had migraines that usually makes her vomit, but this time, after receiving the vaccine, it was worst and more diarrhea. The husband does not know if it was because of the shot or if it was because of the warm front that they are receiving because sometimes that can trigger her migraines. The husband reported that it was pretty typical for her and she will sleep with a fan on, but today she is actually covered up (for clarification) and does not want the fan on. Patient also started sweating and got nauseated on an unspecified date. The husband wanted to know if he needs to take her to the doctor. The outcome of the events really bad migraine and diarrhea was not recovered while the other events was unknown.
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| 47 | 2021-03-02 | fever |
Fever; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old fem...
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Fever; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL 9262, expiration date was unknown), via an unspecified route of administration on 26Jan2021 at 08:30 AM at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as the hospital. The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Jan2021 at 11:00 AM, the patient experienced fever. The patient assessed the event as non-serious. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.
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| 47 | 2021-03-02 | shortness of breath |
numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to ...
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numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); felt acutely short of breath and anxious; felt acutely short of breath and anxious; numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE); This is a spontaneous report from a contactable physician. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 16:00 (at the age of 47 years old) at a single dose for covid-19 immunization. Medical history included known allergies: shellfish, seasonal allergies and psoriasis. Concomitant medications included several medications in two weeks. The patient is not pregnant. The patient had no other vaccine in four weeks. On 29Jan2021 23:45, after being asleep for approximately one hour, felt acutely short of breath and anxious, which lasted less than a minute and was then followed by numbness and tingling in her neck - radiating to the pinnae of her ears, bilateral shoulders and to bilateral upper and lower extremities (BUE and BLE). These events resulted in emergency room visit. The patient underwent lab tests and procedures which included PCR/nasal swab on 29Jan2021 (post vaccination) which showed negative. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL), IVF. Outcome of all the events was recovering. Information on the lot/batch number has been requested.
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| 47 | 2021-03-04 | headache, fatigue, dizziness, weakness |
Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; s...
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Severe headache; lightheadedness; weakness; fatigue; muscle and joint pain; muscle and joint pain; swelling in left armpit; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9Z61), via an unspecified route of administration on 01Feb2021 at 10:00 at a single dose on the left arm for COVID-19 immunization. Medical history included diabetes, hypertension (HTN), depression and polycystic ovarian syndrome (PCOS) all from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EJ1686) on 11Jan2021 at 10:00 on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache, lightheadedness, weakness, fatigue, muscle and joint pain and swelling in left armpit on 02Feb2021. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious.
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| 47 | 2021-03-09 | throat irritation, headache |
Throat scratchy, dry heaving, throat closed, needed epi pen, went to Er, had second episode, over...
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Throat scratchy, dry heaving, throat closed, needed epi pen, went to Er, had second episode, overnight in hospital with body aches, headache, had third episode in the morning 24 hrs after injection
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| 47 | 2021-03-14 | headache, weakness |
PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first sh...
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PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first shot, she complained of body soreness, weakness and headaches that did not go away until she had the stroke on 03/12/2021". Patient is now hospitalized and unresponsive.
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| 47 | 2021-03-14 | headache |
bad front of the head headache; injection site is slightly sore when touched; This is a spontaneous ...
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bad front of the head headache; injection site is slightly sore when touched; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 28Jan2021 13:45 at single dose for COVID-19 immunization in workplace clinic. The patient's medical history included asthma, chronic sinusitis with nasal polyps. The patient have allergies to medications, food, or other products. Concomitant medications included other medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient received other medications within 2 weeks of vaccination. It was reported that, woke up the next morning on 29Jan2021 07:00 AM with a bad front of the head headache and injection site was slightly sore when touched. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was not recovered.
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| 47 | 2021-03-14 | fatigue, headache | severe headache, stiff neck and extreme fatigue |
| 47 | 2021-03-15 | fever, headache |
At 36 hrs after vaccine I started with fever 101 and severe headache. After 3 days later I was diagn...
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At 36 hrs after vaccine I started with fever 101 and severe headache. After 3 days later I was diagnosed with positive Covid pneumonia.
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| 47 | 2021-03-15 | dizziness, fatigue |
Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish...
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Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; Felling Dizzy; Disoriented, Could not finish the drive home due to disorientation; Emotional; Crying; Nausea; Tired; Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269) via an unspecified route of administration, administered in left arm on 04Feb2021 10:30 am at a single dose for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 on 12Jan2021 (at 04:30 PM, Right arm, dose 1) for covid-19 immunisation. The patient experienced felling dizzy (dizziness), disoriented, could not finish the drive home due to disorientation (disorientation), emotional (emotional disorder), crying, nausea, tired (fatigue); all on 04Feb2021 11:00 am and Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) on an unspecified date and (off label use) on 04Feb2021 10:30 am. No treatment received for the adverse events (felling dizzy, disoriented, could not finish the drive home due to disorientation, emotional, crying, nausea and tired). All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events Dose 1: 12Jan2021 04:30 PM; dose 2: 04Feb2021 10:30 AM (inappropriate schedule of product administration) and (off label use) was unknown and for all events, not recovered.
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| 48 | 2020-12-31 | headache, fatigue, weakness, somnolence |
After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, the...
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After monitoring for 15 min post-vaccination, I drove away. On the 17th minute, my face got hot, then I headache started. A minute later fatigue hit and I was starting to fall asleep at the wheel. I live 1 mile away so I made it home. Now my head was getting fuzzy. Called a co-worker to tell her what was happening and she said my speech was slurring. I felt drunk and hungover at the same time. I went to bed and slept for an hour. I woke up and felt very fatigued. I finally went to bed for the night then was awoken with severe arm pain. My entire upper arm felt so tight but I it was soft upon palpation. I fell asleep and awoke to terrible arm pain again. I started crying in bed but fell asleep again. I woke up in the morning with severe upper arm pain and minor headache. I couldn't rotate my arm back to put my bra on so I took some ibuprofen. That had immediate relief for my arm and headache. I ran one errand and was wiped out. The fatigue hit again. The arm pain came back so I took another ibuprofen with relief. I had no energy so laid around for the rest of the day. I woke up on Sunday and finally felt normal with just pain at the injection site. The 2 other medical people that have had similar reactions like mine with dizziness and feeling light-headed have one thing in common with me...we are all vegetarians. I don't know if that makes a difference with protein metabolism or other enzymatic activity, but we are the only 3 that I know of out of all of our co-workers who have received the vaccine to react like this.
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| 48 | 2020-12-31 | fever, headache |
Extreme left arm pain, left arm burning pain, traveling pain up to the neck, headache, low grade te...
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Extreme left arm pain, left arm burning pain, traveling pain up to the neck, headache, low grade temperature for 3 day..left arm still very sore on day 4
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| 48 | 2020-12-31 | dizziness |
Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced s...
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Pt felt dizzy and nauseous after vaccine administration. When she tried to get up, she experienced syncope for about one minute. We administered Epi-pen and pt regain consciousness. Asked facility and patient if 911 call was needed, but patient refused. We monitored her blood pressure for over 1 hours and she stabilized at her baseline. We released her to go home and she will continue to monitor other potential adverse reactions.
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| 48 | 2021-01-01 | chills, fever | Fever, chills, body aches for one day. Took only Tylenol 650mg 6 hrly. |
| 48 | 2021-01-01 | fever, malaise, chills |
Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset ...
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Woke up w/ primarily left sided cervical lymphadenopathy with gum pain/swelling on the left - onset 12/27. Visit to dentist for worsening pain and mild body aches and chills - dentist felt the pain and swelling, + mild ulceration due to new toothbrush head causing abrasions on gums and hard palate - no treatment prescribed - 12/28. Worsening painful lymphadenopathy (now bilateral cervical), body aches, chills, joint pain, fevers, odynophagia, gum pain/swelling, malaise - visit to respiratory clinic - rapid strep negative; COVID negative, bacterial throat culture negative (VS: HR 120, SBP 168, T 100.7 on Tylenol) - no treatment prescribed - 12/29. Development of shallow, painful ulcers LEFT hard palate, gums and a RIGHT lip ulcer - 12/31. Photos of ulcers reviewed with previous dentist - prescribed acyclovir 400 mg TID and magic mouthwash. 12/31. Taking Ibuprofen and Tylenol regularly. As of today, 1/2, improvement in cervical lymphadenopathy, resolution of constitutional symptoms, and odynophagia. Ongoing mouth pain and ulceration. + left facial numbness/burning pain (V1-3) similar to previous episode of trigeminal neuralgia in 1999.
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| 48 | 2021-01-03 | throat swelling |
12/22/20, 13:36: 6 minutes after receiving the 1st Pfizer vaccine injection, there was stiffness fel...
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12/22/20, 13:36: 6 minutes after receiving the 1st Pfizer vaccine injection, there was stiffness felt behind my ears and in the back of my neck. 10 minutes after the injection, there was a fullness noted along my throat and upper pallet. The symptoms only slightly lessened after 30 minutes. I have a hx of Rheumatoid Arthritis, completing prednisone doses 4 days ago and currently taking Celebrex and IBU daily. The Benadryl liquid dose (25mg) taken at 14:15 completely resolved my reaction symptoms by 15:15.
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| 48 | 2021-01-03 | throat irritation |
26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreas...
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26Dec2020 continued decreased perfusion added bilateral knee joint pain; 26Dec2020 continued decreased perfusion added bilateral knee joint pain; 25Dec2020 added facial edema; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen; throat scratchy and tight; throat scratchy and tight; 23Dec2020 slight swelling on feet and ankles; 23Dec2020 slight swelling on feet and ankles; Tingling and best flutter 5 minutes after administration; Tingling and best flutter 5 minutes after administration; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number: EJ1685, expiration date: Mar2021), intramuscularly on 22Dec2020 at 09:45 at single dose for COVID-19 immunization in hospital. The patient medical history included known allergies: Sulfa, Penicillin; fibromyalgia; hypertension; high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications included other medications was received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced on 22Dec2020 09:45 tingling and best flutter 5 minutes after administration; 23Dec2020 slight swelling on feet and ankles; 24Dec2020 ++6 pitting edema on ankles and feet +3 pitting legs and abdomen, throat scratchy and tight; 25Dec2020 added facial edema; 26Dec2020 continued decreased perfusion added bilateral knee joint pain. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL) 50 mg every 6 hours. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: Flutter occurred 5 minutes after vaccination; a possible causal association between administration of the suspect vaccine bnt162b2 and the serious event onset cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-03 | fatigue, chills |
Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Gen...
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Initially had arm pain in the left deltoid area with mild induration, chills and some bodyaches. Generalized fatigue. Two days ago(1/2/21) a large left supraclavicular lymph node came up, it is a little sore. No redness. Moveable. No coughing or SOB. No difficulty swallowing. No rash to that area. No sore throat or other known cause at this time for the adenopathy
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| 48 | 2021-01-03 | sweating, dizziness |
dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, craw...
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dizzy/feel faint; perspiring; like blood not getting to my head; had to get on hands and knees, crawl; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; felt like my heart may be racing 10 min after vaccine/heart felt off beat and like blood not getting to my head/heart rate was 142; arm sore day #1 and #2- not unexpected; This is a spontaneous report from a contactable Physician(patient). A 48-year-old female patient received first dose (BNT162B2, lot number EK5730) , intramuscular at Arm Right on 18Dec2020 14:15 at the 48-year-old at single dose for COVID-19 immunization. The medical history included elevated blood pressure , allergic to sulfa, hypertension and Covid. The concomitant products included alprazolam, diphenhydramine hydrochloride (BENADRYL), spironolactone, metoprolol for hypertension, colecalciferol (VITAMIN D 3). The patient previously took nubaine and experienced drug allergy. The patient also happened to be a physician in private practice and received the vaccine at her local hospital. The patient had hypertension which was under excellent control on metoprolol 25 mg. She took it as prescribed every day surrounding the vaccine. On day #1 at the vaccine she felt like her heart may be racing 10 min after vaccine was about 80 on 18Dec2020 14:25. nothing serious. The patient experienced arm sore day #1 and #2 and not unexpected. On about 7 pm the day after the vaccine 19Dec2020 she was tachy at rate of about 105. She took her metoprolol heart rate never came down. At about 9:30 pm on 19Dec2020 when her rate should have been about70- she got up from couch after falling asleep. Upon standing felt like she was very dizzy. Walked upstairs, started to feel faint, perspiring, heart felt off beat and like blood not getting to my head. She had to get on hands and knees, crawl and heart rate was 142 and sustained for almost a minute. It took over an hour for it to come back to 86 and stayed there all night. There was not treatment to all of the adverse events. The outcome of the events was Recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the palpitations, tachycardia and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-01-03 | headache | headache (base of skull) and neck pain (back of neck) |
| 48 | 2021-01-04 | throat irritation |
15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throa...
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15 minutes after patient received her #1 Pfizer vaccine, she started to feel flushed with some throat irritation. She states she feels " a bit shaky inside ". Given juice and crackers. BP 143/84. heart rate 89. O2 sat 99%. She was moved into another quieter observation area. She claims she felt better. Given H20 to drink. States she had a bit of chest discomfort but this was nothing new to her. She has been having chest discomfort for the past 1-2 weeks periodically. Upon observing patient for 40 minutes, patient states, she felt better. BP 115/78, heart rate 80. Patient was then released. She states this is the first time this has happened while taking an IM injection.
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| 48 | 2021-01-04 | fatigue |
Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: em...
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Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.
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| 48 | 2021-01-04 | skin warm |
Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontin...
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Chest and arms red and warm; metallic taste in mouth; no signs of distress when monitoring discontinued. Proceeded to PCP office the following day due to face, neck and arm stiffness, edema in hands, legs, and face, continued metallic taste, and elevated BP (160/100). PCP prescribed oral steroids, antihistamine, and Epi-Pen.
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| 48 | 2021-01-04 | headache, fever |
Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from ...
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Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from a contactable Nurse (patient herself). This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular, on 20Dec2020 at 18:15 at single dose for COVID-19 immunisation. Vaccine location was Arm Right. The patient was not pregnant. Relevant medical history included elevated rheumatoid factor, restless leg syndrome and depression. Past drug history included allergy to ferrous gluconate. Relevant concomitant medications included pramipexole dihydrochloride (MIRAPEX). The patient was vaccinated at hospital, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination COVID test was not performed. Post-vaccination COVID tests were performed: nasal swab on 28Dec2020 was negative; PCR in Dec2020 was negative. On 21Dec2020 at 18:30, the patient had headaches, muscle pain, body aches, low-grade fever and frequent hot flashes throughout the day at random moments, along with headaches and bod. The patient was not treated for the events. The patient had not recovered from the events.
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| 48 | 2021-01-04 | fever, influenza like illness, weakness, malaise, chills |
I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still fee...
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I can't even read; I'm so freaking sick /I didn't feel well; Flu / like flu side effect; I still feel like very weak and achy; Pain/achy/aches; Teeth chattering; Shaking all night long and 102 fever; Shaking all night long and 102 fever/low grade fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, reason for no lot number: consumer stated, "I can't even read, it says EK or E something 5730. That's what it looks like."), intramuscular in arm in Dec2020 at single dose for COVID-19 immunisation. Medical history included low thyroid, have had thyroid cancer many years ago. Concomitant medication included levothyroxine sodium (SYNTHROID). Consumer stated, "I just have a question, I had a shot done on Wednesday and I have heard the second shot was worst so I was little concern we are all concerned about getting the first shot to begin with. So I had the shot on 11:30 at work at the hospital on Wednesday. I probably about 1:30 to 2 O'clock in the morning total like flu side effect. I thought I got a flu, aches, pain, teeth chattering, shaking all night long and 102 fever. I haven't been sick at all thank god in a while but it feels like I had, so, I have a new born grandson supposed to go there for Christmas so I'm concerned because I was running a 102 Wednesday night and I was so running a low grade so is it normal to have reaction like that?" Consumer stated, "Yes, let me just get a pen. I just don't want to be around the baby. I thought I was fit but I don't usually when your body gets the vaccination your body fighting against the vaccine so I don't think it is going to affect the baby. I just don't want to get this shot if they got affected and if they are on fever. I just want to make sure before I go over there for Christmas." When probed if calling for the first time in Pfizer drug safety department, consumer stated, "No, actually I was just thinking now before I had out I grab these side effects yesterday and I read it I have fever 102, I was like let me call the number from the paper that they gave me with the shot card, let me call you guys and try to figure out what the hell is going on here and why I'm so freaking sick from this shit." .Height and weight: Consumer stated, "I say about 130 and about 5'6.". LOT#: Consumer stated, "Let me see if I have the card, I know I have it somewhere. May be I'm just thinking I shouldn't get the second shot. I can't even read. it's Pfizer, I can't even read, it says EK or E something 5730. That's what it looks like."Manufacturer name: Consumer stated, "Covid 19 Vaccine and I'm pretty sure it's Pfizer.".Lab work: Consumer stated, "I had all my labs on like you know like regular labs CBC's like everything. I have bad thyroid it goes up and down, I didn't feel well so I went to you know I know when my thyroid is up or down so I went and got the whole blood panel done.".Date of administration of first dose: Consumer stated, "It was probably like December 8th. I had it done on 23rd of December." (Not further clarified).Event date: Consumer stated, "The same day I had the shot.".When probed if still experiencing the events, Consumer stated, "Yes. It's not totally improved but it is better than it was but I still feel like very weak and achy." .Treatment: Consumer stated, "Tylenol and Ibuprofen I keep alternating it."Consumer stated, "I just want to make sure I can go back to my grandson today because I went to my daughter last time she is leaving for (place name) tomorrow and she was nervous and now I'm like still running a low grade fever last night and I know my daughter is going to flip out if I show up. I told her it's okay because it's only vaccination but I just want to make sure with the Covid shot I got." .The outcome of events I still feel like very weak and achy and pain/achy/aches was not recovered. The outcome of events flu / like flu side effect, teeth chattering, shaking all night long and 102 fever, shaking all night long and 102 fever/low grade fever, I'm so freaking sick was Recovering. The outcome of other events was unknown. Information on the lot/batch number has been requested.
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| 48 | 2021-01-04 | dizziness |
Patient was vaccinated at 9:21 am on 1/5/2021 after review of consent forms and questions answered. ...
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Patient was vaccinated at 9:21 am on 1/5/2021 after review of consent forms and questions answered. Patient was asked if she had any adverse reactions to vaccine or products containing polyethylene glycol ( bowel preps/ cosmetics/ lotions). Patient denied any allergies except to Penicillin. Patient consented to receive vaccine. Pfizer Covid vaccine administered at 9:21 am. No immediate reaction. Patient denied any pain at injection site. Patient escorted to observation area. At 9:30 am the patient complained of nausea and proceeded with dry heaves. Patient did state she had eaten in the morning. Patient with good radial pulses at rate of 88. Patient then stated she felt dizzy and patient was assisted to the floor and placed in a recovery position. The patient DID NOT have change in mental status or decrease in mental status. Initial BP 162/102 - HR 88. Patient continued with nausea, dry heaves and dizziness. 911 was called. Patient maintained a BP of 160-172 systolic and pulse rate of 120, RR 40. Patient WITHOUT rash, swelling, wheezing, SOB or change in LOC. Benadryl was administered at 0945. Medics arrived at 9:47. Patient was transported to local hospital. No change in patient status upon departure. Patient remained nauseated, with dry heaves and dizziness.
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| 48 | 2021-01-04 | headache, head discomfort, cough, dizziness, discomfort |
Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly...
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Post vaccine 12/18 Shoulder and upper/mid-back soreness pretty quickly; left arm feels stiff shortly after leaving observation area (32 min in observation) 9:30 lip tingling/ numbness, headache, back soreness/tightness/ pressure continues 9:40 hearing muted, fullness/mild pressure in ears - first left then right a little later Headache waxes and wanes - at times feels like vice squeezing my head 11:50 heartburn sensation 12:00 localized swelling/ knot at injection site 12:04 wave of nausea/ mild heartburn Headache continues off and on 3:30 ear ache, nausea, stiff joints, arm/shoulder/back pain, neck pain 16:00 dizzy/ nausea 16:22 flushed feeling in cheeks and neck; itchy cheeks, neck, chest 16:50 still flushed, itchy all over, heart palpitations. Fitbit shows HR 78 Hives for several hours. Hives gone by morning but still intermittently itchy. Eyes itchy/ feels like a contact lens is stuck in a wrong spot (have not worn contacts in 12+ years) Very mild cough started in evening 12/19 Hives in afternoon; itching off and on all day HR 91 (21:30) 21:43 HR 97 dizziness, headache 22:00 hives on face and abdomen 23:09 eye hurts again and is so itchy I want to rip it out of the socket, headache persists 12/20 Mild-to moderate itchiness upon waking, Itchiness off and an Mild headache off and on 9:15 heaviness in chest - feel I like do just before I get bronchitis, very mild cough Itchiness throughout the day. Hives on face in evening/Skin has a sunburn-type feeing Hives on neck and chest at bedtime Eyes itching then hurting - feels almost like pink eye type sensation As I was dozing off to sleep, heart palpitations - HR 97 12/21 Itchy/ hives on face, neck, upper chest By 12/21 afternoon, itchiness and hives abated. No further symptoms
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| 48 | 2021-01-04 | runny nose |
Rhinorrhea; This is a spontaneous report from a contactable nurse. A 48-year-old female patient (not...
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Rhinorrhea; This is a spontaneous report from a contactable nurse. A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular (arm left) on 23Dec2020 17:00 at single dose for Covid-19 immunization. The patient's medical history included obese and seasonal allergies. Concomitant medications included ibuprofen, acetaminophen, loratadine, calcium, vitamin c (ASCORBIC ACID), vitamin d3, probiotics, and fish oil. The patient previously took Nickel and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rhinorrhea on 23Dec2020 (21:00). There was no treatment received for the adverse event. The outcome of event was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 48 | 2021-01-04 | nasal congestion |
Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelli...
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Symptoms: eyelids swelling/itching, nasal/sinus swelling, nasopharyngeal swelling, circumoral swelling-around mouth and lips, not inside mouth. Administered nasal Flonase 2 pumps each nare and 50 mg Benadryl at 2230. At 0430 next morning 12/29, swelling decreased, eyelids remained swollen and minimal swelling in nasal/sinus area. Continued Benadryl 50 mg every 6 hours x 3 doses, by 1900 on 12/29 swelling resolved
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| 48 | 2021-01-04 | fatigue, chills, fever |
Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes...
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Temp max 100.2F (tympanic thermometer); Chills; Body aches; Joint pain; Swollen cervical lymph nodes; Fatigue; This is a spontaneous report from a contactable nurse (patient herself). This 48-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899), via an unknown route, on 23Dec2020 at 11:30 AM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included well-controlled hypertension, gastrooesophageal reflux disease (GERD), seasonal allergies (pollen only) and well -controlled depression. Relevant concomitant medications included losartan, spironolactone, wellbutrin, omeprazole (PRILOSEC) and cetirizine hydrochloride (ZYRTEC). The patient was vaccinated at Workplace Clinic, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. On 24Dec2020 at 01:00 AM, the patient had temp max 100.2 F (tympanic thermometer), chills, body aches, joint pain, swollen cervical lymph nodes and fatigue. No treatments were taken for the events. The patient had recovered from the events on unknown date.
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| 48 | 2021-01-04 | shortness of breath, throat irritation |
chest got tight; Shortness of breath; throat was itchy, and felt like it closed; throat was itchy, a...
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chest got tight; Shortness of breath; throat was itchy, and felt like it closed; throat was itchy, and felt like it closed; This is a spontaneous report from a contactable other health care professional (HCP) (also reported as respiratory therapist) from a Pfizer Sponsored Program. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 48-years-old at a single dose for COVID-19 immunization. Medical history included asthma from 2000 and ongoing (diagnosed 20 year ago). There were no concomitant medications. On 21Dec2020, the patient experienced: chest got tight (non-serious), shortness of breath (non-serious), throat was itchy, and felt like it closed. The clinical course was reported as follows: The caller was a respiratory therapist (also reported as health care professional (HCP)). The patient's first dose of the vaccine was on 21Dec2020 at the hospital where she works. Five hours after getting the vaccine, her chest got tight, she has shortness of breath, her throat was itchy, and she felt like it closed. The patient had asthma (diagnosed 20 years ago) and felt this reaction. It took 48 hours after the initial symptoms that she felt better. For treatment, the patient took her salbutamol (ALBUTEROL) inhaler and diphenhydramine hydrochloride (BENADRYL). The patient was scared to have the second dose; and she was going to talk to her primary care physician (PCP) about the second dose (but she did not think she would have much knowledge on what to do). The patient had a COVID PCR test the day she received the vaccine, and it was negative. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 21Dec2020. The clinical outcome of the events was recovered on an unspecified date.
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| 48 | 2021-01-04 | fatigue |
deltoid muscle pain in left arm where she got the shot; Left arm feeling heavy in within 2 hours of ...
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deltoid muscle pain in left arm where she got the shot; Left arm feeling heavy in within 2 hours of vaccination, hard to lift up; she was feeling very tired and in day-2 she felt fatigue; This is a spontaneous report from a contactable consumer reporting for a patient. A 48-year-old female patient received first dose of BNT162B2, (Pfizer-BioNTech Covid-19 Vaccine, lot number EH9899) , via an unspecified route of administration on 28Dec2020 10:00 at single dose on left arm for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications were none. The patient experienced deltoid muscle pain in left arm where she got the shot (28Dec2020 12:00). Left arm feeling heavy in within 2 hours of vaccination, hard to lift up (28Dec2020 12:00). In the afternoon she was feeling very tired and in day-2 she felt fatigue, took Tylenol multiple times a day. On day-3 she felt perfectly fine and no pain was left. Functioning properly. No known allergies. The patient did not receive other vaccine in four weeks. No covid prior vaccination; no covid tested post vaccination. The patient was not pregnant at the time of vaccination. Therapeutic measures were taken as a result of deltoid muscle pain in left arm where she got the shot. The outcome of the events was resolved on an unspecified date.
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| 48 | 2021-01-05 | shortness of breath, fatigue, headache, lethargy |
12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albutero...
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12/22/2020 2:50pm Shortly after the vaccine was administered experienced SOB and wheezing. Albuterol MDI utilized and symptoms subsided. 3:30pm Mild Headache and back pain. Fatigue and lethargic. Pain scale 3-4 5:15pm Headache increased intensity. Fatigue and lethargic. Back pain still the same, took Motrin 600mg-OTC Wheezing, used Albuterol-MDI 7:30pm Headache and back pain increased intensity 12/23/2020 4:54am Woke up with wheezing, headache and back pain. Pain scale 6 Albuterol-MDI utilized 7:42am Wheezing and SOB, Albuterol utilized and symptoms subsided 3:00pm Headache increased intensity throughout the day. Difficulty focusing and multitasking. Loosing train of thought. Fatigue and lethargic. Pain scale7. Motrin OTC 800mg taken with evening medications and went to sleep. 12/24/2020 7:23am Woke up with severe headache and anosmia. 12/25/2020 Headache and anosmia 12/26/2020 Headache and anosmia 12/27/2020 COVID test-Negative result Headache and anosmia 12/28/2020 Headache and anosmia 12/29/2020 Headache and anosmia. Doctor's appointment. Headache treated with Tramadol 12/30/2020 Headache and anosmia. Pain scale 6 12/31/2020 Headache and anosmia Pain scale 3-4 01/01/2020 Headache and anosmia Pain scale 2-3 01/02/2020Headache and anosmia Pain scale 0-2 01/03/2020 Headache and anosmia Pain scale 0-1 01/04/2020 Anosmia 01/05/2020 Headache and anosmia Pain scale 2-3 01/06/2020 Headache and anosmia Pain scale 3-4
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| 48 | 2021-01-05 | dizziness |
At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I exper...
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At approximately 18:00 on 01/05/2021 I noticed my hearing was hypersensitive. At about 20:00 I experienced hearing loss in my left ear like I had an ear infection. This morning I woke up and it is worse. I can barely hear out of my ear and I have tinnitus. I am dizzy and feel cautious.
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| 48 | 2021-01-05 | fatigue, headache |
Body Aches, Tiredness, Severe Headaches TX-Husband took her to the Urgent Care-5 Jan 2021 two inject...
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Body Aches, Tiredness, Severe Headaches TX-Husband took her to the Urgent Care-5 Jan 2021 two injections given to her-Toradol, Zofran, Iv therapy also, prescription for Urrelvy-for migraines-she didn't fill it yet
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| 48 | 2021-01-05 | dizziness |
C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling i...
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C/o lightheadness, nausea, chest tightness, sinus pressure, chest tightness, numbness and tingling in nose, lips and mouth and eye lid swelling 12 hours after vaccine was given. Took Benadryl at 2230 and again at 12/29 0430. Called us to report s/s at 10:30 on 12/29. States symptoms are subsiding but still has eyelid swelling. Told to follow up with PCP.
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| 48 | 2021-01-05 | chills, fatigue | Chills, shivering , body aches, nausea, fatigue, extreme pain and tenderness at the injection site |
| 48 | 2021-01-05 | fatigue, chills, chills, fatigue | Chills/shivering, body aches, nausea, fatigue, extreme pain and tenderness at the injection site |
| 48 | 2021-01-05 | dizziness, fever, throat pain |
Fever, dizziness / light headedness, servere muscle aches, vomiting, diarrhea, sore throat, like ...
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Fever, dizziness / light headedness, servere muscle aches, vomiting, diarrhea, sore throat, like I got a servere flu
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| 48 | 2021-01-05 | headache | Headache Neck stiffness Narrative: |
| 48 | 2021-01-05 | fatigue, headache, chills | Headache, muscle aches, joint pain, chills, fatigue |
| 48 | 2021-01-05 | fatigue |
Increased fatigue; Medium to large 3-inch knot to left deltoid with increase soreness and tender to ...
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Increased fatigue; Medium to large 3-inch knot to left deltoid with increase soreness and tender to touch; Medium to large 3-inch knot to left deltoid with increase soreness and tender to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female (non-pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0142), via an unspecified route of administration in left arm, on 30Dec2020 08:15, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19. The patient's concomitant medications included topiramate and bupropion hydrochloride (WELLBUTRIN). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Most recent COVID-19 vaccine was administered in the hospital. On 30Dec2020 at 4:30 PM, the patient had increased fatigue on the day of vaccination. Also, the patient had a medium to large 3-inch knot to left deltoid with increase soreness and tender to touch. No treatment was received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events.
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| 48 | 2021-01-05 | dizziness |
Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for ...
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Lightheadedness Tinlging in feet or head Given water and a snack; symptoms resolved. monitored for 30 minutes.
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| 48 | 2021-01-05 | headache |
Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild h...
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Pfizer-Biotech COVID-19 Vaccine EUA Vaccine administered 12/30/20 1202 PM Starting 1/1/2021 - mild headache, numbness in both hands but more significant in the left hand, left foot numbness.
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| 48 | 2021-01-05 | headache, dizziness |
Started on 4th day, around 3 am, woke up with severe muscle aches, extensive lower back pain(unable...
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Started on 4th day, around 3 am, woke up with severe muscle aches, extensive lower back pain(unable to walk properly), dizziness, severe nausea. 5th day- nausea, headache, muscle aches. No fever. 6th day(today) not getting better, still very nauseous, severe headache, dizziness, stomach is upset. Symptoms dont seem to be getting better.
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| 48 | 2021-01-05 | weakness, fever, headache, fatigue |
Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested posi...
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Tested positive for COVID /she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020; Tested positive for COVID/positive via Nasal Swab test/fever/body aches/headaches/She was very very weak, almost lethargic/felt really bad/fatigued; gas; bloated; the weight last week she was 167 and this week she was 180; This is a spontaneous report from a contactable nurse reporting for herself. A 48-year-old female patient received her first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) Lot #EH9899, via an unspecified route of administration on 16Dec2020 at single dose by injection in the right deltoid for COVID-19 immunisation. Medical history included borderline hypertension from 2018 and ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) from 2018 and ongoing for borderline hypertension. The nurse reported that she received the first dose of the vaccine last 16Dec2020 but tested positive via Nasal Swab test on 24Dec2020. She said this kinda weird. She received the COVID vaccine on 16Dec2020. She tested positive for COVID on 24Dec2020. Obviously she was exposed to COVID prior to the vaccine. She was scheduled to have the 2nd dose on 05Jan2021 but her hospital deferred it to 23Mar2021. She was asking if this was what's recommended.She said this was another weird thing, regarding the weight last week she was 167 and this week she was 180 (in Dec2020). She was very bloated in Dec2020, it was bizarre. He husband did not receive the vaccine and had symptoms on 24Dec2020. She had normal seasonal allergy symptoms. She did not think much of it. She took her Xyzal and her normal things.She took her husband to get tested and he tested positive, so she got tested, and was positive. She worked at (address withheld), and all of her patients were immunocompromised. She was shocked. She did not think this had anything to do with the vaccine. If anything, it has helped her fight the virus.By Christmas day 25Dec2020 her fever was 102, she had body aches, she went into overdrive. She had headaches and lots of gas in Dec2020.She went into overdrive from partial recognition from the vaccine.She was very very weak, almost lethargic. Her O2 saturation have stayed good around 98% in Dec2020. She has done really well. Yesterday or the day before she felt really bad again. She did a virtual visit with (name withheld), and the doctor started her on steroids and gave her an inhaler just in case she needed it. She felt better on 30De2020. On 29De2020 she was so bad and bloated, she only had one dose of the steroids, but had unusual weight gain. Then 2 pounds were gone this morning on 30De2020.She had no pitting edema or edema period. She was very fatigued, but had more energy this morning, probably because of the steroids. She had the vaccine, even though day 7 post-injection, instead of day 10, which was about 50%, her body reacted more so than her husbands because her body recognized it. The outcome of the events was unknown. She was unsure of the outcome. It was up and down. She has felt worse and she has felt better. The reporter considered the event Tested positive for COVID was Not serious and unrelated to the BNT162B2.; Sender's Comments: While reporter causality is noted, a possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.
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| 48 | 2021-01-05 | body temperature increased, headache |
c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable...
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c/o headache 5 min after vaccine given initially 4-5/10 then decreased to 3-4/10. vital signs stable 138/91 HR105 no rash, no redness, no induration at site. no resp distress. vital signs recheck 134/91 pulse 97 at 1233, advised to go to ER if symptoms worsened, discharged at 1638. Patient called clinic at 1330 on 1/6/21 c/o continued headache, now improving, Temp 99.2, facial flushing, bilateral arm and leg swelling also now improving. patient advised to go to urgent care or ER however patient refused and said she will go to her new primary MD on 1/8/21 and will go to ER if symptoms worsen. Also patient stated had COVID-19 test by occupational health results pending.
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| 48 | 2021-01-05 | fatigue, night sweats, chills, fever, headache, sweating |
fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache...
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fever 100 - 102, body aches, chills, sever nighttime sweating, intermittent nausea, severe headache, fatigue, face feeling flush for 48hours beginning approximately 3 hours post second vaccination treated with acetaminophen, ibuprofen, fluids and rest
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| 48 | 2021-01-05 | headache |
left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at...
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left ear fullness 1327pm left throat fullness 1328pm Nausea 1328pm sent to emergency room/arrived at emergency room 1330 symptoms increased. airway not obstructed. No tongue swelling reported by MD. Light red rash/flushing on chest. 25mg IV benadryl administered. IV Solumedrol administered, Vital signs stable. Cardiac monitor: regular rate and rhythm. O2 saturations 98% on room air. Symptoms improving at 1345pm. Monitored in emergency room for 1 hour. Discharged in stable condition with instructions to repeat Benadryl 8 hours after first dose if needed Throat fullness ( left side) with mild difficulty swallowing continued. Headache 5pm. Left sided face fullness/tingling: jaw, cheek. Left eye: mild swelling. 25 mg Po Benadryl taken. 01/06/21 0800 AM symptoms Left sided facial fullness/tingling continues: mild. No difficulty breathing. Left eye mild/yet decreased puffiness continues.
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| 48 | 2021-01-05 | headache |
severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous ...
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severe vertigo with headache; severe vertigo with headache; nausea; vomiting; This is a spontaneous report from a contactable health care professional nurse, the patient. A 48-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730, intramuscular in the left arm on 18Dec2020 15:00 as a single dose, for COVID-19 immunization. Medical history included Ongoing Hypertension and Migraines. Concomitant medication included hydrochlorothiazide, losartan potassium (LOSARTAN/HCT) 100/25 daily. The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 29Dec2020 06:00, the patient experienced severe vertigo with headache, nausea and vomiting. The events severe vertigo with headache, nausea and vomiting occurred on Dec 29 and Dec 30, lasted 2 days. Treatment given for severe vertigo with headache, nausea and vomiting was over the counter 'antivert/meclizine'. The clinical outcome of severe vertigo with headache, nausea and vomiting was recovered on Dec2020.
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| 48 | 2021-01-06 | throat irritation |
After 10 minutes of vaccine administration patient report metallic taste, she was oriented to stay i...
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After 10 minutes of vaccine administration patient report metallic taste, she was oriented to stay in the observation area of the vaccine administration site for 10 additional minutes. At 12:00pm patient report throat itching "like chocking". Shock anaphylactic code (RR) was activated. At 12:03pm Epinephrine 0.3mg/1ml was administrated to the left thigh. Venous access was obtained and Solu-Cortef 200mg, Benadryl 50mg and O2 were administrated. Patient vital signs were blood glucose 121mg/dl, Oxygen Saturation 100%, BP 150/90 mmHg. Patient was transfer with the RR code team to the ER for observation.
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| 48 | 2021-01-06 | headache |
Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minu...
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Headache, Myalgia, Rash, Hypoglycemia, subjective tachycardia (heart racing) Narrative: Within minutes of vaccination, employee experienced sternocleidomastoid tenderness/tightness on the side of the vaccination with a feeling of her heart racing. She was transferred to the ED. Evaluation revealed mild rash, vital signs stable, normal oxygen saturation, no SOB, normal sinus rhythm on EKG. No evidence of pulmonary involvement, lung sounds clear. Assessment: Mild allergic reaction. After 5 hours of observation in the ED, patient experienced resolution of her subject tachycardia. She was treated for a headache with APAP during her stay, and reports improvement. She also had a mild hypoglycemia and was given ginger ale and graham crackers. Discharged to home.
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| 48 | 2021-01-06 | headache, fatigue | Headache, soreness at injection site, extreme muscle aches and fatigue lasting from 12/25 to 12/30. |
| 48 | 2021-01-06 | skin warm |
I received my covid -19 vaccine at work at hospital. I sat for my fifteen minutes after vaccination ...
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I received my covid -19 vaccine at work at hospital. I sat for my fifteen minutes after vaccination and felt fine. When I got home two hours later from work and got in the shower, I noticed that I had a red, slightly raised, pinpoint and very defined red rash. The rash was all over my abdomen, my back and my neck. The areas felt warm but I did I not have itching, pain or any other anaphylaxis symptoms. The rash faded entirely in the next 48 hours.
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| 48 | 2021-01-06 | shortness of breath |
Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patie...
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Itching on arm in area of injection site, reports feeling weird, eyes are reddened and itchy. Patient reports feeling short of breath but no noted drop in oxygen saturation. Oral diphenhydramine 50mg administered.
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| 48 | 2021-01-06 | weakness, somnolence, headache, fatigue |
On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 a...
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On January 4th we were made aware of the following: A few minutes after receiving the vaccine at 8 am on 12-23-2020, the associate suffered from a severe headache 8/10, tingling sensation, BP checked Systolic in 180s, Extremely weak and tired, Severe nausea and dry heaving. Rapid response called, and associate was sent to ER. Headache 7/10. 1 gram Tylenol. Associate states ?Shaking, and I experienced delayed response when questioned by staff. 1 liter saline. Hives treated with Benedryl. In ER from 8am to 11:30am. It was determined that this was not an anaphylactic response. Associate went home with a headache 4/10. Groggy all day from Benedryl. I still have headaches constantly in frontal lobe. The headache pain Can rise from 2 / 10 to 8 /10. The constant headache is in the left frontal lobe. When the headache increases, It radiates into the temporal area as well. Dec 31, I went to Patient First. I was given Toradol IM, but the headache didn?t go away. I was given Flexeril, but it doesn?t help the pain. I am now using Excedrin to take the edge off. Associate is awaiting physician?s return call, but Dr. is out of town. Another doctor in the clinic would not see associate, as they don?t cover other physician?s patients. No fever, no respiratory symptoms.
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| 48 | 2021-01-06 | chills |
Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking...
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Shortly after receiving the vaccine, the patient reported feeling flushed and hot with rash, shaking, shivering, and pain in upper chest, which the patient described as being normal because of her COVID pneumonia. I would rate the reaction as moderate. Diphenhydramine 25mg capsule was given by mouth, ice water was offered. Patient was closely monitored but no further intervention was necessary. After about 25 minutes, symptoms subsided and patient decided to leave.
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| 48 | 2021-01-06 | dizziness, headache, fatigue |
Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/heada...
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Site injection pain (days 1-3) 12/30/2020, Days 6-present (1/6/2021-present) nausea, dizziness/headaches, muscle pain, joint pain, arm weakness/unable to lift my arm, fatigue/tiredness
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| 48 | 2021-01-06 | fatigue |
Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous ...
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Sore arm and fatigue after 30 minutes; Sore arm and fatigue after 30 minutes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm 02Jan2021 at 12:00 PM (at the age of 48-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, gastritis, and hypothyroidism. The patient had allergy to Sulfa. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included levothyroxine, formoterol fumarate, mometasone furoate (DULERA), salbutamol (ALBUTEROL HFA), omeprazole (PROTONIX), and alprazolam (XANAX). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Jan2021, at 12:30 PM, the patient experienced sore arm and fatigue after 30 minutes. The events were reported as non-serious. The patient did not receive any treatment for the sore arm and fatigue after 30 minutes. The clinical outcome of the events sore arm and fatigue after 30 minutes was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-01-06 | throat pain, shortness of breath, fatigue |
Tiredness first day after dose, second day 1/5/21 after 4PM extreme nausea, diarrhea, sore throat, a...
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Tiredness first day after dose, second day 1/5/21 after 4PM extreme nausea, diarrhea, sore throat, and some SOB or labored breathing. Felt better after 1/6/21 after 4PM.
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| 48 | 2021-01-06 | fever, fatigue, chills |
Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chill...
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Very sore arm 1st day. 2nd day sore arm and lymph nodes under left arm where I got injection ,chills ,fever ( on Wed 6th pm) fatigue
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| 48 | 2021-01-06 | headache |
left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneousl...
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left hand numbness - resolved spontaneously followed by headache and HTN all resolved spontaneously
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| 48 | 2021-01-07 | fever |
19Dec2020 100 degree temp - self resolved/fever; This is a spontaneous report from a contactable oth...
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19Dec2020 100 degree temp - self resolved/fever; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 48-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) intramuscular (left arm) on 18Dec2020 at 11:30, at a single dose, for COVID-19 immunization. Relevant medical history included psoriasis. Concomitant medications included unspecified vitamins and herbal supplements. The patient previously received gluten and penicillin and experienced allergies. Patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive other vaccines 4 weeks prior vaccination. The vaccine was administered in the hospital. The patient received the vaccine on 18Dec2020. On 19Dec2020, at 19:00, the patient had 100-degree temperature (self-resolved). On 24Dec2020, the patient had a 101 fever which was resolved with Tylenol. The patient had fever of 102.1 on 30Dec2020, 101.4 on 31Dec2020, 102.8 on 01Jan2021, and 101.9 on 02Jan2021 which were not resolved with Tylenol. Outcome of the event was not recovered. Since vaccination, the patient has not been tested for COVID-19.
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| 48 | 2021-01-07 | malaise, fatigue |
3pm, day after vaccine, general malaise, fatigue, body aches, no fever. Slept for 2.5 hours and woke...
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3pm, day after vaccine, general malaise, fatigue, body aches, no fever. Slept for 2.5 hours and woke up feeling better. Went to bed early and feel fine.
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| 48 | 2021-01-07 | weakness, fatigue, chills | Chills, generalized weakness, fatigue |
| 48 | 2021-01-07 | headache | Headache & Myalgia |
| 48 | 2021-01-07 | headache, body temperature increased |
I started feeling achy (body aches) at night and took Tylenol and the next day at work I started hav...
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I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.
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| 48 | 2021-01-07 | sweating, weakness, chills, fatigue |
Initial event was soreness at site which resolved on its own within a few days. 2 days after receiv...
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Initial event was soreness at site which resolved on its own within a few days. 2 days after receiving vaccine, I began having an allergy reaction to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed. I have been experiencing chills then profuse sweating. I also so fatigued, I sleep much of the day. I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.
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| 48 | 2021-01-07 | headache |
Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoul...
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Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; Initially, soreness at the injection site. Over the next 4 days (today is day 4), pain in left shoulder, back, and up the back of head/neck is getting progressively worse - now excruciating.; This is a spontaneous report from a contactable nurse (patient herself). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) intramuscular (left arm), on 03Dec2020 at 16:00, at a single dose, for COVID-19 immunization. Medical history included hypertension (HTN). The patient has no known allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a Public Health Clinic/Veterans Administration facility. On 04Dec2020, at 05:00 a.m., the patient initially experienced soreness at the injection site. Over the next 4 days (today is day 4), patient experienced pain in left shoulder, back, and up the back of head/neck which was getting progressively worse - now excruciating. Ibuprofen managed the pain for the first two days, but the soreness/pain was no longer managed with NSAID's and other comfort measures. Patient was hoping that these are normal and was hoping they will get better. Outcome of the events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 48 | 2021-01-07 | fever, dizziness, fatigue, headache | Metal taste in mouth after receiving the vaccine, headache, fatigue, Fever for 12 hours, dizziness |
| 48 | 2021-01-07 | influenza like illness |
Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she ...
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Patient developed watery eyes later in the afternoon of receiving her COVID. The following day she had flu like symptoms and this morning she has bilateral swollen lymph nodes in the axilla area.
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| 48 | 2021-01-07 | headache, chills, nasal congestion, sweating |
Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuf...
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Pfizer-BioNTech COVID-19 vaccine: Extremely sorry injection site, chills, sweating, body aches, stuffy nose, headache, feeling "foggy".
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| 48 | 2021-01-07 | shortness of breath, cough | Shortness of breath, cough, rash on face and neck, arthralgia |
| 48 | 2021-01-07 | dizziness, malaise, fever |
Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, mala...
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Soreness arm then swelling, very tender, redness. Fever 101-103 with Tylenol/ibuprofen, nausea, malaise, myalgia, dizziness.
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| 48 | 2021-01-07 | migraine |
Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved b...
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Sxs heart palpitations on 12/28/2020 and then 12/29/2020 migrane headache. Sxs persist. Improved but with occasional palpitations.
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| 48 | 2021-01-07 | shortness of breath |
The patient reported shortness of breast and difficulty breathing. The patient's husband stated tha...
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The patient reported shortness of breast and difficulty breathing. The patient's husband stated that he witnessed the patient having a seizure. Patient advised to call EMS. EMS took the patient to hospital. The patient was stabilized after receiving emergency treatment.
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| 48 | 2021-01-07 | dizziness, cold sweat, fatigue, migraine |
about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going...
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about 7-8 mins after getting injection, I felt faint (put myself on floor because I knew I was going down if I didn't) cold clammy, nauseated, BP dropped, HR wnl, After about 20 mins, I felt fine. Went to work, did develop a migraine afterwards, some body ache and fatigue.
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| 48 | 2021-01-07 | dizziness, headache |
diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair t...
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diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair to the ED; my heart started racing; high blood pressure; Sinus tachycardia at 105 bpm; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to fish but patient had a type of fish she was not allergic to on 01Jan2021. Concomitant medications were not reported. The patient received first vaccine on 28Dec2020 at 9:00 am. After about 5-15 minutes her heart started racing, she felt light headed when she went to stand up and patient was taken by wheelchair to the emergency department (ED). The procedures done in ED included Stat EKG which showed sinus tachycardia at 105 bpm and high blood pressure. Patient was normotensive normally. ED gave her Benedryl and pepcid. It took about 3 hours for my heartrate and BP to go back to normal in ED for 3 1/2 hours. Patient takes allergy meds everyday, allegra. The patient stated she went to bed and woke with headache (HA), (tylenol and ibuprofen were taken) lasted for 2 hours and returned the next day and patient took more ibuprofen and then it went away. The patient was allergic to fish, but she had a type of fish she was not allergic to on 01Jan2021 and had diarrhea within 30 minutes (one time occurrence). It was reported that the patient wishes to take the 2nd vaccine and has had no further adverse events. The outcome of the event was Headache (HA), heart rate increased and high blood pressure was recovered on an unknown date and unknown outcome for the remaining events.
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| 48 | 2021-01-07 | headache, lethargy, dizziness | headache, muscle aches, chest tightness, lethargic, lightheaded for three days. |
| 48 | 2021-01-07 | headache |
there is pain radiating down the right side of her back and in the right side of her head and temple...
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there is pain radiating down the right side of her back and in the right side of her head and temple; Bad pain on right side of head, neck, and back; mild - moderate headache; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 11:15 on the left arm at single dose for COVID-19 immunisation. Medical history included immune disorder with high inflammatory markers, gluten intolerance, she is ANA positive (last time she was tested it was 2800) and allergic to sulfites. The patient's concomitant medications were not reported. The patient stated "she received vaccine on 30Dec2020. For the first 24 hours had no side effects, then developed a mild headache after 24 hours and 24 hours after that it worsened and developed pain on the right side of her neck that is like the stem of her headache and there is pain radiating down the right side of her back and in the right side of her head and temple. States that since this developed, it has persisted, not gotten worse or better. Wants to clarify that this does not involve her arms just her neck, head and back. States no amount of pain medication is working to relieve the pain. Ibuprofen is normally her go to and it did not work, she then tried the ADVIL LIQUIGELS, she took 400mg, states it was not working, she then got Bayer Back and Body to try because it has Aspirin in it, took 1500mg, three total pills, helped for an hour and then pain came back. Also tried a daytime THERAFLU just trying to get rid of the body aches, Good Sense Daytime Cold and Flu". The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 48 | 2021-01-08 | throat pain |
Employee Health notified several days after first vaccination that she had a sore throat, felt cold,...
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Employee Health notified several days after first vaccination that she had a sore throat, felt cold, "brief asthma attack" one hour after being vaccinated. Did not seek medical care. Inhaler used and symptoms went away 15-20 minutes later.
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| 48 | 2021-01-08 | fever, headache | Fever (101.4), Body Aches, Headache Treatment - Acetaminophen |
| 48 | 2021-01-08 | fever, dizziness |
Fever of 101 for three days. Around 8 pm on January 1st sever vertigo anytime changing position. Wen...
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Fever of 101 for three days. Around 8 pm on January 1st sever vertigo anytime changing position. Went to open MD who recommended epley maneuver . Was told to do this for "several days" and then come back if it did not go away. Maneuver was done for three days before vertigo went away, but constant dizziness for another three days, and then intermittent dizziness still ongoing. Called into work.
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| 48 | 2021-01-08 | cold sweat, shortness of breath |
Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " ...
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Short of breath, flushed, warm and cold shaky, a little hard to breath, little tight in the chest " I have asthma too too hard to tell the difference" Tearful, skin felt clammy.
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| 48 | 2021-01-08 | throat irritation, fatigue, sweating |
Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse s...
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Within 10 minutes after vaccine, my face became extremely hot and red and left ear red and profuse sweating. Within 30 minutes heart rate increased and a little clearing of throat. A little over an hour nausea started and increased clearing of throat , slight feel of constricture in throat and a slight feeling of heaviness in chest, and jittery and heart rate still feels increased. Nurse at Nursing home watched for 45minutes until I chose to leave. In my vehicle and home is when nausea started. Phone call contacts with nursing home staff continued for an hour. I took 2 benadryl and 2 Tylenol, napped. Felt better. Nausea 3 days. Tired and neck lymph achy.
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| 48 | 2021-01-08 | headache, chills, fever | fever chills body aches, massive headache and nausea |
| 48 | 2021-01-08 | fever, headache, chills | fever, chills, arm pain, muscle aches, severe headache, |
| 48 | 2021-01-09 | chills, fatigue, headache |
1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm l...
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1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm lasting through next day 2: 1/9/21: 9am: headache, injection soreness, tiredness, feeling worn out, chills, body aches, chest tightness: started around 8pm lasting to next day (today)
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| 48 | 2021-01-09 | shortness of breath, throat swelling | Neck tightness, SOB, and throat swelling. |
| 48 | 2021-01-09 | body temperature increased |
Received injection 1/8/2021 at 6:00 pm. 12 hours after injection experienced very sore arm, temp th...
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Received injection 1/8/2021 at 6:00 pm. 12 hours after injection experienced very sore arm, temp that peaked 101, aches and chills. Symptoms lasted about 15 hours. Upon waking on 1/10/2021 no fever, aches or chills. Sore arm continues.
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| 48 | 2021-01-09 | fever, somnolence, chills |
Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. T...
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Woke up in middle of night with fever and chills and body aches. Arm very sore and hard to lift. Tylenol taken with not too much relief. Slept most of the day. Second day arm is much better and can move more. Body is still achey.
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| 48 | 2021-01-10 | headache, fatigue, chills, body temperature increased | 24 hours of chills, myalgia, headache, fatigue. Max temp 99.6 |
| 48 | 2021-01-10 | nerve pain, chills |
6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin...
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6pm same day severe body ache, diarrhia, feeling chills/warmth. didn't take temp took Tylenol/Motrin daily. s/s today left shoulder nerve pain (had injection on right side) 6/10. No body ache, diarrhea, chills today. COVID 1/8 test negative.
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| 48 | 2021-01-10 | dizziness |
After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, an...
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After vaccination, patient was ok, talking and eating. Suddenly, patient complains of dizziness, and "didn't feel right". Patient was laid flat on a couch, but then passed out and was not responsive to sternal rub. After a code was called, the patient woke up. At no time was there a loss of pulse or SOB. Patient was transported to the ER and was subsequently discharged same day. Patient did report that prior to the vaccination, she ran 13 miles in the morning, which may have had something to do with the reaction.
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| 48 | 2021-01-10 | headache | Body ache, headache and nausea. |
| 48 | 2021-01-10 | headache, chills, sweating | Chills, sweats, body aches, headache joint pain |
| 48 | 2021-01-10 | fever | Fever 100.8 and sever aches. |
| 48 | 2021-01-10 | throat swelling |
I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt sever...
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I waited 15 minutes and was fine. As I was driving to my work, my injection site began to hurt severely and I felt my throat swelling, it became increasingly difficult to swallow. My tongue felt larger and my lips and face began to feel numb. I felt flushed and I became tachycardic. It lasted about 45 seconds and then waned and then would flare again. I was able to speak and called my husband (a physician) who stayed on the phone with me while I drove to the hospital. I went straight to an outpatient unit and was given hydrocortisone IV, loratidine PO and famotidine. By the time I was on the unit, my throat only felt slightly tight with tachycardia down to 103. Following the injection of steroids, I only had one further flare of throat tightness and tachycardia that was transient lasting 30-40 seconds. Everything resolved within 40 minutes of receiving therapy. Of note, I apparently had erythema on the anterior of my neck which corresponded to the area of throat tightness.
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| 48 | 2021-01-10 | fever, headache | Low grade fever 100.5, headache, severe body aches, redness and swelling at the site of injection. |
| 48 | 2021-01-10 | chills, fever, headache | Patient experienced low grade fever, chills, headache and soreness at injection site. |
| 48 | 2021-01-10 | shortness of breath, nasal congestion |
Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine...
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Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer). Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions. Given diphenhydramine, famotidine, and prednisone in emergency department. During observation in ED, started having throat and chest tightness with hyperventilation. This improved with lorazepam. Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.
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| 48 | 2021-01-10 | night sweats, fever, weakness |
Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and...
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Patient report bones hurting, skin hurting, eyes and scalp hurts, chills, pain at injection site and fever, night sweats and spreading pain throughout the body. Also reporting weakness
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| 48 | 2021-01-10 | weakness, fever, chills, fatigue, headache |
Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea,...
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Weakness, fatigue, fever to 101, chills, muscle aches, shivers, joint pain, severe headache, nausea, loss of appetite lasting approximately 72 hours
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| 48 | 2021-01-10 | fatigue, chills |
extreme fatigue (began about 24 hours post-injection, resolved within 12 hours), chills (began about...
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extreme fatigue (began about 24 hours post-injection, resolved within 12 hours), chills (began about 28 hours post-injection, resolved within 8 hours)
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| 48 | 2021-01-10 | headache, throat pain | sore throat, headache, earache. called in sick to work. |
| 48 | 2021-01-11 | malaise, headache, fatigue |
Bad headache, real tired, did not feel all that well sort of sick to my stomach. Also I could not ...
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Bad headache, real tired, did not feel all that well sort of sick to my stomach. Also I could not sleep on my left side that evening. ( that was the side I got vaccine in)
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| 48 | 2021-01-11 | chills |
Developed muscle aches and chills in the middle of the night post vaccine. unable to report to work...
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Developed muscle aches and chills in the middle of the night post vaccine. unable to report to work the following day. symptoms resolved at this time
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| 48 | 2021-01-11 | headache |
Difficult time sleeping last night; Woke up with all joints achy; Aching all up my spine; sort of we...
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Difficult time sleeping last night; Woke up with all joints achy; Aching all up my spine; sort of weird headache; body aching; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. Medical history included depression, had hip surgery last year (from 2020) and anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) for anxiety and depression. esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), on regular basis naproxen sodium (ALEVE) and paracetamol (TYLENOL) because of her hip. Patient was calling because she was vaccinated yesterday, 03Jan2021. Patient was a nurse and she got the COVID Vaccine yesterday. she wanted to go into the symptom checker or whatever because she was having, she woke, she wasn't (incomplete sentence). she had a difficult time sleeping last night. She woke up like with all her joints start just achy and she did not have a great time. she wanted to report her symptoms. patient have other things. No really big co-morbidities, like, she had depression. she had some body issues like she had a "torn labor" and stuff like that but that needs to be repaired but not like blood pressure, diabetes, none of those things. she had hip surgery last year. she took two Aleve in the morning and two 500 Tylenol. And she took one more Aleve in the evening and two more Tylenol. As of causality, patient stated she believe so. It's much more intense than it was, than she was feeling yesterday. she definitely could feel it after she had the vaccination. she got like this aching all up her spine and sort of the weird headache for about (incomplete sentence). it was for the rest of the day about an hour after she got the vaccination. She was a little too un-tuned with her body aching. Consumer stated, "Is there, I mean, more I was calling to register with that CDC thing or whatever to report, you know just what's happening. I figured it was probably, kind of part of the research study or whatever for symptoms and tracking and all that. Is that what I am doing as well too by doing this or is that something separate?" When probed if reported through CDC questionnaire, consumer stated, "No, I went onto the website and it said that on CDC website the worst thing and it said that you needed a code or something a key code to get into the program and I don't. Is this where the reporting is going or how do I register with the (app Name) or whatever? Is that what I did by telling you what's going on?" When informed about the role of Pfizer Drug Safety, consumer stated, "I did not understand that safety report or I figured that we were like also assisting in some kind of research trial type thing too. Are they going to call me or no? Is this the last time I'm hearing from anyone?" No investigation assessment. No Lab Work. No Treatment. Outcome of the events was unknown.
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| 48 | 2021-01-11 | fever | Fever >100 21hrs after vaccine |
| 48 | 2021-01-11 | malaise, dizziness, weakness, headache |
I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt littl...
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I got the vaccine and had a headache that lasted 2-3 minutes. I then got in my car and I felt little bit sick and I picked up food and I started to feel sick. I went to work and my symptoms got worse and I sat in my desk and I felt like fainting. I just felt so sick and I thought it was my diabetes. A coworker saw me and told me i looked deathly pale and felt fainting and they took me to a ER room. They gave me Benadryl and IV fluids. I started seeing the floor and ceiling warped out, I was hallucinating. My legs felt numb as well. My eyes were twitching constantly. My blood pressure 147/95 and pulse was 112. I went home, ate and went to sleep. On Saturday I felt better and went back to work 12-28-2020, I felt weak and stayed working at my shift. On Tuesday I worked 1 hour and still felt super weak. Today I am starting to feel like myself again. I will not get my second dosage due to my symptoms I have experienced.
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| 48 | 2021-01-11 | chills, fatigue, headache, influenza like illness |
Patient describes, chills, nausea and a headache along with fatigue. Also describes flu like body ac...
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Patient describes, chills, nausea and a headache along with fatigue. Also describes flu like body aches
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| 48 | 2021-01-11 | dizziness | Patient reports dizziness 3 hours after getting vaccination and nausea. Dizziness has since resolved |
| 48 | 2021-01-11 | dizziness |
Patient states that she felt the vaccine go through her body. She says that after about 20 minutes s...
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Patient states that she felt the vaccine go through her body. She says that after about 20 minutes she developed dizziness and throat tightness. She developed erythema across her chest. BP 180/108. O2 sats 98%. No SOB or difficulty breathing
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| 48 | 2021-01-11 | chills, fatigue, headache | Severe chills followed a few hours later by fatigue and headache |
| 48 | 2021-01-11 | malaise, chills, fever |
Symptoms - ? EE reports she woke up Sunday am not feeling well and reports symptoms of body aches, c...
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Symptoms - ? EE reports she woke up Sunday am not feeling well and reports symptoms of body aches, chills, axillary lymph node tenderness and swelling, fever (Tmax 102.2). EE reports she called off of work Monday but later came to work later at approximately 09:00. EE reports Monday resolution of all symptoms except still worsening lymph node tenderness and swelling. EE reports she emailed Woodlands EH RN and advised to contact HR vaccine support line to notify of adverse reaction. EE report she filled out V-safe. Last day of work and shift - ?currently working today Home remedies? - rest and motrin (last dose at 8:30 PM on Sunday 1/10) Any improvement? ? EE reports resolution of all symptoms except lymph node swelling and tenderness Recommendation? EE encouraged to rotate Tylenol and motrin q3h and to contact PCP for appointment.
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| 48 | 2021-01-11 | fever, fatigue, chills |
developed fever day after vaccination. fever reduced with medication, but then later developed ache...
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developed fever day after vaccination. fever reduced with medication, but then later developed aches, fatigue and chills
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| 48 | 2021-01-11 | fatigue, headache |
mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immedi...
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mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place/ "stupid" with brain fog that I called in; mild fatigue; mild intermittent headache; mild intermittent headache/ only mild joint ache in knees; This is a spontaneous report from a contactable other health care professional. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 04Jan2021 11:30 at single dose at right arm for COVID-19 immunization. Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included beclometasone dipropionate (QVAR), and metoprolol. On 04Jan2021 15:30, noted starting around 4 hours after vaccine, the patient experienced mild fatigue, mild intermittent headache, mild intermittent ache in knee joints. The patient was unsure if they were vaccine related but became a little more intense as the evening went on (next 5 hours) but still overall were mild, but enough for the patient to determine they seemed related to the vaccine. Also noted about 6 hours after vaccine, on 04Jan2021 17:30, mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place. The patient went to bed about 8-9 hours after vaccine (8pm). The patient usually gets up at 4:45-5am. She was so tired the next morning and "stupid" with brain fog that she called in. She wasn't uncomfortable per se, no headache the next day, only mild joint ache in knees, fatigue and brain fog. No serious reactions. The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive treatment for the events. Information about lot/ batch number is requested.
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| 48 | 2021-01-11 | fever | patient developed a fever unable to return to work the following day. |
| 48 | 2021-01-12 | headache, chills |
11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observa...
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11:45 am 1/12/21 received Covid vaccine. Shellfish allergy and required to stay 30 mins for observation post vaccine. No symptoms during 30 minute observation post vaccine administration. Approximately 12:45pm right hand, tongue, mouth started tingling, and felt tongue was swelling. Reported feeling flush with chills, headache, and generalized weakness in legs. Went back to vaccine clinic to report symptoms at 2:15pm.
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| 48 | 2021-01-12 | chills, fever |
2nd shot, 12 hrs after body aches; 24 hrs after fevers high 102.5; rigors; felt I was burning up; Th...
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2nd shot, 12 hrs after body aches; 24 hrs after fevers high 102.5; rigors; felt I was burning up; This is a spontaneous report from a contactable other healthcare professional reporting for herself (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) intramuscularly at Left arm on 05Jan2021 12:00 at SINGLE DOSE for COVID-19 immunization. Facility type vaccine was Hospital. Medical history included allergies to Sulfa, mild ragweed. Concomitant medication included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC ALLERGY), estradiol (VIVELLE DOT). The patient received the first dose of BNT162B2 vaccine (Lot number EK5730) via intramuscular route of administration in the right arm on 15Dec2020 at 12:30 at single dose for COVID-19 immunization. On 15Dec2020 at 12:30, the patient experienced warm feeling throughout body and heart race which lasted 10 seconds. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination she had not been tested for COVID-19. Adverse events reported as "2nd shot, 12 hrs after body aches, 24 hrs after fevers high 102.5, rigors and felt was burning up". Adverse event start date was reported as 06Jan2021 06:00AM. No treatment received for the events. Outcome of the events was recovered in Jan2021. Information about Batch/Lot number has been requested.
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| 48 | 2021-01-12 | fatigue, body temperature increased, chills, headache |
Approximately 6:00 pm on 1/11/21 began experiencing muscle aches and fatigue. On 1/12/21 these cont...
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Approximately 6:00 pm on 1/11/21 began experiencing muscle aches and fatigue. On 1/12/21 these continued but became progressively worse with headache starting around noon. By 3;30 pm, symptoms were: fatigue, muscle pain, severe headache. Body chills around 6 pm and temperature at 7 pm was 100.5. By 6:00 am on 1/13, all symptoms resolved.
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| 48 | 2021-01-12 | headache, chills |
Approximately 8 hours after receiving the vaccine, I started to have body aching and intense right a...
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Approximately 8 hours after receiving the vaccine, I started to have body aching and intense right arm pain where I received the injection. That evening/night the symptoms progressed to headache and severe chills through the night.
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| 48 | 2021-01-12 | dizziness |
Brief but very severe abdominal pain waking me from sleep. Pain was so intense I almost passed out. ...
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Brief but very severe abdominal pain waking me from sleep. Pain was so intense I almost passed out. It restocked just as quickly, lasted 3-5 min
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| 48 | 2021-01-12 | migraine, fever, headache |
Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours ...
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Fever 100 F Severe body aches Migraine type of headache Nausea and diarrhea All lasting 16 hours Still slight headache
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| 48 | 2021-01-12 | dizziness, chills, headache, fever |
Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vo...
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Fever, body aches, uncontrolled chills, chest tightness, heart palpation, dizziness, lightheaded, vomiting, mind splitting headsche
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| 48 | 2021-01-12 | fever, headache, chills | Fever, chills, body aches, headache, injection site pain, swollen lymph nodes left axilla |
| 48 | 2021-01-12 | thirst |
Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy an...
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Patient received dose of vaccine at 1630. At this time, Alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any distress/discomfort. At 1640, patient complained of itching at injection site. Patient stated she has a history of developing itchy feeling due to adhesive from bandages. Patient removed the bandage. RN administering IM injection inspected site: no swelling, rash, hives, or other s/s of inflammation. Patient still alert and oriented x 3, respirations easy and unlabored, skin pink warm and dry, denies any feeling of doom, nausea, vomiting, shortness of breath, elevated heart rate, etc. RN administering injection gave patient an ice pack to apply to left upper arm. Monitoring patient. Patient sitting in chair in vaccine clinic waiting room area. Sipping on H2O due to complaint of feeling thirsty. No difficulty swallowing water. EMS called to Vaccine Clinic for unrelated issue. Once EMS on scene, patient further evaluated by EMS (Biox 98%). Patient asking to be transported to ER. EMS taking patient per patient request.
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| 48 | 2021-01-12 | headache, chills, dizziness |
Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to fe...
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Symptoms started mild after 14 hours after administration: body aches, after 22 hrs. I started to feel nauseous at first then I had chest pain, headache, chills, back pain, body aches (muscle pain) and dizziness
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| 48 | 2021-01-12 | headache, shortness of breath |
Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170...
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Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170/101 while lying down, heart rate 119, 100% o2 sat, difficult breathing. Patient was visibly nervous and apprehensive prior to receiving vaccine. ER via EMS. -Severe.
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| 48 | 2021-01-12 | headache, shortness of breath |
Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170...
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Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170/101 while lying down, heart rate 119, 100% o2 sat, difficult breathing. Patient was visibly nervous and apprehensive prior to receiving vaccine. ER via EMS.-Severe
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| 48 | 2021-01-12 | weakness |
The vaccine was administered too high on the shoulder. Within 2 hours a report was made. symptoms w...
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The vaccine was administered too high on the shoulder. Within 2 hours a report was made. symptoms were pain, weakness, tenderness of shoulder joint and upper arm
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| 48 | 2021-01-12 | chills, sweating, headache | Woke up at 12:30 am with severe chills and shaking. Headache, muscle aches, sweating and sore arm |
| 48 | 2021-01-13 | cough, throat pain, runny nose, runny nose, throat pain, cough | 1-12-2021 Cough, runny nose 1-13-2021 sore throat |
| 48 | 2021-01-13 | dizziness |
After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, g...
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After she left the vaccine site she began feeling lightheaded. She was wheeled back to the clinic, given a dose of epi, and IV fluids. Her BP was elevated. EMS was called and she was transported to the ED, released several hours later.
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| 48 | 2021-01-13 | headache, chills |
By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle ache...
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By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; By 2am extreme headache, by 4am- vomiting, chills, to sleep til 5p, headache, chills and muscle aches. Back to normal in 72 hours; This is a spontaneous report from a contactable nurse (patient). This 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Dec2020 09:00 at single dose in Arm Right for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Migraines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included nortriptyline, bupropion, magnesium sulfate, fish oil , ca. The patient experienced By 2am extreme headache, by 4 am vomiting, chills, to sleep till 5p, headache, chills and muscle aches on 24Dec2020 02:00 AM, Back to normal in 72 hours. The outcome was recovered. No treatment received for the adverse events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 48 | 2021-01-13 | dizziness, headache, fatigue |
Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise ...
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Day 1-3 Injection site pain; Muscle pain; Joint pain; Headaches; Dizziness; Nausea; Unable to raise my arm/arm weakness; Pain was at a 10 and I had to go to the ER for care; Fatigue/tiredness; This is a spontaneous report from a contactable other HCP (patient). A 48-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 30Dec2020 14:15 at single dose in Left arm for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Breast cancer, Hypertension (HTN), high cholesterol, lymphedema, endometriosis, hysterectomy, myomectomies x 2, anxiety, seasonal allergies, hx of pleurisy x 3. Known allergies included adhesive glue in tape and bandaids, pollen, dust, pet dander. The patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram, losartan potassium 50 mg, anastrozole (ARIMIDEX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Day 1-3 Injection site pain Day 6-7-muscle pain, joint pain, headaches, dizziness, nausea, unable to raise my arm/arm weakness, pain was at a 10 and had to go to the ER for care, fatigue/tiredness. All the events were reported onset on 06Jan2021 18:00. AE resulted in Emergency room/department or urgent care. Received Morphine, Muscle relaxer, steroid via IV, RX as treatment. The events were assessed non-serious.
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| 48 | 2021-01-13 | fever, weakness, chills, dizziness, dehydration |
Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covi...
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Dec 24 felt light headed and loss of appetite, Dec 25, fever 103 and chills, Dec 26 Team member Covid hub had me do a Covid test, negative result, continue high fever, no appetite, chills and body ache, Health Hub contacted me daily with app to review symptoms, Dec 27-29 continued symptoms, unable to eat and little bit of water intake, Dec 29 appointment made with Health Urgent Care, received text from Urgent Care cancelling appointment and instructed to take sips of water and Tylenol that I was having an immune reaction to vaccine. Dec 29 virtual appointment with PCP continued symptoms, Dec 31 repeat of COVID swab along with Flu swab both negative, Jan 2-3 hospital admission for abnormal labs, jaundice, dehydration, Sodium/Potassium and Magnesium boluses given, and work up for infectious process was negative. Discharged to home Jan 3 with low grade fever, dry mouth, dry eyes, nausea, body ache and continued loss of appetite. Jan 4-7 continued worsening jaundice and appetite with low grade fever, GI Clinic consulted at Health Clinic, PCP in daily contact, repeat liver function labs on Jan 8 showed worsening labs. Jan 9-12 afebrile, started Ursodiol, low appetite better energy, continue dry mouth, GI appointment Jan 12 with plan to repeat liver functions on Jan 15, jaundice improved and able to eat liquids. No Tylenol or antipyretic taken since Jan 3 due to liver function tests.
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| 48 | 2021-01-13 | dizziness |
Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experience...
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Employee is self-reported COVID "long hauler" with hx of HTN. Vaccine #1 given at 9:05am. Experienced lightheadedness, nausea, bilateral hand tingling, hypertension after administration of her first COVID vaccination. No airway involvement. No rash, chest pain or SOB. Patient states that she thinks she had COVID in March though she tested negative. Patient has never had prior vaccine reaction. She was taken to ED, given PEPCID IV and liter of LR. Her vitals were stable throughout and she felt back to baseline and was released to go home after about 2 hrs.
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| 48 | 2021-01-13 | chills, headache | FIVE DAYS OF SISTOMES,HEADACHE,MUSCULAR PAIN, CHILLS GANGIOS INFLAMATION ,SWELLING OF LIPS. |
| 48 | 2021-01-13 | influenza like illness, headache, fatigue, chills, fever |
Fever. T 101 F; The flu like symptoms lasted about 36 hours; headache; chills; Tiredness; Went to sl...
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Fever. T 101 F; The flu like symptoms lasted about 36 hours; headache; chills; Tiredness; Went to sleep early; This is a spontaneous report from a contactable Nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 14:00 for the 2nd dose at single dose, intramuscular on 18Dec2020 11:00 for the 1st dose at single dose for covid-19 immunisation. Medical history included I am allergic to pollen, dust mite. The patient experienced Four hours after 2nd shot, headache, chills. Tiredness. Went to sleep early. The next day still tiredness, headache , chills and fever. T 101 F. The flu like symptoms lasted about 36 hours. All events were non serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolved. No follow up attempts are possible; information about lot/batch number cannot be obtained.
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| 48 | 2021-01-13 | headache, fever, chills |
H/A, low grade fever up to 100.0, chills, muscle and body aches, pain at site, pain in front underar...
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H/A, low grade fever up to 100.0, chills, muscle and body aches, pain at site, pain in front underarm area of affected side. Symptoms have lasted from about 10 hours after the dose and are continuing now (82 hours after the dose)
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| 48 | 2021-01-13 | headache |
Head ache and sharp shooting pains in head neck and jaw every day since vaccine only on left side ...
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Head ache and sharp shooting pains in head neck and jaw every day since vaccine only on left side of head comes and goes all day. No relief from otc pain meds
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| 48 | 2021-01-13 | dizziness |
Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at...
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Immediate flushing followed by HTN and rash. Became dizzy and throat "tightness". Was surprised at the reaction since she is ex-military and had received a full complement of vaccine for overseas deployment with no issues.
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| 48 | 2021-01-13 | skin warm, chills, headache |
got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painfu...
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got vaccine yesterday. 4 am this morning staff wake up with warm and chill, injection site so painful, headache and body ache. Took a day off today.
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| 48 | 2021-01-13 | headache, fatigue | headache, tiredness, extreme pain at injection site |
| 48 | 2021-01-13 | dizziness |
knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition ...
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knot developed behind left ear, swelling and redness in lower part of face; confusion and cognition issues; dizziness
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| 48 | 2021-01-13 | headache, chills, shortness of breath, fever, throat pain, malaise |
pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of ...
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pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient). A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
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| 48 | 2021-01-14 | headache, chills, body temperature increased | "11p that night I had a 101 -102 temp, chills, headache, hard shakes" |
| 48 | 2021-01-14 | fever, fatigue |
"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have ex...
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"the next day (1/8/21) i started with a low grade temp, it never got over 100.2, now i still have extreme fatigue. My arm was sore for a couple of days only. The first vaccine was on 12/17/20 and i had 11 days of nausea afterwards"
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| 48 | 2021-01-14 | chills, fatigue |
Body, muscle and joint pain; Body, muscle and joint pain; Body, muscle and joint pain; Chills; Tired...
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Body, muscle and joint pain; Body, muscle and joint pain; Body, muscle and joint pain; Chills; Tired; This is a spontaneous report from a non-contactable healthcare professional. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 (13:00) (Lot number: EK5730; Expiration date was not reported) and the second dose on 07Jan2021 (07:00) (Lot number: EL0140; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. Medical history included sulfa allergy. Concomitant medications included colecalciferol (VITA D) and magnesium sulfate (MG). On 07Jan2021 (19:30), the patient had body, muscle and joint pain; chills; and tired. The patient did not receive any treatment for the events. The patient's COVID test was negative on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. The outcome of the events, 'body, muscle and joint pain', 'chills' and 'tired', was recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
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| 48 | 2021-01-14 | headache, chills, body temperature increased, fatigue |
Chills, borderline rigors lasting 4 hours followed by temp of 102 (checked at 2am), took 1 GM of Tyl...
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Chills, borderline rigors lasting 4 hours followed by temp of 102 (checked at 2am), took 1 GM of Tylenol, decreased to 101 after 2 hours of taking Tylenol. Afeb at (6am 1/13/21) but increase temp again to 100.9 at 11am took 1GM of Tylenol, temp down after ~ 1 hour. Nausea and severe headache evening of 1/12/21 starting around ~ 9 pm. Nausea and severe headache lasted until 5m on 1/13/21, nausea resolved, headache improved but continued until 11 am on 1/14/21. Fatigue severe 1/13/21, improved but continued 1/14/2021, resolved by ~ 6pm on 1/14/201. Pain in axilla and groin bilaterally evening of 1/12/2021, resolved by 5am on 1/13/2021, no adenopathy. Muscle pains 1/12 until mid morning 1/13/021
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| 48 | 2021-01-14 | headache, fatigue | Extreme fatigue, strong headache, pain on injection site, muscle pain all over the body |
| 48 | 2021-01-14 | fever, fatigue | Fever, fatigue. Resolved. |
| 48 | 2021-01-14 | fatigue, fever |
Fever; body aches; fatigue; This is a spontaneous report from a contactable nurse. A 48-year-old fem...
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Fever; body aches; fatigue; This is a spontaneous report from a contactable nurse. A 48-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 22Dec2020 11:30 to 22Dec2020 11:30 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took aspirin, erythromycin, vancomycin and cipro; all experienced allergies. The patient had fever, body aches and fatigue on 01Jan2021. The outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.
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| 48 | 2021-01-14 | influenza like illness, fatigue, chills, fever, headache |
Flu like symptoms severe chills, fever of 102, headache, body aches, fatigue. Had second COVID, had ...
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Flu like symptoms severe chills, fever of 102, headache, body aches, fatigue. Had second COVID, had fever about 100, chills, body aches, chills, headache that lasted for two days.
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| 48 | 2021-01-14 | fatigue, dehydration, headache |
GI issues, severe cramping, diarrhea >10/day , dehydration, headache, tired Normal activities affec...
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GI issues, severe cramping, diarrhea >10/day , dehydration, headache, tired Normal activities affected
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| 48 | 2021-01-14 | headache, fatigue | Intense headaches, fatigue |
| 48 | 2021-01-14 | headache, dizziness, shortness of breath, fatigue |
Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed...
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Lightheaded briefly at about 15 minutes. Lips tingling and red, chest and neck hot and very flushed at about 25 minutes. Feeling winded at about 30 minutes, lips very slightly blue-ish. Vitals were all normal and no treatment was given. Approx six hours later I experienced a "lump in my throat" for about two to three hours - took Benadryl, which resolved it. Also around five or six hours later ordinary side effects began - fatigue, aches, headache, sore arm. These all resolved by the following morning.
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| 48 | 2021-01-14 | fatigue, headache, weakness, body temperature increased, malaise |
Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday...
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Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday morning, I was aching all over and still had a headache. The aches were so severe that I was unable to tolerate anything or anybody touching me. By that afternoon, I was weak and fatigued. I was sent home by my director and by that evening I had developed a temp of 101.0. Friday morning, I was not feeling any better so I went to Urgent Care at around 0800. COVID test was negative but possibly too early to detect. Here we are today and I am still having body soreness that has become unbearable. I went to the walk-in clinic here at the hospital and have now been told that I will have to be admitted based on my lab results that indicates rhabdomyolysis.
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| 48 | 2021-01-14 | fever, chills, fatigue | Sévère arthralgia, not able to walk. Facial paresthésie. Extreme fatigue, chills and fever |
| 48 | 2021-01-14 | chills, headache |
Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then...
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Within 24 hrs of injection, I had chills and headaches, no fever; these went away after 24 hrs, then my injection site on my L arm was swollen and red the following day after injection, my arm was sore. On the 13th of Jan, I was at work from 7am-7pm and my arm was even more swollen, sore, itchy and reddish, no fever, I was still able to work, but my L axillary area was sore the whole day. I went home and took a shower and noticed that my L armpit was swollen, like the size of a tennis ball! No redness, no fevers but sore and discomforting due to the swelling.
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| 48 | 2021-01-14 | skin warm, runny nose, fatigue, lethargy, night sweats, chills, fever, headache |
day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, w...
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day 1- no side effects Day 2- low grade temp, very sore arm, red, swollen, chills, felt lethargic, woke up in wet clothes from sweat, headache, runny nose Day 3- sore arem, red and swollen, warm to touch, felt lethargic day 3- arm just red and warm to touch. big red circle where shot was given day 4- sitting down and out of nowhere a sharp pain felt in back by neck and shoulders. could not move my neck. arm still a little red but not warm to touch. swelling went down. (went to ER on day 4. blood work and xrays were negative for anything. was given muscle relaxer.) day 5 sore muscles but on muscle relaxer to help day 6 until day 10 - just fatigue and sore muscles/joint pain but tolerable.
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| 48 | 2021-01-14 | throat pain, headache |
face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat start...
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face, with periorbital swelling and wheezing 38 to 45 hours post vaccine, to sore throat started 24 hours after vaccine . Severe headache and joint pain started 27 hours after vaccine
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| 48 | 2021-01-14 | influenza like illness |
positive for Covid; positive for Covid; This is a spontaneous report from a contactable healthcare p...
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positive for Covid; positive for Covid; This is a spontaneous report from a contactable healthcare professional (patient). A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiration date unknown), via an unspecified route of administration in right deltoid, on 18Dec2020 07:15 at a single dose for Covid-19 immunization. Medical history included ongoing hypothyroidism and hysterectomy. Concomitant medications included estradiol (taking after hysterectomy) and levothyroxine for hypothyroidism, both ongoing. The patient has no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient stated that she received the Covid vaccine mid- Dec2020. She stated she was supposed to receive the 2nd dose 2 days ago, 06Jan2021. On 03Jan2021, she started feeling bad the day before testing positive, went to urgent care to be tested, thought she had the flu. She tested positive for Covid on Monday 04Jan2021, so she has been in quarantine. She was unable to receive her 2nd dose because she was in quarantine. She wanted to know if it's ok to delay the second dose or if she needs to re-start the series. The reporter assessed the event relatedness was unknown, patient stated that she doesn't know the causality, she has not been in contact with anyone that was known to be positive, but she is a healthcare worker who sees multiple patients a day, so one of them could have been asymptomatic. Outcome of the events was not recovered.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
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| 48 | 2021-01-14 | headache, fever, weakness |
severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness...
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severe headache; severe nausea; severe vomiting; upper GI pain; tingling in hands and feet; weakness; fever; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), via Intramuscular at single dose in the arm left, first dose on 17Dec2020 08:15, second dose on 07Jan2021 08:15, both for COVID-19 immunisation. Medical history included Epilepsy. Concomitant medications included fluvoxamine maleate (LUVOX), oxcarbazepine (OXTELLAR XR), liraglutide (SAXENDA) and bupropion hydrochloride, naltrexone hydrochloride (CONTRAVE). On 07Jan2021 17:00, the patient experienced severe headache, severe nausea, severe vomiting, upper gi pain, tingling in hands and feet, weakness, fever. The patient underwent lab tests and procedures, which included Nasal Swab on 08Jan2021 with negative result. Therapeutic measures were taken as a result of severe nausea and severe vomiting and included treatment with Zofran. Outcome of events was recovering.
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| 48 | 2021-01-14 | headache, fatigue |
slight headache, upset stomach, tired, muscle soreness in back and shoulders, soreness of thigh musc...
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slight headache, upset stomach, tired, muscle soreness in back and shoulders, soreness of thigh muscles. started around 5pm 1/12/2021. relieved by 1/14/2021 0800 am
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| 48 | 2021-01-15 | throat irritation |
About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it ...
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About 40 minutes after the vaccine i noted my throat was dry and my voice started to change and it was deep and scratchy, The change in voice got worse as i was speaking to my friend so i went to the ED (building next to where I work). I had no problems breathing but was eventually treated for anaphylaxis with epi, prednisone, benadryl, and pepcid
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| 48 | 2021-01-16 | fatigue, chills, headache, sweating, malaise |
@1106 on 1/16/21 experienced arm tenderness at injection site. @1400 on 1/16/21 experienced head...
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@1106 on 1/16/21 experienced arm tenderness at injection site. @1400 on 1/16/21 experienced headache and took ibuprofen and headache resolved about 1 hour later @2130 on 1/16/21 began to experience chills and general malaise and another headache, took ibuprofen. @0130 on 1/17/21 woke up sweating, with a headache, continued malaise, and chills, took ibuprofen @0730 on 1/17/21 woke up with headache, took ibuprofen @1300 on 1/17/21 fatigue, chills and malaise returned. Still present at time of this submission. Rest and ibuprofen have provided minimal relief.
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| 48 | 2021-01-16 | throat pain, headache, fatigue, chills |
A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccinat...
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A metallic taste when through my mouth & got my mouth dry as soon as they where putting the vaccination. Then I got a really bad headache & very nauseas within 5 min of getting the vaccine. I had pain on the vaccine area. I also felt very tired very exhausted about 4 or 5hrs later. I started getting chills & achiness started the next day on 12/24/2020. On 12/25/2020 I felt nauseas, still had the chills, headaches, still felt fatigue, achiness, sore throat & also had diarrhea. I had all this symptoms all the way till 12/29/2020. Seen doctor on 12/28/2020 and they decided I should get tested for Covid.
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| 48 | 2021-01-16 | dizziness, weakness | Dizzy, weakness, tingling in lips and fingers, increased heart rate |
| 48 | 2021-01-16 | throat swelling, shortness of breath |
Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, t...
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Feeling flushed, nauseated, hot flashes, lips tingling, tongue/throat swelling, SOB, leg weakness, tachycardia.
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| 48 | 2021-01-16 | throat swelling | Lips tingling, tongue/throat swelling, flushed, hot flashes, leg weakness, nausea, tachypnea |
| 48 | 2021-01-16 | fatigue, headache, chills, dizziness |
Severe myalgia, headache, dizziness, fatigue, nausea, GI cramping, chills for 36 hours Headache pers...
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Severe myalgia, headache, dizziness, fatigue, nausea, GI cramping, chills for 36 hours Headache persistent through today mild myalgia persistent through today
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| 48 | 2021-01-16 | fatigue, chills, body temperature increased | Temperature 102 Fatigue Sore arm Chills |
| 48 | 2021-01-17 | fatigue, malaise | Chills, muscle pain, tiredness, injection site pain, feeling malaise |
| 48 | 2021-01-17 | fatigue, headache, fever |
Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4...
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Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4 Nausea loss of appetite headache
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| 48 | 2021-01-17 | malaise, dizziness |
I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a la...
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I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
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| 48 | 2021-01-17 | throat swelling |
Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, ...
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Patient received second dose of Pfizer vaccine on 1/11/21 @1240pm. Presented to ED with dry throat, throat swelling and hoarse voice. Symptoms started approximately 40 minutes post vaccination at 1320. Pt has hx of food allergies. Pt was treated with epinephrine 0.3mg IM, diphenhydramine 25mg po, and famotidine 20mg po and prednisone 40mg PO. Observed in ED until 1758 and was noted to have no worsening of symptoms and improvement in hoarse voice. Discharged with prescription for prednisone 40mg x4 days.
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| 48 | 2021-01-19 | dizziness |
10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. S...
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10 minutes after injection, pt complained of right arm numbness, It began to spread to her throat. She reported throat tightness. , nausea and dizziness. 2 MDs were in the Observation area. They assessed her, gave her 25 mg Benadryl IM and 3 puffs of Albuterol inhaler. Heart rate 110, Resp Rate 12, O2 sat 98% on room air. Pt continued to fell warm and "weird." MDs wanted her to go to hospital but pt refused. Her employer offered to drive her to the ER but she refused. The MDs remained with her, monitoring for another hour. Pt was feeling better and chose to have her husband pick her up.
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| 48 | 2021-01-19 | lethargy, body temperature increased |
14 hours post vaccine, mild muscle pain. 18 hours post vaccine began: lethargy, temp 99.5, joint pai...
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14 hours post vaccine, mild muscle pain. 18 hours post vaccine began: lethargy, temp 99.5, joint pain, muscle aches.
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| 48 | 2021-01-19 | fever, chills, dizziness |
Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheade...
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Approximately 7 hours after receiving the second dose of COVID-19 vaccine, reporter noted lightheadedness, dizziness, mild intermittent aches and neck pain. Approximately 12-13 hours post dose, reporter developed serious systemic aches and pains, uncontrollable shaking, chills, nausea, vomiting, and developed a fever of up to 103.1. These more severe symptoms lasted approximately 3 hours and were treated with acetaminophen and ibuprofen only.
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| 48 | 2021-01-19 | chills, fatigue, fever |
Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to...
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Chills, Fever 100.6, Joint/Muscle Pain, Fatigue, Injection Site Arm Pain, Abdominal Pain, Unable to work.
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| 48 | 2021-01-19 | fever, headache, fatigue, chills |
Chills, Muscle and joint pain, Loss of Appetite, Extreme fatigue, headache and fever (up to 103.5 ev...
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Chills, Muscle and joint pain, Loss of Appetite, Extreme fatigue, headache and fever (up to 103.5 even when on Advil). Had low grade fever up till 4 days after vaccine Fatigue has persisted a week later
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| 48 | 2021-01-19 | throat irritation, cough |
Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, onl...
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Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.
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| 48 | 2021-01-19 | chills, fever, headache, malaise, weakness |
Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade feve...
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Extreme Headache, Pain all over my body, general sick feeling, watery red itchy eyes, low grade fever and chills all over my body especially the head, extreme weakness. It lasted for 2 days.
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| 48 | 2021-01-19 | fever, chills, headache |
Fever , t max 101.8- started 20 hours after vaccine, lasted over 24 hours. Minor symptoms of chills ...
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Fever , t max 101.8- started 20 hours after vaccine, lasted over 24 hours. Minor symptoms of chills and headache and myalgia
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| 48 | 2021-01-19 | fever | Fever, body aches, nausea, vomiting, injection site pain |
| 48 | 2021-01-19 | fatigue, headache |
HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, ...
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HEADACHE, TIRENESS, ITCHING, BURNING SENSATION OF THE SKIN, MILD FINE, GENERALIZED SYMETRICAL RASH, WORSE IN ARMS, CHEST AND ABDOMEN. NOW NO HEADACHE/PAIN IN INJECTION SITE, BUT CONTINUES WITH RASH, BURNING SENSATION AND ITCHING DESPITE SOLUMEDROL INTRAVENOUS ON 10/13/2020 AT DOCTOR'S OFFICE, HYDROXYZINE 25 MG THREE TIMES A DAY, BETAMETHOSNE CREAM SINCE 01/13/2020 AND PREDNISONE 50 MG BY MOUTH DAILY SINCE 1/18/2020
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| 48 | 2021-01-19 | chills, fever |
Had fever up to 100.4; chills; body aches; This is a spontaneous report from a contactable physician...
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Had fever up to 100.4; chills; body aches; This is a spontaneous report from a contactable physician. A 48-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular 09Jan2021 10:00 am in left arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. Facility type vaccine was in hospital. Other medications in two weeks was none. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient had fever up to 100.4, chills, body aches on 10Jan2021 09:00 AM. No treatment was received for the events. Outcome of events were recovering. Information on the batch/lot number has been requested.
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| 48 | 2021-01-19 | fever, chills, headache | Headache occurred, body aches, chills, nausea, and fever of 99.4 |
| 48 | 2021-01-19 | headache, fatigue |
Injection soreness; headache; tiredness/feeling rundown; This is a spontaneous report from a contact...
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Injection soreness; headache; tiredness/feeling rundown; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) on 20Dec2020 16:30 at single dose in left arm COVID-19 immunization. Medical history included Allergies to Sulfa, Factor IV Leiden, diabetes. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D), lisinopril and Multivitamin (unspecified) . On 20Dec2020 at 20:00 the patient experienced injection soreness, headache, tiredness/feeling rundown. No treatment given and patient recovered from all the events on an unknown date. Patient was tested pot vaccination: a Nasal Swab was done on 29Dec2020 and was negative. On 09Jan2021 at 21:00 patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) at single dose in Left arm for COVID-19 immunization.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015299 same patient, different event and vaccine
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| 48 | 2021-01-19 | shortness of breath, cough, throat irritation |
It was stated that approx 1 hour after getting the Covid Vaccine she developed SOB. It was stated th...
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It was stated that approx 1 hour after getting the Covid Vaccine she developed SOB. It was stated that she was given Benadryl 50 mg IM and Epi pen 0.3 mg sq. It was stated that she got the vaccine at 1330 and the reaction began at approx 1430 hours. She states that she has allergies to bees, meds and foods. She states that she feels the same way as a major allergic reaction. She states that she feels like her throat is itchy and scratchy. She states that it feels like her throat is gong to close. She has more problems with coughing than she does with SOB. H She denies any headache, neck, chest or abd pain, numbness or tingling. She further denies any N/V, Dizziness, fever or chills, blurred or double vision, photophobia. Respirations are without shoulder lifts or intercostal retractions. She is primarily coughing. She is able to speak in 3 - 5 word sentences. No drooling are noted, mild stridors are noted. Lung sound are clear and equal bilateral. She appears to be atraumatic without signs of gross deformity. She moves all extremities well and equally without other c/o pain or discomfort. She appears to be in no acute distress. Patient discharged home and referred to PCP and allergist
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| 48 | 2021-01-19 | chills, fatigue, influenza like illness, migraine, nasopharyngitis |
Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, ex...
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Migraine, progressively worsening approx 2 hr after 2nd vaccine. Then chills, body aches, nausea, extreme fatigue. Lasted for 30 hrs. Fatigue remained another 24hrs. Felt like bad cold or mild flu. I treated with over the counter medication after my physician said that was appropriate. Still worth getting the vaccine! I?m thankful I could receive it.
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| 48 | 2021-01-19 | fever, chills, headache |
SYMPTOMS STARTED MORNING OF 1/18: BODY ACHES, CHILLS. 12MD FEVER (101);2PM NAUSEA; AT NIGHT, HEADACH...
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SYMPTOMS STARTED MORNING OF 1/18: BODY ACHES, CHILLS. 12MD FEVER (101);2PM NAUSEA; AT NIGHT, HEADACHE AND NAUSEA. TUESDAY 1/19, MORNING NAUSEA. FELT BETTER TUESDAY AFTERNOON.
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| 48 | 2021-01-19 | throat irritation | Throat tight and scratchy |
| 48 | 2021-01-19 | headache |
diarrhea; headache; bodyache; no appetite; This is a spontaneous report from a contactable consumer ...
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diarrhea; headache; bodyache; no appetite; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not reported, expiration date: Mar2021), via an unspecified route of administration on the left arm, from 05Jan2021 at a single dose for Covid-19 immunisation. Medical history included blood pressure (abnormal). Concomitant medication included ongoing hydrochlorothiazide for blood pressure. On 06Jan2021, the patient has had body aches, headache and no appetite. On 08Jan2021, she had diarrhea. She was going to work today but was unable to because she had to run to the bathroom. She has gone to the bathroom 6 times. She called her doctor at 7:30am but has not heard back. She is unsure what to do. She is asking if these are side effects of the vaccine. She is unsure if the lot number on the card is SK4176 or PK4176. Outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 48 | 2021-01-19 | headache, body temperature increased, chills |
injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node...
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injection site pain; headache; body aches; chills; joint pain; T 99.3; L axillary swollen lymph node; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; administration date=24Dec2020,dose number=1/administration date=11Jan2021, dose number=2; This is a spontaneous report from a contactable nurse reported for herself. The 48-year-old female patient (not pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) , via an unspecified route of administration at left arm on 11Jan2021 16:15 at single dose for covid-19 immunisation. Medical history included none, had no allergies to medications, food, or other product. Concomitant medication included ethinylestradiol/norgestimate (ORTHO TRI-CYCLEN). Patient previously received first dose BNT162B2 ( lot number: EK5730) , via an unspecified route of administration at right arm on 24Dec2020 at 08:30Am at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Jan2021 04:00AM, 12hrs after 2nd dose injection she experienced injection site pain, headache, body aches, chills, joint pain, T 99.3, L(Left) axillary swollen lymph node; Symptom improvement with Tylenol and Ibuprofen. 48hrs later(14Jan2021)- all symptoms resolved except left axillary swollen lymph node. There is no covid prior vaccination. Patient had covid tested post vaccination, rapid antigen via nasal swab on 12Jan2021 with negative result. Treatment (Tylenol and Ibuprofen) were taken as a result of all events. Outcome of left axillary swollen lymph node was recovering, of injection site pain, headache, body aches, chills, joint pain, T 99.3 was recovered on 14Jan2021. Events were non-serious by reporter.
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| 48 | 2021-01-19 | malaise |
just doesn't feel well; high blood pressure; feels like throwing up; This is a spontaneous report fr...
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just doesn't feel well; high blood pressure; feels like throwing up; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "having some high blood pressure", she "feels like throwing up" and "she doesn't feel well". The patient outcome of the events was unknown. The information on the batch number has been requested.
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| 48 | 2021-01-19 | headache |
mild headache from Jan 11-16th, starting on the 16th __complete left facial numbness and burning fro...
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mild headache from Jan 11-16th, starting on the 16th __complete left facial numbness and burning from left shoulder to the top of the head and moderate to severe headache
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| 48 | 2021-01-21 | fever | I experienced a low grade fever for 24 hours, body aches |
| 48 | 2021-01-21 | fatigue, fever, chills | SYMPTOMS starting 01/18/21 6p chills,fever 100.0, fatigue ended 01/20/21 3p |
| 48 | 2021-01-23 | cough, dizziness, runny nose |
chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking....
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chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen
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| 48 | 2021-01-24 | headache, chills, fever |
01.15.21 nauseous, headache with Fever with chills. 01.20.21 fever with chills still have chills an...
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01.15.21 nauseous, headache with Fever with chills. 01.20.21 fever with chills still have chills and body aches.
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| 48 | 2021-01-24 | headache |
23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe...
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23 Jan-Saturday-severe Headaches Sunday-24th Jan-Left under arm-swollen lymph nodes 25th Jan -Severe HA, site of injection-left deltoid-swollen-swollen behind neck-lymph nodes-she said Motrin-HELPS
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| 48 | 2021-01-24 | sweating, fatigue, chills, body temperature increased, headache |
Fever 102, + covid test 2 weeks ago, Body aches, chills, fatigue, headache, BOB, sweats, Soreness at...
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Fever 102, + covid test 2 weeks ago, Body aches, chills, fatigue, headache, BOB, sweats, Soreness at injection site.
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| 48 | 2021-01-24 | shortness of breath, fever, sweating, fatigue |
Fever, body aches, SOB, fatigue, sweats, Injection site soreness.. Was Covid + 2 weeks prior to vacc...
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Fever, body aches, SOB, fatigue, sweats, Injection site soreness.. Was Covid + 2 weeks prior to vaccine.
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| 48 | 2021-01-24 | dizziness |
Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able t...
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Increased blood pressure, light headed, nausea. Symptoms resolved in the ER and employee was able to return to full duty.
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| 48 | 2021-01-24 | shortness of breath | Left arm pain leading to chest wall pain with pmhx of angina. 6/10 pain radiating to left neck, SOB. |
| 48 | 2021-01-24 | sweating, dizziness, headache |
Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness a...
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Sudden onset nausea, profuse sweating, pale, tingling hands and felt like would lose consciousness approx 1.25-1.5 hours after injection. around 12:10 pm or so. Removed excess clothing, put head between legs and turned on fan. Symptoms improved within 15 minutes. Headache later Saturday evening. Face hot and flushed and bad headache around 6pm Sunday evening. Face hot and flushed still Monday 1/25 in am but is getting a little better (I think) at the time of report.
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| 48 | 2021-01-24 | dizziness | Vertigo for 3 hours intermittently, then nausea and mild dizziness from 7am- 5pm |
| 48 | 2021-01-24 | headache |
approximately 5 minutes after vaccine administration, reported headache and nausea. Brief chest dis...
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approximately 5 minutes after vaccine administration, reported headache and nausea. Brief chest discomfort. No respiratory symptoms, REsolved after 30 minutes and discharged to home.
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| 48 | 2021-01-25 | headache | 12/22 - HEADACHE. TOOK TYLENOL 12/23 - MILD HEADACHE IN THE MORNING |
| 48 | 2021-01-25 | throat pain, chills, fever | Chills, rash, sore throat, low grade fever starting one week after the vaccine |
| 48 | 2021-01-25 | fever, headache, chills |
Covid/Pfizer vaccine #2 given approx 12:20 pm. Woke approx 1 am with shaking chills, HA, vertigo,103...
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Covid/Pfizer vaccine #2 given approx 12:20 pm. Woke approx 1 am with shaking chills, HA, vertigo,103.4fever.
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| 48 | 2021-01-25 | fatigue, headache, weakness |
My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal B...
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My HBP rise up to 49 points 169/96, headache (not normal because i usually very healthy my normal BP runs usually 115/78 to 120/78)paramedic check me at 15min twice at that time. my tong was felt numb; i went home and took some Benadryl and a Tylenol for my headache , rise my legs up for about 1hr drink 3 water bottles and less than 1/2hr, my BP drop to 113/75 i went to bed felt very tired , next day, very tired my BP low 106/70 muscles achy, got diarea and nausea per one day, since then my BP keeps low, I have no energy, I call my dr. yesterday, he advised that I should be good by today; my BP keeps been in the lows, my back hurts, i have no energy; I need to call back my dr. by Thursday or Friday to see how am i doing;. he referral to ENT to check on my smell and test as follow up because i have covid back in june2020 and I'm having a hard time with it.
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| 48 | 2021-01-25 | nasopharyngitis, shortness of breath, dizziness |
Patient felt dizzy and cold within 15 minutes of receiving the vaccine. Her BP and pulse were eleva...
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Patient felt dizzy and cold within 15 minutes of receiving the vaccine. Her BP and pulse were elevated and she stated to feel short of breath. Rapid response team responded and the patient was taken to the ED for evaluation.
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| 48 | 2021-01-25 | shortness of breath, throat irritation |
Same day of injection, recipient felt itching in back of throat, had to keep clearing throat; same d...
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Same day of injection, recipient felt itching in back of throat, had to keep clearing throat; same day recipient was seen in the ED with itchiness and dry heaves. Was treated with steroids, Benadryl, and Pepcid. On 1/17/2021 recipient returned to the ED with complaints of shortness of breath and itchy throat; she was unable to take oral steroids
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| 48 | 2021-01-25 | weakness | Sore Injection Site, Neck Pain, Nausea and Weakness |
| 48 | 2021-01-25 | shortness of breath |
Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal ...
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Sudden onset of nausea, vomiting, diarrhea, shortness of breath, uncontrolled shaking and vasovagal response with near syncope episode. Gave Diphenhydramine approximately 25 minutes after onset.
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| 48 | 2021-01-25 | dizziness |
Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes...
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Symptoms: Lightheaded, elevated blood pressure. Treatment: Given water, monitored another 15 minutes. No further symptoms or treatment.
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| 48 | 2021-01-25 | shortness of breath, headache |
Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night...
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Within 3 hours of the event, started having expected side effects of headache, bodyaches. That night had difficulty sleeping and new onset neck pain as well. Finally took tylenol at 3AM. Woke up at 9:15 and walked from bedroom to kitchen at which time had severe orthostatic hypotension with near sycope that did not progress to full syncope due to lying down quickly. Continued with tachycardia for several days and mild shortness of breath for two days. That evening, had new onset RUQ abdominal pain for 2-3 hours that resolved.
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| 48 | 2021-01-25 | weakness, fatigue |
extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which afte...
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extreme fatigue. I slept for two days following both vaccines, decreased energy. Sore arm which after the second dose remains a dull ache now at two weeks and 3 days after the second dose. Still have severe fatigue. I want to sleep all day.
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| 48 | 2021-01-25 | fatigue, headache |
headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny ...
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headache; tiredness/overwhelming feeling of tiredness; nausea; feeling "funny" in the head; a funny taste in the mouth; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 13Jan2021 07:50 at a single dose on Left Upper Arm Muscle for COVID-19 immunization. Medical history included thyroid disorder and antidepressant therapy. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder, duloxetine hydrochloride (CYMBALTA) as Antidepressant and multivitamins. The patient stated that she is calling about the COVID Vaccine, she just had the shot at 7:50AM this morning. After getting the shot she heard that she is not suppose to get the shot if she had tested positive for COVID before the vaccine. She wanted to know if this was true or a rumor. Back around Nov2020 she did test positive for COVID. It was the week before the holidays on Wednesday 18Nov2020 when she lost taste and smell, she then got tested on 19Nov2020 Thursday then got results Friday or Saturday morning, the weekend before the holidays that she was positive. The test was a nasal swab. The girls in the office said she was not suppose to get the shot if it had not been 3 months. When she had COVID shot they didn't tell her if she could take it or not. This morning she woke up everything was fine, she drove over to get vaccine, after they put the vaccine in, they made her wait 15- 30 minute, while waiting she was getting a headache, then the headache went away and she then felt funny in the head. She was a little nauseous then that went away. Then she had this overwhelming feeling of tiredness like she could go to bed. She felt bad a little bit. When she then drove back to work at the school she had this funny taste in the mouth. Her boss wanted to call and see if this is all normal. The date of first dose was 13Jan2021, all the symptoms she experienced occurred within half hour of receiving the vaccine. She thinks she is fine. At the moment she does not have the taste in mouth any longer and her headache left. She still feels funny in head as well as she just feels bad inside, she has the feeling of overwhelming tiredness, she just feels like something is coming on, like she knows she is getting sick. She has no Lot or Expiry to share, she vaccine CDC card is outside in the car and not physically with her. Her drive to get the vaccine was an hour away to a Hospital and all the medication was taken an hour before. She went to the hospital to have the vaccine administered. Then she drove to work at a school. She has had an antibody test, in which they draw blood, it was negative but that was even before she caught COVID, it was back in Aug2020 or Sep2020. She has had no issues with vaccines in the past. The outcome of the event headache, a funny taste in the mouth, and nausea was recovered on 13Jan2021, tiredness/overwhelming feeling of tiredness was unknown, feeling "funny" in the head was not recovered. The events were assessed as non-serious. Information about lot/batch number has been requested.
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| 48 | 2021-01-26 | fatigue, chills, headache | Chills, aches, headache, tiredness |
| 48 | 2021-01-26 | fatigue | Extreme fatigue, foggy mind, for 48 hs starting six days after vaccination. |
| 48 | 2021-01-26 | fever, chills | Fever, chills, fatigue, muscle and joint pain x2 days Advil, Tylenol, muscle relaxer |
| 48 | 2021-01-26 | cough, fever |
First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with...
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First inject lot # ej1685 in right arm. had itchy rash with open wounds all over right breast with burning pain. Was told is was shingles but wasn?t treated. Was told to get the second vaccine in the opposite arm to see if the same thing happens. Received 2nd injection in left arm and ended up with full blown symptoms of COVID. Uncontrollable shakes, cold, fever, severe body aches, cough, diarrhea and the rash still remains. As of today, I have an upper respiratory infection as well as the open rash, which the PCP listed has taken control of and deemed the cause side effects of the second injection.
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| 48 | 2021-01-26 | headache |
Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest...
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Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine
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| 48 | 2021-01-26 | malaise, fatigue | Sore Arm, Fatigue, General feeling of sick, Hives, |
| 48 | 2021-01-26 | headache |
Sudden headache, nausea, then itching all over, rash on chest then stomach. Swollen and redness lik...
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Sudden headache, nausea, then itching all over, rash on chest then stomach. Swollen and redness like golf ball size at and around site the next morning. Still itching the next morning after taking Benadryl and Tylenol every 4 hours as suggested by physician.
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| 48 | 2021-01-26 | fatigue |
a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar b...
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a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; feelings of like disconnection; Feelings of like of being drunk; another larger bulge under her right axillary and that one was causing off and on under the armpit, she was getting some shooting pain; Fatigue; This is a spontaneous report from a contactable Nurse. This 48-year-old female Nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant drugs included lisinopril for blood pressure/hypertension, omeprazole and vitamin supplements. Historical vaccine included the first dose of BNT162B2 (lot# EK5730) on 21Dec2020 for COVID-19 immunization and having a swollen lymph node along her collar bone on the left side which was on the side where she got the shot and it didn't really change much, it just kind of stayed the same size and it remained there for whole three weeks. Nurse stated then she got the second dose of the vaccine and thought that what she was having were a bunch of swollen lymph nodes, and that lymph node was now larger and she had a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary (12Jan2021) and that one was causing off and on under the armpit, she was getting some shooting pain and her lymph node was larger now as well, the lymph node along her collar bone. Nurse further stated she also had some intermittent fatigue that she expected and also off and on feelings of like disconnection or feelings of like of being drunk. But that's not very bothersome, that's just once in a while since 11Jan2021. But she was concerned about the swelling of lymph nodes. No treatment was received for events. Outcome of events was not recovered. Nurse believed that swollen lymph nodes, fatigue and feeling drunk were due to the Covid 19 Vaccine.
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| 48 | 2021-01-27 | cold sweat, weakness, chills |
severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weaknes...
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severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weakness; This is a spontaneous report from a contactable Other Health Professional. A 48-year-old female patient (not pregnant) received 2nd dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via intramuscular on 12Jan2021 13:30 at single dose on left arm for covid-19 immunisation. Medical history included mild asthma. There were no concomitant medications. Historical vaccine included 1st dose of bnt162b2 (lot: EJ1685) on 23Dec2020 left arm at single dose for COVID-19 Immunization (age at vaccination was 48 years old). Approximately 11 hrs after 2nd vaccine, patient developed severe rigors, severe arthralgias and myalgias as well as skin parasthesia, severe cold sweats and profound weakness. Symptoms improved with APAP (acetaminophen) plus ibuprofen alternating q3 hrs x24 hrs. Outcome of the events was resolving. This case was reported as non-serious.
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| 48 | 2021-01-28 | headache, chills |
pain on left side of head that extends from left temple to above and behind my left ear and down the...
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pain on left side of head that extends from left temple to above and behind my left ear and down the back of her neck; chills; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received the first dose of bnt162b2 (lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 04Jan2021 at 13:30 at a single dose in the workplace clinic for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not have COVID prior to vaccination. The patient is not pregnant. The patient experienced sharp pain on left side of head that extends from left temple to above and behind my left ear and down the back of her neck on 05Jan2021 at 15:00. Sudden onset and fades over 10-60 minutes and reoccurs off and on throughout the day. Also have noticed chills at the same time, on 05Jan2021 at 15:00. The patient did not receive treatment for the events. Outcome of event chills was not recovered while recovered on 05Jan2021 for the other event. Information on the lot/batch number has been requested.
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| 48 | 2021-02-03 | throat swelling |
Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid...
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Rash chest and face. Face and throat swelling. Difficulty swallowing. Taken to ER and given steroid, benadryl, and pepcid. Systemic affects x3 days. Medications given for a total of 5 days.
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| 48 | 2021-02-08 | fatigue |
Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in t...
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Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse. A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose via an unspecified route of administration in right deltoid for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially. At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-16 | weakness, shortness of breath |
Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram ...
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Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath
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| 48 | 2021-02-17 | headache |
pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contac...
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pass out; vomiting; Severe muscle pains; Severe headache; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 at 10:00 at single dose in left arm for COVID-19 immunisation at the age of 48-year-old. Lot number was EL3248. Medical history included asthma, migraine headaches, thyroiditis. Concomitant medications included levothyroxine, fluoxetine, bupripion, clonazepam. The patient was not pregnant. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021 at 15:00 at single dose in right arm for COVID-19 immunisation at the age of 48-year-old. On 02Feb2021 at 23:00, the patient experienced severe vomiting which kept the patient up most of the night, she had to stay by toilet; the patient was feeling like she was going to pass out with any movement, the patient experienced severe muscle pains that felt almost like bones were breaking inside; the patient experienced severe headache; the patient almost took her-self to the emergency room in the middle of the night, but she did not want to expose her compromised immune system to others. The patient was not treated for the events. The patient was recovering from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the LOC and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics including chemistry panel, Head CT/MRI and EKG, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 48 | 2021-02-21 | headache |
Friday injection site hurt almost immediately (first dose didn't feel anything until 6 hours after s...
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Friday injection site hurt almost immediately (first dose didn't feel anything until 6 hours after shot)... started to ice arm an hour after appointment and continued to ice throughout the day Friday. Saturday morning the injection side was significantly swollen (bump and felt like a knot) and continues to be swollen and ache as of Monday a.m. Have a red circular patch around injection site which also occurred after first shot and lasted 10 days. Saturday woke up with bad headache... took tylenol and slept.. headache gone by late afternoon. Sunday morning woke up covered in a rash that was from my neck to below my belly button on front side, entire back area (including neck) and both sides of torso. Took 2 doses of Benadryl on Sunday. Rash has faded (not as red) and took another dose of Benadryl Monday morning.
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| 48 | 2021-02-21 | headache |
Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old...
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Headache; Sore arm; This is a spontaneous report received from a contactable consumer. A 48-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache and sore arm on 27Jan2021. The outcome of the events was reported as unknown. Information about Lot/ Batch has been requested.
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| 48 | 2021-02-21 | somnolence |
I am diabetic and my blood sugar dropped in the middle of the night; I am diabetic and my blood suga...
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I am diabetic and my blood sugar dropped in the middle of the night; I am diabetic and my blood sugar dropped in the middle of the night; Sleeping a lot; Confusion; This is a spontaneous report from a contactable consumer, the patient. A 48-years-old female patient received bnt162b2 (BNT162B2, Lot Number Unknown) via an unspecified route of administration on an unspecified date (at 48 years of age) as a SINGLE DOSE for Covid-19 Vaccination , insulin (INSULIN) 'regular Insulin for sliding scale' Lot Number Unknown 'number under the bar code C:1011:1030310691833329. via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin detemir (LEVEMIR) Lot Number 310018652576, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , insulin aspart (NOVOLOG) Lot Number 374934031098, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose for diabetes mellitus , semaglutide (OZEMPIC) weekly, via an unspecified route of administration from an unspecified date to an unspecified date at unknown dose, weekly for diabetes mellitus. Medical history included hypertension. Concomitant medication included lisinopril (LISINOPRIL). The patient reported I am diabetic and my blood sugar dropped in the middle of the night, so my husband had to get up and give me something (Unspecified Medication) and then I am sleeping a lot and I do have some confusion on an unspecified date. The patient underwent lab tests that included blood glucose: dropped on an unspecified date. Treatment was given for diabetic and blood sugar dropping. Consumer also stated, No, it is not that severe The clinical outcome of the events diabetic, blood sugar dropped in the middle of the night, Sleeping a lot and Confusion was Unknown. The action taken in response to the event(s) for insulin was unknown, for insulin detemir was unknown, for insulin aspart was unknown, for semaglutide was unknown. The lot number for the vaccine, bnt162b2 was not provided and will be requested during follow up.
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| 48 | 2021-02-21 | chills |
arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tende...
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arm very painful; swollen and tender left axillary and left supraclavicular nodes; swollen and tender left axillary and left supraclavicular nodes; chills; red x 5 days; This is a spontaneous report from a contactable healthcare professional (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249; dose 2) via an unspecified route of administration on 20Jan2021 at 1:30 PM (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypertension and mild asthma. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient took concomitant medications which were unspecified. The patient did not received any other vaccines within four weeks prior to the vaccination. The patient previously took penicillin on unknown dates for an unknown indication and experienced allergy. The patient received dose 1 of BNT162B2 (lot number: EL0104) on 30Dec2020 at 11:30 AM in the left arm as a single dose for COVID-19 immunization. On an unspecified date after the second vaccination, the patient had arm very painful, red for 5 days, and swollen and tender left axillary and left supraclavicular nodes. On 21Jan2021, 24 hours after the vaccine, the patient experienced chills lasting three to four hours. The patient did not have adverse effects at all after the first vaccine. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient did not received treatment for the events. The outcomes of arm very painful and red, swollen and tender left axillary and left supraclavicular nodes, and chills were recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
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| 48 | 2021-02-21 | shortness of breath |
patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second d...
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patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second dose on Monday 2/15/21. Tuesday patient experienced n/v/d. Went to an ED on Wednesday and was cleared and sent home. Thursday reported shortness of breath to her caregiver and then collapsed. Patient was brought to as PEA arrest and ultimately died.
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| 48 | 2021-02-22 | fever, chills, headache, fatigue |
I received the Vaccine on 2/18 .At 22:00 I had chills and low grade Fever. Middle of the night I fe...
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I received the Vaccine on 2/18 .At 22:00 I had chills and low grade Fever. Middle of the night I felt fatigue and body aches, dull Headache. In the morning I was nauseus. The symptoms lasted for 24 hours.
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| 48 | 2021-02-22 | shortness of breath |
I received the first vaccine 1/11/2021 and the second dose on 02/03/2021. On 02/16/2021 my hair fe...
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I received the first vaccine 1/11/2021 and the second dose on 02/03/2021. On 02/16/2021 my hair fell out in clumps. I am post COVID and was Dx on 07/14/2020. I was discharged from the hospital on 09/17/2021. From my stay in the hospital on 07/14/2020 up until 02/15/2021 I had the minimum hair loss that one would loss in a day. I am not sure if the vaccines caused it , but my hair literally came out in clumps. I also started experiencing heart palpitations along with SOB in the evenings after the first vaccine. Upon the second week in February, I started experiencing the palpitations and SOB in the evenings. Again, I am not sure if the vaccines caused this as I am post COVID.
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| 48 | 2021-02-22 | throat irritation | Itchy, tingley, throat. Itchy bottom of feet. Drank water. Lasted ~20 minutes. No visible rash. |
| 48 | 2021-02-22 | sweating |
Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SO...
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Pt received dose 2 of Pfizer Covid vaccine at 12:00pm and soon after reported symptoms of nausea, SOB, wheezing, sweating, and numbness on left side from face to arm. Pt was given oxygen and 0.3mg of epinephrine was given intramuscularly at 12:05pm, followed by 25mg of diphenhydramine intramuscularly at 12:08, both administered by RN on site. Paramedics arrived at the scene at 12:05pm and took over monitoring of pt; pt was taken to ambulance at 12:10pm
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| 48 | 2021-02-23 | cough, shortness of breath, influenza like illness |
Drug Ineffective; felt like she had Covid plus the flu; very congested chest; Flu like symptoms; Che...
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Drug Ineffective; felt like she had Covid plus the flu; very congested chest; Flu like symptoms; Chest pain; Cough; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (Lot # EL1283) intramuscular at single dose in the right arm on 15Jan2021 and the second dose at single dose in the left arm on 03Feb2021 11:30, for covid-19 immunisation. Medical history included exposure to sars-cov-2 in Dec2020 (Her mother ended up positive for Covid and she was exposed to her and showed symptoms). There were no concomitant medications. On 03Feb2021, the patient experienced felt like she had Covid plus the flu with outcome of recovered on 05Feb2021, very congested chest with outcome of recovered on 06Feb2021, flu like symptoms with outcome of recovered on 05Feb2021, chest pain with outcome of recovered on 05Feb2021, cough with outcome of recovered on 06Feb2021, shortness of breath with outcome of recovered on 06Feb2021. The patient underwent lab tests and procedures which included oxygen saturation: normal on an unspecified date, sars-cov-2 antibody test: positive on an unspecified date. Therapeutic measures were taken as a result of felt like she had covid plus the flu, flu like symptoms. The events were described as follows: Patient said that she had some weird side effects from the 2nd vaccine, but not the first dose and believes that she had Covid in Dec2020. Patient said that she had flu like symptoms, she said it felt like she had Covid plus the flu. She said that she also had chest pain, a very congested chest, a cough, and shortness of breath. She did not have that with Covid. She said that her symptoms came on about 10 hours after the vaccination and were gone within 48 hours. Patient said that she does not know if having Covid so recently plays into it at all. Patient said that she received the last dose on 03Feb2021 at 1130. Patient said that the phlegm started in her throat and she had the chills. She woke up with the whole shebang. She stated that it got worse by the next day. She said that she did not feel a thing from the first injection and had no side effects. She never tested positive for Covid in Dec2020. Her mother ended up positive for Covid and she was exposed to her and showed symptoms. She had exhaustion vertigo, and general feeling of being unwell with Covid. She had all of that again, but she was told not to expect anything respiratory. She got concerned with the chest pain, cough, phlegm, and shortness of breath. She saw the doctor on 05Feb2021 and she was instructed not to take anything because it could affect the vaccine, but her symptoms went away within 48 hours. She said that she felt like the congestion felt like a allergic reaction for her, said that it was hard to swallow, and had a lot of phlegm in her throat. She said that it is not inherently different if you were allergic to flowers. Chest pain she described like you are full of phlegm and like there is inflammation. Shortness of breath: Feel panicky when you try to breath and you feel the phlegm. Patient said that when she gets sick she does have a tendency to get upper respiratory infections. Like with a cold that she would end up with a cough that would linger a little bit. She still thinks getting the vaccine was worth it. She just wished that it would have been a listed side effect, because when it is not, you panic. Most people are worried about the shortness of breath. She reported that her O2 levels were ok when she checked. Doctor gave her a vitamin IV to make her feel better. Told her that her lungs were clear and it was all upper respiratory.
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| 48 | 2021-02-23 | fatigue, dizziness, headache | Headache and dizziness Diarrhea Nauseated Pain in arm and numbness from shoulder to elbow Fatigue |
| 48 | 2021-02-23 | chills, headache, throat pain |
chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactabl...
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chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the right arm, on 05Jan2021 10:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications included omeprazole; metoprolol; methocarbamol; vitamin d3; pregabalin; and levothyroxine. The patient did not have Covid prior vaccination. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first shot the patient experienced chills, headache, sore throat, nausea and, loss of smell - all on 08Jan2021. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for these adverse events. At the time of the report, the patient was recovering from the events. The patient had a nasal swab for Covid on 11Jan2021 with results of negative.
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| 48 | 2021-02-24 | headache, fatigue, fever |
Headache; Fever; Body aches; Fatigue; stiffness in neck; This is a spontaneous report from a contact...
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Headache; Fever; Body aches; Fatigue; stiffness in neck; This is a spontaneous report from a contactable nurse (patient). A 48-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on 26Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine 2 dose 2 days ago on Tuesday and from Tuesday night, she had pretty significant headache, fever, body aches, fatigue, and stiffness in neck. The patient wanted to know if that is normal and how long they last. The outcome of the events was unknown. Information on the batch/lot number has been requested.
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| 48 | 2021-02-25 | fever, cough |
Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer....
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Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer. A 48-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176) via an unspecified route of administration in right arm on 22Jan2021 12:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, cough, diarrhea, swelling, burning on 22Jan2021 16:00. The patient didn't receive any treatment for events. The outcome of events was recovering.
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| 48 | 2021-02-25 | chills, headache |
chills; moderate shoulder pain at injection site/shoulder pain; severe headache for 28 hours; axilla...
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chills; moderate shoulder pain at injection site/shoulder pain; severe headache for 28 hours; axillary rash under armpit/painful armpit rash; burning on injection on left arm; This is a spontaneous report from a contactable other healthcare professional (who is also the patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266, expiry date unknown), intramuscular on the left arm, on 12Feb2021 16:00, at single dose, for COVID-19 immunization, at the pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. There were no allergies to medications, food, or other products. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown) received at age 48 years, intramuscular on the left arm, on 22Jan2021 15:45, for COVID-19 immunization and the patient experienced moderate shoulder pain on injection arm. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 12Feb2021 at 16:00, the patient experienced burning on injection on left arm. On 12Feb2021 at 19:45, the patient experienced moderate shoulder pain at injection site for 24 hours and there was no shoulder pain 36 hours after the injection 14Feb2021 at 04:00; severe headache for 28 hours; and axillary rash under armpit/painful armpit rash which was still present 45 hours after the injection. On 13Feb2021 at 20:00 (reported as 28 hours after injection), the patient experienced chills which lasted for 2 hours. The patient was not tested for COVID-19 since the vaccination. No treatment was given for the events. The patient recovered from chills on 13Feb2021 at 22:00, severe headache on 13Feb2021 at 23:45, and moderate shoulder pain at injection site/shoulder pain on 14Feb2021 at 04:00. The outcome of burning on injection on left arm, axillary rash under armpit/painful armpit rash was not recovered.
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| 48 | 2021-03-03 | headache, chills, fever |
chills; headache; low-grade fever (100 F); This is a spontaneous report from a contactable consumer ...
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chills; headache; low-grade fever (100 F); This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (EN5318) in left arm on 16Feb2021 14:00 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history was not reported. Allergies to medications, food, or other products was no. Pregnant at the time of vaccination was no. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Concomitant medication included iron. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no. List of any other medications the patient received within 2 weeks of vaccination was iron. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) in left arm on 26Jan2021 14:00 for COVID-19 immunization. Patient experienced chills, headache and low-grade fever (100 F) on 17Feb2021 02:00 for about 16 hours. No treatment was received. The outcome of the events was recovered. Events was considered non-serious. Since the vaccination, has the patient been tested for COVID-19 was no.
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| 48 | 2021-03-07 | fatigue |
fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable hea...
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fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3248 and expiry date: unknown), via an unspecified route of administration on the left arm, on 02Feb2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 12Jan2021 11:00 on the right arm (lot number: ej1656). Medical history included cancer. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and no other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, warming feeling, sore arm, joints sore on 02Feb2021 15:00. No treatment was received for the events. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. Covid test was on 03Feb2021 with unknown results. The reporter considered the events non-serious.
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| 48 | 2021-03-10 | throat irritation, cough, fever, fatigue, runny nose, dizziness, throat pain |
COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat;...
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COVID-19 pneumonia; Fever (body temperature at 102.7 Fahrenheit); Threw up; littles scratchy throat; Cough; Sore throat; Dizzy spells; Runny nose /nose was a faucet; Little sore arm; Fatigue; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 48-year-old female patient (weight: 148.32 kg, height: 170 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL9262) intramuscularly, in the left arm, at single dose, on 28Jan2021, at 13:30, for COVID-19 immunisation. Relevant medical history included light Crohn's disease from an unspecified date. Concomitant medications included oral fexofenadine hydrochloride (ALLEGRA) 60 mg, twice daily (60 mg, 1 tablet every 12 hours), from 02Feb2021 to 05Feb2021, for nasal congestion; oral paracetamol (TYLENOL, capsule) 500 mg capsule (she took 2 as needed), from 02Feb2021 and ongoing, for fever and headache; salbutamol (ALBUTEROL) 90 mcg, 2 puffs every 4-6 hours as needed, from 06Feb2021 and ongoing, for breathing problems and oral benzonatate 100 mg, thrice daily (100 mg capsules, 1 by mouth three times daily as needed) from 06Feb2021 and ongoing, for cough. On an unspecified date, in Feb2021, the patient developed little sore arm and fatigue. On 01Feb2021, the patient experienced runny nose, nose was a faucet. On 02Feb2021, she had little scratchy throat, cough, sore throat and dizzy spells. On 04Feb2021, she threw up and on 05Feb2021, the patient experienced fever (she had temperature at 102.7 Fahrenheit) and then was hospitalized. Post the vaccination, the patient has been tested for COVID-19 on 05Feb2021 and resulted positive and pneumonia requiring hospitalization. She was admitted on the 05Feb2021 discharged on the 09Feb2021. Chest x-ray and CT chest performed on 05Feb2021 showed pneumonia. Body temperature on 05Feb2021, at night, was 102.8 Fahrenheit. Oxygen saturation (pulse ox) showed the following value: 80s, 84 and 93 on an unspecified date, in Feb2021. Emergency Room Visit and Physician Office Visit required for runny nose, throat irritation, cough, sore throat and pneumonia. Treatment was received for COVID-19 pneumonia, fever, runny nose, throat irritation, cough and sore throat. She was supposed to get the second vaccine on the 18Feb2021. The patient recovered from fever on 07Feb2021, did not recover from dizzy spells, while clinical outcome of the other events was unknown at time of this report.
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| 48 | 2021-03-10 | chills |
Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a con...
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Chills; Pain in hips; Cramping in abdomen; Pain in left ear; This is a spontaneous report from a contactable consumer(patient) reported that. A 48-years-old female patient started to receive bnt162b2 (BNT162B2Formualation:Solution for injection ) ,via an unspecified route of administration from 28Jan2021 14:45 to 28Jan2021 14:45 at SINGLE DOSE for an unspecified indication .Medical history included sialadenosis from an unknown date and unknown if ongoing , cervix carcinoma from an unknown date and unknown if ongoing , covid-19 from an unknown date and unknown if ongoing If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The patient experienced chills on 28Jan2021 19:00 , pain in hips on 28Jan2021 19:00 cramping in abdomen on 28Jan2021 19:00 pain in left ear on 28Jan2021 19:00 and The patient underwent lab tests and procedures which included body temperature: 97.3 on Temperature under the tongue was 97.3 and outcome of the events was unknown Information on the Lot/Batch number has been requested.
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| 48 | 2021-03-10 | headache |
anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a ...
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anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 48-years, via an unspecified route of administration in left arm on 28Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included nerve damage; multiple surgeries from a wreck. Patient was not pregnant, was not pregnant at time of vaccination, there was no other vaccine in four weeks. No COVID-19 prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA); loratadine (CLARITIN); colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C); probiotics nos. The patient previously took rofecoxib (VIOXX), miconazole nitrate (MONISTAT), gabapentin, flu shot, all experienced allergies. At 10:45 AM on 28Jan2021, the patient experienced shortness of breath (SOB), BP 209/109 within 15 minutes of the shot, clammy, major headache. Received diphenhydramine hydrochloride (BENADRYL) on site and transferred by ambulance to hospital where she received Epishot, dexamethasone and ketorolac tromethamine (TORADOL). Diagnosed with anaphylactic shock. Went home with elevated BP and major headache. Daughter called an ambulance that night because the headaches were so bad. Ambulance driver stated they couldn't do anything for patient at the hospital unless she exhibited stroke like symptoms. BP stayed elevated for 2 days and headaches continued. Started to feel better 5 days later. Followed up with her PCP and patient was put on steroids for 5 days to taper down. The adverse events resulted in doctor or other HCP office/clinic visit, emergency room/department or urgent care. Patient received BENADRYL, epinephrine, dexamethasone, TORADOL as treatment for AEs. Lab data included: patient was tested negative for COVID-19 virus test (nasal swab) on 23Feb2021. Outcome of the events was recovered in Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events anaphylactic shock, BP increased and headache with BNT162b2 use can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 48 | 2021-03-14 | dizziness, fatigue, headache, fever |
nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This i...
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nausea; vomiting; headache; feeling feverish (no fever); Feeling beat up; dizziness; fatigue; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm, on 05Feb2021 at 11:45 (at the age of 48-years-old) at a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included fingolimod hydrochloride (GILENYA), baclofen (MANUFACTURER UNKNOWN), mirabegron (MYRBETRIQ), bupropion hydrochloride (WELLBUTRIN), and hydroxyzine hydrochloride (HYDROXIN). The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies and ibuprofen (MANUFACTURER UNKNOWN) and experienced allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness and fatigue on 05Feb2021 and nausea, vomiting, headache, feeling feverish (no fever), and feeling beat up on 06Feb2021 at 13:30. The events were reported as non-serious. The clinical course was reported as follows: Within one to two hours (as reported), on and off, the patient felt dizziness and fatigue. After 26 hours (as reported), the patient felt nausea, vomiting, headache, fatigue, feeling feverish (no fever) and feeling beat up. The feeling beat up lasted 12-14 hours and the headache lasted 2 days. The patient did not receive any treatment for the events. The clinical outcome of dizziness, fatigue, nausea, vomiting, and feeling feverish (no fever) was recovered on an unspecified date, feeling beat up was recovered on 07Feb2021, and headache was recovered on 08Feb2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 48 | 2021-03-14 | shortness of breath, somnolence, dizziness |
out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported ...
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out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported sleeping more heavily than usual; woke with her hair wet as if had experienced a fever overnight; anxious; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient started received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient has known allergies to sulfur and penicillin. Concomitant medications were not reported. The patient received first dose of vaccine on 03Feb2021. Immediately following injection, felt as if her heart rate increased; felt as if it remained out of rhythm through Thursday evening eventually returning to a more regular rhythm. She also experienced shortness of breath, impaired vision and some dizziness noted in Feb2021. She also been sleeping more heavily than usual woke with her hair wet as if had experienced a fever overnight. She stated she felt better, but still not at what she would consider her normal self and was anxious about receiving the second dose and wanted to speak with someone to further discuss her concerns. Outcome of anxious was unknown while recovering for the remaining events Information on the Lot/batch number has been requested.
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| 48 | 2021-03-14 | headache, chills, somnolence, fever, throat swelling |
pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore...
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pins & needles tingling; hot/cold flashes; temp/fever; chills; Headache; body aches; dry mouth; sore R arm; LOSS OF TASTE; partial throat swelling 90 min after 2nd injection; drowsy; This is a spontaneous report from a contactable health care professional. A 48-years-old female received 2nd dose, bnt162b2 (BNT162B2) Lot number= Lot EL3247 , intramuscular in right arm, on 29Jan2021 at 15:30 as a single dose for COVID-19 immunization . Medical history included sjogren's syndrome, irritable bowel syndrome , raynaud's phenomenon, fibromyalgia , food allergy to peanuts, honey, oranges, strawberries, lobster, molasses, brown sugar, cinnamon. She had the first dose of COVID-19 on 08Jan2021 at 1545 in the right arm. There were no other vaccinations given in the past 4 weeks. She was not tested for Covid prior to vaccination.Concomitant medication included collagen (COLLAGEN), medium-chain triglycerides (MCT OIL [MEDIUM-CHAIN TRIGLYCERIDES]), ergocalciferol (VIT D), fish oil (FISH OIL). The patient previously took gluten and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. Course as follows: On 29Jan2021: partial throat swelling 90 min after 2nd injection. Took 50mg Benadryl. Became very drowsy and went to bed at 7:30pm. 30Jan2021: Woke at 5am w/chills, headache, body aches, sore R arm, temp of 101.3, dry mouth & LOSS OF TASTE. By 11:30am, fever went up to 103.5. Took 400mg ibuprofen. Went and got a Rapid Covid test (It was negative/undetectable). 4pm diarrhea. Took 400mg Ibuprofen at 6pm and 11:30pm. 31Jan2021: fever 100-101, headache, body aches, sore R-arm, diarrhea, loss of taste, sore throat. 01Feb2021: fever 99-100, headache, body aches, sore R-arm, dry mouth, loss of taste, sore throat. Went to get a 2nd Covid Rapid Test to r/o a false negative (It was negative/undetectable again). 02Feb2021: Fever 99-100, headache, dry mouth, loss of taste. 03Feb2021: temp normal, headache, dry mouth, loss of taste. 04Feb2021- 07Feb2021: temp normal, headache, dry mouth, weird continuous hot/cold flashes, pins & needles tingling all persist. Appt w/PCP scheduled for 17Feb2021. The patient was not hospitalized for the events. The patient was tested for Covid-19 on 01Feb2021 and was negative. The outcome of the events was recovering.
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| 48 | 2021-03-15 | cough, shortness of breath, dizziness |
Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes...
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Numbness of nose & upper lip, shortness of breathe, anxiety, heart palps, coughing within 14 minutes of injections.
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| 48 | 2021-03-17 | nasal congestion, shortness of breath, cough, throat pain, sweating, chills |
Patient received COVID-19 vaccine on 1/4/2021. Later that day developed chills/sweats, body aches, ...
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Patient received COVID-19 vaccine on 1/4/2021. Later that day developed chills/sweats, body aches, cough, nasal congestion, sore throat and shortness of breath. She continues to have shortness of breath and has not been able to return to work.
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| 48 | 2021-03-21 | chills |
I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactab...
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I'm paralyzed; Anxiety; chills; Shaking but not fever; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included hypertension, brain injury (doesn't have a good memory), menopause and menopausal problem. The patient is on a lot of medications (unspecified medication) for her Brain injury. The patient previously received the first dose of BNT162B2 on unspecified date for COVID-19 immunization. The patient had her second dose on 06Mar2021 and had been having bad like chills and shaking too but not fever. The patient was shaking bad (not clarified) there but she doesn't know if it's part of her menopausal problem from my menopause (as reported) but she was shaking. The patient mentioned that she was paralyzed. The patient stated that she was taking some Ativan for anxiety, she has been so anxious; and she had been taking Benadryl. The outcome of the events was unknown.
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| 48 | 2021-03-22 | headache | Seizure the next day plus headaches, tremors and vomiting. |
| 49 | 2020-12-31 | headache, chills, fatigue |
12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tig...
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12/26-Had the vaccine, 27th evening felt nauseated, woke up in the middle of the night with head tightness(headache), rigors, hot flashes.28th feeling off and fatigued, continued to feel better as the days went on and on the 31st had diarrhea, rigors, temp of 99.3F, hot flashes, muscle aches now.
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| 49 | 2020-12-31 | throat pain, fatigue, fever | Intermittent fever , sore throat fatigue for over 5 days |
| 49 | 2020-12-31 | headache, weakness, dizziness, malaise, fatigue |
mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1...
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mild dizziness (at time of injection); injection site soreness (12 hours after injection; duration 1 day); 3 says after injection: nausea, dizziness and weakness, headache, tiredness, feeling unwell.
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| 49 | 2021-01-01 | fatigue, headache |
12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , ...
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12 hrs after vaccination, had mild frontal headache and fatigue. 24 hours after, itching, burning , stinging sensation around eyes, itchy forehead with mild erythema including eyelids, mild circumoral numbness with occasional burning/stinging sensation.
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| 49 | 2021-01-02 | dizziness |
2:37 pm 10 minutes after receiving vaccine pt reports feeling dizzy and nervous. She has a history o...
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2:37 pm 10 minutes after receiving vaccine pt reports feeling dizzy and nervous. She has a history of anxiety and has been seen before for anxiety attacks. Pt denies chest pain, shortness of breath or pain. 2:45 pm pt evaluated by EMS BP 138/78, Pulse 98. pt reports feeling better. 2:55 pm pt declined transport to ED, signed out AMA. Pt was escorted out to car.
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| 49 | 2021-01-03 | sweating |
10 min after initial injection, I experienced a brief flush of heat that resolved after a few minute...
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10 min after initial injection, I experienced a brief flush of heat that resolved after a few minutes. 6 hours later, I had a sudden onset of intense heat, diaphoresis, and a rash to my arms/legs, along with intense muscle tremors, nausea, vomiting and stomach cramps.
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| 49 | 2021-01-03 | fatigue, headache |
12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit ...
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12/29 - Left arm - large painfull, swollen area at injection site. Pain radiated from neck, arm pit to wrist. All over fatigue, joint pain, brain fog, and temp of F. Nausea and headache. 12/30 - Pain in left worse, incressed pain, redness, and swelling at injecition site. Painful swollen area in left armpit. Pain with any movement of left arm. Headache, fatigue, nausea, and muscle weakness. 12/31 - Continued pain in left arm, but improved. Continue to have pain swollen area with warmth and redness size of an orange. Headache and fatigue. 1/1 - fatigue, arm sore. Bilateral arm weakness. 1/2 - headache throughout day, not responsive to Tylenol or Advil, fatigue 1/3 - Vertigo, fatigue 1/4 - Left arm slightly sore to touch, fatigue.
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| 49 | 2021-01-03 | dizziness, night sweats, weakness |
Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. S...
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Four days after receiving vaccine, awoke at 3am to roll over in bed and had dizziness and nausea. Symptoms are ongoing. Also, complaints of insomnia (ongoing), joint pain (day after vaccination), right lower quadrant pain (first night after vaccination), weakness (for 3 days after vaccination), moderate muscle pain at injection site (resolved after 48 hours), night sweats (ongoing).
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| 49 | 2021-01-03 | cough |
I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around ...
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I had lip swelling, flushing and coughing the day of the vaccine. I had swelling and redness around the vaccine site. The next morning I had swelling of my hands, feet and legs.
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| 49 | 2021-01-03 | fatigue |
Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigu...
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Intense pelvic/thigh ache started day 2. I still have the ache, but it?s tolerable. I am very fatigued. Nausea the first two days, with diarrhea.
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| 49 | 2021-01-03 | fatigue | Very sore arm, required Tylenol Moderate fatigue Sore are resolved next day Fatigue continues |
| 49 | 2021-01-03 | weakness, dizziness, headache | headache, weakness, brain fog, confusion, dizziness. weakness in limbs |
| 49 | 2021-01-03 | fatigue |
pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at tim...
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pain at injection site that radiated down left arm then turned into overall body aches on 1/3 at time of injection. Nausea started on 1/4 around 930am. overall fatigue
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| 49 | 2021-01-04 | malaise, headache, fever |
By evening I began running a fever (101-102), headache, body ache, general malaise. I went to bed ar...
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By evening I began running a fever (101-102), headache, body ache, general malaise. I went to bed around 10 pm, I woke the following day around 4pm. This is very unusual for me. Confined to not feel well into the next day , but by that evening I felt better.
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| 49 | 2021-01-04 | dizziness |
Dizziness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non-pregna...
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Dizziness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in the last four weeks. Concomitant medications included omeprazole (PRILOSEC), metoprolol, levothyroxine sodium (SYNTHROID), aciclovir sodium (ACYCLOVIR VIAL), and meloxicam (MOBIC). The patient previously had allergies with morphine. On 28Dec2020, the patient experienced dizziness 12 hours after injection with outcome of recovering. The patient did not receive treatment for the reported adverse event. The report was considered non-serious. Information on the batch/lot number has been requested.
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| 49 | 2021-01-04 | headache, dizziness |
Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue are...
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Headache, dizziness, numbness/soreness in the left side of my face-cheek, eye, mouth, and tongue areas. Affects similar to receiving a Novocain shot. No treatment, went away on its own Lasted four hours-was closely monitored
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| 49 | 2021-01-04 | chills, fatigue, fever, headache |
High fevers (103/104 degree F) with chills for five days followed by low fevers ( upto 101) for anot...
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High fevers (103/104 degree F) with chills for five days followed by low fevers ( upto 101) for another six days and still ongoing; High fevers (103/104 degree F) with chills for five days followed by low fevers ( upto 101) for another six days and still ongoing; headaches; fatigue; This is a spontaneous report from a contactable physician, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Dec2020 at 15:15 (at 49-years-old) as a single dose for COVID-19 immunization. Medical history included severe iron deficiency, hypothyroidism, osteoporosis, and low baseline IgM antibodies levels (unknown cause). The patient did not have any allergies to medications, food, or other products. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), and biotin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Dec2020 at 18:00, the patient experienced high fevers (103/104 degrees Fahrenheit) with chills for five days followed by low fevers (up to 101 degrees Fahrenheit) for another six days, headaches, and fatigue; all reported as non-serious. On 24Dec2020, the patient had a post vaccination nasal swab rapid antigen test and SARS-CoV-2 PCR test with negative results. The patient took paracetamol (TYLENOL) and ibuprofen (ADVIL) for treatment for the events. The clinical outcomes of the fever, chills, headaches, and fatigue were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of high fevers with chills. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-04 | sweating, headache, chills |
I broke out, I was sweating; Terrible headache; Chills; My body hurt; This is a spontaneous report f...
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I broke out, I was sweating; Terrible headache; Chills; My body hurt; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for seasonal allergy. On 29Dec2020 (within a few minutes), she broke out and was sweating. She had sweat at her face and sweated in her clothes. The patient also have a terrible headache, her body hurt and have chills. The patient did not receive any treatment for the events and was going to ask if she can take diphenhydramine (BENADRYL) as she do not know what to do. She doesn't know if she can take medicine because it was terrible. Outcome of the events were unknown.
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| 49 | 2021-01-04 | chills, headache, fever |
Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is...
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Received Pfizer covid 19 vaccine 1/2/21(Saturday). Bed time Saturday injection site was and still is tender. Also notice mild body aches at this time. Sunday came home from work w fever chills headache and vomiting
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| 49 | 2021-01-04 | dizziness, fatigue, weakness, chills |
difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; ...
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difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-04 | chills, fever, headache |
headache; Muscle aches; Chills; 102.5 fever; This is a spontaneous report from a contactable Nurse. ...
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headache; Muscle aches; Chills; 102.5 fever; This is a spontaneous report from a contactable Nurse. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at Arm Left at single dose for COVID-19 immunisation. Medical history included Low thyroid, Covid (diagnosed with COVID-19: Yes). Concomitant medication included levothyroxine sodium (SYNTHROID). The patient experienced muscle aches, chills, headache, 102.5 fever on 28Dec2020 18:00. All events were non serious. No treatment was received. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient underwent lab tests and procedures which included body temperature: 102.5 on 28Dec2020. The outcome of the events was resolved in Dec2020. No follow up attempts are possible. No further information is expected.
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| 49 | 2021-01-04 | fatigue, fever, headache |
left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some p...
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left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.
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| 49 | 2021-01-04 | headache |
she had a slight headache that turned into a bad headache; threw up/ vomited; Nausea; This is a spon...
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she had a slight headache that turned into a bad headache; threw up/ vomited; Nausea; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received one dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER5730) via unspecified route on right upper arm single dose for COVID-19 immunization on 30Dec2020 before 10:30AM, at 49-year-old. Medical history and concomitant medication were not reported. On 30Dec2020, 20 minutes after getting the vaccine, the patient had a slight headache that turned into a bad headache by 11AM. Then she went to lunch at 11:30, and after she ate something, she took ibuprofen, then got back from lunch, worked an hour, and threw up. She vomited between 1 and 1:30PM, and vomited a few times and was done, but could still feel a little nausea, but was not going to go throw up. She checked her temperature but didn't have one. Action taken for BNT162B2 was not appliable. Outcome of the event headache was resolving, outcome of the event threw up/ vomited was resolved on 30Dec2020, outcome of the other event was unknown. It was reported as non-serious.
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| 49 | 2021-01-04 | migraine, headache, shortness of breath, runny nose |
swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle an...
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swelling and redness in the face; swelling and redness in the face; Muscle and body aches; Muscle and body aches; shortness of breath; headache/migraine; headache/migraine; runny nose; sneezing; soreness in upper and lower left arm; swelling in left arm and in both hands; This is a spontaneous report from a contactable Other HCP (patient). This 49-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EJ1685) at single dose on 28Dec2020 at 02:00 PM on left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included fibromyalgia; skin lupus; sacroiliitis; chronic migraines; allergies to Latex, TB shot skin test, several foods, environmental things (trees, grass, pollen, cockroaches, etc.). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was not reported. Since the vaccination, the patient had not been tested for COVID-19. On 29Dec2020 at 06:15 AM, the patient experienced swelling and redness in the face, muscle and body aches, shortness of breath, fatigue, headache/migraine, runny nose, sneezing, swelling in left arm and in both hands. There was not treatment received for all the adverse events. All events considered non-serious as all not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was not resolved.
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| 49 | 2021-01-04 | headache, weakness, throat swelling, throat pain, chills, fatigue |
throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it ...
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throat sore and pain in neck; her throat is sore, feels like it may be swelling; some neck pain; it feels like muscle spasms; extremely tired; soreness in her arm; Chills; Nausea; felt weak/having some weakness; massive headache/mild headache; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration on 28Dec2020 11:00 on left arm at a single dose for COVID-19 immunization. The patient was positive for Covid back in Jun2020, it was a bad case that she was hospitalized for 6 days, that she did not have to go on respirator. She stated these days she still struggled with chest pains and still struggled with her taste, she went to the emergency room in Sep2020 with some issues from that. The patient concomitant medications were none. The patient stated she was retired who works security at a hospital that she got her first dose of the Pfizer Covid vaccine yesterday on 28Dec2020. She was calling to report some side effects from the vaccine. She was skeptical about shot but she went ahead and got the vaccine, she took it and waited the 15 minutes and everything was fine except some soreness in her arm, about an hour after the shot, she felt extremely tired, could not even read, by last night she was getting chills, nauseated and weak, all she wanted to do was sleep, she had a massive headache. She kept thinking she was going to have to go to the ER. She woke up this morning and her throat was sore, felt like it may be swelling, felt sick. She took two advil and her headache was better. She was taking tumeric and ginger root and honey with lemon for her throat. She knew she was not sick that it is just the vaccine and she would power through it but wanted to call. She was starting to feel better but still having some weakness, still tired, had pain in the arm of the injection site, a mild headache. She stated these side effects are still ongoing but are improved. She was also having some neck pain started this morning sometime, but does not know exact time, it feels like muscle spasms. Caller wanted to know if because she had Covid before her side effects are so bad. The patient did not do any relevant tests. The outcome of the events soreness in her arm, extremely tired, Headache was recovering, the outcome of the events Chills, Nausea was recovered in Dec2020 and the other events was not recovered.
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| 49 | 2021-01-05 | lethargy, fatigue |
A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and i...
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A couple of hours after the vaccine, I began to have extreme muscle pain, both in the left arm and in my other arm, back. I became extremely fatigued and felt lethargic. I felt flushed and slightly nauseated, but mostly I felt body pain and extremely tired. This continued through the evening and night. In the morning of 1/6/21, I felt better, but today I still have severe muscle pain in both arms and shoulders and back and neck and I am still fatigued, with some loss of appetite.
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| 49 | 2021-01-05 | fever, chills | Chills Muscle and joint aches Fever Nausea |
| 49 | 2021-01-05 | headache, chills | Chills,joint pain,muscle aches,nauseated, headache, sore arm |
| 49 | 2021-01-05 | thirst, body temperature increased, fatigue, headache |
Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did ha...
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Day of next day after vaccine administration-only had mild headache, thirst and fatigued. I did have a hematoma and bruising, No fever On Jan 1st, I started feeling fatigued again and noticed round reddening approximately 2 inch in diameter appear about a inch under vaccination location which is still bruised. There is no pain or itching at reddened site. Jan 2, 3 and 4th-Fatigue worsened and developed low grade temp never surpassing 100. My throat developed allergy reaction feeling, same reaction I get with nuts. Throat did not swell and benedryl managed the reaction on Jan 3rd. My eyes began swelling and I could not stop sneezing. Developed laryngitis from the post nasal drainage. I was up whole night but still went into work as normal on Jan 4th. Struggled through the days but swelling and itching subsided. I experienced the muscle aches on the 3rd and 4th. On Jan 5th, started feeling better and rested. Still have reddened reaction on arm but is fading. It is faintly visible today on Jan 6th, I feel better, just have the sneezing currently and a mild headache. Benedryl is the only medication besides daily meds I took during the past several days. I did not want to interrupt the immune system's work.
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| 49 | 2021-01-05 | fatigue, somnolence, malaise |
Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat w...
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Eyes were red; Tiredness and needed to sleep extra; Tiredness and needed to sleep extra; Heartbeat was fast; Felt like she had to throw up; Pain in right arm; Does not feel good; It felt like there was oil in her mouth; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of BNT162B2 via an unspecified route of administration on 30Dec2020 10:45 at single dose in right arm for COVID-19 immunization. The vaccination was given in hospital, not a military facility, at 10:45 and left hospital at 11:05 on 30Dec2020. Prior vaccinations within 4 weeks was none. Additional vaccines administered on same date of the Pfizer suspect was none. Medical history included ongoing migraine and family medical history included mother has high blood pressure and father has diabetes. Concomitant medication included verapamil from Oct2020 at 40 mg twice daily by mouth for migraine. Additional Information for concomitant products Verapamil included 1 for one week, 2 for second week 3rd week 3 and after 3 months, then came back down to 2. The patient experienced does not feel good at 11:30 on 30Dec2020. She was driving and did not feel good. She felt like she had to throw up at12:00 on 30Dec2020 and had it all night until she went to bed. Eyes were red when she woke up at 23:30 on 30Dec2020, that's when she first noticed. Heartbeat was fast around 12:30 on 30Dec2020. Tiredness and needed to sleep extra at 17:00 on 30Dec2020. Pain in right arm at 12:00 on 30Dec2020. When she went to drink something, she noticed her arm was painful. No ER or physician's office required. Received call from patient regarding the COVID vaccine. She received it on 30Dec2020 (yesterday) and was a healthcare worker. She later stated she works in patient transportation in a hospital. She did not feel good. Yesterday, she felt like she had to throw up. When she slept, she felt very tired and when she woke up, her eyes were red. She washed her face when she woke up around 11. Then she noticed her heart beat was kind of fast. She took another medication she takes all the time. Her doctor said that she can take it with it but she was not sure. She did not feel herself. Yesterday after she took it, she had to wait there for 15 minutes. It felt like there was oil in her mouth. She just drank water and came home. When she came home, her heart beat was fast. She had to sit down. She liked to eat spicy food, and she needed to sleep. Her kids said she never slept like this. Both eyes were red, red like blood. Her daughter told her to go look at them in the mirror. There was no pain or nothing in her eyes, they were just red and they improved today. If she goes to bed now, she can sleep, but she just wakes up and drinks tea and wants to wake up. She didn't want to sleep, but she felt like she could. Regarding the pain in her right arm, she had to hold her shoulder when she first woke up. It was worse then, but it's better now that she keeps moving it. She has 3 more weeks to get the next dose of the COVID Vaccine. Hopefully it will be this shot only and she can go back to work. She planned on going back to work on Saturday. She would like to know if she can continue to take Verapamil. She will call her pharmacy to find out. The outcome of the events does not feel good and tiredness and needed to sleep extra was not recovered. The outcome of the events felt like she had to throw up, eyes were red, heartbeat was fast and pain in right arm was recovering. The outcome of the other event was unknown. Information on Lot/Batch Number has been requested.
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| 49 | 2021-01-05 | headache, fever |
Fever (101F), body aches, joint pain, headache, left upper abdominal pain (under base of ribs) all l...
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Fever (101F), body aches, joint pain, headache, left upper abdominal pain (under base of ribs) all lasting apx 16hrs. Then the next 24 hrs just mild HA and some body aches.
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| 49 | 2021-01-05 | headache | Headache for 4 days following vaccine. On day 5 following vaccine developed hives on arms and chest. |
| 49 | 2021-01-05 | headache, dizziness |
I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was si...
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I did let the nurse know right after I got the vaccine It did feel like a huge water balloon was sitting on my arm and very heavy at the site. I went to the waiting area and the last 5 minutes and I started feeling weird, kind of getting dizzy and my heart started racing really fast. Am I can tell I was getting really hot and my face was flushed and my heart was racing and my hands started shaking, trembling almost like I couldn't control it. I've never experienced something like this. The part that really scared me was my heart racing like it was going to come out of my chest. They called a code, put me in a wheel chair and took me to the ER (where I work). They took my blood pressure which was really high, they did EKG, blood work and urine test. They kept me there for about five hours, while watching me. And the last weird thing that happened at one point I felt like liquid was running thru my body and my feet were really cold for several hours, It felt like someone was pouring liquid over me. I kept asking the nurse if this is normal and no one knew what to tell me. After everything started slowing back down and it had been a couple hours and the next day i felt like I had a slight head ache and felt out of it, kind of like I had a hangover and of course my arm was really sore. The Doctor in the ER did advise me not to get the second dose as it will be worse than the first one.
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| 49 | 2021-01-05 | throat irritation, shortness of breath, headache, chills, fever |
I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itch...
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I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itchy, I left at 3pm by 3:15 my head started hurting, mild. at 7pm I had a pounding headache, chills, body aches on the 24th AM I could not warm up my body was shivering I went to work at 8 am I thought I had a fever and I checked it was 100.2 when I got home my temp was 101 and 102.9 and my body aches were horrible I couldn't move nausea no appetite, shortness of breath, I did a telemed and talked to my primary and she said this was all related to the vaccine, she prescribed something for the nausea was asked to get a covid test and it came back negative, I started getting better Dec 27th .
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| 49 | 2021-01-05 | headache, chills, night sweats |
Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM...
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Night sweats followed by chills and rigors, followed by severe headache and nausea/vomiting from 2AM on 1/5/2021 to 0730 1/6/2021. Massive headache still lingering.
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| 49 | 2021-01-05 | dizziness |
Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine admi...
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Patient experienced dizziness, "brain fog", and elevated blood pressure 15 minutes post vaccine administration
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| 49 | 2021-01-05 | migraine |
UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to...
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UrticariaPruritus HOT flashes, prickly skin of jaw line to chest EMP was injected in the ER due to a previous flu vax reaction 2 years. She did consequently have a migraine headache upon awakening this AM which prevented her from working. Treated with Benadryl 25mg PO in the ER, monitored via cardiac monitor and then she was discharged with 25mg of Benadryl that she took when she got home at 1630.
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| 49 | 2021-01-05 | cough, shortness of breath |
coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and...
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coughing; Itching; chest tightening; large whelps all over body, face, eyes; high blood pressure and heart rate noted; high blood pressure and heart rate noted; 18 hrs after vaccine mild rash on back and arms and mild sob; 18 hrs after vaccine mild rash on back and arms and mild sob; This is a spontaneous report from a contactable nurse, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9231), via an unspecified route of administration in the right arm on 23Dec2020 at 19:30 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, kidney stones, and gastrooesophageal reflux disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethynylestradiol/norgestrel (OGESTREL-28), cetirizine hydrochloride (ZYRTEC), and cefdinir (OMNICEF). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took nicotinic acid (NIACIN) on unknown dates for an unknown indication and experienced drug allergy in the form of mild flushing. On 24Dec2020 at 13:30, 18 hours after the vaccine, the patient experienced mild rash on back and arms and mild shortness of breath (SOB). On 25Dec2020, the next day, the patient had a severe rash with large whelps all over body, face, eyes. She had extreme SOB, chest tightening, coughing and itching. The patient went to the hospital emergency room and high blood pressure and heart rate were noted. On 25Dec2020, the patient had a nasal swab done for COVID and it was negative. The patient was treated for the events with IV methyprednisolone (MANUFACTURER UNKNOWN), IV famotidine (MANUFACTURER UNKNOWN) and hydroxyzine pamoate (VISTARIL). The clinical outcomes of the rash, SOB, large whelps, chest tightening, couching, itching, high blood pressure, and high heart rate, were recovered in Dec2020.
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| 49 | 2021-01-05 | malaise, chills |
nausea; chills; malaise; This is a spontaneous report from a contactable nurse reported for herself....
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nausea; chills; malaise; This is a spontaneous report from a contactable nurse reported for herself. A 49-year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via unspecified route of administration at left arm on 23Dec2020 15:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included Sjogren's syndrome, and chronic sinusitis. The patient was not diagnosed with COVID-19 and did not receive other vaccine in four weeks prior to Covid vaccination. Concomitant medications included hydroxychloroquine sulfate (PLAQUENIL), colestyramine (questran), lifitegrast (XIIDRA), and chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX); all from unspecified date for unspecified indication. The patient previously took codeine and Ceftin; both experienced allergies. On 26Dec2020 08:00 three days after receiving vaccine, the patient experienced nausea, chills and malaise. The symptoms lasted for four days (Dec2020). The patient has not been tested for Covid-19 since the vaccination. The patient received no treatment due to the events. The outcome of the events nausea, chills and malaise was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. Follow-up activities are possible, information on the batch number has been requested.
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| 49 | 2021-01-06 | dizziness, headache |
12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed...
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12:14pm Received vaccine and returned to office after 15 minute observation period. 2:30pm developed headache, 3pm developed nausea, vomiting and dizziness, flushing of skin. Rapid Response called at 3:52pm and patient sent to Emergency Room at 4pm. VS on arrival were BP 144/105, HR 146, RR 22, T 97.9, O2 sat on Room air 98%. ED treatment included IV of 0.9NS (1L), EKG, IV Zofran 4mg, IV Benadryl 25 mg, IV Ativan 0.5mg, IV Compazine 10mg. Also had CT head.
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| 49 | 2021-01-06 | dizziness, shortness of breath |
?Pfizer-BioNTech COVID-19 Vaccine EUA Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 1...
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?Pfizer-BioNTech COVID-19 Vaccine EUA Pfizer Covid 19 vaccine 30mcg/0.3ml Vaccine administered on 12-31-20 at 3:38 pm. Pfizer vaccine Lot EL0142. 0.3ml IM, left deltoid. states felt dizzy after receiving injection. left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 1-1-21; knot grew to ~5x5 cm max size over 48 hrs. Itchy, but painful if tried to scratch. Took Benadryl 1-3-21, took Zyrtec 1-4-21. Evaluated at Employee Health on 1-5-21. Some dizziness with position change. Exam: No fever. No orthostatism to BP. Pulse 77-- >94 from lying to standing. Left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Instructed to take OTC antihistamine (Zyrtec) daily until 7 days after symptoms resolve. PMH significant for Covid 19 infection (positive test Oct. 28, 2020). Hospitalized 11-4-20 for decreased O2 saturation. Treated with Remdesivir. Post-Covid infection shortness of breath/dizziness. A picture of the affected area is available if requested
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| 49 | 2021-01-06 | sweating, dizziness |
@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained ...
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@12:45pm Pt c/o slight dizziness w/nausea, blurred vision after 5 minutes and diaphoretic, obtained v/s (stable) assisted laying down on stretcher. Bottle water offered and took several sips. Â @12:54pm Dr arrived for provisder Assessment and noted stable just continue monitoring. Waiting for longer observation for 20 more minutes. Pt states,"I feel a lot better." Â Pt taking Ceftriaxone currently and finished prednisone x2 days after a course of several days. Â Pt advise to call if s/sx return or get worse. Â Allergies updated and Covid-19 vaccine added, suggested "not recommended for 2nd dose" and 2nd dose appt canceled.
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| 49 | 2021-01-06 | migraine, headache, chills, fatigue |
About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills. All sympt...
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About 1.5 hours after injection: migraine, bad sinus pressures, major fatigue and chills. All symptoms lasted about 22 hours. I still have a minor headache and fatigue
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| 49 | 2021-01-06 | cough, fever, headache, shortness of breath, chills |
About an hour after the injection I had pain and burning going down my left side and in the left sid...
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About an hour after the injection I had pain and burning going down my left side and in the left side of my chest that lasted about 45 min. I was fine for the next 12 hr. Around midnight I started with chills, joint pain body aches and a headache. I woke up around 2 am with a fever. All day on the 6th I felt horrible with body aches, joint pain and a severe headache. Around 10 pm on the 6th I started again with chills fever chest pain SOB Cough and vomiting (3 episodes throughout the night.) My lungs currently feel like they are on fire and I continue to have chest tightness, joint pain Severe headache and a cough. I am approximately 56 hr post second vaccination. I had no problems with the first vaccination
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| 49 | 2021-01-06 | skin warm |
DEVELOPED HIVES ON BACK, THAT THEN WENT DOWN THE RIGHT ARM. ARM GOT VERY HOT TO THE TOUCH AND INJECT...
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DEVELOPED HIVES ON BACK, THAT THEN WENT DOWN THE RIGHT ARM. ARM GOT VERY HOT TO THE TOUCH AND INJECTION SITE GOT HARD. LAST A FEW HOURS AND THEN HIVES WENT AWAY. NO MEDICINE WAS TAKEN TO HELP RESOLVE.
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| 49 | 2021-01-06 | dizziness | Dizziness |
| 49 | 2021-01-06 | headache, weakness, dizziness |
Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, g...
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Dizziness, Headache, pins and needles injection site, one side shoulder, arm, neck pain, weakness, generalized weakness Narrative: employee considered response mild, needed a heat pack for pain relief, staying in bed on Jan 5. Taking 800 mgm ibuprofen every eight hours, has not recovered yet.
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| 49 | 2021-01-06 | fever | Fever and body aches. Stayed Home |
| 49 | 2021-01-06 | weakness, headache, chills, fever, fatigue |
Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02...
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Fever, chills, feet felt frozen-Sat day & evening w/ABD pain Exhausted-she slept, next day Sunday@02 or 03 sleeping clothes all wet-she had to change her clothes, Sunday-she feels drained, She laid in bed Saturday & Sunday drank water and took Motrin. Monday-too weak to work. Body aches, headache. Monday severe ABD cramps-heating pad to help/nauseated. Tuesday diarrhea starts. Wednesday-left side of her back-pain-diarrhea & Tired. No SOB. Drinking Pedialyte and taking Motrin-she said IF she gets worse she will go to the Urgent Care-near her home.
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| 49 | 2021-01-06 | fever, chills | Fever, chills, shaky |
| 49 | 2021-01-06 | headache | Headache & NauseaVomiting Narrative: |
| 49 | 2021-01-06 | dizziness, chills, headache | Headache, Myalgia, ARM PAIN,CHILLS,LIGHT HEAD Narrative: |
| 49 | 2021-01-06 | chills |
Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm...
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Medical Imaging Associate - Received vaccine on 12/18/20 @ 0845hrs. Associate has developed neck/arm soreness, chills, and hives/welts on her face, neck, back, and thighs. The associate is taking Benadryl and self-monitoring her symptoms currently from home. The associate was instructed to seek medical attention if symptoms worsen.
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| 49 | 2021-01-06 | headache, weakness, shortness of breath, dizziness |
Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad...
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Nausea, Headache, Weakness, Shortness of breathing, elevated heart rate, light-headed. Just felt bad (Still having some of these problems)
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| 49 | 2021-01-06 | headache, fatigue, chills |
Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4...
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Nausea, tick to mouth, headache, muscle aches, fatigue, bruising, chills and low grade fever of 99.4 beginning at 8PM on 1/6/2021. Vaccine given at 7:30 AM on 1/6/2021. Still experiencing body aches as of 10am on 1/7/2021 but all other symptoms have improved. No treatments given.
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| 49 | 2021-01-06 | weakness | Patient reported weakness and pain in neck and back |
| 49 | 2021-01-06 | headache, dizziness, fatigue |
Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the l...
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Patient reports Disoriented, patient feels like she was drugged, dizziness, facial numbness on the lft side, especially on the cheek, coming from neck. Back of head. numbness and tingling feeling on the back of the head and both arms and the hands. Patient reports headache as well. Also feeling fatigued
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| 49 | 2021-01-06 | fever |
Received Pfizer lot EL1284 on 12-31-2020 in right arm. That night she developed a fever and her arm...
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Received Pfizer lot EL1284 on 12-31-2020 in right arm. That night she developed a fever and her armpits swelled up that she was not able to put her arm down. It lasted several days.
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| 49 | 2021-01-06 | body temperature increased, headache, sweating, chills | SWEATS, HEADACHE,BODY ACHES,CHILLS,TEMP .OF 101.1 , |
| 49 | 2021-01-06 | fatigue, migraine, cold sweat, sweating |
This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vacci...
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This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vaccine recipient reported that after 10 minutes of receiving the 2nd vaccine they developed a headache that felt like a migraine. The vaccine recipient took Advil, then a few minutes later started sweating, felt clammy, and hot. The symptoms started to pass 15 minutes later. That night they reported that their chest felt tight but it went away before bedtime. This morning 1/7/2021, vaccine recipient reported feeling tired and mind felt foggy. They were able to continue to go to work.
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| 49 | 2021-01-06 | dizziness |
Today was my second dose of the COVID vaccine and just a few short minutes after the injection the i...
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Today was my second dose of the COVID vaccine and just a few short minutes after the injection the injection site start itching. At just about the 15 min wait time after ionjection a nurse asked if i was feeling ok. I told her i was feeling gine but my arm was very itchy. She checked the site and I had redness all around the site and welt size hives around the site. She asked me to stay 15 min longer and I agreed. Shortly after that the hive started to spread to my neck and chest area and I became lightheaded and faint feeling. I became very hot. They gave me and injection of benadryl and since my BP was high and my syptoms were not going away completly I was taken to the ER for monitoring and IV fluids. There I was given more Benadryl, steroids, Pepcid and IV fluids and monitored. I felt much better and was released to go home with a RX for 4 days of steroids.
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| 49 | 2021-01-06 | throat pain, headache, fatigue, dizziness, malaise |
felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, al...
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felt drugged, bumping into things, everything going in slow motion both arms were numb an tingly, also hands flushed feeling over neck facial numbness on the left check headache dizziness neck pain throat pain numbness and tingling on right arm fatigue feels unwell
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| 49 | 2021-01-06 | headache, dizziness, throat swelling |
throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallo...
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throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 49 | 2021-01-07 | dizziness, fatigue, shortness of breath |
1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience q...
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1/7/2021 I was extremely tired and could not raise left arm without assistance. I also, experience quit a bit of pain at the injection site. Arm pain decrease the next day and was able to raise arm without assistance. 1/8/2021 Tired and lightheaded. I felt like I would pass out if I did not sit down. Cannot stand on my feet longer than 30 minutes at a time. Also experience shortness of breath.
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| 49 | 2021-01-07 | migraine, headache, chills, body temperature increased, fatigue |
100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is ver...
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100.7 temperature/her temperature and it was 101.7; she was up all night/she didn't sleep; It is very painful; migraines; she felt warm; joint pain; dull headache; tenderness at the injection; chills; as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it; fatigue/joint pain and fatigue are getting worse; This is a spontaneous report from a contactable consumer. A 49-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on the left arm on 30Dec2020 10:40 at single dose for covid-19 immunisation. Medical history included from Feb2020 and ongoing she is currently a breast cancer patient/she had breast cancer, has lymphedema in the right due to breast cancer and on 31Oct2020, she tested positive for COVID and that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. Had joint pain and fatigue ever since her COVID-19 diagnosis in October. There were no concomitant medications. The patient previously took H1N1 shot and her arm got really big and they watched for cellulitis discomfort. The patient stated on Dec2020, "received the COVID-19 vaccine on 30Dec2020 and is reporting 100.7 temperature, dull headache, tenderness at the injection, chills, joint pain and fatigue. She reported that she has had joint pain and fatigue ever since her COVID-19 diagnosis in October. The patient contacted COVID, she tested positive on 31Oct2020, and still has no taste or smell, and the biggest thing right now, that ever since she was positive, her joints and skin, shins and upper arms and legs are really tender, and hips, wanted to know if that is normal. She wants to know, where it has gone into the joint, the arthritis has flared from it, from her testing positive, it will be 9 weeks tomorrow since she had COVID, and she is not 100%, and yesterday she had the COVID vaccine, her first dose, and she was up all night, her joints and muscles were in a lot of pain, but she had been like that, and this morning she took her temperature and it was 101.7. Does it mean can't have the shot in 3 weeks? She has had health issues this year, she had breast cancer, and her oncologist wanted her to have the vaccine, but it concerns her with all the pain in her joints swelled, and wanted to know if it is a side effect due to COVID. States she is still coughing, she wants to know if Pfizer thought this was a side effect of COVID, since she tested positive in October, will she have to live like that? It is very painful. Her shot went fine at 10:40 yesterday morning, fine, but she has been experiencing stiffness and joint pain, and she contacted COVID in October, thinks this doesn't have to do with the shot, this has been this way since October, and her husband said to ask- will it be like this since she contacted COVID, and the only thing, this morning she had a headache, but she didn't sleep and she gets migraines it she doesn't sleep, and she took her temperature, she felt warm and it was 101.7. Her temperature was 101.7 about a half hour ago (31Dec2020), she takes her temperature now, states it is now 100.8. Stated that she probably needs to speak to her doctor for her questions. Got up a 1am and took Ibuprofen. Her joints were so sore from when having COVID and so she went back to sleep and slept off and on. Got up at 4am this morning with the dull headache, it was not enough to be considered a migraine, so she took another 800mg Ibuprofen. Headaches: states it is just a dull headache, she hasn't taken Ibuprofen yet this morning, she is not a big medicine person, she is trying to see if it will go away, but if it is worse she will take migraine medicine". The outcome of "as had joint pain and fatigue ever since her COVID-19 diagnosis in October/the arthritis has flared from it", "she was up all night/she didn't sleep", "It is very painful", "migraine" and "she felt warm" were unknown. Other events was not recovered.
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| 49 | 2021-01-07 | sweating, influenza like illness, chills, headache |
12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand ...
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12 hours after injection I acutely developed headache, chills, sweating, muscle aches, nausea, hand and face swelling, swelling and tenderness around injection site, general flu-like symptoms making it difficult to sleep. I was able to go to work the next morning despite symptoms. Symptoms, other than mild soreness in arm where injected, resolved 36 hours after onset.
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| 49 | 2021-01-07 | fatigue, headache, weakness, chills |
Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after inject...
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Chills with goose bumps, headache, severe aches, weakness/fatigue which began ~ 7 hours after injection and progressively worsened over 24 hours, ~40 hours after injection symptoms were gone. -took advil, increase fluids and went to bed to sleep ~ 7 hours
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| 49 | 2021-01-07 | fatigue, headache, throat swelling, discomfort |
EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, ...
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EE received vaccine, waited in room for about 20 minutes. About 10 minutes after receiving vaccine, she felt warm but she had a coat on and her eyes started to hurt and she felt tired but she works night shift. She felt this was normal for working the night before and having stayed up to get the vaccine. After her wait period she went to her car and remembers feeling warm for having to walk in the cold. Her right side of face became reddish purple and warm. She sat in car for a few minutes. As she drove her face started to swell and turn all red. When she arrived home she had heavy pressure middle of face-nose area. Her face continued to turn reddish purple with a rash on right side of face and down to her neck. She felt her sinuses and throat swell with irritation and in throat and wheezing. Her mom is a nurse and they waited to see if it worsen or got better. She decided since she could breath she would not go to hospital. After about 5 hours she felt much better. She continued to have a headache for 4 days. She had swelling and soreness of left arm for a couple of days. She continued to go to work.
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| 49 | 2021-01-07 | fatigue |
Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the...
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Fatigue; She said it felt like painful poking/"needle pokes" on the inside of her left elbow and the inside of her left wrist; "Needle pokes" on the inside of her left elbow & left wrist. She said what she was experiencing was like pins & needles, but with just the needles.; This is a spontaneous report from a contactable consumer (ophthalmic technician, also patient herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 29Dec2020 11:44 at single dose on her left upper arm (non-dominant arm) for COVID-19 immunization. Medical history included ongoing lupus from 1993. The patient had no concomitant medications were received. No additional vaccines administered on same date. No emergency room and physician office were visited. The patient had no prior vaccinations (within 4 weeks). The patient took part in a COVID-19 Vaccine program and had fatigue as a side effect. She received the COVID-19 Vaccine on 29Dec2020 at 11:44AM. Reported she started experienced fatigue at around 7:00-8:00PM. She said she all of a sudden became really tired, like she hit a brick wall. She said she could still do stuff, but was really tired. She said the fatigue lasted about 24 hours. She said she generally experiences fatigue in winter, but this fatigue was more than the usual fatigue. Reported she also experienced "needle pokes" on the inside of her left elbow and the inside of her left wrist. She said what she was experiencing was like pins and needles, but with just the needles. She said it felt like painful poking, but the pain was not severe and only lasted a half hour. Reported she recently had full blood work done with her primary care doctor, and all was fine. She said she also had some testing done with her gynecologist, and all was fine, saying there was nothing weird. The patient declined any treatment. The outcome of the event fatigue was recovered on 30Dec2020. The outcome of the event She said it felt like painful poking was recovered on 29Dec2020. The outcome of the rest event was recovered in Dec2020.
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| 49 | 2021-01-07 | fever, headache |
Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea S...
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Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea Still present 33 hours later
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| 49 | 2021-01-07 | fever |
I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in ...
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I woke up the following morning with pain and inflammation in RT armpit.. by midday the swelling in armpit lymph nodes was the size of a very large egg. I couldn't comfortably put my arm down at my side. Pain radiated down arm to elbow, and up neck into ears. I had fever of 100.1, but took ibuprofen to try and alleviate pain. The symptoms lasted about 5 days.
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| 49 | 2021-01-07 | headache, dizziness |
Left sided parentheses and numbness sensation which then spread to right side. Strong headache initi...
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Left sided parentheses and numbness sensation which then spread to right side. Strong headache initially then resolved, rapid heart rate, confusion, dizziness, high blood pressure,
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| 49 | 2021-01-07 | headache |
Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching ove...
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Metallic taste in mouth after injection. Then 45 minutes later, had rapid heart rate and itching over the injection side. Later that night had itching throughout body. She has since had a HA.
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| 49 | 2021-01-07 | fever, sweating, headache | Nausea, Headache, Fever, Sweats, Sore Arm |
| 49 | 2021-01-07 | chills, fever | Patient report fever of 101.2 and chills. Treatment include Tylenol with improvement. |
| 49 | 2021-01-07 | headache, respiratory tract congestion |
Received first vaccine on 12/22/2020. 1/7/21 I developed symptoms of head congestion, headache and...
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Received first vaccine on 12/22/2020. 1/7/21 I developed symptoms of head congestion, headache and loss of taste & smell. 1/8/2021 tested positive for Covid.
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| 49 | 2021-01-07 | body temperature increased, dizziness |
Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12...
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Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12 hours. All symptoms resolved. Patient Included the following information: 1 st dose Phizer EH 9899 2nd Dose Phizer EK 9231
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| 49 | 2021-01-07 | throat pain, headache | Sore Throat Hard to Swallow Throat hot Headache |
| 49 | 2021-01-07 | headache, fatigue, fever, throat pain |
Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarr...
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Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; Sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea; This is a spontaneous report from a contactable health care professional nurse, the patient. A 49-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) in the left arm on 22Dec2020 14:30 as a single dose, for COVID-19 immunization. Medical history includes Lupus, Endometriosis, Epilepsy from an unknown date and unknown if ongoing. Concomitant medication included belimumab (BENLYSTA), prednisone (PREDNISONE), topiramate (TOPAMAX), levetiracetam (KEPPRA), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient previously took Percocet [oxycodone hydrochloride; oxycodone terephthalate; paracetamol], Sulfa Drugs and hibiclens and experienced drug hypersensitivity. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient experienced sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea on 23Dec2020 07:00. Events continues through now 10 days later and still feel horrible. The events resulted in a physician office visit. The patient underwent lab tests that included SARS-CoV-2 test Nasal Swab (Both rapid and PCR) on 30Dec2020; influenza test and Streptococcus test on an unspecified date. The results of all laboratory tests influenza Streptococcus test and COVID (Both rapid and PCR) were negative. No treatment was received given for the events. The clinical outcome of sore throat, fever, neck and shoulder pain, heavy chest, headaches, extreme fatigue, nausea, diarrhea was not recovered.
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| 49 | 2021-01-07 | cough, shortness of breath, headache |
Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepc...
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Swollen lips/tongue, shortness of breath, cough, hives, nausea, headache Epi shot, Benadryl, Pepcid, prednisone
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| 49 | 2021-01-07 | headache, throat pain | Throat hurting , really hot Neck Swollen , back of Neck hurt really bad Joint Pains Headache |
| 49 | 2021-01-07 | dizziness |
developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-1...
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developed flushed sensation, tingling all over, lightheadedness right after receiving Pfizer COVID-19 vaccine. By the time of assessment in ED, sxs have resolved other than residual numbness of lips.
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| 49 | 2021-01-07 | malaise, fatigue, somnolence, fever, headache |
fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhaust...
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fever of 2-3 degrees; slept most of the day; didn't feel well at all; headache; achey; tired/exhausted; sore arm; woke her up briefly; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration in the right arm on 31Dec2020 10:00 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included spending 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. The patient has no known allergies. The patient has no covid prior vaccination, and she was not tested for covid post vaccination. The patient's concomitant medication included multivitamin. The patient did not receive other vaccine in last four weeks. The patient was vaccinated on 31Dec2020 at 10am for her 1st Pfizer vaccine. No symptoms for 6-8 hrs. By bedtime at 06:00 PM, she experienced headache, achey, tired, and sleeping on her sore arm woke her up briefly. Next day on 01Jan2021, more achey, exhausted, fever of 2-3 degrees, slept most of the day and didn't feel well at all. She could tell that her body was fighting something, but she is much better 48 hours out. The patient did not receive any treatment for the reported adverse events. She stated she had no regrets. She stated that she loves Pfizer, because it has given hope. She just wasn't expecting any side effects after the 1st vaccine, only for the 2nd. Anecdotally, it seemed her hospital coworkers who have had Covid react more to the 1st vaccine, possibly for them, 1st vaccine is like the 2nd. She doesn't know if she has had Covid, but as an Acute Care PT on Covid units, she spends 4-6 hrs/day face-to-face with Covid patients for months since early Apr2020. She stated that possible her immune system already recognizes Covid. She is curious. No complaints, only curious. Again, she said thank you. She stated that she has seen too many good people die this year, thus, she didn't hesitate on the vaccine. The outcome of the events was recovered in Jan2021. The report was considered non-serious. Information on the lot/batch number has been requested.
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| 49 | 2021-01-08 | headache, chills, weakness, fatigue, head discomfort |
01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills...
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01/08/21: Sudden onset of extreme body/muscular pain, such that moving was difficult. Extreme chills, headache. Needed pain medicine to alleviate pain. Fatigue. 01/09:21: AM: Less body pain , but feeling of heaviness in head; weak. PM: Had onset of lower GI symptoms: painful abdominal/cramps, stomach pain, nausea. No vomiting, but had several episodes of diarrhea. Feeling like passing out but never did. Loss of appetite. Slowly resolving.
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| 49 | 2021-01-08 | shortness of breath, fatigue, dizziness |
After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light ...
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After the vaccine was administered I walked away maybe 50' and I started to feel dizzy I felt light headed and as if I was drunk my legs feel real week they took me outside so I could catch some fridge fresh air and they set me down on a chair I was very dizzy my legs and my knees felt like I couldn't stand up and they were very weak I kept seeing a the rails double vision and I started to have a tightness in the back of my neck I felt they warrant come over my head and my forehead got very very cold And then I felt as I was gonna blackout and pass out and I was gasping for air and suddenly my tongue went into a spasm and it went to the top of my the roof of my Roof of my mouth and I couldn't breathe and I was able to send a message for someone to come and help me as I was sitting there by myself they rushed over by now looking at my text message it was for 02 which was within 15 minutes of the vaccine when I had my 1st episode and then minutes after that 3 more came with the same oh unable to swallow I lost the ability to swallow and my tongue fell like I had no control it was just automatically stuck to the roof of my mouth.. Upon the arrival of Ems I was told there was no treatment and there was nothing they could do told me to wait 24 to 48 hours in the symptoms should subside it's been over 72 hours in the symptoms are still occurring. I continue to feel dizzy light headed and now have high blood pressure which was not present before visit ER prescriptions for steroids with issued, I Told to go home and rest. Followed up with family doctor in the morning and was told it was not an allergic anaphylactic reaction probably more so neurologically ransom blood tests waiting for results continue to have loss of control over tounge spasms unable to eat Accompanied by fatigue dizziness and high blood pressure
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| 49 | 2021-01-08 | fever |
BlurredVision, Myalgia, Arthralgia, Fever, red painful eye diagnosed as nodular episcleritis Narrati...
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BlurredVision, Myalgia, Arthralgia, Fever, red painful eye diagnosed as nodular episcleritis Narrative: Took Tylenol 500mg, 1000mg BID
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| 49 | 2021-01-08 | chills, fever, migraine, headache, fatigue |
Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into...
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Day one I had a headache. Wouldn?t go away with any medication. Day 6 still had headache turned into migraine and severe exhaustion. Chills, diarrhea and nausea. Day 10 woke up in the middle of the night with fever 99.6. At this point I went and got tested for Covid and it was negative. Finally on 09/09/2021 woke up without a headache but it came back later on.
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| 49 | 2021-01-08 | fever |
Fever and body aches occurred about 10 hours after I received the second dose Fever ranged from 101...
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Fever and body aches occurred about 10 hours after I received the second dose Fever ranged from 101.8 - 100.4 for about 24 hours Treated with Tylenol 650mg every six hours for a total Of three doses
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| 49 | 2021-01-08 | dizziness, sweating, headache, shortness of breath, weakness |
Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphor...
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Got out of bed, after a few minutes of standing vision became white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter. 10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
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| 49 | 2021-01-08 | respiratory tract congestion, headache, chills | Headache chills, feels hot (no fever), body aches, stuffiness, and headache |
| 49 | 2021-01-08 | headache | Headache & NauseaVomiting Narrative: |
| 49 | 2021-01-08 | fatigue, headache | Headache, Myalgia, Arthralgia, fatigue |
| 49 | 2021-01-08 | sweating | Heat/flushing from injection site to neck to face to upper body x 20 minutes; sweating |
| 49 | 2021-01-08 | cough |
mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vo...
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mouth itching, slight tongue swelling, tachycardia, coughing, feeling of impending doom, nausea, vomiting, diarrhea, itching This started at minute 13 after the vaccine administration. I have had several infusion reactions before to biologics to treat my autoimmune disease and this is how it always starts. There was nothing available at the administration place so I left and took zyrtec, benadryl and pepcid. The symptoms stopped in about 25 minutes.
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| 49 | 2021-01-09 | fatigue, throat pain, shortness of breath, fever, headache, cough, respiratory tract congestion, runny nose |
1st & 2nd day extreme /Joint & musculoskeletal pain, head ache, fatigue , short of breath, Cough...
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1st & 2nd day extreme /Joint & musculoskeletal pain, head ache, fatigue , short of breath, Coughing, runny nose, congestion, fever, ringing in ears, 3rd day musculoskeletal & joint pain, inner ear pain, fatigue, cough, throat pain This is 3rd day and I am still miserable
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| 49 | 2021-01-09 | headache, chills |
Approx 10 hrs after injection severe left arm pain, progressed to all over body aches about 12 hrs p...
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Approx 10 hrs after injection severe left arm pain, progressed to all over body aches about 12 hrs post vaccination. Approx 24-30 hrs post vaccination chills and slight headache added and remained until approx 48 hours post. Took Motrin for aches and rested with restricted movement
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| 49 | 2021-01-09 | fever | DAY ONE - FEVER >101.1F |
| 49 | 2021-01-09 | sweating, chills, headache, fever |
Felt achy and trouble sleeping all night post 2 nd injection. Woke up at 3 am with fever 100.5. Head...
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Felt achy and trouble sleeping all night post 2 nd injection. Woke up at 3 am with fever 100.5. Headache, chills, sweating, low grade fever 99.5 all day until about 10:00 pm on 1/8/21. 80% better on 1/9/21 just lower back soreness and mild headache. 100% better on 1/10/21. This was my second vaccine.
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| 49 | 2021-01-09 | fatigue | Stomach cramping, diarrhea, fatigue. |
| 49 | 2021-01-09 | migraine |
Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had...
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Woke up with a severe migraine at 3:30 am, and again the following night another migraine. Also had swelling and a red lump at site of injection, with pain and soreness around injection site.
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| 49 | 2021-01-09 | chills, fever, headache |
fever, chills, headache, overall aches. Started 11 hours after receiving vaccination. symptoms (al...
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fever, chills, headache, overall aches. Started 11 hours after receiving vaccination. symptoms (although not as uncomfortable) still continuing at 42 hour mark
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| 49 | 2021-01-10 | fatigue, lethargy |
1/08/21 I was very fatigued, and a little bit of body aches. 01/09/21 I was very lethargic and had ...
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1/08/21 I was very fatigued, and a little bit of body aches. 01/09/21 I was very lethargic and had body aches, mostly in my joints
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| 49 | 2021-01-10 | chills, headache, fatigue, malaise |
After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mi...
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After the awcond vaccine: Woke up at 4 am the next morning with body aches, chills, nausea and a mild headache that was intermittent. I had malaise and fatigue. I took some cold medicine 3 times in the course of 24 hours and woke up the next morning with none of those symptoms but did have lympadenopathy under my left arm that decreased through the course of the day. It was painful to touch and tender once the lymph node decreased in size. The only other reaction was the site pain and tenderness and warmth. That lasted a few days.
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| 49 | 2021-01-10 | headache, chills | FEVER, HEADACHE, SHIVERS |
| 49 | 2021-01-10 | chills, fever | Fever body aches chills |
| 49 | 2021-01-10 | headache, chills, fever | Fever, body aches, chills, headache, left lower quadrant pain front and back. Lasted 36 hours. |
| 49 | 2021-01-10 | cough, fever, fatigue | Fever, fatigue , chest heaviness, cough. Treatment: Robutussin, Motrin. Fever and fatigue improved. |
| 49 | 2021-01-10 | fever | Lymph pain, low grade fever, aches |
| 49 | 2021-01-10 | headache, malaise | Pfizer-BioNTech COVID-19 Vaccine EUA headache injection site pain general malaise |
| 49 | 2021-01-10 | fever, fatigue, headache |
Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injecti...
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Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injection administered. Fatigue and headache occurred by the same afternoon and low grade fever of 99.6° that evening at 8:30 PM. Right armpit tender and swollen lymph nodes remain present 2 days post 2nd IM injection and right arm injection site is warm to touch with redness and firmness to touch.
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| 49 | 2021-01-10 | headache, shortness of breath |
Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotte...
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Within 20 min of administration my face began to become Hot. Shortly after It felt as if I had gotten a CT contrast, where my whole body began to feel warm, also a metallic taste in my throat. A few hours later I had a horrible headache, with tightness in my chest and palpitations. My muscles and joints ached, my hands became swollen and I was unable to remove my ring. These symptoms continued for 24 hours. I also experienced shortness of breath.I almost took myself to ER. They eventually went away and I feel fine now
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| 49 | 2021-01-10 | headache, fatigue | chills exhaustion, headache |
| 49 | 2021-01-10 | chills | chills, aches, lymph pain |
| 49 | 2021-01-10 | fatigue, malaise |
her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all ...
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her nerve was bad; Getting all sick, cold, sick and experiencing terrible side effects; Getting all sick, cold, sick and experiencing terrible side effects; Fatigue; Muscle ache; Nauseous; Felt awful; Can't eat all the day, no appetite; phobic something to drinking water; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced getting all sick, cold, sick and experiencing terrible side effects, fatigue, muscle ache, nauseous, cannot do anything, felt awful, cannot eat all the day, no appetite, phobic something to drinking water. The patient has been sick for three days now. The patient was a "senior" (not clarified) care giver at the nursing home. Everybody at nursing home at the nursing home got the shot and now everybody has cold and sick. She has only one day of work and she has to come into her job to take care of elderly people. As since current everybody is experiencing the terrible adverse, terrible side effects, everything. Fatigue, muscle ache everything. The bosses at her nursing home cannot give them three days or even seven days off of work after receiving a contract to give them shot. It was confirmed that the patient received the COVID vaccine. The patient also stated that they are off of that side effects. They are not interrupted not just the "arm" (not clarified) been there. The patient said she getting everything. She was getting all the side effects. So when they had this Pfizer drug shot "they didn't get seven days off of" (not clarified) work. If a person gets a shot, they are feeling fatigue, nauseous (incomprehensible voice). They can't do anything. They should be allowed to stay home from work. Right now everybody in the nursing home is feeling the adverse effect. The entire building. So, she was telling Pfizer to report the report is that all of sudden that the nursing home "seniors" (not clarified) and nurses they got the shot, they can't even get to work. The effects are so bad that they can't do anything. The patient also stated that fatigue, she had fatigue all day. The first day she got the shot her nerve was bad but the second day was everything fatigue. She felt awful, she could not eat, she had no appetite. She was phobic something to drinking water, she cannot eat all the day. "Fruit or something 5 I can eat" (incomprehensible voice)." When probed for the LOT#, the reporter stated, "No they did not give me anything. All they did is I think 037 I think it looks like a 'K' 20A. (further not clarified) like it says (further not clarified) 037K20A that's (further not clarified)." The outcome of the events was unknown. Information on lot number/batch number was requested.
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| 49 | 2021-01-11 | fatigue, headache, malaise, chills |
1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins We...
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1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins Wed, Thursday neck shoulders blades hurt, and achy. Friday Chills, no fever, hurt to the bone all over, sick to stomach, noticed some lips swollen, felt foggy in head. Headache constant top of head. 10:45am spots and vision blurry. Felt very sick. Laid head down then woke black spots. Sat occasionally in sun saw black spots. /sun off not looking at computer did not see black spots. Monday increase black spots. Saw an eye doctor.
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| 49 | 2021-01-11 | cough |
C/o cough, upper throat tightness, no wheezing, administered benedryl 50 mg IM, called med team, sen...
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C/o cough, upper throat tightness, no wheezing, administered benedryl 50 mg IM, called med team, sent to ER, o2 sat 98%, HR 107, Bp 162/93, Lung sounds CTA
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| 49 | 2021-01-11 | fever, headache |
Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by...
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Elevated blood pressure and headache at immediate injection body aches about 2 hours later follow by nausea low grade temp. On Sunday about 4am I started vomiting with diarrhea, joint pain, Headache, BP of 168/109 and temperature of 100.1.
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| 49 | 2021-01-11 | chills, fatigue |
Fatigue, muscle soreness primarily at shoulders, upper back, neck & abdomen, L worse than R. Chills ...
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Fatigue, muscle soreness primarily at shoulders, upper back, neck & abdomen, L worse than R. Chills but no fever.
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| 49 | 2021-01-11 | chills |
Mild chills the day after. Muscle aches day 2 (mild). Diarrhea day 3 (mild). Injection site swollen ...
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Mild chills the day after. Muscle aches day 2 (mild). Diarrhea day 3 (mild). Injection site swollen and red and sore (mild)
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| 49 | 2021-01-11 | headache |
Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other ...
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Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other HCP (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Vaccine location was right arm. Patient is not pregnant. Patient received the first dose on 17Dec2020 05:45 PM also at right arm for covid-19 immunization. Lot number was also EJ1685. The facility type vaccine was hospital. Medical history included Celiac. Concomitant medication included pregabalin (LYRICA), celecoxib (CELEBREX), escitalopram oxalate (LEXAPRO), spironolactone. Known allergies: Penicillin, morphine, lactated ringers. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient experienced Sore arm, headaches at 05Jan2021 06:00 PM with outcome of recovered in Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. No follow up attempts are possible. No further information is expected.
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| 49 | 2021-01-11 | sweating, dizziness |
The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness...
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The patient received the vaccine at 10 am and an hour later the patient experienced slight dizziness, sweating, and shakiness. The ambulance was called just to be on the safe side. She was taken to the hospital via ambulance and was later discharged that same night as symptoms improved.
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| 49 | 2021-01-11 | weakness, headache, malaise |
doesn't feel good; her body is hurting/her left side hurts/her body hurts/it's like somebody hit her...
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doesn't feel good; her body is hurting/her left side hurts/her body hurts/it's like somebody hit her hard; headache; so weak; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date: unknown), via an unspecified route of administration on 06Jan2021 at 12:30 at a single dose for Covid-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine the day before (06Jan2021) and doesn't feel good in the morning, her body is hurting, and she has a headache. The patient is a CNA and she got the vaccine the day before at around 12:30 and she just got up in the morning, so weak, and her left side hurts. Her body hurts and she doesn't feel good too, reportedly "all the body hurts now, it's like somebody hit her hard". The patient asked if she can take Tylenol or pain medication. After receiving a verbal response, the patient added that she would take Tylenol and pain medication together and hopefully get some sleep. The patient then asked if headache and body ache are normal side effects of the vaccine. The outcome of the events was unknown. Information about batch/lot number has been requested.
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| 49 | 2021-01-11 | fever, throat pain, shortness of breath, headache |
painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nau...
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painful swollen red arm shoulder to elbow joint and muscle pain sore throat low grade fever 99.5 nausea vomiting shortness of breath headache some periods of confusion
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| 49 | 2021-01-11 | cough |
positive COVID test result; positive COVID test result; cough; This is a spontaneous report from a c...
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positive COVID test result; positive COVID test result; cough; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 16Dec2020 (at the age of 49 years old) as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On 21Dec2020, the patient experienced a strange cough. The patient reported that she received the first dose of COVID vaccine on 16Dec2020 and that she was then exposed to her husband who tested positive on 17Dec2020. Due to a strange cough, she was tested on 21Dec2020, which resulted in a positive COVID test result. The outcome of the events strange cough and positive COVID test was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 49 | 2021-01-12 | headache, dizziness, fever |
2 nd dose : Dizziness, lightheaded, severe headache, fever all night. 1/9/21 Dizziness, lightheaded,...
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2 nd dose : Dizziness, lightheaded, severe headache, fever all night. 1/9/21 Dizziness, lightheaded, nausea. Nausea continues all other symptoms have resolved. 1 dose: no ae to report
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| 49 | 2021-01-12 | dizziness |
About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She repor...
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About 10 minutes into observation, she felt very nauseated, and then reported being dizzy. She reported "having waves of dizziness" that "made me feel like she was going to pass out but was clearly not" also reported "dizzy spots" in her vision. She had 3 separate episodes, each lasting about 4-5 minutes each. BP @ onset 100/63, pulse 57, after resolution, 100/62, pulse 62. O2 sat 100%. All symptoms resolved after a total of 30 minutes post vaccination.
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| 49 | 2021-01-12 | dizziness | Dizzy, light headed, hives on left side of neck and chest. |
| 49 | 2021-01-12 | headache, fatigue, cough, runny nose |
First day, HA and extreme fatigue, then next day cough, runny nose, achy joints ( mild, mostly arms)...
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First day, HA and extreme fatigue, then next day cough, runny nose, achy joints ( mild, mostly arms), and fatigue, by day 4 after vaccine, just cough and headache with mild fatigue, by day 6, mostly resolved
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| 49 | 2021-01-12 | throat pain | Injection site raised and sore Sore throat |
| 49 | 2021-01-12 | headache |
Nausea; Headache; This is a spontaneous report from a contactable healthcare professional (patient)....
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Nausea; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine, brand: Pfizer-BioNTech) lot no: EH9899, intramuscular in left arm on 06Jan2021 01:00 at a single dose for Covid-19 immunization in a hospital. The patient medical history and concomitant medications were not reported. The patient was not pregnant and no known allergies. No other vaccine was administered in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced nausea and headache on 06Jan2021 18:00. The events were reported as non-serious. Treatment was not given for the events. The patient was recovering from the events.
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| 49 | 2021-01-12 | respiratory tract congestion, influenza like illness |
Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels ...
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Patient describes flu like symptoms, sore arm at injection site, congestion with no cough but feels "heavy in her chest".
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| 49 | 2021-01-12 | fever | Tingling on tongue and lips, fever 101.0, nausea |
| 49 | 2021-01-12 | headache, fatigue, dizziness |
about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No ...
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about 4 hrs after vaccination ee had "tunnel vision" dizzy, abd upset, "churning stomach" gas, No diarrhea but soft stools. today headache, and fatigue
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| 49 | 2021-01-12 | fatigue, fever, sweating, chills |
chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to...
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chills which lead to shivers and putting on 3 layers, 2 down comforters and a throw blanket to go to sleep, fever (I can't remember what it was), sweating (even after taking layers and blankets off), fatigue, arm swelling, and pain where the injection was, nausea, unable to stand for short periods of time, This lasted over 24 hours, the next day the same but on a lesser progression but included diarrhea and a swollen supraclavicular lymph node being swollen-- > 5"x2".
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| 49 | 2021-01-12 | chills, headache | headache, chills, shivering, muscle aches |
| 49 | 2021-01-13 | fever, chills, headache |
-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on...
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-Right hand & forearm numbness/within 10 minutes of vaccine -Fever, Bodyacheeks, headackes, -Pain on the right side - Jaw, neck & right -Lyphnote under the right arm is swollen. -Neck & under armpit pain because of this -The night after getting the 2nd vaccine Covid I started getting chills, fever of 102+ Extreme body ackes -Right arm armpit lymph nodes swollen the size of my fist -Right side of my neck also swollen -The Right lower back hurts as well -From 1 to 10 is an 8 acute pain
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| 49 | 2021-01-13 | headache, shortness of breath |
1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and ches...
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1st dose 12/21/20 with no reported side effects. 3:00pm c/o blurred vision BP 180/110 neck and chest tightness headache 5:30pm BP 172/109 tachycardia and SOB nausea BP still 185/107 so went to prompt care who sent via ambulance to ER. Given nitro, fluids and morphine. Sent home. Next morning BP 188/118 and 213/122. C/o body aches temp 99 and loss of smell and taste. Saw primary care provider 1/14/21. Added Lisinopril and increased current betablocker and said was vaccine reaction. BP there 209/122 pulse 126. PCP did not test for COVID. Reports she did Binax test herself after visit and was negative
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| 49 | 2021-01-13 | weakness, malaise, fatigue |
Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling ...
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Body ache; fatigue; Weakness; Abdominal noises; Sick to her stomach/super sick stomach; Not feeling good; awful stomach ache; could not eat/she can't eat; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1284), via an unspecified route of administration, on 30Dec2020, at single dose, for COVID-19 immunisation. Medical history included ongoing overweight. Concomitant medications were not reported. The patient experienced sick to her stomach/super sick stomach on 03Jan2021 with outcome of unknown, not feeling good on 03Jan2021 with outcome of unknown, awful stomach ache on 03Jan2021 with outcome of unknown, could not eat/she can't eat on 03Jan2021 with outcome of unknown, body ache on 07Jan2021 with outcome of unknown, fatigue on 07Jan2021 with outcome of unknown, weakness on 07Jan2021 with outcome of unknown, abdominal noises on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown on 05Jan2021. Therapeutic measures were taken as a result of sick to her stomach/super sick stomach (nausea) and included treatment with Pepto-Bismol.
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| 49 | 2021-01-13 | headache, fever, chills |
Fever; chills/rigors; Severe myalgia; Nausea; vomiting; Severe headache; This is a spontaneous repor...
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Fever; chills/rigors; Severe myalgia; Nausea; vomiting; Severe headache; This is a spontaneous report from a contactable physician (patient). A 49-year-old female patient (no pregnancy) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), with first dose (lot number: ACEK5703) at 16:00 on 16Dec2020 and with second dose (lot number: EK9231) at 16:00 on 06Jan2021, both intramuscularly at site of left arm at single dose for COVID-19 immunization. Medical history reported none. The patient's concomitant medications were not reported. The patient experienced fever, chills, rigors, severe myalgia, nausea, vomiting, and severe headache at 01:00 AM on 07Jan2021. Facility where the most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No list of any other medications the patient received within 2 weeks of vaccination. The patient received treatment of paracetamol (TYLENOL) for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. No allergies to medications, food, or other products. This case was identified as non-serious by reporter. The outcome of events was recovered in Jan2021.
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| 49 | 2021-01-13 | headache, fatigue |
Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site p...
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Left upper arm swelling Left facial swelling Neck pain Headache General fatigue Left leg ache Site pain
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| 49 | 2021-01-13 | respiratory tract congestion, cough | On 24 I had sinus and watery eyes. I went to ER because I was congested and coughing. |
| 49 | 2021-01-13 | fatigue, headache | Patient describes nausea, fatigue and headache. Also has arm soreness, but very mild |
| 49 | 2021-01-13 | throat irritation |
SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she beg...
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SM presents today for second dose of Pfizer vaccine at 0724 13 mins post injection SM states she began feeling her throat was scratchy, mouth tasted metallic and a flushed felling over her entire body. SM attached to VS machine. Initial set of vitals were HR 77 bpm, spo2 100% on RA, and left arm blood pressure 158/84.
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| 49 | 2021-01-13 | headache, fatigue |
Severe body aches; headache; nausea; diarrhea; exhaustion; This is a spontaneous report from a conta...
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Severe body aches; headache; nausea; diarrhea; exhaustion; This is a spontaneous report from a contactable nurse. A 49-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 06Jan2021 16:30 at the first single dose for covid-19 immunisation. Medical history included ongoing hypertension , ongoing hypothyroidism , ongoing blood cholesterol increased , Known allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced severe body aches, headache, nausea, diarrhea, exhaustion on 07Jan2021 03:00. The patient did not receive any treatment for the events. The outcome of events was not recovered. Information on the lot/batch number has been requested.
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| 49 | 2021-01-13 | headache, fatigue, chills |
blurry vision 1st day. asthma attack 1st night inhaler worked. next morning. Massive severe headac...
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blurry vision 1st day. asthma attack 1st night inhaler worked. next morning. Massive severe headache (almost as bad as the spinal headache from my 1st child) , chills, fatigue, nausea. Called PCP and he gave me Tylenol with codeine for the headache and a prednisone for the asthma even though it was under control.
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| 49 | 2021-01-13 | dizziness |
felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of ery...
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felt dizzy; left arm soreness; 'knot' noted on left deltoid Itchy, but painful/indurated area of erythema; 'knot' noted on left deltoid Itchy, but painful; pulse 77 to 94 from lying to standing; 'knot' noted on left deltoid Itchy, but painful/left lateral deltoid with 3.75 x 5 cm mildly tender; indurated area of erythema, with central erythematous punctum (presumed site of injection); indurated area of erythema, with central erythematous punctum (presumed site of injection); This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, 30mcg/0.3ml), intramuscular on 31Dec2020 15:38 (also reported as 08:30 am) at 0.3 mL, single at left deltoid for covid-19 immunization. Medical history included significant for Covid 19 infection (positive test 28Oct2020), shortness of breath, dizzy, hospitalized for decreased O2 saturation from 04Nov2020. Patient was treated with remdesivir for Covid 19 infection. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, it was unknown if patient had been tested for COVID-19. Patient felt dizzy after receiving injection on 01Jan2021, left arm soreness noted during night; 'knot' noted on left deltoid, when awoke on 01Jan2021; knot grew to 5x5 cm max size over 48 hours, itchy, but painful if tried to scratch. Some dizziness with position change. Examination: no fever, no orthostatism to BP, pulse 77 to 94 from lying to standing, left lateral deltoid with 3.75 x 5 cm mildly tender, indurated area of erythema, with central erythematous punctum (presumed site of injection). Patient took diphenhydramine hydrochloride (BENADRYL) 03Jan2021, and cetirizine hydrochloride (ZYRTEC) 04Jan2021 for events (Instructed to take OTC antihistamine (cetirizine hydrochloride) daily until 7 days after symptoms resolve). Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment diphenhydramine, certitizine for events. The report is considered as non-serious. Outcome of events was unknown.
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| 49 | 2021-01-13 | fever |
heart palpitations and tachycardia, mild resolved within 9 hours of administration; after that, feve...
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heart palpitations and tachycardia, mild resolved within 9 hours of administration; after that, fever and myalgia x 6 hours; next day, general myalgia only
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| 49 | 2021-01-14 | fever |
1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches...
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1/8/2021 3PM vaccination 1/9/2021 24 hours later, fever went up to 102.4. Tylenol @ 10pm. Body aches, lump in armpit. *First dose; slight fever of 100 on day 3,4 and pain at injection site.
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| 49 | 2021-01-14 | fever |
1/8/2021 vaccine 1/9/2021 fever spiked to 101.4. Took tylenol @ 10pm. Body aches, lump armpit. *f...
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1/8/2021 vaccine 1/9/2021 fever spiked to 101.4. Took tylenol @ 10pm. Body aches, lump armpit. *first vaccination; slight fever of 100 on days 3,4.
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| 49 | 2021-01-14 | fatigue |
After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated s...
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After second dose of Pfizer COVID-19 vaccine, patient felt nauseous. She did not vomit. She stated she has 2 bowel movements, denies diarrhea. She felt very tired. Both her hands felt tingly. BP 117/75 - 85bpm - 98% RA. She was not pale or diaphoretic. No medication given. She slept for ~90 minutes in the vaccination room on the gurney. She felt well upon awaking. Drank water and ate crackers. She left in stable condition.
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| 49 | 2021-01-14 | shortness of breath |
At 6 days after my second COVID-19 Pfizer vaccine (first dose given 12/17/20), I had acute onset of ...
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At 6 days after my second COVID-19 Pfizer vaccine (first dose given 12/17/20), I had acute onset of chest pain and shortness of breath prompting a trip to the Emergency Department. A chest CT Angio to rule out pulmonary embolus was done and negative for pulmonary embolus. My EKG showed some mild ST changes and a troponin I level was elevated at 0.08 (normal 0.04). Subsequent troponin levels 90 minutes apart showed a rising troponin at 0.18 and 0.38. An echocardiogram was performed which showed regional wall motion abnormalities consistent with Takotsubo cardiomyopathy and an ejection fraction of 45%. I was then taken to cardiac catheterization lab for coronary angiograms which were normal. My LV angiogram was consistent with Takotsubo cardiomyopathy and my LVEDP was elevated. I was started on a beta blocker and sent home the following day.
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| 49 | 2021-01-14 | sweating |
Burning and itching at site, increased blood pressure, redness and burning down both arms, redness i...
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Burning and itching at site, increased blood pressure, redness and burning down both arms, redness in face, hot, sweaty, and cold
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| 49 | 2021-01-14 | chills, fever |
Chills, fever, body aches, swollen lymph nodes occipital and posterior superficial cervical lymph no...
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Chills, fever, body aches, swollen lymph nodes occipital and posterior superficial cervical lymph nodes began afternoon 1/14/21
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| 49 | 2021-01-14 | malaise, body temperature increased |
Employee received the first vaccine on 12/18 with no problems. Developed "sinus symptoms" which bega...
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Employee received the first vaccine on 12/18 with no problems. Developed "sinus symptoms" which began on Dec 28, was rapid tested on 12/30 and read as positive. Did well and was due to come back to work when received the second dose of Pfizer vaccine on 1/6. She was symptomatic at the time. The day following the second vaccine, developed temperature, body aches and generalized malaise. Has been out of work since that time. Did see nurse practitioner on Wednesday.
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| 49 | 2021-01-14 | weakness, fever, headache, fatigue, dizziness, chills |
FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAI...
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FOUR DAYS OF SINTOMES, DIZZINESS,WEAK, PAIN INJECTION SITE,HEADACHE,TIRED,MUSCULAR PAIN, CHILLS, PAIN JOINTS,FEVER,NAUSEATE,FEELING BAD.
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| 49 | 2021-01-14 | fever | Fever >101, nausea, urticaria. Treated for urticaria with steroids, H2 and H1 blockers |
| 49 | 2021-01-14 | fever, chills, chills, fever | Fever, chills, body ache |
| 49 | 2021-01-14 | shortness of breath | PT presents with respiratory difficulty, anxiety. |
| 49 | 2021-01-14 | headache, shortness of breath, dizziness |
Patient had headache with dizziness about 30" after injection. 90" later had sudden onset left-sided...
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Patient had headache with dizziness about 30" after injection. 90" later had sudden onset left-sided Chest pain with difficulty breathing. Patient's chest pain was so bad she thought she was going to die. Was transported to ER via ambulance, had cardiac workup, blood clot workup (had left leg pain the day before incident). Was discharged home on zanaflex and motrin with diagnosis of Chest Wall pain about 4 hours later. Follow up on 1.15.2021 at 1000 and patient doing better but still has chest pain. Will not be getting 2nd COVID vaccination.
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| 49 | 2021-01-14 | fatigue, runny nose | fatigue, difficulty swallowing, runny nose |
| 49 | 2021-01-14 | chills, fever | fever, chills, body ache, joint pain. |
| 49 | 2021-01-14 | malaise, headache, influenza like illness, fatigue |
immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and move...
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immunization (site on the right upper arm) on 1/10/21 with increased right arm pain at rest and movement, then flu like symptoms 1/11-14/21: aches, fatigue, malaise, head ache; on 1/12/21 in the afternoon I noticed right axilla pain in axilla, same level at the upper back/ribcage under the shoulder blade and corresponding pectoralis muscles and swell in axilla and upper pectoralis muscles, I could also palpitate multiple firm and tender lymph nodes at the right axilla.
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| 49 | 2021-01-14 | chills, fatigue |
left arm pain, generalized body aches, chills and fatigue. Treatment included Tylenol the next day....
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left arm pain, generalized body aches, chills and fatigue. Treatment included Tylenol the next day. Outcome: Moderate improvement has continued c/o of mild fatigue and generalized body aches that does interfere with ADL's currently working.
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| 49 | 2021-01-15 | shortness of breath, chills, dizziness, headache, fatigue |
Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Diz...
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Day 10 post injection I experienced: Severe Headache Palpitations Increased Heart Rate SOB Cough Dizziness Lightheadedness Fatigue Chills Sneezing Sore arm (first 3-4 days). I had a negative COVID test on 1/12/21.
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| 49 | 2021-01-15 | fatigue, headache, fever | Headache, Myalgia, Fever, Fatigue Narrative: missed work 1/14/21 |
| 49 | 2021-01-15 | dizziness, shortness of breath, fatigue, headache | SOB, dizziness, headache, fatigue. |
| 49 | 2021-01-15 | headache, fatigue, fever, dizziness |
dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued a...
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dizzy, nausea, headache, myalgia, fatigue, arthralgia, then on 1/14 fever 10.3 headache continued arm sore, did call out of work 1/14 took Tylenol and motrin
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| 49 | 2021-01-16 | chills, headache |
Chills, muscle aches, headache, sore and stiff neck with headache worsening upon change of position....
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Chills, muscle aches, headache, sore and stiff neck with headache worsening upon change of position. This lasted for 60 hours
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| 49 | 2021-01-16 | chills, fever | Fever, chills, aches |
| 49 | 2021-01-16 | chills, malaise, headache, fever |
Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Fe...
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Thursday 1/14/21 5:30 PM began having chills and body aches. Temperature of 102, taken by ear. Felt Strange just not well. Ran a fever through the night into the next morning., Friday 1/15/21 had a fever of 100.5 taken by ear. Fever subsided. Began having a slight headache that lasted through Sunday. Also had Nausea that started Friday and continued through today. Sunday. Injection arm has been very sore. I also have a very sore enlarged lymph node under my left arm pit. Markedly swollen.
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| 49 | 2021-01-16 | headache, chills |
Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. ...
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Upon waking up on 1/13/21 had a headache and 99.8 F temperature. Arm with injection was quite sore. Had a feeling of being in a fog and not quite myself. Taste and smell felt distorted and could not fully taste and smell my coffee. Took 2 max strength tylenol which helped bring temp down to 98.F and remained steady till the afternoon when temp went up to 102F. Had feeling of body aches and chills. Took a hot shower and another dose of tylenol and went to bed. Next morning felt much better with no fever symptoms. Left arm was sore but better than day before. Woke up with a vertigo feeling and hot flashes but not enough to interrupt daily activities. Treated with meclizine
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| 49 | 2021-01-17 | headache, body temperature increased |
Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as...
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Patient experienced abdominal pain on January 12th. She reported having a headache and joint pain as well. Her temperature was 103.5. On January 14th the patient was admitted for acute appendicitis with perforation, localized peritonitis, and gangrene. Patient was discharged on January 16th post appendectomy.
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| 49 | 2021-01-17 | throat swelling |
palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on ...
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palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on my arms and abdomen; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), intramuscular in the left arm on 06Jan2021 16:00 (at the age of 49 years old) at a single dose for COVID-19 immunization. Medical history included psoriasis, microscopic colitis, allergies to shellfish, and coconut. The patient's concomitant medications were not reported. The patient previously took estrogen patch, etanercept (ENBREL) and sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies to all. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medications with 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 16:15, the patient experienced a very warm flush feeling, nausea started and by 15 minutes, she had swelling of the throat and rash on her arms and abdomen and the palms of her hands were bright red. The events resulted in Emergency room/department or urgent care visit. The patient was treated with diphenhydramine hcl (BENADRYL), steroids (unspecified), famotidine (PEPCID) and ondansetron (ZOFRAN) in response to the events. The patient assessed the events as non-serious. The outcome of the events was recovered with sequel on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-01-17 | skin warm |
swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout t...
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swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
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| 49 | 2021-01-19 | malaise, dizziness, discomfort |
29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my...
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29 minutes after vaccine was given i felt tingling and numbness on my left cheek and left side of my lips. i informed nurse and she began taking blood pressure and oxygen levels while asking if i was breathing ok. i said yes. i then felt the right side of my lips go numb. i felt a faint tightness in my throat but after about two minutes it felt like my right side of the lips started to feel normal and my throat. then all at once i felt the blood rush from my body and tingling all over. i told the nurse i didnt feel good. she layed me down on the floor and put my feet up. she asked what i was feeling and i said i felt like i was going to faint. i was aware that my tongue felt heavy and i wasn't talking clear. another nurse got the allergist or doctor on standby and she asked me what i was feeling. i just rubbed my throat and my cheeks and lips and felt numbness and my throat tight and my tongue very thick. she asked if i was having a hard time swallowing. i nodded so she said they were going to sit me up because they needed to give me an Epipen. i nodded, tgey brought a wheekchair for me and as they helped me stand because i had no strength, a nurse stabbed me with the Epipen then they took me to the emergency room and observed me until 2:30pmish to make sure i didnt have another episode. then i wss discharged and was told to follow up with my primary care doctor within 3 days. An allergist will also see me to do a skin test.
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| 49 | 2021-01-19 | fatigue, headache |
: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and ...
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: TM received a COVID 19 #1 vaccine on 1/11 to the left deltoid. She had arm soreness, headache and fatigue following the vaccination. Those symptoms lasted a few days and resolved. On 1/17 she noticed a sore area under her left arm. she has a small firm painful lymph node under the left arm. She also noticed that she has a slight " fullness" in the neck area. She feels like her thyroid gland is more pronounced. than it was prior to the vaccine. She denies any dysphagia or odynophagia. No SOB or tachypnea. No fever or chills. No hx of thyroid dysfunction.
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| 49 | 2021-01-19 | headache | Chronic headache |
| 49 | 2021-01-19 | throat pain, shortness of breath, runny nose, cough |
Day 1, loose stools that night. Day 2, loose stools and a sore throat. Day 3, sore throat and runny ...
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Day 1, loose stools that night. Day 2, loose stools and a sore throat. Day 3, sore throat and runny nose. Day 4, nose runny like a faucet and cough. Day 5, runny nose, sore throat, coughing a lot. Took some Theraflu. Day 6, no more sore throat but coughing and some shortness of breath on exertion and at rest. Day 7, coughing, nose not running as much, shortness of breath still present. Day 8, shortness of breath, coughing a lot. Day 9 (Tuesday, January 19, 2021) still coughing and experiencing Shortness of breath. Texted my manager and explained whatvhad been going on since I got the second vaccine and that I wasn't sick prior to getting it. And that no other family member in my home was sick besides me. She put me in touch with the HR director who scheduled n e for a COVID test that same night. I went to have the test done and also had the ER doctor to evaluate me because I was feeling so bad with the coughing and Shortness of breath. Today, I am still coughing, producing nasal drainage, and feeling short of breath at times.
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| 49 | 2021-01-19 | fever, respiratory tract congestion, cough | Fever, congestion, cough |
| 49 | 2021-01-19 | shortness of breath, fever, headache, fatigue, chills |
Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chil...
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Headache; fatigue; aches/soreness of the shot; shortness of breath; eyes hurting; swollen site; chills; fever; muscle pain; This is a spontaneous report from a contactable other HCP. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number=EL1284 via an unspecified route of administration on 06Jan2021 13:00 at SINGLE DOSE for covid-19 immunisation dose number=2 vaccine location=Left arm facility type vaccine: Military Base. Medical history included diabetes mellitus, asthma, dry eye, blood cholesterol increased, rubber sensitivity Known allergies: Latex, food allergy: Nuts. Concomitant medication included lactobacillus reuteri (BIOGAIA), rosuvastatin calcium (CRESTOR), celecoxib (CELEXA [CELECOXIB]), sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]), metformin hydrochloride (GLUCOPHAGE XR) , benazepril hydrochloride (LOTENSIN [BENAZEPRIL HYDROCHLORIDE]), magnesium oxide (MAG-OX), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), ciclosporin (RESTASIS), montelukast sodium (SINGULAIR) , liraglutide (VICTOZA), ascorbic acid, bioflavonoids nos (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]), colecalciferol (VITAMIN D [COLECALCIFEROL]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), zinc (ZINC). The patient previously took remeron and experienced drug hypersensitivity, amoxicillin and experienced drug hypersensitivity, percocet [oxycodone hydrochloride;paracetamol] and experienced drug hypersensitivity. The first dose of BNT162B2 vaccine for covid-19 immunisation was done on 16Dec2020 08:30 Intramuscular at single dose, Vaccine location Left arm Dose number 1 Lot number=EK5730. On 06Jan2021 13:00 the patient experienced headache outcome of recovered, fatigue outcome of recovered, aches/soreness of the shot outcome of recovered, shortness of breath on 06Jan2021 13:00 with outcome of recovered, eyes hurting on 06Jan2021 13:00 with outcome of recovered, swollen site outcome of recovered, chills outcome of recovered, fever outcome of recovered, muscle pain outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative on 06Aug2020. The action taken was not applicable.
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| 49 | 2021-01-19 | weakness, fever, chills, fatigue, headache |
I awoke with severs chills, fever at 5 am. I have muscle/joint pain, very fatigued, slight headache...
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I awoke with severs chills, fever at 5 am. I have muscle/joint pain, very fatigued, slight headache, fever of 101.2, arm soreness on first day. Today (2nd day) temp of 100, body fatigue/weakness, slight headache, arm soreness, but overall feeling better.
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| 49 | 2021-01-19 | weakness, dizziness |
I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level ...
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I woke up early in am (2:35am) with terrible bone pain, joint pain, it hurt to MOVE. My pain level was 8 out of 10. When I tried to get out of bed, I was dizzy and had to hold to the walls to make it to the bathroom. I had severe dry mouth, nausea, muscle weakness, loss of appetite and chills. I was unable to go to work. The symptoms did not begin to subside until later in the evening the next day around 6:30pm. Today I am still weak but making it. Still having chills, and some minor muscle aches and spasms.
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| 49 | 2021-01-19 | headache, chills, fever | Increased fever to 99.6 degrees F. Achy - muscle. Chills Headache. Missed work. |
| 49 | 2021-01-19 | headache |
She stated she felt upper lip tingling and a headache. She said she did not feel itchy or had any di...
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She stated she felt upper lip tingling and a headache. She said she did not feel itchy or had any difficulty breathing. I took vital signs: HR: 64, BP 128/92, O2: 100%. Observed for additional 15 minutes. She stated that she felt better and decided to go home. I recommend that she check in with her health care provider if symptoms come back or worsen.
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| 49 | 2021-01-19 | fatigue, headache |
Sore arm, moderate body aches, fatigue, mild headache 14 hrs post 2nd vaccine First vaccine zero sid...
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Sore arm, moderate body aches, fatigue, mild headache 14 hrs post 2nd vaccine First vaccine zero side effects except arm soreness
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| 49 | 2021-01-19 | throat irritation |
Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard t...
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Within 20 minutes lips, face, left arm felt numb. Not long after that I had an asthma attack, hard time catching my breath, throat became itchy. This lasted for around 35 minutes.
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| 49 | 2021-01-19 | chills, fever | chills, low-grade fever (99.6 F), injection site pain |
| 49 | 2021-01-19 | chills, dizziness, headache, fever | dizzy headache chills body aches low grade fever diarrhea |
| 49 | 2021-01-19 | headache, throat pain, fever, fatigue |
fever; extreme body/ muscle aches; extreme body/ muscle aches; headache; sore throat; I can't get ou...
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fever; extreme body/ muscle aches; extreme body/ muscle aches; headache; sore throat; I can't get out of bed; extremely tired; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EL3248), via an unspecified route of administration in the right arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history was none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number EK5730) on 19Dec2020 at 11:30 AM in the left arm. The patient's concomitant medications were not reported. On 09Jan2021 10:00 the patient experienced fever, extreme body/ muscle aches, headache, sore throat, can't get out of bed, extremely tired all with outcome of not recovered. The patient received no treatment due to the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
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| 49 | 2021-01-19 | dizziness, headache, shortness of breath |
he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mi...
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he received her first Covid 19 vaccination shot and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She reports that her symptoms occurred approximately 10-15 minutes after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. Impression: Vasovagal reaction w/ mild allergic reaction to vaccine
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| 49 | 2021-01-20 | headache, chills |
fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches...
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fast heart rate; tingling in feet; mild tightness in the chest; shaking chills; sore arm; body aches; headaches; This is a spontaneous report from a contactable physician (reporting for herself). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 23Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included hashimoto thyroiditis and hypertension. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide (HCTZ), biotin, cyanocobalamin, folic acid (MVI 3), influenza vaccine inact split 3v (FLULAVAL) taken for immunization on 03Dec2020. On 23Dec2020 12:15, the patient experienced fast heart rate, tingling in feet, mild tightness in the chest, shaking chills, sore arm, body aches and headaches. The patient underwent lab tests and procedures which included heart rate: fast on 23Dec2020. There was no treatment given for any of the events. The outcome of the events was recovered in Dec2020. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 49 | 2021-01-21 | headache | Body aches, headache |
| 49 | 2021-01-21 | chills | CHILLS, BODY ACHE. INJECTION SITE SORENESS. |
| 49 | 2021-01-21 | chills, fever | Fever, chills, muscle and joint aches. Redness and large lump with swelling at injection site. |
| 49 | 2021-01-21 | fever, chills, weakness | Fever-around 101.7 had lasted for 36 hours. Chills and extreme muscle pain Weakness |
| 49 | 2021-01-21 | headache, fatigue | I had moderate headaches, fatigue, muscle pain for 1 day. the headaches are still very present. |
| 49 | 2021-01-21 | headache, dizziness |
Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We ...
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Individual felt dizzy and had a severe headache about 15 min post injection of 2nd vaccination. We sat her down and then she said her chest felt tight and said she felt as if her heart was racing. Went unresponsive, still breathing, for almost 1 min. Came to and then began to dry heave. Her breathing became wheezy and rapid and her bottom lip began to turn blue. We administered an EpiPen about 5:03pm and the rescue squad took her to the hospital. They administered Benadryl and Ativan in the ER and sent patient home that evening.
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| 49 | 2021-01-21 | headache, fatigue |
My left arm was sore and second day I felt very fatigued. I had really bad headaches. My muscle pa...
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My left arm was sore and second day I felt very fatigued. I had really bad headaches. My muscle pain was mild but my headaches have not gone away they are usually mild to moderate.
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| 49 | 2021-01-21 | fever, chills, headache, sweating |
Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over bod...
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Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over body aches, severe right ankle/heel pain, headache, fever 101, chills, sweats. 1/22/2021 left axillary lymph node swelling and soreness.
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| 49 | 2021-01-21 | shortness of breath, dizziness, headache |
Within about 15 min my heart rate started going up.. it has been running 120-130 since I got it. I ...
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Within about 15 min my heart rate started going up.. it has been running 120-130 since I got it. I feel short of breath. I have pounding in my chest. I got dizzy after a bath and almost fell. I am very well hydrated I have drank at least 2 liters of water. I can?t get rid of my headache or body aches. I have taking ibuprofen , Pepcid , zomig for my headache which didn?t help , 600 mg of gabapentin, 20 of prednisone .. I feel like I can?t get enough air.
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| 49 | 2021-01-24 | headache | Headache, nausea and muscle aches |
| 49 | 2021-01-24 | fever |
positive for Covid; positive for Covid; pneumonia; fever; This is spontaneous report from the Pfizer...
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positive for Covid; positive for Covid; pneumonia; fever; This is spontaneous report from the Pfizer sponsored program, IBCC (Inbound Call Center for HCPs) via a contactable nurse (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EKS730), via an unspecified route of administration in deltoid left on 22Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient received the first dose of the vaccine on 22Dec2020 and a week later she was tested positive for COVID on 29Dec2020. She was due for the second dose the day before the time of the report. She was concerned about the immune system before getting the second dose. She got a significant pneumonia on 29Dec2020 with COVID infection that her coworkers did not get and she was worried about the condition of her lungs and getting the second dose of the vaccine. She had done her research and read what the CDC said about waiting longer for the second dose. Patient had a fever on 26Dec2020, 4 days after getting the vaccine, she was scheduled to get the second dose on 12Jan2021, but she did not go in, since she couldn't get straight answers from anyone about the second dose, her question was: when could she get the second dose? Patient was feeling better, she didn't get a repeat chest X-ray, but she felt, like she didn't have fevers, she felt like much better. Her fevers started 4 days after the vaccine on 26Dec2020, and lasted 5 days, maybe 2 days into the antibiotics it stopped. She had recovered completely from fevers. Stated her first test, she tested negative, on 27Dec2020, then tested positive on 29Dec2020. She had no test since then, since one could shed the virus for months, and she didn't feel the need to retest, she was past the point on quarantine. Lab data included Chest X-ray: Pneumonia on 29Dec2020, COVID 19: Negative on 27Dec2020, COVID 19: Positive on 29Dec2020. Outcome of event fever was resolved, and of other events was unknown. Causality: She couldn't say for sure no, but she questioned if put her in a more vulnerable state.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported "positive for Covid" and pneumonia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-25 | cough, somnolence, throat swelling, shortness of breath |
? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat...
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? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days
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| 49 | 2021-01-25 | malaise, headache |
First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.;...
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First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.; swollen lump nose; swollen lump nose; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular in right arm on 07Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included valley fever treatment for 4 months. No known allergies. Concomitant medication included fluconazole. On 07Jan2021 18:00, the patient experienced first day-headache, second day feeling unwell, and third day tenderness/ swollen lump nose, lymphadenopathy, right underarm. Patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Treatment received for the events included TYLENOL tabs. The outcome of the events was not recovered.
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| 49 | 2021-01-25 | fever, headache |
Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous repor...
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Injection site pain; joint pain; mild fever; headache; nausea; diarrhea; This is a spontaneous report from a non-contactable nurse (patient). A 49-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13248), via an unspecified route of administration on right arm on 11Jan2021 08:30AM at a single dose for COVID-19 immunization at workplace clinic. Medical history included hypertension and obesity. The patient had no known allergies. Concomitant medication included zinc and melatonin in two weeks. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on right arm on 23Dec2020 7:45AM. The patient did not receive other vaccine in four weeks. The patient was not pregnant and was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site pain, joint pain, mild fever, headache, nausea and diarrhea on 12Jan2021 10:00AM. The events were reported as non-serious. The patient did not receive treatment for the adverse events. The outcome of events was recovering. The patient had not been tested for COVID-19 since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 49 | 2021-01-25 | fever, headache, chills |
joint pain; Chills; Headache; Muscle pain; had a temp (fever); This is a spontaneous report from a c...
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joint pain; Chills; Headache; Muscle pain; had a temp (fever); This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: A1284, expiration date: 30Apr2021, NDC number was unknown), via an unspecified route of administration at the left arm (by needle left arm one time) on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history included having Covid from 20Nov2020, headaches, and plasma transfusion on 26Nov2020. There were no concomitant medications. The patient reported that she had the COVID-19 vaccine on 05Jan2021 and on the following day had a really bad SE (a lot of them) and caller couldn't understand why she reacted that way. She supposed it was because of the 90 day wait after getting the COVID-19 infection. She also mentioned that she had plasma transfusion when she had COVID-19 prior to the vaccine. She had the vaccine after having Covid. She was tested positive for COVID-19 on 20Nov2020 and was on quarantine for almost 3 weeks in the hospital. She already tested negative for COVID-19 and is already getting back to work. She is scheduled for her second dose on 26Jan2021. The patient asked " If a person had COVID-19, do they have to wait 90 days before getting the vaccine?". The patient had a temp (fever) on 05Jan2021. The patient experienced joint pain, chills, headache, and muscle pain on 06Jan2021. The patient stated that she had the Pfizer vaccine and had side effects the following day. Stated that it was really bad. She wanted to know if she still takes second dose. Is for Covid. She stated that she got shot on 05 Jan2021 and reported that a nurse told her to wait 90 days because she had the plasma transfusion when she was in the hospital with Covid. The patient is supposed to get second dose 26Jan2021. The patient stated that they came to her job and gave them the shot from (pharmacy name). The patient stated that the temp and chills went away early morning on 07Jan2021 (as reported). She stated that the muscle and joint pain, chills ended hours later (as reported). Stated that 1-1.5 weeks after she recovered from Covid that she started getting headaches again but has not had them since. Captured as provided by the patient about the headaches during Covid diagnosis but prior to receiving the vaccine. The patient stated that she was quarantined three weeks for Covid. The patient underwent lab tests and procedures which included COVID-19test: positive on 20Nov2020, and COVID-19: negative on Dec2020. The outcome of the events fever and headache was recovered on 07Jan2021. The outcome of the events joint pain, chills, and muscle pain was recovered on 06Jan2021. The report was reported as non-serious.
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| 49 | 2021-01-25 | migraine, dizziness |
migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a con...
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migraine; vertigo; diarrhea; sore arm injection site; dizzy; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142 and expiry date unknown) via unspecified route of administration at the left arm on 08Jan2021 13:45 at single dose for Covid-19 immunization in a hospital. Medical history included vestibular migraines, allergies to ragweed, and allergies to PCN (penicillin). The patient was not pregnant. The patient has no covid prior vaccination. Concomitant medications included amitriptyline hydrochloride (ELAVIL), propranolol hydrochloride (INDERAL), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC), riboflavin (VIT B2), and colecalciferol (D3) and multivitamins; all from unspecified date for unspecified indication. The patient has no other vaccine in four weeks. On day 1 (08Jan2021), the patient experienced sore arm injection site. On day 2 (09Jan2021), the patient experienced diarrhea once. On day 3 (10Jan2021), the patient experienced migraine, vertigo attack. On day 4 (11Jan2021) and 5 (12Jan2021), the patient was still little dizzy. The patient did not receive treatment due to the events. The outcome of the events sore arm injection site, diarrhea, migraine and vertigo was recovering, while dizzy was not recovered.
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| 49 | 2021-01-26 | night sweats, weakness, chills, headache, fatigue |
I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I w...
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I received the shot in the morning on Jan. 21, 2021 and had no issues until 12:20am (Jan 22)when I woke up sweating profusely and had major chills. My body ached all over and had a hard time sleeping due to all of this the entire evening. I woke up and tried to get ready but quickly realized I was weak, my joints hurt, body ached, headache and couldn't do it. This continued throughout the morning and part of the afternoon. Then around 2pm, I was still tired and achy but my joints didn't hurt as bad and I was able to manage the headache with ibuprofen. The body aches continued through most of the next day (Jan. 23) as well. By Jan. 24th I was perfectly fine and back to normal. I had covid early in the year on Nov. 6 which kept me out of work for almost 3 weeks. These few days were very similar to how I felt when I had covid but not as intense.
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| 49 | 2021-01-26 | dizziness |
Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then ...
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Patient received her 2nd Pfizer vaccination dose around 11:45. Was observed for 15 minutes and then left the clinic. She returned to the clinic 30 minutes later with complaints of dizziness, chest pressure, and tingling on her tongue. She ambulated in with her husband. She also stated she has a history of anxiety and was not sure if this was related to that or not. Due to the ongoing chest pressure, she was advised to go to the ED for further assessment. Per ED note, patient left the ED prior to receiving a medical screening exam by provider.
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| 49 | 2021-01-26 | weakness |
Severe shoulder and arm pain, weakness, numbness finger tips. Diagnosed with Parsonage Turner Syndro...
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Severe shoulder and arm pain, weakness, numbness finger tips. Diagnosed with Parsonage Turner Syndrome
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| 49 | 2021-01-26 | fever, chills, headache | headache chills fever lasted for a day and a half |
| 49 | 2021-01-27 | headache, chills |
Chills; headache; body aches; This is a spontaneous report from a contactable other health professio...
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Chills; headache; body aches; This is a spontaneous report from a contactable other health professional. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, intramuscular in the right arm, on 12Jan2021 17:00 at a SINGLE DOSE for covid-19 immunization. Prior vaccination, the patient had COVID-19 on an unspecified date. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), rosuvastatin calcium (CRESTOR), colecalciferol (VITAMIN D), ibuprofen, paracetamol (TYLENOL). Patient was not pregnant during vaccination. The patient previously took Tetracycline and Wellbutrin; she experienced allergy to both on unspecified dates. On 13Jan2021 17:00, the patient experienced chills, headache and body aches. outcome of events was recovered. The patient did not receive any treatment due to events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
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| 49 | 2021-01-27 | fatigue, dizziness, headache |
Patient received COVID19 vaccine on 1/26/21 (mfg unknown); headache started 1/27/21 at 2pm. Patient...
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Patient received COVID19 vaccine on 1/26/21 (mfg unknown); headache started 1/27/21 at 2pm. Patient had headache and tiredness and diarrhea and body aches after 2nd dose covid vaccine. Symptoms progressed to severe headache associated with N/V, dizziness that started 1/28@0800am. The patient admitted to Emergency Room at Hospital on 1/28/21 and diagnosed with aneurysmal subarachnoid hemorrhage. Patient transferred to Medical Center for care.
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| 49 | 2021-01-28 | cold sweat, headache, chills |
BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse ...
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BP 218/116; headache; cold sweats; shivering; This is a spontaneous report from a contactable nurse (patient) reported that a 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKS730), via an unspecified route of administration on the right arm on 20Dec2020 11:15 at a single dose for Covid-19 immunization. Medical history included allergic rhinitis and atopic dermatitis both from an unspecified date. Patient is not pregnant. Concomitant medications included montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), doxycycline, prednisone, and diphenhydramine hydrochloride (BENADRYL); all were taken from an unspecified date for an unspecified indication. The patient received the second dose of other vaccine (unspecified, Pfizer product, lot number: EK9231), via an unspecified route of administration on the right arm on 14Jan2021. On 20Dec2020 11:45, the patient had headache, cold sweats, shivering, and BP (blood pressure) 218/116. The patient called Rapid Response Nurse, and she was wheeled to the hospital E.R. The patient was seen by a doctor and opted to just monitor her BP, no medication or IV line started. The patient was discharged with SBP of 159. The outcome of the event BP (blood pressure) 218/116 was recovering while the rest of the events was unknown.; Sender's Comments: The subject received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Dec2020 11:15. On 20Dec2020 11:45, the patient had blood pressure high, 218/116 mmHg. Based on information available, the reported high blood pressure was probably causally related to the first dose of BNT162B2, considering the plausible temporal relationship, and clinical course. However, the concomitant medications, especially prednisone, for unspecified indications, could be confounding factors. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-28 | fatigue, dizziness, headache |
Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my enti...
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Day 1: mild headache, dizziness and loopy, tired. Day2: soreness at the injection site and my entire right arm. I was only able to lift my arm up to my shoulder. Very fatigue, body aches, dizziness and drunken feeling. Day 3: less arm soreness. Very fatigued and dizzy. Body aches, joint and muscle pain. Pain in my body. Day4: muscle and joint pain, still very fatigued and my vision began to become blurry. Day 5: fatigue, joint pain, headache and blurred vision has worsened. Day 6: fatigue joint pain, sever headache, dizzy, vision is still bad. I contacted the ophthalmologist and Optometry to schedule an appointment.
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| 49 | 2021-01-28 | chills, fever | Fever 101, body aches, chills |
| 49 | 2021-01-28 | malaise, headache |
Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph no...
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Fullness under my armpit which is on the same side as the vaccine, which looks like swollen lymph nodes under my armpit/kind of benign; Generalized malaise low grade; Headache; Both eyes are very swollen; inflammatory prosthesis in my eye; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3247) via an unspecified route of administration at arm on 15Jan2021 11:00 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. Nurse stated that she just wanted to report what she thinks is adverse reaction to the Covid-19 vaccine from Pfizer not sure what to do about it at this point. She was vaccinated Friday 11 o'clock in the afternoon. Both days felt really fine. Last night (16Jan2021) got some fullness under her armpit which was on the same side as the vaccine, which looked like swollen lymph nodes under her armpit which you can see was kind of benign. But in addition to that some generalized malaise lowgrade and headache (Jan2021). Seems totally fine but her both eyes are very swollen (Jan2021). Nurse took some ibuprofen (ADVIL)-600 mg, she was taking Prednisone for inflammatory prosthesis in her eye as treatment (Jan2021). Outcome of the events was unknown. The nurse considered the occurrence of the events are because of COVID-19 Vaccine.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Swollen eyes and Eye inflammation cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-01-28 | headache |
Headache Vertigo; Headache Vertigo; This is a spontaneous report from a contactable other health car...
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Headache Vertigo; Headache Vertigo; This is a spontaneous report from a contactable other health care professional (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), intramuscular (left arm) second dose on 14Jan2021 08:00 at single dose for covid-19 immunisation. The patient's medical history included Diabetes and PKD. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686) via Intramuscular left arm first dose on 22Dec2020 08:00 AM for covid-19 immunisation. On 16Jan2021 08:00, the patient experienced headache and Vertigo. The patient did not received treatment for the events. The outcome of the events was recovering.
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| 49 | 2021-01-31 | shortness of breath |
Patient began having increasing shortness of breath about a week after receiving first dose of Pfize...
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Patient began having increasing shortness of breath about a week after receiving first dose of Pfizer COVID-19 vaccine. Symptoms worsened and persisted to the point where patient called her PCP on 1/26/2021, who advised her to report to ED if experiencing worsening symptoms and/or low oxygenation. Patient reported to ED on 1/29/2021 due to tachycardia and O2 sats <90%. On presentation, patient was found to have bilateral pulmonary emboli involving the upper and lower lobe regions bilaterally including segmental branches without evidence of right heart strain.
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| 49 | 2021-01-31 | malaise, sweating, fever, fatigue |
Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees ...
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Sick; woke up 12 hours later and had a temp of 102 and arm pain/ temp gotten as high as 103 degrees Fahrenheit; arm pain; sweating; she was really tired; This is a spontaneous report from a contactable nurse. This 49-year-old female nurse reported for herself that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL8982) at single dose for Vaccination on 14Jan2021. The vaccine was injected to left deltoid/shoulder about 2:15 pm. Relevant medical history included ongoing uterine fibroids since Dec2019, ongoing obesity since Oct2000 and COVID-19 from Dec2020 to Dec2020. Relevant concomitant drug was unknown. The patient had surgical procedures when she had her first child. No Family Medical History Relevant to AE(s). Her mother got the shot a couple of days before caller did and she had no problems. The patient was administered her first dose of Pfizer BioNTech COVID-19 Vaccine on 14Jan2021. She reported that she became sick (Medically significant) about 12 hours later on 15Jan2021. The patient Went to sleep and woke up about 12 hours after she got the Pfizer-BioNTech COVID-19 Vaccine with a body temperature of 102 degrees Fahrenheit and arm pain. She could not really go back to sleep. When she got up it went away. She tried to go to work that day, and did go to work but she was really tired. When she finally got home she got in the bed and really had not been out of bed since then except for today she was sitting in a chair; so she thought maybe she had improved a little bit at on the reporting day. She had maintained a constant fever since 15Jan2021 that had gotten as high as 103 degrees Fahrenheit. At the reporting time her temp was 100.5. She had alternated Tylenol and Motrin for the fever. She was sweating profusely so it may be the temperature trying to break, but she had been struggling since she had it. This was so unlike her, she did not just stay in bed. She could not kick it. She had been unable to work since 15Jan2021 and she had to work tomorrow. She believed this was medically significant because she cannot work. The patient did not have vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No Additional Vaccines was administered on Same Date of the Pfizer Suspect. Relevant Tests was None. The patient did not visit the emergency Room nor Physician Office due to the events. The outcome of event being sick was resolving. The outcome of event temperature had gotten as high as 103 degrees Fahrenheit was not resolved. The outcome of other events was unknown. The patient thought the causality was yes 100% because her COVID-19 symptoms were not even this bad; she never had a fever with COVID-19; and she had never before had a fever this high for this long.; Sender's Comments: There is a plausible chronological association between vaccine administration and onset of the event; causality therefore cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-01 | cough, fever, fatigue, head discomfort |
Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, ...
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Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, loss of appetite, diarrhea. Missed 5 days of work
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| 49 | 2021-02-01 | influenza like illness, cough, fever, malaise, runny nose |
a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny ...
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a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.
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| 49 | 2021-02-02 | headache, malaise, fatigue |
Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypot...
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Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypotension; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Dec2020 at single dose at right arm for covid-19 immunization. Medical history included chronic fatigue, hypothyroidism, allergic rhinitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took promethazine hydrochloride (PHENERGAN) and experienced allergies: phenergan. After 1st dose, patient had severe headache for five days, malaise, fatigue on 19Dec2020 09:45 PM, day 6 syncope and collapse - orthostatic hypotension in Dec2020. The adverse events resulted in emergency room/department or urgent care. Adverse events treatment included CT head, carotid doppler, echocardiogram, lab work. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. Covid test type post vaccination included nasal swab on 24Dec2020: negative. Patient received second dose of bnt162b2 (lot number: el0142) on 08Jan2021 10:00 at single dose at left arm for covid-19 immunization. Outcome of events was recovered on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of syncope, orthostatic hypotension and other events due to temporal relationship. However, the events may likely possibly represent concurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-02 | shortness of breath, headache, dizziness |
Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath;...
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Vasovagal reaction; allergic reaction to vaccine; became lightheaded, dizzy; mildly short of breath; developed a headache/onset 6 out of 10 left-sided frontal headache; chest tightness; room is spinning around her however does not feel that she is presyncopal; This is a spontaneous report from a contactable pharmacist. A 49-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EJ1685; expiration date: unknown), intramuscular left arm on 18Dec2020 20:00 at a single dose for covid-19 immunization. Medical history included wheezing, hypertension, hyperlipidaemia and non-insulin-dependent diabetes. She was not diagnosed with Covid prior to vaccination. The patient has no known allergies. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medication included salbutamol sulfate (ALBUTEROL) for wheezing, fluticasone propionate (FLOVENT HFA), hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS), pravastatin, colecalciferol (VIT D3), colecalciferol (VITAMIN D3 1000), latanoprost and metformin. The patient did not receive other vaccine in the last four weeks. On 18Dec2020, the patient reported that she received her first Covid 19 vaccination shot in a hospital and shortly thereafter became lightheaded, dizzy, mildly short of breath, and developed a headache. She further reported that her symptoms occurred approximately 10 to 15 minutes (reported onset time of 08:00 PM) after receiving the shot and started after she walked a short distance and then sat down when she became mildly short of breath, had one episode of chest tightness that since resolved. She also had acute onset 6 out of 10 left-sided frontal headache that has stayed constant since onset. She feels that the room is spinning around her however does not feel that she is presyncopal. The impression was vasovagal reaction with mild allergic reaction to vaccine. The adverse events resulted in an emergency room/department or urgent care visit and treatment was received for the adverse events which included ketorolac 15mg x 1 dose, meclizine 25mg x 1 dose, NaCl 1,000 mL bolus. The patient was not COVID tested post vaccination. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-02-03 | malaise |
Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; a...
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Elevation of Blood pressures proceeded with high 155/95; heart flutter; extreme breast tenderness; axillary swelling; felt general unwell feeling; This is a spontaneous report from a contactable healthcare professional reporting for self. This 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EL0140) via intramuscular on 18Dec2020 12:00 PM at right arm at single dose for COVID-19 immunization. Medical history included known allergies: cinnamon. Patient did not have COVID prior vaccination. Concomitant medications included cyanocobalamin (B12), zinc, 4-(4-hydroxyphenyl)butan-2-one, crocus sativus, magnesium oxide (BELL DE NUIT PRECIOUS MAGICAL). It was reported that first day approx 6 hours after injection patient felt general unwell feeling, next day (19Dec2020) extreme breast tenderness and initiation of axillary swelling. At day 10 post injection (28Dec2020) she experienced some type of heart flutter. Elevation of Blood pressures proceeded with high 155/95 on unspecified date. PCP visit with normal EKG and blood work following week. BP in office 135/85 (from memory). Patient did not receive second dosage at day 21 and BP has currently returned to normal this a.m. (20Jan2021) 117/68. There was no treatment received for events. Patient did not test COVID post vaccination. The outcome of events was recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-07 | headache, fever, fatigue |
After receiving COVID injection patient tasted metal in mouth, and developed severe dry mouth. Gave...
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After receiving COVID injection patient tasted metal in mouth, and developed severe dry mouth. Gave water and observed for 40 minutes. Oxygen was 98-100% HR 70-78 BP 146-150/96-100s. Symptoms lasted around 1 hour. After arriving home BP was 110/78. Patient felt better. No hospitalization needed. Next day patient felt Body aches, Head ache, fever last 20 hours. Patient feels better today 2/8/2020 the only symptom left is fatigue.
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| 49 | 2021-02-07 | shortness of breath |
Patient had shortness of breath, stridor, chest pain 10 minutes after 2nd COVID-19 vaccine dose. Rec...
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Patient had shortness of breath, stridor, chest pain 10 minutes after 2nd COVID-19 vaccine dose. Received epi-pen, nebulized bronchodilators, steroid injection, diphenhydramine and famotidine. Patient was in ER about 7 hours for observation, improved and was discharged home with supportive care.
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| 49 | 2021-02-10 | dehydration, dizziness, headache |
First week had headache, nausea, dizziness with room spinning. Starting the second week had a Crohn'...
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First week had headache, nausea, dizziness with room spinning. Starting the second week had a Crohn's flare with abdominal pain and diarrhea, which has continued. Hospitalized due to dehydrating and low potassium, given steroids, fluids, and potassium supplement.
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| 49 | 2021-02-16 | dizziness, malaise, headache |
About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very ver...
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About 3am the next morning I woke up to a loud ringing in both my ear. When I sat up I was very very dizzy. I got up and showered and my feet swelled very bad. I did not feel well but I went to work but the feelings never got better. So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well. The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days. The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date. On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work. On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.
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| 49 | 2021-02-21 | dizziness | Patient felt light headed. Denies SOPB, chest pain, palpitations, V/V, or visual changes. |
| 49 | 2021-02-22 | headache, fever |
Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic S...
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Fever Headache Body Aches Diarhea Swollen Lymphnodes Terrible Shoulder/Arm pain Attacked Lymphatic System
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| 49 | 2021-02-22 | throat swelling, throat irritation |
hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis;...
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hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event "anaphylactic reaction/ Anaphylaxis") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 49 | 2021-02-25 | fever, malaise |
Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had...
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Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had a COVID 19 exposure ~ 1/3. The person she was exposed to tested positive 1/6 (daughter had a fever and cough). On 1/11 the patient received the 1st dose of the Pfizer vaccine. 12-24 hours after the Pfizer vaccine she developed fevers, malaise, myalgias that lasted 2-3 days (Called off work). She then returned to a normal state of health. On 2/1 she received the second dose of the vaccine. On 2/6 she developed right pleuritic chest pain so went to an urgent care. COVID 19 PCR was positive and CXR unremarkable. She was told to take naproxen and her pleuritic chest pain slowly improved. On 2/8 she started to have general malaise followed by nausea. On 2/11 she developed increased nausea and vomiting followed by diarrhea-eventually that day she had a near syncopal episode prompting her presentation to the hospital. Seen at an outside hospital between 2/11-2/12. CT abd/pelvis showed patchy ground glass opacities at the base of the lungs and she was noted to have diffuse mural thickening. There was concern for possible cholecystitis so a perc cholecystostomy tube was placed. Ultimately she developed significant hypoxic respiratory failure and had to be intubated.She was transferred to another hospital on 2/12. Initially she was started on treatment with dexamethasone but continued to clinically get worse. Also on empiric antibiotics.
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| 49 | 2021-02-28 | migraine, head discomfort, headache |
dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; t...
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dull achiness on the right side of temple area/headaches; head was sensitive; really bad migraine; turn off the lights in the office/has to have the lights low, still sensitive; arm hurt worse with second dose; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EK9231, expiry date Apr2021), via an unspecified route of administration on 19Jan2021 at a single dose, administered left arm at 4:10-4:15pm, as a coworker came down with Covid (COVID-19 immunization). The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm hurt with first dose of bnt162b2 given intramuscularly in the left arm (Lot number EL1284) on 29Dec2020 for COVID-19 immunization. Patient had her second Covid vaccine last Tuesday, 19Jan2021. She had a really bad migraine Friday, 22Jan2021 and had to turn off the lights in the office. On Saturday, 23Jan2021, her head was sensitive, but on Sunday, 24Jan2021, later in the evening she had this dull achiness on the right side of temple area that went down behind the right eye down to the temple. The dull and achiness was just enough to where she couldn't function and been like that ever since. She was prone to headaches and migraines, this was just different and so she took Tylenol and Aleve (both with believed dose was 200mg, 2 tablets by mouth since Jan2021), and another medication for migraines, Ubrelvy (lot number: 1084537, expiry Jan2022, dosage text: 100mg, 1 by mouth at first sign of headache, started in Jan2021). She took the Tylenol and it maybe of help, but the migraines/headaches are almost constant all day long. She took the Tylenol early Friday and when the migraine got really bad that was when she took the Ubrevly. She took the Aleve only yesterday, but she still has to have the lights low, still sensitive. Patient knew that the headaches are a sign of Covid, but when she had her first dose her arm hurt. This second arm hurt worse, arm hurt worse with second dose (Jan2021), and she did fine the first few days and Friday was when all of a sudden she had the migraine and had to turn off the lights in the office. She sits at a computer. The events did not require emergency room or physician office visits. Therapeutic measures were taken as a result of really bad migraine, "turn off the lights in the office/has to have the lights low, still sensitive", and "dull achiness on the right side of temple area/headaches". The patient had not recovered from really bad migraine, head was sensitive, and "dull achiness on the right side of temple area/headaches". The outcome of the events "turn off the lights in the office/has to have the lights low, still sensitive" and arm hurt worse with second dose was unknown.
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| 49 | 2021-03-03 | nasal congestion, somnolence, headache |
Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appet...
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Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
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| 49 | 2021-03-07 | fatigue, dizziness |
Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a...
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Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.
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| 49 | 2021-03-08 | headache, thirst |
hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; he...
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hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 49 | 2021-03-09 | fatigue, somnolence, fever, headache |
right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult...
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right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; right arm was feverish, painful and difficult to move; fatigued; developed a fever/reached 101.3 and was steady at 100 F for the duration of day/fever broke; piercing headache; sleepiness; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 49-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262, Expiry date: unknown), via an unspecified route of administration on 30Jan2021 at 09:15 am (Age at the time of vaccination was 49-years-old) at single dose on right arm for covid-19 immunisation. Medical history included hypertension an obesity. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included propranolol, triamterene, bupropion, valaciclovir hydrochloride. The patient reported that, within 4 hours of injection, on 31Jan2021 at 08:00 my right arm was feverish, painful and difficult to move. Within 8 hours, I became fatigued and developed a fever the next day at 8 am that reached 101.3 and was steady at 100 F for the duration of day. I also developed a piercing headache and sleepiness. At 1:45 am on 02Feb2021, my fever broke. My headache remained until 02Feb2021. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient recovered from the event headache on 02Feb2021 and recovered from other events on an unspecified date in 2021.
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| 49 | 2021-03-13 | shortness of breath, dizziness |
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: C...
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Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium
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| 49 | 2021-03-14 | lethargy |
Patient has MS and UC - weeks of lethargy; Patient has MS and UC - weeks of lethargy; lethargy; This...
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Patient has MS and UC - weeks of lethargy; Patient has MS and UC - weeks of lethargy; lethargy; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Feb2021 01:00 PM at single dose for COVID-19 immunisation. Medical history included COVID-19 prior vaccination. The patient's concomitant medications were not reported. The patient was not pregnant. Patient has MS (multiple sclerosis) and UC (ulcerative colitis) - weeks of lethargy on Feb2021. AE resulted in doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The patient underwent lab tests and procedures which included SARS-CoV-2 test: COVID yes prior vaccination. Events outcome was recovering. Information about lot/batch number has been requested.
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| 49 | 2021-03-15 | shortness of breath |
I went to get vaccinated at clinic on March 4, and I wait my 20 minutes at the time of leaving I got...
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I went to get vaccinated at clinic on March 4, and I wait my 20 minutes at the time of leaving I got itchy all over my body, my face turned red and with many outbreaks, I went back to clinic and the doctor gave me an injection, I got better a little but it gave me a lot of hyperactivity, when I arrived at home I couldn't handle the itch in the body and I felt my throat closing my husband took me to emergency, I couldn't breathe well, and I was itchy from head to toe. I stayed in emergency and I got some green discoloration very big on my legs, I have to go to the allergist because I still had itchy in the body
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| 49 | 2021-03-22 | fever, headache, chills | Fever, chills, nausea, vomiting, severe headache, neck and body pain |
| 50 | 2020-12-31 | fatigue, headache, chills |
Extreme tiredness started 30 minutes after vaccination into the day after. Chills, pain at the injec...
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Extreme tiredness started 30 minutes after vaccination into the day after. Chills, pain at the injection site, headache, tiredness day after vaccination. Took Motrin 600 mg which relieve headache.
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| 50 | 2020-12-31 | dizziness, fatigue |
I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was...
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I did immediately feel some slight dizziness but I also ad worked all night and was exhausted. I was driving home and did become itchy and developed a couple of small hives that quickly went away. The main event that I am reporting is a severe outbreak of eczema. I used to get it on my hands as a child and it was caused by citrus. On the morning of 12/24, I noticed itching and a red rash starting on my right wrist and my left hand. I thought perhaps it was from over washing or not rinsing all of the soap off. The rash became worse and I noticed a small area above my lip on the left side, I then developed a large area on the right side of my lower face. There were also a few spots elsewhere but these were the worst.
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| 50 | 2021-01-01 | dizziness, chills, shortness of breath |
Went to see an urgent care MD that day, he confirmed it was a swollen lymph node. Followed up at my ...
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Went to see an urgent care MD that day, he confirmed it was a swollen lymph node. Followed up at my primary care office next week Dec 28th, MD confirmed it was swollen lymph node likely related to immune response to COVID vaccine.
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| 50 | 2021-01-03 | nasopharyngitis |
After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was e...
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After receiving the vaccine, my arm was in a lot of pain. Then that night and the next day, it was extreme pain, I couldnt lay on it. Then about 3-4 days later, the color is blue and black. Then I started having cold symptoms. Like a head cold. On my left side, my arm and my leg is sore. In addition, my face broke out too. I did not go to the ER. I let Employee health examine my arm . No ER visit
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| 50 | 2021-01-03 | chills, headache | Chills Headache Body Aches No fever |
| 50 | 2021-01-03 | shortness of breath, headache, fatigue |
Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortne...
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Had heart palpitations within two hours of vaccine, severe headache, body aches, fatigue and shortness of breath. Sore left arm all the way down arm. Rested and took ibuprofen. Today I returned to work still having headache
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| 50 | 2021-01-03 | runny nose, cough, headache |
Nursing home staff member vaccinated at mass vaccination event for nursing home residents and staff ...
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Nursing home staff member vaccinated at mass vaccination event for nursing home residents and staff on 12/18/2020. Developed headache, cough, runny nose on 12/26/2020. Tested + for COVID-19 on 12/28/2020. Recovering well at home. No hospitalization or ED visits.
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| 50 | 2021-01-03 | dizziness, dehydration, body temperature increased, somnolence, fatigue, chills, headache, sweating, skin warm |
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to ...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine received at 11:40 AM. At approximately 9pm I began to experience whole body chills, teeth chattering, and extreme fatigue. I took Ibuprofen and went to sleep. I experienced chills until approx 3 AM. My watch alerted my heart rate rose above 120 bpm three separate times during the night in the 1, 2 and 3:00 hours. Upon review of the summary it appears to have been sustained at just over 120 for that entire time. I awoke at noon, with a temp of approx 99.5 F, I felt extreme fatigue and a sense of cold but body was warm to touch and I was very sweaty this entire time. I slept most of the day and at 5 pm awoke with a temp of 102.4F. I contacted my physician who directed me to use tylenol and Benadryl. I took a dose at 5 pm, anther at 9 PM. Upon waking the next morning I was afebrile. At that time I felt slightly dizzy and lightheaded but also dehydrated. Forcing fluids relieved symptoms. I experienced a very mild headache and very mild queasiness as well.
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| 50 | 2021-01-03 | headache |
Received the injection on Wednesday afternoon. I woke up around 3am with an excruciating headache, s...
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Received the injection on Wednesday afternoon. I woke up around 3am with an excruciating headache, started vomiting around 6am and continued until 7:30pm. The headache continued and as of this morning 1/4 the headache is still there and my stomach is not settled completely.
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| 50 | 2021-01-03 | dizziness |
dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given. ...
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dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given. Vitals monitored, were normal, sent home and advised to take Benadryl. More hives on upper lip/chin appeared 36 hours after vaccine given. Patient was at home, self-treated with benadryl, zyrtec, famotidine and ice pack applied to area.
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| 50 | 2021-01-03 | dizziness | dizziness, palpitations and lightheadedness right after vaccination and lasted up to 2 hours |
| 50 | 2021-01-04 | throat irritation |
8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and bro...
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8:31 Reported to us increased heart rate and tingling lips. Stated she had several allergies and brought her epi pen with her. Brought her to EMS station. 8:32 Gave epi 8:35 HR126 SPO2 100% 8:38 IV placed 8:39 POC 108 8:39 Benadryl 50mg IV push 8:40 Solumedrol 125 mg IV push Continued tongue/throat/ head itching 8:42 second epi given 8:46 136/64 HR 125 8:48 Transported to Medical Center via EMS
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| 50 | 2021-01-04 | dizziness |
Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and...
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Admit to ER post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness. She was given benadryl and pepcid, monitored for 3hrs before discharge from ED. Patient still experiencing same symptoms 1 week later per follow-up (12/29)
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| 50 | 2021-01-04 | shortness of breath, sweating |
BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase flui...
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BP; 170/110 mild SOB palpitation (HR 80bpm) hot flashes mild sweating Took Claritin, increase fluid intake, and extra Valsartan x 1.
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| 50 | 2021-01-04 | malaise, chills, headache |
Chills; Muscle ache; Headache; Did not feel well in general; Right arm soreness in the same arm that...
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Chills; Muscle ache; Headache; Did not feel well in general; Right arm soreness in the same arm that the COVID vaccine was given; It was hard to lift her arm and woke her up when she was sleeping; It was hard to lift her arm and woke her up when she was sleeping; This is a spontaneous report from a contactable consumer (patient, occupation: Respiratory Therapist). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 22Dec2020 11:00 (reported as Approximately 11am in the morning) at single dose to help stop the spread of COVID. Location of the COVID Vaccine: Right arm. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no prior Vaccinations with 4 weeks. Medical history included she had tested positive for COVID on 02Oct2020. The patient did not have any illness at time of vaccination. Family Medical History Relevant to adverse event also reported as none. There were no concomitant medications. The patient previously had flu vaccine given at the hospital she works at and She had mild arm soreness after the Flu vaccine. The patient experienced Right arm soreness in the same arm that the COVID vaccine was given on 22Dec2020, Chills on 23Dec2020, Muscle ache on 23Dec2020, Headache on 23Dec2020, did not feel well in general on 23Dec2020. Caller reported that she experienced right arm soreness, in the arm she received the vaccine, that was unlike any other vaccine she had ever had. The arm soreness began the same evening as the day she received the COVID vaccine. It was hard to lift her arm and woke her up when she was sleeping in Dec2020. The remainder of the side effects began the following morning after she had received the COVID Vaccine. Other side effects included chills, which lasted until the 24th or 25Dec2020. Muscle aches, which lasted until the 24th or 25th Dec2020. Headaches, which she is still getting off and on, but it is hard to say if the headaches that she is still getting is still from the COVID vaccine. The headaches are coming less often. She has had to take something for the headaches. Caller stated that she did not feel well, in general. Asked caller what other vaccines she had received and had experienced arm soreness but not to the extent she had after the COVID Vaccine and caller stated that she had mild arm soreness after the Flu vaccine. Previous flu vaccines had been given to her at the hospital she works at; therefore, she did not have any lot number information for these flu vaccines. The reported adverse events did not require a visit to Emergency Room and Physician's office. The patient was not hospitalized. The outcome of event Right arm soreness in the same arm that the COVID vaccine was given was recovered on 26Dec2020, the outcome of the event Chills, Muscle ache was recovered in Dec2020, the outcome of the event did not feel well in general was recovered on 25Dec2020. The outcome of the event Headache was recovering. The outcome of the other events was unknown. The causality assessment for events Right arm soreness in the same arm that the COVID vaccine was given, Chills, Muscle ache, Headache, did not feel well in general with suspect COVID vaccine was assessed as related by Primary Source Reporter via Method of assessment Global Introspection. Information on the lot/batch number has been requested.
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| 50 | 2021-01-04 | fatigue, headache |
Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, b...
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Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; Extreme fatigue, body aches, and headaches that began around day 4 post vaccine.; This is a spontaneous report from a contactable Other HCP reporting for herself. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), Intramuscular on 22Dec2020 17:45 at single dose for covid-19 immunisation. Vaccine administered in left arm. Medical history included Anemia and Hypothyroidism. Patient is not pregnant. Concomitant medication was not reported. Patient had allergies to Levaquin. The patient experienced extreme fatigue, body aches, and headaches that began around day 4 post vaccine on 26Dec2020. Patient has not been tested for coronavirus disease (COVID-19). Patient was not diagnosed with COVID-19. Outcome of events was not recovered.
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| 50 | 2021-01-04 | fever, headache, shortness of breath, chills | Fever 100.3 Body aches Trouble breathing Chills Headache |
| 50 | 2021-01-04 | headache |
In response to the vaccine on 21Dec2020 I started to get a headache; This is a spontaneous report fr...
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In response to the vaccine on 21Dec2020 I started to get a headache; This is a spontaneous report from a contactable nurse (patient). An 50-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration in the left arm on 21Dec2020 at 12:00 PM in a hospital at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination, had no known drug allergies (NKDA), and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included diazepam (VALIUM). In response to the vaccine on 21Dec2020, the patient started to get a headache, 600 mg ibuprofen was taken. Overnight, she woke up with a debilitating headache, stayed in bed on 22Dec2020 taking Tylenol 1000 mg q (every) 8 hours and Ibuprofen 600 mg q (every) 6 hours to keep the headache manageable. The entire week, she had 2 days where if she didn't keep rotating the doses of Tylenol and Ibuprofen, the headache would become severe. The side effects included "headache" but this was no common headache and she was not a person who routinely gets them. It has been a week since the injection and she still had to continue the cycling of Tylenol/ibuprofen to maintain this headache, to continue ADL's. Outcome of the event was not recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 50 | 2021-01-04 | headache | Red face rash morning of 2 days following vaccine Dull headache, day of vaccine |
| 50 | 2021-01-04 | headache, chills, cough, fever, migraine |
Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Naus...
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Sometimes her headaches are migraines; Chills; Fever; Cough; Really lazy; Body aches; Headache; Nausea; This is a spontaneous report from a contactable Registered nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: E10140), via an unspecified route of administration on 23Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included ongoing Diabetic for at least 7 years, ongoing hit in the head (She was a psych nurse and was hit in the head at work maybe a month to two months ago in 2020. She did have headaches from that incident). There were no concomitant medications. The patient experienced headache on 23Dec2020, fever on 24Dec2020 14:30, nausea on 23Dec2020, cough on 24Dec2020, really lazy on 24Dec2020, chills on 24Dec2020 14:30, body aches on 24Dec2020, sometimes her headaches were migraines on an unspecified date. Specifically, it was reported that when she first got the vaccine, she didn't have anything but a headache and a little bit of nausea. She had worked the night before and didn't sleep before the shot. So maybe that had a part in it. She was a diabetic. It was fine, and no big deal that night. Then, the next day on 24Dec2020 at 2:30 pm she woke up and she was freezing and couldn't get warm. She had chills and a fever of 102.1 on 24Dec2020. She took Tylenol, and it came down to 101 on an unspecified date in Dec2020. All weekend long, she has had a fever. It has been controlled by Tylenol. She had chills so bad she had to use her heated blanket. She has had a cough. She has been really lazy. She has had chills and body aches. She has had nausea here and there. She has had a headache. She received the vaccine on the 23Dec2020, which was Wednesday. She had to stay 15 minutes after. That is when she developed the headache and nausea. Sometimes her headaches were migraines. She developed the fever on 24Dec2020 14:30. Or noticed the fever when she woke up. Her fever was 101.2 this morning on 28Dec2020. Within the 15 minutes of getting the vaccine, she developed the nausea. It has gotten better. Her body aches are getting better. She still has chills when she is running a fever. She has gotten better overall. Thursday (24Dec2020), Friday (25Dec2020), and Saturday (26Dec2020) it was awful. Sunday (27Dec2020) the symptoms lightened up. Today (28Dec2020) she was better. She still had a headache and fever this morning, but nothing like she had been feeling. She felt like dying those days. She was a Psych nurse, and she got hit in the head. So she did get headaches from that incident. They are about the same as these headaches so she didn't know if it was related. It just went along with the flu like symptoms. But sometimes these headaches were migraines. Therapeutic measures were taken as a result of fever and chills. The outcome of the events headache, chills was not recovered. The outcome of the event really lazy was recovered on 27Dec2020. The outcome of the events fever, nausea, cough, body aches was recovering. The outcome of the event migraines was unknown.
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| 50 | 2021-01-04 | weakness, fever, malaise |
allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her l...
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allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
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| 50 | 2021-01-04 | fever |
body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to ex...
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body aches; decreased appetite; cotton mouth; everything tastes metallic and it's kind of hard to explain it very well; change of sense of taste; loss of taste; body rash on upper torso only described as "not bad" and "not itchy" or bothersome; low grade fever 100.3; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (lot number: EH9899), via an unspecified route of administration in left upper arm, on 21Dec2020 06:30 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital.The patient's weight was 67.13 kg and height was 173 cm. The patient's medical history included nausea and flu like symptoms. Concomitant medications included omeprazole(PROTONIX) from Dec2020 at 40mg once a day for nausea. The patient stated that a week before she received the vaccine she had flu like symptoms and she was tested for COVID-19 and the test result was negative in Dec2020. The patient experienced low grade fever 100.3 which started in the evening of the vaccine(21Dec2020) and she took Tylenol and went to sleep and the next day felt better, which resolved by the next day(22Dec2020). The patient experienced body aches on an unknown date, body rash on upper torso only described as "not bad" and "not itchy" or bothersome which started on 21Dec2020(a few hours after receiving vaccine) and resolved on 23Dec2020. The patient experienced change of sense of taste, "everything tastes metallic and it's kind of hard to explain it very well" on 24Dec2020. The patient experienced loss of tastewhich started on either 23Dec2020 or 24Dec2020. She was starting to be able to taste. She has anything it is bland. She can taste some saltiness. That started coming back on approximately Saturday, 26Dec2020. The patient experienced decreased appetite, "cotton mouth" on an unknown date. The outcome of the events "low grade fever 100.3", "body rash on upper torso only described as "not bad" and "not itchy" or bothersome", "loss of taste" was recovered and of other events was unknown.
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| 50 | 2021-01-04 | headache |
day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days ...
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day of vaccine: dull headache for the majority of the day (I don't typically get headaches) 2 days after vaccine: minor bilateral rash on face - both cheeks red, slightly raised bumps, no itching or pain, lasted for about 24-36 hrs
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| 50 | 2021-01-04 | headache, sweating, dizziness |
diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bi...
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diaphoretic; woozy; heart rate went down to 43; blood pressure down to 83/57; headache; feeling a bit cruddy; This is a spontaneous report from a contactable other healthcare professional. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: paa156051), via an unspecified route of administration (arm left, dose number 1) on 17Dec2020 10:30 at single dose for COVID-19 immunisation. Medical history included Psoriatic arthritis from an unknown date and unknown if ongoing. Concomitant medication included etanercept (ENBREL), propranolol, and curcuma longa (TURMERIC CURCUMIN). Patient is on unspecified birth control and unspecified vitamins. No other vaccines in four weeks were given. The patient previously took steroids and experienced allergies (similar reaction to steroid 1 year before), and FLONASE and experienced allergies. On 17Dec2020, It was reported that the patient was fine for the first 15 minutes, afterwards became very diaphoretic, woozy, heart rate went down to 43 and blood pressure down to 83/57. The patient recovered enough to leave about 20 minutes. After that, patient's heart rate was back into the 60's and BP stayed the same but the patient was feeling better. Patient's heart rate is usually in the 70's and his BP around 115/75 or so. The patient has no breathing problems. Other than headache and feeling a bit cruddy, the patient has been fine since. Patient mentioned she really wanted to take the second dose, but she does not know if she should. No treatment for the adverse events. No COVID prior vaccination and patient has not tested for COVID post vaccination. Event outcome was recovered on Dec2020. Events were considered non-serious.
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| 50 | 2021-01-04 | dizziness, sweating, headache |
headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, som...
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headache, right arm to leg sore, sweating dizzy, hot & cold, want to throw up, loss of appetite, some chest pain, feel woosy, felt confussed right after vaccine,
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| 50 | 2021-01-04 | headache, fatigue |
hives in her chest and neck; Her neck and chest were itchy; had a headache and was tired; had a head...
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hives in her chest and neck; Her neck and chest were itchy; had a headache and was tired; had a headache and was tired; This is a spontaneous report from a contactable Other HCP reporting for herself. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the right arm on 23Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included seasonal allergies to: Ragweed, bees, mold, trees, lots of seasonal things. The patient's concomitant medications were none. On 23Dec2020 the patient had a headache and was tired with outcome of unknown, the patient attributed it to having a stressful day. On 24Dec2020 (between 00:00 and 06:00), she had hives across her neck and part of chest. Her neck and chest were itchy and she had hives the next morning. The patient took diphenhydramine hydrochloride (BENADRYL) for 2 days for hives and was all better. She would like to know if she should get the second dose.
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| 50 | 2021-01-04 | body temperature increased |
temperature between 100.5 to 101.8, swelling of L arm (sever) and pain into arm pit, swelling of lym...
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temperature between 100.5 to 101.8, swelling of L arm (sever) and pain into arm pit, swelling of lymph nodes
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| 50 | 2021-01-04 | headache |
underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting he...
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underneath my armpit is a little bit swelling; arm hurt a little bit more; headache; body hurting her; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH5730), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunisation. There were no medical history nor concomitant medications. The consumer received the vaccine on the 28Dec2020. She doesn't have a prescribing doctor. During the night after receiving the vaccine, her body was hurting her on 28Dec2020. She started to develop side effects 4-5 hours after receiving the vaccine. The side effects started during the evening the same day she got the shot. On 29Dec2020, the side effects were worse, she had a headache, and her arm hurt a little bit more. She then realized under her armpit was swollen a little bit / underneath her armpit was a little bit swelling on 30Dec2020. She talked to someone earlier about this and they told her to call her doctor. She had a lot of headaches. Everything is hurting her. The outcome of under her armpit was swollen a little bit was not recovered, of her arm hurt a little bit more was unknown. The outcome of the other events was recovering.
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| 50 | 2021-01-05 | runny nose, skin warm |
Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a t...
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Approximately 2 hours post injection, my left arm started to feel warm and itchy. I was wearing a thick hoodie and when I pulled my sleeve up, it was covered with hives and welts. My lower lip started to feel full and nose started to feel runny. I was close to a pharmacy when I discovered the hives so I went and bought Tylenol and Benadryl and took it immediately. After that, I headed to the emergency room of the facility where I got my covid 19 -Pfizer injection. When I got there, my right arm started to feel itchy as well and I also broke out in a rash on my left upper chest. They gave me a steroid injection and steroid taper prescription. When I got home that night, my right forearm broke out in hives. The next couple of days, my left arm intermittently had hives.
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| 50 | 2021-01-05 | dizziness | Dizziness, Elevated |
| 50 | 2021-01-05 | headache, fatigue, chills, fever |
Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; Low grad...
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Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female received first single dose of BNT162B2, (Pfizer, Solution for injection, Lot number: EK 9231, exp date not reported), intramuscular (anatomical location: arm left) on 29Dec2020 09:15 for immunization. Medical history included asthma, hypothyroid, high cholesterol, and allergies: latex and shellfish. The patient was diagnosed with COVID-19 Prior to vaccination.Concomitant medication (Other medications in two weeks) include: magnesium sulfate, ibuprofen, cetirizine hydrochloride (ZYRTEC ALLERGY), levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), simvastatin, and cimicifuga racemosa root, glycine max extract (BLACK COHOSH & SOY ISOFLAVONES). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Hospital. The patient experienced low grade temp 99.6, chills, was tired, and headache on 29Dec2020 19:00. No treatment was received. Patient was not Covid tested post vaccination. The outcome of the events was unknown.
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| 50 | 2021-01-05 | headache | Mild headache |
| 50 | 2021-01-05 | dizziness |
Patient stated after 15 minutes of getting vaccination and stated she felt like she felt light head...
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Patient stated after 15 minutes of getting vaccination and stated she felt like she felt light headed, felt like head and tongue were swollen, but they didn't appear to be swollen. Speech was clear. Treated with 25mg benadryl po and monitored for 45 minutes and patient stated symptoms resolved.
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| 50 | 2021-01-05 | headache, cough, throat pain |
Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began...
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Severe Nausea within 30 minutes - has not subsided - still present after 24 hours Chest Pain - began after 10 hours - reduced pain after 24 hours, but still present Headache - began after 8 hours - still present Cough - began after 8 hours - still present Sore Throat - began after 8 hours - still present Shaking hands - began next morning - still present
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| 50 | 2021-01-05 | weakness, dizziness |
Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115...
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Tachycardia/her heart rate at 11:00PM last night was at around 100/ she checked her pulse it was 115; she was not feeling right, so she took the day off from work today; Lightheadedness; wobbly; she felt weak; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, expiration date: Apr2021), via an unspecified route of administration at right deltoid on 29Dec2020 17:45 at a single dose for Covid-19 immunization. Medical history included asthma from 2003 and ongoing, tachycardia and major surgery. Concomitant medication included maintenance inhaler (unspecified) for asthma. Patient was officially diagnosed with asthma in 2003. She said her asthma was controlled, and she takes a maintenance inhaler every day. She said she has been taking the same maintenance inhaler since she was first diagnosed with the asthma. She said she rarely uses a rescue inhaler. Reported she was prescribed the Metoprolol Tartrate 25mg for her tachycardia that she had after her major surgery, but she did not take the full 25mg dose during that time. She said she hasn't had taken the Metoprolol Tartrate 25mg in almost a year, clarifying it was last Jan2020 that she used the Metoprolol Tartrate. The patient previously received a flu shot in Oct2020, and felt rundown for a day afterwards, but that she always does after she receives a flu shot. She said she had no heart issues after receiving the flu shot in Oct2020. The patient who is a registered nurse reported she received the COVID-19 vaccine last night at work, on 29Dec2020, at 5:45PM, and had experienced some tachycardia after receiving the vaccine. Reported the COVID-19 Vaccine was offered through her employer. She said the COVID-19 vaccine was optional and offered to all employees if they work at the hospital. She experienced the tachycardia at 11:00 PM last night, 29Dec2020. She said her normal resting heart rate is between the high 60s to low 70s. She said her heart rate at 11:00PM last night was at around 100, clarifying she was not running a fever at that time. She stated after she received the COVID-19 vaccine, she was not feeling right, so she took the day off from work today, and slept in. She said when she woke up this morning (in Dec2020), she still didn't feel right, saying she felt weak and wobbly, and when she checked her pulse it was 115. She said she does have a past history of tachycardia. She said a year ago she had major surgery, and she had tachycardia after the major surgery. She said the tachycardia eventually went away, but she did have to see a cardiologist and take a beta blocker. She said she took a tiny dose of the beta blocker this morning, and called the cardiologist to let him know what was going on. She said she has not heard back from the cardiologist yet. She said the tachycardia went away once she took the beta blocker this morning. She said she took the beta blocker because her heart rate was going higher, and higher. She said she didn't want to end up like last year after her major surgery with a heart rate in the 170s. She said the tachycardia she was experiencing after receiving the COVID-19 Vaccine was not normal for her. She said once she got over the major surgery last year, her heart rate was fine. Reported her employer was making employees wait around for 15 minutes after the employees received the COVID-19 Vaccine to make sure no one had a major reaction to the COVID-19 Vaccine. She said after she received the COVID-19 Vaccine, she waited around longer than the 15 minutes. She said she felt weird after she received the COVID-19 Vaccine and thought maybe she was experiencing anxiety. She said she was lightheaded on 29Dec2020 after she received the COVID-19 Vaccine and completed a report right then on the website. She said the website is for reporting adverse events, and she was sent a website link to complete the adverse event reporting. She said she signed into the website link while she was still at the hospital. She said one of the website's first questions asked was how she was feeling. She said the question made her wonder if her lightheadedness was due to her heart rate being up because she becomes lightheaded when that happens. She clarified she reported only the lightheadedness on the website, and not the tachycardia. She said her lightheadedness got better and she was fine, and then at 11:00PM the tachycardia hit her like a switch. Reported this morning she felt fine, and then all of sudden she wasn't fine. Tachycardia Treatment: Reported she took a 8.5mg dose, or one quarter of a 25mg tablet (as provided by the reporter) of the beta blocker Metoprolol Tartrate 25mg tablet this morning and called her cardiologist to let him know. She said she split the Metoprolol Tartrate 25mg tablet this morning, and only took a quarter of the 25mg tablet (reported as a 8.5mg dose by the reporter). Reported she believes 100% that her tachycardia was caused by the COVID-19 Vaccine, saying she has been fine up until receiving the COVID-19 Vaccine. She said she got the COVID-19 Vaccine because she was afraid of getting the COVID-19 Virus with her asthma. She said she has no other preexisting conditions besides the asthma. Reported she is not going to get the second COVID-19 Vaccine dose. She said it was scary when her heart rate shot up out of nowhere. She said the COVID-19 Vaccine is the only thing different she has done. She said before the COVID-19 Vaccine, she was completely fine. Patient asked if the Pfizer DSU agent had heard of anyone else who has experienced tachycardia after receiving the COVID-19 Vaccine. The outcome of the event tachycardia was recovered in Dec2020, event lightheadedness was recovering and unknown for the other events. The reporter assessed the event 'tachycardia' as Serious (Medically Significant).; Sender's Comments: Based on the close temporal relationship, the association between the event tachycardia with BNT162b2 can not be fully excluded. The medical history of tachycardia and asthma medication may be contributory as well. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-05 | throat swelling |
anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-o...
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anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension, lipids (as reported) and asthma. The patient was known allergies: codeine, iodine, shellfish, latex, and cefatrizine propyleneglycolate (CEFTIN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. The patient experienced anaphylaxis and throat swelling on 22Dec2020 with outcome of recovered in Dec2020. The events were reported as non-serious. The events resulted in Emergency room/department or urgent care. Treatment of epinephrine, steroids, antihistamines, observation was received for the events. Information on lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis and throat swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-05 | chills, fatigue |
swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ w...
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swelling and tingling in face after waiting 40 minutes of injection. left side of tongue swelling/ went down chills/fatigues soreness to injection site( which was excepted)
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| 50 | 2021-01-06 | fever, chills | CHILLS, FULL BODY SKELETAL ACHES AND FEVER |
| 50 | 2021-01-06 | lethargy |
Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stingin...
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Day after vaccine: Upper back and neck stiffness and ache; injection site swollen/ache; eyes stinging; extreme lethargy
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| 50 | 2021-01-06 | fatigue, headache | Fatigue, body aches, headache x 3 days now resolved. |
| 50 | 2021-01-06 | headache |
Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 he...
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Headache Left arm pain Narrative: 12/29 - onset of left arm pain. 12/30- onset of headache. 12/31 headache still present but improve. Arm is mildly sore - much better
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| 50 | 2021-01-06 | lethargy, fatigue, headache | Lethargy/fatigue, mild headache (off and on) since approx. 5.5 hrs after vaccine. |
| 50 | 2021-01-06 | migraine |
MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN A...
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MIGRAINE HEADACHE BEGAN ABOUT 2 HOURS POST INJECTION, BODY ACHES BEGAN ABOUT 3:30PM, THROBING PAIN AND SWELLING TO INJECTION SITE BEGAN AT APPROXIMATELY 10:00 PM. TOOK TYLENOL 500MG AT 1:45pm THEN AGAIN AT 10:30 pm, also applied ice to injection site.
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| 50 | 2021-01-06 | chills | Nausea, Chills, Achiness, pain from head to toes |
| 50 | 2021-01-06 | dizziness |
Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive ...
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Numbness and tingling in fingers and arm. It has slowly gone away but is still lingering. Cognitive impaired, dizzy, disoriented
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| 50 | 2021-01-06 | dizziness, somnolence |
PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, B...
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PATIENT COMPLAINED OF LIGHTHEADEDNESS, VOMITING X2, GAGGING, DROWSY, UNSTABLE, TACHYCARDIC HR 110, BP 142/91
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| 50 | 2021-01-06 | malaise, chills |
Pfizer BioNTech COVID 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning aft...
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Pfizer BioNTech COVID 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning after the vaccine
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| 50 | 2021-01-06 | malaise, chills |
Pfizer BioNTech COVIS 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning aft...
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Pfizer BioNTech COVIS 19 Vaccine EUA developed body aches, chills, malaise, vomiting the morning after the vaccine
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| 50 | 2021-01-06 | throat irritation, throat swelling |
Pfizer Vaccine 45 min after dose, needed to clear my throat allot. Took Claritan and quieted down. B...
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Pfizer Vaccine 45 min after dose, needed to clear my throat allot. Took Claritan and quieted down. By 8 pm left side neck ache. By 3 am the next day lots of trouble with throat and swallowing. Moderate to sever neck pain, muscle tight and contracted like cervical dystonia. Took another claritan. 2 hours later 25 mg Bendadryl. 830am called healthcare clinic and was seen. "Immune response" Not "allergy" Recommends not getting shot number 2
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| 50 | 2021-01-06 | dizziness, nasal congestion, malaise, sweating |
Pt given 2nd dose of pfizer vaccination given by LVN RN informed that pt was not feeling well at 08...
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Pt given 2nd dose of pfizer vaccination given by LVN RN informed that pt was not feeling well at 0834 by LVN. RN informed front desk to call rapid response at 0835. Pt transferred from waiting area to wheel chair then to gurney 0836 vs: bp:151/109 hr:95 02sat: 90 room air- complaint of dizziness, feeling like she is going to pass out, headache 6/10, diaphoretic hands bilaterally, tearful, feeling like she is going to pass out, complaint of congestion, notes she has history of htn and sleep apnea, pt states that she was not feeling well since administration of vaccination however did not inform LVN. 0837:2L o2 via nasal canula 0840: vs: BP 138/75 hr:83 02 sat:94 97.7 temp: on 2L nasal cannula, rapid response arrived report given, pt still feeling the same. 0845: vs bp: 133/84 hr: 79 o2sat: 94 0850: rapid response nurse cleared pt to be discharged, pt given option of going to ED for observation however declined at the time. 0851: pt sat up repeat o2sat: 95 on room air- states that she is feeling better, stating "I think I just have to go home and take a nap" 0855: pt requesting to be discharged, encouraged to have someone drive her home states she will call her sister- pt never picked up phone to call sister- then insisted she is fine to dive herself home. 0856: cleared with -supervisor that pt okay to be wheeled down to car by LVN be wheeled down to car- pt given ed precautions. 0907: LVN reported that pt elected to go to ED as she was experiencing dizziness per LVN. In ED pt given IV Benadryl 25 mg, tordol 15mg iv, 1 liter Lactated ringers, 4 mg Zofran iv
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| 50 | 2021-01-06 | malaise, headache, fatigue |
The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pf...
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The patient is a 50 yo female with a history of IBS who reports concerns about Covid vaccine AE. (Pfizer EK5730) receipt 16 DEC 2020. She reports no immediate reaction except experienced a dry throat which she noted after her 30 minute wait, but no urticaria, SOB, wheezing, oral/face/throat/tongue edema, flushing, pruritic, CP n/v/d. She states about 3 hours later she developed a dermatitis initially to her legs. The lesions were raised, pink, initially nonpruritic, fixed but no vesicles, pustules or bruising. She took a shower which exacerbated the symptoms with erythematous patches and severe burning sensation. She reports she was seen in ER and her spouse noted lesions to her neck and ears. Her eyes felt swollen. She left ER due to the wait and obtained Benadryl OTC. She saw her PCP in the morning. She received IM dexamethasone and oral prednisone dose pack. She continued to not feel well. She experienced heart palpitations, feeling hot and flushed, fatigue and headache which she treated with Tylenol. She treated the dermatitis with Zyrtec 10-20 mgs q1-2 x daily, but sometimes took Benadryl. Last dose was Benadryl at midnight, Zyrtec 10 at 0600 and has one day of prednisone left. She also experienced bilat tingling in her feet starting day 5. which the left resolved but her right foot continued. She has no paresis, paralysis, altered gait, tripping or fall, difficulty emptying her bladder. She saw PCP on 05 January. ESR was normal . Overall symptoms improved but continued r foot numbness, pain to her legs. She reports PCP ordered CXR and abdominal series which were normal.
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| 50 | 2021-01-06 | headache, fatigue | achy muscles, joint pain, fatigue, headache |
| 50 | 2021-01-06 | shortness of breath, chills |
feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chill...
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feeling close to loss of consciousness; intense chest pressure/tightness; shortness of breath; chills while driving home; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the left arm, on 02Jan2021 at 11:30 (at the age of 50-years-old) as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home on 02Jan2021 at 12:00. The patient did not receive any treatment for the events. The clinical outcome of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath, and chills while driving home was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of feeling close to loss of consciousness, intense chest pressure/tightness, shortness of breath cannot be excluded, considering the plausible temporal relationship. The underlying predisposing condition of penicillin allergy may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-06 | respiratory tract congestion, shortness of breath |
patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 an...
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patient had Covid 19 vaccine from Pfizer with lot #EJ1686 with expiration date 3/2021 on 1/7/2021 and after 45 minutes, she came back and stated she has chest tightness, lip swelling, chest congestion, shortness of breath, asthma-like symptoms with mucus type in her chest. her BP at that time was 184/109. She was given 1 EpiPen and 2 Benadryl 25mg tablets.
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| 50 | 2021-01-06 | shortness of breath |
warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u...
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warm, trouble breathing, nausea, chest pressure, arm burning, increased blood pressure Next day f/u - stick neck, shoulder pain + heat, left cheek swollen been taking tylenol and benadryl saw PCP - received rx for prednisone
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| 50 | 2021-01-07 | chills, fever, cough |
01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Ty...
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01/08/2020 2:00AM extreme pain in arm at injection site ; 11:00AM chills, jaw pain, fever 103. 2, Tylenol reduced fever to 100.8, body aches and joints, slight cough
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| 50 | 2021-01-07 | chills |
10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were ...
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10 hrs. after receiving the vaccine, I started getting chills followed by muscle pain. My eyes were burning. I went to bed under 3 blankets and couldn't get warm. 5 hours later, the chills went away, but the pain persisted. 3 hours later, I took tylenol for the pain and felt much better 1 hour later.
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| 50 | 2021-01-07 | chills, cold sweat, shortness of breath |
20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/...
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20 minutes after vaccine, cold chills sweat. 30 minutes after shortness of breath blochy rash neck/ torso. went to urgent care, wouldnt let me enter becuase didnt have a phone on to call. Went home, took 50 mg benadryl pepcid PO. took albuterol inhaler due to tachypnea. tried to wait it out at home. apporox 0200, rigors/ seizure tachypnea continued with respirations ranging 32-38/min. took 600 mg ibuprofen and albuterol inhaler, additional 50 mg benadryl. continued blocky rash. next day, called urgent care asking for appointment, thought needed steroid, they instructed to go to ED to check for covid. explained to them not covid, but allergic reaction. afraid to go to ED in thinking may need to get intubated. approx 1030 am, had 2 addtional episodes of rigors/ seizure. temp never above 99.0 F. found epi pen in house and used it. no further rigors, no further tachypnea, rash disappeared.
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| 50 | 2021-01-07 | throat irritation | Anaphylaxis with a hives, itching, and airway involvement |
| 50 | 2021-01-07 | fever, fatigue, nasal congestion, chills, cough |
Congestion; Felt warm; took temp, I was 101.5; Chills; Everything hurts; Feel sick; Coughing; Really...
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Congestion; Felt warm; took temp, I was 101.5; Chills; Everything hurts; Feel sick; Coughing; Really tired/exhausted; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included Hashimoto's Goitre, migraine, Pacemaker, she just had her third one replaced, that was since I was 27. Concomitant medication included levothyroxine for Hashimoto's Goitre, sertraline, topiramate (TOPAMAX). The patient received the vaccine on 30Dec2020. She had congestion, she was still congested. That night on 30Dec2020 she was tired, just tired and exhausted and woke up Thursday on 31Dec2020, really tired. The patient had been really busy with work with everything, so, she just 'threw to the wind'. She was really tired on Thursday, 31st, just like, she really feel sick, coughing, really exhausted. she came home and just got to go to bed and 7 to 3:30. She felt warm but she didn't get hot and she took temp, she was 101.5. She had chills, a cough. She was so exhausted, everything hurts her. The patient don't feel like terrible, terrible, like mostly she would say Friday on 01Jan2021, she was mostly in bed. She just didn't want to just lay there. She thought that was worse laying there. She didn't know if I was positive with COVID in the middle of this, or was it the vaccine. About causality, the reporter stated that she didn't know, 50-50, it partly felt like she didn't know if she was having a reaction to the vaccine or she was positive for COVID or she was getting (incomplete sentence). She was congested and the all of a sudden, she didn't know if positive for this. She guessed if she get tested which she was assuming if she call or occupational health, they want her to get tested for COVID because she already have the symptoms. She didn't do anything yet for events. She had just been home and quarantined. Her brother who she have been around, he doesn't live with her but he lived down the street. He was in critical care right now in (state) and with COVID, so that's another concern, why she was thinking she could be COVID. The outcome of the events was unknown. Information for Lot/Batch number has been requested.
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| 50 | 2021-01-07 | dizziness |
Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear,...
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Day 1 Night: Sleeplessness Day 2: Muscle aches in left arm, left shoulder, neck. Fullness in ear, dizziness.
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| 50 | 2021-01-07 | shortness of breath, weakness |
Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf ...
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Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf of his mother). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 31Dec2020 between 09:00 and 10:00 at single dose on left arm for covid-19 immunisation (works in food staff at a hospital). Medical history and concomitant medications were none. Patient experienced: difficulty breathing and weakness on 01Jan2021. Events were ongoing and had gotten a little worse today (05Jan2021). The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.
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| 50 | 2021-01-07 | fatigue |
Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she w...
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Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she was drugged/felt foggy; Feeling out of it, like she was drugged; Feeling restless at night; She hasn't been able to sleep at night; This is a spontaneous report from a consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Dec2020 on the left arm at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). Medical history included ongoing Grave's disease from 2007. There were no concomitant medications. On 16Dec2020 (19:00), the patient was feeling out of it, like she was drugged, and felt foggy. On 17Dec2020, the patient had felt exhausted. In Dec2020, the patient was feeling restless at night; and has not been able to sleep at night. On an unspecified date, the patient had felt like her thyroid was off and could not function well. The outcome of the events was recovered in Dec2020 for 'feeling out of it, like she was drugged, and felt foggy'; was not recovered for 'feeling restless at night' and 'has not been able to sleep at night'; and was unknown for all the other events. The patient was leery about receiving the second COVID-19 vaccine dose.
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| 50 | 2021-01-07 | headache, fatigue, chills, fever |
I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.;...
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I experienced rigors; Extreme fatigue; Fever spiked to 102.4 in the evening, the day after vaccine.; Very mild headache and very mild queasiness; Very mild headache and very mild queasiness; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the left arm on 31Dec2020 at 11:45 at a single dose for COVID-19 immunization in the hospital. The patient has not have any vaccines in four weeks and did not take any medications in two weeks. The patient is not pregnant. Medical history included asthma, grade 1 casein allergy, environmental allergies, mild hypertension and high cholesterol. Concomitant medications included montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), nifedipine (PROCARDIA) and atorvastatin (LIPITOR). On 31Dec2020 at 09:00 PM, approximately 9 hours after receiving the vaccine, the patient experienced rigors which lasted much of the night. Extreme fatigue. Patient reported that ibuprofen was taken with no relief. Tylenol taken the next day. Fever spiked to 102.4 in the evening, the day after vaccine. The patient did not record her temperature overnight during rigors. The patient also reported of a very mild headache and very mild queasiness. The patient also took Benadryl, self-administered per MD. The symptoms were gone by the morning of the second day. The patient assessed the events as non-serious. The patient recovered from the events on an unspecified date in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination. Information about Lot/Batch number has been requested.
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| 50 | 2021-01-07 | dizziness, weakness |
Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body...
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Immediately after client got her vaccine, she started feeling dizzy, and tingling "all over her body." She was monitored and placed in a reclining position which did not help her. At 11:30 am client reported feeling weak. EMS was called and client was transported to hospital. She was given IV fluids and monitored and released 2-3 hours after the incident. She has not had any other problems since taking the vaccine.
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| 50 | 2021-01-07 | chills, malaise | Nausea, child, feeling unwell. NO fever |
| 50 | 2021-01-07 | throat swelling |
Patient experienced swelling of the throat and numbness in the neck within 10-15 minutes of vaccine ...
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Patient experienced swelling of the throat and numbness in the neck within 10-15 minutes of vaccine administration while still under observation. Two oral Benadryl tablets were given (50mg total) and epipen was administered in the left thigh. 911 was immediately called and patient was taken away in ambulance
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| 50 | 2021-01-07 | shortness of breath |
Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the...
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Pt with history of allergic reactions, premedicated w/ Benadryl 50 mg po. 30 min after receiving the vaccination, she started to have difficulty breathing and chest tightness. No wheezing. Pt had neck and face flushing without hives. Pt tachycardic at 120 bpm. SOB and tachycardia lasted 1.5 hrs. Pt denies anxiety, dizziness or GI symptoms. Pt monitored and advised to avoid 2nd dose of mRNA vaccine; pt declined to see PCP
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| 50 | 2021-01-07 | shortness of breath |
Tachycardia (HR in the 110s), shortness of breath, chest pain 15 min post vax Observation and fluids...
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Tachycardia (HR in the 110s), shortness of breath, chest pain 15 min post vax Observation and fluids Sxs resolved after 15 mins of close monitoring NKA
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| 50 | 2021-01-07 | cold sweat, chills, shortness of breath |
approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness o...
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approx 20 after injection 1420, started getting chills, cold sweat, elevated heart rate, shortness of breath and blocky red rash on neck and torso. immediately drove to urgent care, was not allowed in for treatment due to did not have phone on med to call for appointment. went home, took 50 mg benadryl and pepcid po. had tachypnea and continued blocky rash on neck and torso with chest tightness. took albuterol inhaler. approx 0200 had rigors/ seizure. with continued prior symptoms. took additional 50 mg benadryl and albuterol inhaler. temp 99.0. in am 1/6 called urgent care to make appointment thought neded steroid. they said to go to ED. was afraid to go to ED in fear would be intubated as had before for allergic reaction. took additonal 50 mg benadryl, pepcid and zyrtec along with a shot of epi pen. within minutes, all symptoms ressolved. will be calling place where I got vaccinated today to report. 1/8/21
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| 50 | 2021-01-07 | dizziness |
dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives ...
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dizziness; itching/small hives on forearm (same side as injection but not at injection site); hives on chin/upper lip; This is a spontaneous report from a contactable pharmacist (patient). A 50-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration (arm right) on 02Jan2021 08:15 at single dose for Covid-19 immunization. Medical history included asthma, hypothyroidism, and migraines. Concomitant medications included cetirizine hydrochloride (ZYRTEC), famotidine, salbutamol (ALBUTEROL), fluticasone propionate (FLOVENT), and fluticasone propionate (FLONASE). The patient previously took Keflex [cefalexin] and experienced drug allergies: hives, angioedema. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 30 minutes after the injection on 02Jan2021 (08:45 AM), the patient experienced dizziness and itching/small hives on forearm (same side as injection but not at injection site). Vital signs were measured, all was normal. It was also reported that 36 hours after the injection, the patient got hives on chin/upper lip. The patient was treated with Benadryl, Pepcid, and Zyrtec to stop itching and resolve the hives. Benadryl was taken at home, upon advice from nurse. The outcome of events was recovered on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
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| 50 | 2021-01-07 | malaise, headache, runny nose, fatigue, weakness, throat pain, fever |
headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the bod...
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headache, sore throat, runny nose, arm pain that migrated to the axilla and down the side of the body, joint pain ( hands, wrist, feet, hips, knees, spine, neck), insomnia, general malaise, fatigue, and lower grade fever. Most symptoms lasted about 7 -10 days. However, it is now day 20 after the initial vaccine and I still have joint pain that has not gone away. esp in hands, wrists, and feet. When I sleep I still wake up with all my joints hurting it gets better as I start moving but the wrist, hands, and feet pain has not gone away. This pain will wake me in the night when I change positions. I called my doctor today to inquire if it is a good idea if I should take the second dose because the first dose made me so dibiliated. Awaiting for a response. I am due to take the second vaccine on 2/9/21.
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| 50 | 2021-01-07 | headache, dizziness, chills | inject site soreness, dizziness, headache, chills |
| 50 | 2021-01-07 | chills, chills | muscle pain, chills, joint pain, nausea |
| 50 | 2021-01-07 | dizziness |
numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a...
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numbness at end of tongue; dizziness; increased oral secretions; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), intramuscular on 22Dec2020 at single dose for Covid-19 immunisation. Patient was not pregnant. The patient medical history was not reported. Concomitant medication included meclizine, ondansetron (ZOFRAN), famotidine. The patient was admitted to emergency room (ER) post-vaccine administration for numbness at end of tongue, increased oral secretions and dizziness on 22Dec2020. She was given Benadryl and Pepcid, monitored for 3 hours before discharge from ER. Patient still experiencing same symptoms 1 week later per follow-up (29Dec2020). This case was reported as non-serious. The outcome of events was unknown.
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| 50 | 2021-01-07 | head discomfort, dizziness, throat pain, throat irritation |
sores and redness at the back of throat and tongue; sores and redness at the back of throat and tong...
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sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; sores and redness at the back of throat and tongue; numbness; tingling; burning sensation in throat and the back of tongue; burning sensation in throat and the back of tongue; mild nausea; allergic reaction; dizzy, light-headed; ashen pale; head felt heavy; Burning and itchiness on chin persists; Burning and itchiness on chin persists; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 29Dec2020 12:00 at first single dose for COVID-19 immunization. Medical history reported as none. No known allergies. Concomitant medication the patient received within 2 weeks of vaccination included ergocalciferol (VIT D), linum usitatissimum seed oil (FLAX SEED OIL), cyanocobalamin (VITAMIN B12) and multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 2 min after shot the patient was dizzy, light-headed, ashen pale, and head felt heavy. After sitting and lying down about 45 min, the patient felt numbness, tingling, and a burning sensation in throat and the back of tongue. MD took O2 sat (99%) and heart rate (72). The patient felt mild nausea for 5 min. MD gave her Pepcid 20 mg as antihistamine. About 30 min later, the patient noticed sores and redness at the back of throat and tongue. The patient consulted MD and she advised the patient to go to employee health clinic. The clinic MD stated the patient was probably having some kind of allergic reaction to vaccine. The patient was given steroid shot and Benadryl 25 mg PO (per oral) and observed for 90 min. The patient left and was given Medrol Dose pack if symptoms persisted after 2 days. The patient was told to take Benadryl 25 mg PO (per oral) 4-6 hours and Pepcid 20 mg PO (per oral) BID (twice a day) for 1-2 days. Redness, sores at back of throat and tongue persist. Burning and itchiness on chin persists. The patient had no difficulty breathing at any time. Adverse event start date was reported as 29Dec2020 12:15 PM. Events were non-serious. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included: Benadryl 25 mg PO and a steroid shot IM. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events sores and redness at the back of throat and tongue, burning and itchiness on chin persists not recovered, of other events was recovered with sequel.
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| 50 | 2021-01-07 | headache |
vomiting; severe headache; This is a spontaneous report from a contactable nurse. A 50-years-old fem...
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vomiting; severe headache; This is a spontaneous report from a contactable nurse. A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899, expiry date not reported), intramuscular on 30Dec2020 16:00 at a single dose in the left arm as Covid vaccine. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no known allergies; no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications the patient received within 2 weeks of vaccination. Patient received vaccine on 30Dec2020 at 4pm. On 01Jan2021, at approximately 3am, patient woke up with a severe headache, and approximately 6am, patient started vomiting which lasted until after 7pm. The headache was not as intense but it was still there today. Since the vaccination, the patient has not been tested for COVID-19. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events headache and vomiting was reported as recovering.
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| 50 | 2021-01-08 | weakness, nasal congestion, headache, body temperature increased, head discomfort |
01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and...
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01/08/21 03:30am Body Aches, 04:00am Chills, 05:00am hands and feet swollen and headache, nausea and head congestion/sinus congestion, eyes hurt and bright red. 07:00am temp 99, took Tylenol 1000mg. 10:00am weakness and severe body aches and difficulty getting out of bed and almost fell several times and reported skin hurt. 2:57PM temp 102.7, took Tylenol 1000mg and Motrin 800mg , 06:00pm temp 100.4 took another 1000mg Tylenol and continued with symtpoms through the night and woke up around 3:30am 01/09/2021 soaking wet with sweat. 01/09/21 1:50pm continues with mild body aches and moderate headache.
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| 50 | 2021-01-08 | respiratory tract congestion, shortness of breath, dizziness, migraine, throat pain |
About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and B...
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About 15 min after injection my heart started racing and I got lightheaded. Heart rate was 95+ and BP was 190/90 something. My resting HR is 56 and BP is usually around 120/80. Began to drop after about another 15 minutes. Followed by migraine for the rest of the day. Felt okay when I woke up, but had one episode during the day today in which my heart rate shot up again and was a little short of breath even though I was not exerting myself. Lasted about 10 minutes. Injection site hurts to the touch, but otherwise is painful. Throat hurts a little and a little congested, but probably unrelated.
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| 50 | 2021-01-08 | headache |
Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left a...
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Arm pain and injection site that worsened over 24 hours. I developed swelling of entire upper left arm and severe headache 12/19/20
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| 50 | 2021-01-08 | fatigue |
Deltoid muscles (noticeably more than even tetaus vax) and less so joint soreness R shoulder, possib...
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Deltoid muscles (noticeably more than even tetaus vax) and less so joint soreness R shoulder, possibly slight fatigue - started approx >6hrs after shot. Did a 40min dance workout (a little sluggishly) but doable. Hot tub x 15 min, naprosyn, and feel good now despite some fatigue (which may be unrelated to vaccine).
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| 50 | 2021-01-08 | fever, fatigue |
Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever...
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Fever Facial tingling, blue nailbeds Narrative: Facial tingling resolved. Still has low grade fever, fatigue
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| 50 | 2021-01-08 | headache, chills, shortness of breath | Since administration - Chest pain, Shortness of breath, blurred vision, headache, nausea, and chills |
| 50 | 2021-01-08 | fatigue, fever, influenza like illness, headache |
Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot ...
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Swelling and pain under arms - no treatment (seemed to mostly subside when Celebrex was taken) Spot on tongue-no treatment still visible but no pain or irritation Other symptoms were expected and include injection site pain, heat rash likely from fever during the night but never had a recorded fever-subsided through day, fatigue, mild headache, overall just feeling like I was fighting a cold. (Viewed as immune response to me)
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| 50 | 2021-01-09 | chills |
Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Start...
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Chills/shivers, injection site pain, back pain/body aches, nausea, syncope, low blood pressure Started getting chills at 0300, back pain started and injection arm became very painful. at 0430, got out of bed, nausea became severe and I passed out for 2 minutes. Subsequently fractured my nose from the fall after passing out and ended up in the ER for 6 hours with low blood pressure.
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| 50 | 2021-01-09 | fatigue, weakness, chills |
Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness ...
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Diarrhea started after having mild chills at around 1300hrs on 1/8/2021; then followed by tiredness and weakness. Got home at around 1545hrs and I continued to have diarrhea all night until Saturday -all day. Diarrhea settled at around 1800hrs.
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| 50 | 2021-01-09 | fever | Low grade fever, large hard painful lump in right arm, achy joints |
| 50 | 2021-01-09 | headache, fever, chills |
Pfizer-BioNTech COVID-19 Vaccine EUA Fever, Chills, Joint Pain, Muscle Pain, Headache Symptoms last...
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Pfizer-BioNTech COVID-19 Vaccine EUA Fever, Chills, Joint Pain, Muscle Pain, Headache Symptoms lasted for 36 hours
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| 50 | 2021-01-09 | chills, shortness of breath |
STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB,...
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STRANGE FEELING IN THROAT AND CHEST THAT PROGRESSED TO CRUSHING CHEST PAIN. CHILLS, BODY ACHES, SOB, NAUSEA, RASH. I STILL HAVE SOB AND I DONT KNOW IF IT WILL BE TEMP OR PERMANENT.
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| 50 | 2021-01-09 | throat irritation |
Within 15 minutes of vaccine administration, I developed difficult swallowing, scratchy throat and s...
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Within 15 minutes of vaccine administration, I developed difficult swallowing, scratchy throat and severe flushing of face, neck and chest. This lasted about 1.5 hours. Symptoms resolved within 2 hours. Treated with oral Benadryl and Tylenol
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| 50 | 2021-01-10 | fatigue, chills | Chills Body aches Fatigue |
| 50 | 2021-01-10 | chills, headache | Chills, body aches, slight headache |
| 50 | 2021-01-10 | dizziness, headache | Dizzy, Room Spinning, headache |
| 50 | 2021-01-10 | chills |
Dose 1: Chills and upset stomach by 11:00am (4hours after vaccination) until bed rest same day, pain...
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Dose 1: Chills and upset stomach by 11:00am (4hours after vaccination) until bed rest same day, pain in the site of injection making arm unable to rise more than 30 degrees from 11:00am day of vaccination until 12/20/2020
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| 50 | 2021-01-10 | chills, fatigue, headache, fever |
Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body...
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Dose 2: Chills, body ache, headache by 10:00pm (13.5hrs after vaccination 01/07/2021), severe body ache, nausea, pain on the site of injection but mild compared to first dose, tiredness, fever from 9:00 am until bedtime on 01/08/2021
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| 50 | 2021-01-10 | fever, headache | Fever 99.4-100.6 for 3 days after mild headache and body aches now resolved |
| 50 | 2021-01-10 | body temperature increased, chills, fatigue, headache, sweating, fever |
First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but ...
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First night had fever (102.4), chills, body aches, fatigue and slight headache. My arm was sore but my armpit was so painful (felt like stabbing sensation). This lasted until around 2:00 pm Saturday. I felt ok except for being tired and armpit still hurting quite a bit. On Sunday, I was very tired and slept during the day and went to bed around 8:30 pm feeling like I had a slight sore throat, tired and mildly nauseous. My armpit still hurt quite a bit. I woke up Monday at 5:30 am and showered and was profusely sweating when I was getting ready for work - my temperature was 100.6 so I took 800 mg of Ibuprofen to help with the temp and the pain in my armpit. I did not go into work. I am still tired and my current temp is 100.1 (12:30pm) and sweaty. I do feel as though the severity of my armpit pain is lessening but it is still bothersome.
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| 50 | 2021-01-10 | fatigue, runny nose, headache |
Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER...
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Headache, fatigue, lymph nodes inflamed, shoulders sore, runny nose, scratchy throat, resulted in ER visit.
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| 50 | 2021-01-10 | headache, shortness of breath |
Received first COVID-19 vaccine Friday 1/8/21 - experienced an episode of palpitations, chest tightn...
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Received first COVID-19 vaccine Friday 1/8/21 - experienced an episode of palpitations, chest tightness w/ sob, hypertension, and headache - it subsided that night. Had 2 similar episodes since that time. Seen in ED 1/11/21 for symptoms. Similar episode occured after receiving the Flu vaccine about 3 years ago.
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| 50 | 2021-01-10 | shortness of breath | Right upper chest pain, constant, pain increased with deep breathing, HA |
| 50 | 2021-01-10 | fatigue, headache |
Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at sit...
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Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at site of injection that progressed to L sided lymph node swelling on day after vaccine and has progressed to Left side lymph node swelling in L side of neck, axilla, Left side of breast, chest wall with pain still present and worsening 4 days after vaccine given (2nd dose)
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| 50 | 2021-01-10 | fever | body ache, fever, nausea. called in sick to work. |
| 50 | 2021-01-10 | chills, fever, throat pain |
fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness i...
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fever, chills, sore throat, difficulty swallowing, body aches, joint pain, hypertensive, tightness in chest. Went to ER @ Hospital
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| 50 | 2021-01-10 | fever, headache | nausea, headache, fever. called in sick to work. |
| 50 | 2021-01-10 | throat irritation |
patient with c/o increased HR and scratchy throat, BP 113/78 HR 130 Pulse Ox 95% on RA, patient resp...
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patient with c/o increased HR and scratchy throat, BP 113/78 HR 130 Pulse Ox 95% on RA, patient response called, patient transported to Emergency Department and received Famotidene 20mg IV, Diphenhydramine 50mg IV, Lorazepam 1mg Oral, Ketoralac 15mg IV, one liter normal saline. Observed and discharged home.
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| 50 | 2021-01-10 | headache |
severe headache-took Naprosyn and Maxalt with slight reduction in intensity but did not relieve-ease...
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severe headache-took Naprosyn and Maxalt with slight reduction in intensity but did not relieve-eased by 2nd day out from vaccine myalgias throughout both arms and legs-rest-eased by 2nd day out from vaccine
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| 50 | 2021-01-11 | sweating |
30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tig...
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30 minutes after injection patient experienced flushing of face, sweaty palms and shakiness, jaw tightness and nose tingling, heart felt like it was racing. Blood pressure was 150/80 , Pulse 108, respirations 22
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| 50 | 2021-01-11 | weakness, headache, chills |
Approximately 11 hours after the vaccination my arm became very sore, to the point that it was diffi...
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Approximately 11 hours after the vaccination my arm became very sore, to the point that it was difficult to lift it. I then developed body aches and chills. I did not develop a fever that I know of but the body aches and chills continues throughout the night. During the night a severe headache developed as well as generalized weakness. I was unable to sleep and had to miss work the next day. Because the weakness and body aches continue, I plan to miss a second day of work tomorrow. I treated the symptoms with Tylenol.
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| 50 | 2021-01-11 | migraine | Chills, body aches, migraine, nausea. Improving |
| 50 | 2021-01-11 | fatigue, chills, headache |
Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of sympto...
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Chills, body aches, terrible headache, nausea, tired for approximately 24 hours upon onset of symptoms Left axillary lymphadenopathy for approximately 3 days
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| 50 | 2021-01-11 | fatigue, fever, headache | Fever, headache, nausea, muscle spasms, sensitive to noise and light, loss of appetite, very tired |
| 50 | 2021-01-11 | weakness |
GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DU...
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GIVEN ON 12/23. SORENESS FELT ON LEFT ARM SITE THE NEXT DAY, WITH DECREASED MOBILITY AND STRENGTH DUE TO SEVERE SORENESS AND PAIN. PAIN PROGRESSIVELY LESSENED BUT THE SORENESS STILL VERY APPARENT. ON 1/5, SPOKE TO PRIMARY MD, XRAY ON LEFT SHOULDER DONE ON 1/6. ON 1/7, STIFFNESS WITH SEVERE PAIN UPON MOVEMENT NOTED ESP IN THE MORNING. ULTRASOUND WAS DONE ON 1/8, NOTED BICEPS TENOSYNOVITIS. ORTHOPEDIC SURGEON SEEN ON 1/11, W DX OF ADHESIVE CAPSULITIS, SUGGESTED FOR PT FOR NOW, AND OFF WORK, AND TO BE FOLLOWED UP ON 2/1 BY SAME ORTHO SURGEON. WILL NOT OFFER CORTISONE SHOT FOR NOW AS IT MAY COMPROMISED OR WEAKEN IMMUNE RESPONSE, IN WHICH MY SECOND COVID SHOT DUE ON THE 15TH OF JANUARY. FIRST APPT FOR PT ON 1/15
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| 50 | 2021-01-11 | fatigue, fever, headache | Headache, Body aches, Low grade Fever, Fatigue |
| 50 | 2021-01-11 | fatigue, fever, throat swelling, chills, headache |
INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PAR...
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INFLAMATION OF THROAT,PAIN INJECTION SITE , HEADACHE,TIRED,MUSCULAR PAIN CHILLS,JOINT PAIN,FEVER,PARNASAL INFLAMATION AND HOARSLY.
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| 50 | 2021-01-11 | headache, fever, fatigue, cough, chills | INJECTION SITE, HEADACHE TIRED, CHILLS,FEVER,NAUSES,MODERATE COUGH |
| 50 | 2021-01-11 | fatigue | Left neck pain started 1/11/21 fatigue |
| 50 | 2021-01-11 | chills |
One hour after receiving the COVID Pfizer vaccine, I experienced tightness in my throat. The tightn...
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One hour after receiving the COVID Pfizer vaccine, I experienced tightness in my throat. The tightness lasted about one hour, then I began with all over muscle shaking, which lasted about five hours. I had chills with the shaking, and sat on the sofa with a blanket and heater until the symptoms resided.
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| 50 | 2021-01-11 | chills, headache, fever |
Pain at injection site, eventually inability to move/rise left arm. Same day at 7pm temp started to ...
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Pain at injection site, eventually inability to move/rise left arm. Same day at 7pm temp started to rise, all night fever as high as 104.2 despite multiple doses of Tylenol, chills, severe headaches
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| 50 | 2021-01-11 | dizziness, headache |
Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 m...
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Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in right deltoid. Pain progressed over the next 5 days to arm and left eye. Dizziness, mouth drooping, and numbness developed. Went to ED and diagnosed with Bell's Palsy. Evaluated in ED for possible causes. Vital signs stable. CVA ruled out. Patient given ketorolac, droperidol, and IV fluids for her headache. Prescribed steroids and acyclovir for Bell's Palsy treatment. Prescriber instructed patient to return to ED immediately if symptoms worsen or additional symptoms develop. Follow up with patient on 1/5/21 with patient reporting some improvement in symptoms. Patient reported having a headache for 2 weeks straight prior to presenting to the ED on 1/3/21. Vaccine was administered on 12/28/21. Unsure if the Bell's Palsy was a result of the vaccine or some other inciting factor.
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| 50 | 2021-01-11 | cough | Pt c/o difficulty swallowing, which worsened, began coughing. Epi given IM and pt transferred to ED |
| 50 | 2021-01-11 | dizziness | Received 1st dose vaccine and became nauseated, dizzy, lightheaded and almost passed out. |
| 50 | 2021-01-11 | chills, cough, headache |
Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started f...
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Received her COVID-19 vaccine. Patient stated "within 10 mins of receiving the vaccine, I started feeling like I'm going to have an asthma attack." She reported having headache, chills, her heart racing, "I feel like my airway is closing that I had to cough". Vital signs were taken by staff at the clinic. Patient reported BP was elevated, HR elevated, but O2 Sat was 100%. Within 15 mins symptoms resolved. Patient returned to her work area in the ED that same morning. During her shift she took Motrin for a headache. On 1/8/21, @ 2330 started feeling burning sensation on the injection site, noticed that there was a blister and redness on the area. . 1/11/2021, she reported redness at the injection. All other symptoms resolved on its own.
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| 50 | 2021-01-11 | fever, headache | Severe head pain, severe muscle pain, vomiting Fever 101.8, swollen right axillary lymph node |
| 50 | 2021-01-11 | fever, headache | Severe muscle pain, severe headache , fever and nausea |
| 50 | 2021-01-11 | chills, sweating, throat pain, headache |
Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; inject...
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Severe nausea; headache; sore throat; sweating with chills; sweating with chills; chest pain; injection site soreness; shaking hands; This is a spontaneous report from a contactable other HCP reported for herself. A 50-year-old female patient received first dose of BNT162B2 (lot number: ej1686), via intramuscular in right arm, on 05Jan2021 06:30 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient hasn't been tested for COVID-19. Medical history included Known allergies: sulfa antibiotics, avascular necrosis, multiple joint replacements, anticoagulation, chronic pain, multiple hospitalizations in 2020 for diverticulitis. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccines was received within 4 weeks prior to the COVID vaccine. Concomitant medications which patient received within 2 weeks of vaccination included warfarin, oxycodone, linaclotide (LINZESS), cyanocobalamin (VIT B12), ergocalciferol (VIT D) and iron. The patient experienced severe nausea, headache, sore throat, sweating with chills, chest pain, injection site soreness, shaking hands on 05Jan2021 07:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was recovering.
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| 50 | 2021-01-11 | headache, head discomfort |
Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensif...
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Within 24 hrs, developed headaches, burning sensation down spine and neck. fullness in head intensified next day. balance was off, numbness and tingling throughout body. Went to ER. Diagnosed Paresthesia
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| 50 | 2021-01-11 | fatigue |
both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ...
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both ears felt hot; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; both ears felt hot, mildly itchy, slightly puffy, and bright red in color; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; tongue & mouth felt slightly tingly with a metallic taste; felt tired most of the day; felt soreness at injection site; joint pain; This is a spontaneous report from a non-contactable nurse (patient). A 50-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685), via an unspecified route of administration on left arm at 13:45 on 21Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension, central serous retinopathy, known allergies to penicillin and Nickel. Concomitant medication included losartan, hydrochlorothiazide, cetirizine hydrochloride (ZIRTEC) and multivitamin. The patient previously took clindamycin, Septra and Keflex and experienced drug allergy. Within 30 min on 21Dec2020 started at 02:30 PM, both ears felt hot, mildly itchy, slightly puffy, and bright red in color. The patient's tongue and mouth felt slightly tingly with a metallic taste. She felt tired most of the day. Next day felt soreness at injection site and joint pain. Soreness at injection site lasted several more days. Events resulted in Doctor or other healthcare professional office/clinic visit, events were reported as non-serious. The patient received Benadryl 50 mg & additional dose of Zyrtec as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date. No follow up attempts are possible. No further information is expected.
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| 50 | 2021-01-11 | throat pain, chills, runny nose, headache, malaise, sweating |
not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she wa...
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not feeling well; sore; runny nose; sore throat; swollen glands; sweats; chills; feeling like she was hot and cold; dry throat; nausea; a little stomach upset; left arm was sore for several days too; Headache; muscle ache; joint pain; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable a 50-year-old female Registered Nurse reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 11:40 on Deltoid Left at single dose for covid-19 immunisation. Medical history included was none. There were no concomitant medications. The patient experienced headache, muscle ache, joint pain, left arm was sore for several days too on 17Dec2020; not feeling well, sore, runny nose, sore throat, swollen glands, sweats, chills, feeling like she was hot and cold, dry throat, nausea, a little stomach upset on an unknown date. The detail clinical course was provided as following: the nurse reported side effects and want to verify if side effects that "keep coming and going back every couple days" are "normal". Received first dose last 17Dec2020 and felt side effects on the evening. Returned on Monday last week, lasted until Friday, and back on 06Jan2021. The patient had developed a runny nose, sore throat, and feeling like she was hot and cold. She said she had sweats and chills, but no fever. She said she kept getting a warm sensation, and checked her temperature several times, but did not have a fever. She said she had a super dry throat, and her throat felt like a desert. She said she had swollen neck glands, clarifying the swollen neck glands were underneath her mandible. She said she had nausea, and a little stomach upset with no diarrhea. She said she was still not feeling well in her stomach. Reported last week she had 3 days with a nonstop headache, swollen glands, and a sore throat. She said the headache, swollen glands, and sore throat went away, but are back again, 06Jan2021. She said she was thinking what she was experiencing was more a side effect of the COVID-19 Vaccine than being ill because her symptoms went away and now were back. She said when a person was ill, the person got through the illness, and that was it, but her symptoms kept going away and coming back. Clarified the night of 17Dec2020, she had a headache and some muscle aches and joint pain, specifically in her neck. She said her left arm was sore for several days too. She said everything went away. She said she started feeling sick again last Tuesday, 29Dec2020, and felt ill through Friday, 01Jan2021. She said over the weekend she felt fine, and then on 06Jan2021, she was feeling ill with the same symptoms of a headache, sore throat, runny nose, and swollen glands. She said she thought it was odd that the symptoms came back again. She said maybe what she was experiencing were not side effects from the COVID-19 Vaccine, and she was ill. She said it was odd that she felt bad and then felt better, and then the symptoms come back again. Reported she can work through her symptoms, clarifying she had mild symptoms. The event outcome was unknown. All events were reported as non-serious. The events did not require a visit to: Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks): None. Relevant Tests: None. Treatment: Declined any Reported she was scheduled to get her second COVID-19 Vaccine dose on 07Jan2021. Information on the lot/ batch number has been requested.
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| 50 | 2021-01-11 | fever, headache, chills |
woke up in the middle of the night with fever and chills, had headaches and body aches for 3 days af...
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woke up in the middle of the night with fever and chills, had headaches and body aches for 3 days after
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| 50 | 2021-01-12 | fatigue, headache, nasal congestion, runny nose |
1/9-had body aches and fatigue. ibuprofen helped. 1/10-fatigue 1/11-fatigue stuffy nose. headache. 1...
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1/9-had body aches and fatigue. ibuprofen helped. 1/10-fatigue 1/11-fatigue stuffy nose. headache. 1/12-fatigue, runny nose, headache, diminished taste and smell 1/13 -fatigue, runny nose, headache, diminished taste and smell -PCR tested today.
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| 50 | 2021-01-12 | fever | 14 hours after dose symptoms as follows. Nauseous, fever and body aches lasting 24 hours. |
| 50 | 2021-01-12 | chills |
3 am woke up with stomach upset cramping, nausea, chills, took Tylenol; no appetite not eating anyth...
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3 am woke up with stomach upset cramping, nausea, chills, took Tylenol; no appetite not eating anything
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| 50 | 2021-01-12 | fever, headache, fatigue |
30 hours post-injection I experienced intense body aches, fatigue, headache and fever (100.9F). Fol...
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30 hours post-injection I experienced intense body aches, fatigue, headache and fever (100.9F). Following the first injection in the series I experienced very mild body aches and minor fatigue, also noted at approx 30 hours post-injection. Symptoms following the second injection were much more intense, included a fever and headache, and lasted longer (12-13 hours). Symptoms experienced following the second injection caused a missed work day.
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| 50 | 2021-01-12 | fatigue, chills |
Chills, joint pain, fatigue the night of injection. The next day, my left underarm was swollen and s...
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Chills, joint pain, fatigue the night of injection. The next day, my left underarm was swollen and sore if I let my arm hang down at my side.
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| 50 | 2021-01-12 | chills, fatigue | Fatigue, body aches, chills. |
| 50 | 2021-01-12 | fever, chills | Fever up to 104F, associated with chills and muscle aches |
| 50 | 2021-01-12 | fever, chills, fatigue, malaise | Lt arm injection site soreness, body malaise, low grade temp, chills, fatigue |
| 50 | 2021-01-12 | dizziness |
My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitati...
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My b/p shot up as well 180/107; My heart started racing....noted at 133/I had strong heart palpitations; Feeling of lightheadedness; This is a spontaneous report from a contactable nurse reporting for herself. A 50-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration in the right arm on 29Dec2020 at 12:15 pm, at 50-years of age, at single dose for COVID-19 immunization. The patient received the vaccine in Hospital and didn't receive any other vaccine in the previous four weeks. Medical history included hypertension from an unknown date (controlled) and no known allergy. Concomitant medication included amlodipine besilate 10 mg (NORVASC). The patient reported that, on 29Dec2020, within 6 minutes after receiving the vaccine dose, her heart started racing, it was noted at 133, her blood pressure shot up as well to 180/107, she had strong heart palpitations with feeling of lightheadedness. Prior to the vaccine the patient was at work, feeling well and taking care of her patients. Emergency Room visit and Physician Office visit were required, moreover fluids and potassium were administered to the patient as a result of the events. She reported she spent 8 hours in the ER. The events were reported as non-serious but they were assessed as important medical events by the Company. At the time of the report the reported events were resolving. Information about Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hypertensive crisis, Palpitations, and Lightheadedness cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-12 | fever, fatigue | Pain at injection site, extreme fatigue, general body ache, temperature 102 F |
| 50 | 2021-01-12 | fever |
Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm sh...
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Patient complaints of left hand tingling and upper arm pain and Right hand tingling and upper arm shoulders pain body aches and fever
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| 50 | 2021-01-12 | dizziness | Patient felt intense dizziness with nausea for three hours before symptoms resolved. |
| 50 | 2021-01-12 | headache | headache, nauseous; taking Tylenol; feel the same as when the reaction started |
| 50 | 2021-01-13 | chills, fatigue, headache, nasopharyngitis |
"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my ar...
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"I have had a headache and been fatigued for about 4 days along with what feels like cramps in my arms and legs. My arm is red and lumped up but not as bad as it was second day. Also having cold chills as well."
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| 50 | 2021-01-13 | chills, headache, fatigue |
1/7/2021 @1600 nausea lasted 2hr 1/8/2021 @ 0200 body aches & chills lasted off & on & continues pre...
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1/7/2021 @1600 nausea lasted 2hr 1/8/2021 @ 0200 body aches & chills lasted off & on & continues presently. Woke up 1/9/2021 @0400 with headache & severe body aches & chills lasted 2hr Currently: body aches, chills, exhaustion (these symptoms come & go since 2nd injection)
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| 50 | 2021-01-13 | fever, headache |
102.6 fever; headache; body ache treated with tylenol fever went down to 100.9 with Tylenol and brok...
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102.6 fever; headache; body ache treated with tylenol fever went down to 100.9 with Tylenol and broke at 3:30 pm (approx 12 hours after onset)
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| 50 | 2021-01-13 | sweating, dizziness, dizziness, sweating |
Adminsitration of vaccine at 8:40am; At 8:53; experienced dizziness and diaphoresis. Placed in supi...
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Adminsitration of vaccine at 8:40am; At 8:53; experienced dizziness and diaphoresis. Placed in supine position and provided a wet cloth for her forehead. Vital signs and blood pressure remained stable. She was provided a snack and discharged home.
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| 50 | 2021-01-13 | headache, chills, fever | Chills, fever, headache, myalgia |
| 50 | 2021-01-13 | migraine, chills, headache, fatigue |
Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontan...
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Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient had the vaccine at her work and like in the night, in the morning, she started experiencing side effects. She was having like chills and muscle pain and she called her doctor and they told her that she had to report the side effects. She felt like real tired and she was having a headache. The patient took some Excedrin for headache, it's like migraine. She took two in the morning at 8:30. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-01-13 | fatigue, weakness, sweating, malaise, dizziness, headache |
Fatigue/headache/body malaise one hour after 2nd dose of COVID 19 vaccine. Now c/o (L) arm pain rad...
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Fatigue/headache/body malaise one hour after 2nd dose of COVID 19 vaccine. Now c/o (L) arm pain radiating to (L) elbow/(L) leg pain/dizziness/diaphoresis weakness to (L) lower extremity.
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| 50 | 2021-01-13 | fever, chills, headache |
Fever of 102; Body aches; Chills; Confusion; Headache; This is a spontaneous report from a contactab...
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Fever of 102; Body aches; Chills; Confusion; Headache; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EKS730 and expiration date not provided), via an unspecified route of administration in the right arm on 05Jan2021 09:30 at a single dose for COVID-19 immunization. The patient has no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 02:00, the patient experienced fever of 102, body aches, chills, confusion, and headache. Treatment was not provided in response to the events. The outcome of the events was recovering. The patient assessed the events as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
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| 50 | 2021-01-13 | fever, headache, malaise, chills | Fever, chills, headache, malaise. Resolved. |
| 50 | 2021-01-13 | cough, dehydration |
HOSPITAL COURSE: Patient is a 50 y.o. female with a history of anxiety and migraine headaches who pr...
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HOSPITAL COURSE: Patient is a 50 y.o. female with a history of anxiety and migraine headaches who presented to hospital with cough and diarrhea. The patient had felt the symptoms on 12/31/2020 and eventually went to have a COVID test on 1/1/2021. She was subsequently positive but due to dehydration and diarrhea she came to the emergency department where she was admitted for remdesivir and dexamethasone. She was able to be weaned off any supplemental oxygen. Her diarrhea resolved. She is feeling well and will be discharged home in good condition.
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| 50 | 2021-01-13 | fever, chills | I had a fever of 101.6 and chills. |
| 50 | 2021-01-13 | fever, fatigue |
Occipital neuralgia on same side as vaccine administered; muscle pain entire body; fever; joint pain...
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Occipital neuralgia on same side as vaccine administered; muscle pain entire body; fever; joint pain; fatigue
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| 50 | 2021-01-13 | cold sweat, fever, chills |
Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdo...
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Reported chills, shaking cold sweats throughout the whole night, fever of 102F, body aches and abdominal pain.
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| 50 | 2021-01-13 | shortness of breath, throat irritation |
Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours afte...
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Shortness of breath, chest tightness, throat itching, ear closing and itching developed 4 hours after vaccine dose. Treated with inhaler, Claritin, Zyrtec and Benadryl. Symptoms reoccurred every 4 hours x3 and then resolved.
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| 50 | 2021-01-13 | fever | Swollen lymph node warmth area fever pain |
| 50 | 2021-01-13 | fatigue, malaise |
Symptoms - ? EE reports at approximately 2:00 pm she began feeling tired and so fatigued she left wo...
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Symptoms - ? EE reports at approximately 2:00 pm she began feeling tired and so fatigued she left work. EE reports at time of call still fatigued, with muscle weakness and joint pain. EE denies fever. EE denies COVID-19 exposure without proper PPE and recent travel. Last day of work and shift - ? yesterday Home remedies? - rest Any improvement? - mild Recommendation? EE reports she called off of work today due to feeling unwell. EE encouraged to continue to monitor her symptoms and to contact the vaccine support line for further questions or concerns. EE educated to continue to manage per Illness in the Workplace Policy. EE verbalized back understanding and denied further questions at this time.
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| 50 | 2021-01-13 | chills, headache |
bad headache(9) for at least 3hrs my head still hurts (5) all day and today.... nausea joint pain c...
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bad headache(9) for at least 3hrs my head still hurts (5) all day and today.... nausea joint pain chills
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| 50 | 2021-01-14 | malaise, weakness, fatigue, chills |
1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tendernes...
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1/12/2021 @ 1045hrs - Received vaccine in left arm. 1/12/2021 @ 2200hrs - Vaccination site tenderness, body/muscle aches. 1/12/2021 @ 2300hrs - Body/muscle aches, chills. 1/13/2021 @ 0300hrs - Body/muscle aches, chills, fever 99.0, general malaise. 1/13/2021 @ 0600hrs - Body/muscle aches, chills, general malaise, no energy. Did not report to work. 1/13/2021 @ 1000hrs - Symptoms continued. Took Advil 600mg PO. Slept from 1030-1230hrs. 1/13/2021 @ 1230hrs - No energy, very tired, rested the entire day. Took Advil 600mg every 4 to 6 hours. 1/13 to 1/15/2021 - Left arm site tenderness with raised, hard area at injection site. Left armpit soft tissue swelling, possibly lymphadenopathy. 1/15/2021 - Reported symptoms to provider, awaiting appointment.
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| 50 | 2021-01-14 | fever, cough, chills, shortness of breath |
1/13 10:30am - 2:30pm Extreme Chills 1/13 2:30pm - 1/14 5:00am Fever (102.7 at the high point...
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1/13 10:30am - 2:30pm Extreme Chills 1/13 2:30pm - 1/14 5:00am Fever (102.7 at the high point) Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels (down to 92%), Cough 1/14 5:00am - 7:00am Chills 1/14 7:00am - 11:00am Fever, Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels, Cough 1/14 2:00pm - 3:00pm Chills 1/14 3:00pm - 5:00pm Fever, Shortness of Breath, Increased Heart Rate, Lower Blood Oxygen Levels, Cough
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| 50 | 2021-01-14 | cough |
10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing....
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10:40 Employee complains of difficulties swallowing, sensation in throat. Denies troubles breathing. Is experiencing watering eyes and occasional coughing 10:49- received dose of 25mg diphenhydramine with slight improvement in symptoms, not resolved. 10:52- notes sensation of tingling tongue- Emergency Response Team called 11:02- 2nd dose of 25mg PO diphenhydramine administered Emergency Response Team Staff transports Employee to Emergency Room
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| 50 | 2021-01-14 | headache, dizziness |
1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 ...
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1340-EE c/o nauseated( with heaves but no emesis), dizziness, with a severe HA. BP 193/83 HR 62 O2 88-96%RA; 1345-EE to ED room 14 for further evaluation.
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| 50 | 2021-01-14 | fever | 2nd dose- Fever, joint pain, severe neck and chest pain for 36 hours |
| 50 | 2021-01-14 | headache, cough, throat irritation |
Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient beg...
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Approximately 10 minutes after receiving the second dose of the Pfizer Covid-19 vaccine, patient began coughing. Patient reported throat tingling and itching that spread to her face as well. Patient reported a severe headache as well.
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| 50 | 2021-01-14 | throat irritation |
Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable co...
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Arm was very sore; Muscle aches; Scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 9899), via an unspecified route of administration in right arm, on 21Dec2020 at 19:00, at a single dose, for COVID-19 immunization. The patient's medical history included attention deficit disorder (ADD), gastroesophageal reflux disease (GERD), migraines, allergies to latex and cinnamon (severe), gluten intolerance, and lactose intolerant. The patient's concomitant medications included amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), candesartan, galcanezumab GNLM (EMGALITY), glucosamine, magnesium, melatonin, iron, escitalopram oxalate (LEXAPRO), omeprazole, ursodiol, colecalciferol (VIT D3), and buspirone hydrochloride (BUSPAR). The patient previously took acetylsalicylic acid (ASPIRIN), fentanyl, and codeine and experienced allergies to the medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 22Dec2020 at 9 AM, the patient's arm was very sore and had some muscle aches and scratchy throat. These lasted a little over 48 hours (2 days). The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on 24Dec2020.
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| 50 | 2021-01-14 | dizziness, sweating |
Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to ...
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Dose at 12:25 12:32: Employee reported warmth, flushed, diaphoretic, dizzy, nauseous 12:34: Lied to floor with feet elevated. BP: 112/52 Reported Tingling lips- administered diphenhydramine 50mg at 12:36 1239: 122/78 1245: Feeling better, sat up in chair 12:56: Another wave of heat, nausea, dizziness- lied to floor. drank water. Denies breathing or troubles swallowing . Lip tingling has resolved
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| 50 | 2021-01-14 | shortness of breath, cough |
Employee received vaccine at 10:30 10:40- during post-vaccination observation period, Employee repor...
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Employee received vaccine at 10:30 10:40- during post-vaccination observation period, Employee reported sensation in throat while swallowing, eyes watering, occasional cough-Denies troubles breathing, denies swelling of lips tongue or throat. Drank water without difficulties 10:49- Provided 25mg of PO liquid diphenhydramine Observed- continued to have symptoms. Emergency Response Team called 10:55- Pt reports some improvement in symptoms- coughing resolved 11:02- Additional 25mh of PO Liquid diphenhydramine provided. Pt was transported to Emergency Room for Evaluation
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| 50 | 2021-01-14 | dizziness |
Funky lightheadedness; Normal tinnitus got louder and oscillating up and down; Sinus headache; Verti...
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Funky lightheadedness; Normal tinnitus got louder and oscillating up and down; Sinus headache; Vertigo; This is a spontaneous report from a contactable pharmacist. A 50-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscular at arm right on 17Dec2020 13:30 at single dose for COVID-19 immunization at a Workplace clinic. The patient's medical history was reported as none. No known drug allergies. Concomitant medication (received within 2 weeks of vaccination) included ergocalciferol (VIT D). The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that while getting first dose, patient experienced instant "funky lightheadedness, vertigo. Normal tinnitus got louder and oscillating up and down. Next day after first dose (18Dec2020), patient had sinus headache and vertigo, took meclizine and went back to bed. Felt fine when she woke up. The outcome of the events sinus headache and vertigo was recovered on an unspecified date, for the rest of events was unknown. The reporter consider the evens as non-serious.
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| 50 | 2021-01-14 | chills, fever, headache | Headache, chills, fever, muscle aches beginning 11 hours after vaccine received. |
| 50 | 2021-01-14 | nasal congestion, fatigue |
I woke up at 12:39am feeling nauseous and with a pounding heartbeat. I also had a headache and seve...
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I woke up at 12:39am feeling nauseous and with a pounding heartbeat. I also had a headache and severe body aches, and chills, but no fever. I drank some water and sat up in bed for a while. The pounding heartbeat settled down in about half an hour. I did not take Advil or anything else because of the nausea. Later in the morning I had some nasal congestion. Symptoms persisted but slowly waned until 6:00pm that day. After that, fatigue was the only symptom that lasted until about the 48 hour mark.
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| 50 | 2021-01-14 | headache |
Sx - mild wheezing, mild headache, mild nausea, muscular pain injection site. Tx- self administered ...
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Sx - mild wheezing, mild headache, mild nausea, muscular pain injection site. Tx- self administered inhaler
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| 50 | 2021-01-14 | shortness of breath |
We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on sta...
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We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.
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| 50 | 2021-01-14 | headache, chills, throat pain, malaise |
diarrhea; nausea; loss of appetite; chills; body aches; malaise; headache; sore throat; This is a sp...
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diarrhea; nausea; loss of appetite; chills; body aches; malaise; headache; sore throat; This is a spontaneous report from a contactable nurse, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EH9899), intramuscular in the left arm from on 16Dec2020 20:00 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, thyroid nodule, and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 17Dec2020 20:00, 24 hours after receiving the first dose of BNT162B2 the patient experienced chills, body aches, malaise, headache and sore throat. On 18Dec2020 20:00, 48 hours after receiving the first dose of BNT162B2 the patient experienced diarrhea, nausea and loss of appetite. The patient was treated for the chills, body aches/malaise, headache and sore throat, diarrhea, nausea and loss of appetite with ibuprofen (Manufacturer Unknown). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events, chills, body aches/malaise, headache, sore throat, diarrhea, nausea and loss of appetite, were all recovered on an unknown date. No follow-up attempts possible. No further information is expected.
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| 50 | 2021-01-14 | fatigue, weakness, headache |
feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; wea...
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feeling extremely tired; severe headache; large palpable knot on her left upper lateral deltoid; weak; her middle finger and index finger feel tight; her left shoulder feel really tight but has full sensation; unable to lift her left arm more than 30 degrees; pain in her arm; unable to sleep very well last night; This is a spontaneous report from a contactable nurse (patient) reported that a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 08Jan2021(yesterday morning, Deltoid Left) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Historical Vaccine was included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Patient received her second dose and within an hour she started feeling extremely tired, had a severe headache. When she woke up she noticed a large palpable knot on her left upper lateral deltoid in Jan2021. She stated that the injection went well and noticed no problems when she received the shot. At this time she was still very weak, her headache was still severe and she has noticed that her middle finger and index finger feel tight and her left shoulder feel really tight but had full sensation. She stated that she was unable to lift her left arm more than 30 degrees. She does not have a primary care physician at this time as she just relocated to her current residence. She stated that she was so uncomfortable due to the pain in her arm she was unable to sleep very well last night. She was going to seek medical attention at a local urgent care to be safe. The outcome of events, fatigue, knot on her left upper lateral deltoid, finger feel tight, shoulder feel really tight, unable to lift her left arm more than 30 degrees, pain in her arm, unable to sleep very well was unknown. The outcome of events of severe headache, weak was not recovered. Information about lot/batch number has been requested.; Reporter's Comments: her symptoms online per the Fact Sheet instructions. Potential
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| 50 | 2021-01-14 | dizziness |
funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This ...
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funky lightheadedness; weird feelings in head; tinnitus was noticeably oscillated up and down; This is a spontaneous report from a contactable pharmacist. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FK4176), intramuscularly on 07Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscularly on 17Dec2020 at 13:30 on the right arm for COVID-19 immunization and experienced funky lightheadedness, vertigo, normal tinnitus got louder and oscillating up and down, and sinus headache. Concomitant medication included colecalciferol (VITAMIN D). On 07Jan2021 at 13:30 (as reported), patient experienced funky lightheadedness, weird feelings in head, and tinnitus was noticeably oscillated up and down. The events were assessed as non-serious. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on 07Jan2021 at 15:30.
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| 50 | 2021-01-15 | cough, chills, fatigue, fever | Fever, chills, vomiting, cough, diarrhea, painful lump at injection site, fatigue |
| 50 | 2021-01-15 | chills, headache, sweating |
I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 1...
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I had the first vaccine 12/22, no side effects at all. After this booster, I was fine until about 10 hours later-then had severe neck down my entire back pain, with restlessness, chills, and headache-this lasted about 24 hrs. The pain subsided and then I had liquid stooling for about 8 hrs with intermittent hot flashes. I am still having an "odd" feeling in my head, like foggy sensation, vertigo, and the sweating episodes as we speak.
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| 50 | 2021-01-15 | headache |
I received my 2nd covid vaccination on 01/11/21. I started feeling muscle aches about 2 hours after ...
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I received my 2nd covid vaccination on 01/11/21. I started feeling muscle aches about 2 hours after vaccination. On Tuesday I went to work and was getting worse. on Wed, I have severe muscle aches, severe headache, abdominal pain, diarrhea. on Thursday, I was feeling a little better and returned back to work on Friday
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| 50 | 2021-01-15 | chills, malaise, fatigue |
Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, ...
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Swollen, painful, tender left deltoid Shaking chills Body aches, muscle aches, joint aches Fatigue, malaise
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| 50 | 2021-01-15 | fever, fatigue, chills | chills, fever 101.3, headache, myalgia, arthralgia, fatigue |
| 50 | 2021-01-15 | headache, fatigue |
nausea, swollen around injection site, arm very painful for 2 days, persistent headache, and extreme...
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nausea, swollen around injection site, arm very painful for 2 days, persistent headache, and extreme exhaustion. I had to leave work early and take the next day off. I slept 14 hours on that day off.
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| 50 | 2021-01-16 | fever, headache |
At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102...
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At 2AM, woke up with a fever of 103.6 and had a fever till Tuesday 1/12/21. Temp stayed between 102-103 till 1/10/21 and on 1/11/21, temp stayed in the 100?s. I had redness from above the injection site down to my elbow x 4 days. The area was raised 1/2 inch. I had to take Benadryl to help with the reaction. On 1/10/21, my lymph node in my axilla on the same arm where the injection was administered started swelling and had redness and had redness and tenderness that extended to the left breast. Had a severe headache x 4 days with neck stiffness. The swelling in my axilla improved by 1/15/21. The redness and swelling in the arm resolved by 1/15/21. Headache still lingered till 1/16/21. Was out of work x 4 days
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| 50 | 2021-01-17 | chills, fever |
I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a...
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I have a fever, it maxed of this morning at 101.5; Nauseous; Body ache; Arm hurts; Chills; This is a spontaneous report from a contactable nurse (patient). This 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK9231), via an unspecified route of administration, on 06Jan2021 at 5:15 at single dose for COVID-19 immunisation. Vaccine location was left shoulder. The patient was vaccinated at hospital, age at vaccination was 50-years-old. Medical history and concomitant medications were none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE an unknown date. Nurse stated she was just reporting some side effects from COVID Vaccine. She had second one last night at 5:15 and she is a nurse and she worked over night which she would never do that again. So, she has a fever, it maxed of this morning at 101.5 and chills, body ache, and she feels nauseous, and her arm hurts. Nausea was first at about 1:30 in this morning (07Jan2021) and then chills and then fever by about quarter to 6 this morning (07Jan2021), she started to check her temperature. Outcome was not recovered. No treatment was received for the events. She just didn't wanted to mask the fever. She wanted to see how it developed and her highest temperature was 101.5, then it came down a little bit, it's tolerable. About causality, nurse stated Yeah, most definitely.
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| 50 | 2021-01-19 | fever, fatigue, chills |
1/18 10pm started with chills then fever 1/19 not feeling right 8am chills 10am fever 101.1 severe n...
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1/18 10pm started with chills then fever 1/19 not feeling right 8am chills 10am fever 101.1 severe nausea near vomiting severe fatigue had fever all night 11/20 diarrhea put no fever
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| 50 | 2021-01-19 | fatigue |
2-3 hours after the injection she began having joint achiness that progressed to body aches, fatigue...
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2-3 hours after the injection she began having joint achiness that progressed to body aches, fatigue and swelling in her hands and ankles. Symptoms were significant until 1/11/21 but have been improving.
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| 50 | 2021-01-19 | headache, weakness, chills, fever | Chills fever muscle cramps weakness headache |
| 50 | 2021-01-19 | fever, headache, chills | Chills, headache, stomach/groin cramping, low grade fever. Took ibuprofen 800 mg |
| 50 | 2021-01-19 | fever, chills, headache | Fever, headache, chills, dry throat, body aches |
| 50 | 2021-01-19 | chills, pneumonia, fever, fatigue |
Had fever, chills, vomiting, diarrhea fatigue starting 12/22 fever stop 12/23 other symptoms stayed ...
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Had fever, chills, vomiting, diarrhea fatigue starting 12/22 fever stop 12/23 other symptoms stayed until 12/26. 12/27 started with fever again symptoms came back and was tested12/28 and 12/29, 12/29 was negative 12/28 was positive 1/12 pneumonia
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| 50 | 2021-01-19 | headache | I had a headache for about a week. I took Tylenol |
| 50 | 2021-01-19 | fever |
Muscle aches; fever; This is a spontaneous report from a contactable physician. A 50-years-old femal...
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Muscle aches; fever; This is a spontaneous report from a contactable physician. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot numbers EL0140 and EK9231), first dose via an unspecified route of administration on the left arm on 19Dec2020 at 08:00 and then via an unspecified route of administration on the on second dose via an unspecified route of administration on the right arm at 08:30 at a single dose, all for Covid-19 vaccination. Patient medical history was not reported. The patient has known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID). Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested. On 19Jan2021, The patient experienced muscle aches and fever. There was no treatment for the events. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 50 | 2021-01-19 | fever |
Muscles aches; Fever up to 101.2 F; This is a spontaneous report from a contactable nurse reporting ...
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Muscles aches; Fever up to 101.2 F; This is a spontaneous report from a contactable nurse reporting for herself. A 50-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), intramuscular, on 08Jan2021 at 06:45 AM, at single dose, for COVID-19 immunisation. Medical history included mild hypertension, Hashimoto's disease, gastrooesophageal reflux disease (GERD), insomnia. Patient did not have COVID-19 prior to vaccination. Concomitant medications included hydrochlorothiazide (unknown manufacturer), gabapentin (unknown manufacturer), acetylsalicylic acid (BABY ASPIRIN), omeprazole (PRILOSEC), trazodone (unknown manufacturer), cefixime (FLEXERIL), levothyroxine (unknown manufacturer), elderberry [sambucus nigra] (unknown manufacturer), vitamin c [ascorbic acid] (unknown manufacturer), colecalciferol (VITAMIN D). Previously the patient received the 1st dose of bnt162b2 (lot# EK5730), for immunisation, on 19Dec2020 at 03:30 PM, intramuscular in right arm. The patient experienced muscles aches on 09Jan2021 at 15:30 with outcome of recovered, fever up to 101.2 F on 09Jan2021 at 15:30 with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: up to 101.2 F on 09Jan2021. Therapeutic measures were taken as a result of the events and included treatment with Tylenol. Patient was not tested for COVID-19 post vaccination.
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| 50 | 2021-01-19 | headache, dizziness, shortness of breath | Palpitation, shortness of breath, dizzy, nausea, headache, pain on injection site |
| 50 | 2021-01-19 | malaise |
Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. ...
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Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill. She was observed for 30 minutes and felt better. Symptoms resolving.
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| 50 | 2021-01-19 | fatigue |
Reported fatigue and terrible pain to the left hip. Went to the ED for the pain. CT at hospital was...
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Reported fatigue and terrible pain to the left hip. Went to the ED for the pain. CT at hospital was negative and ED doctor said that the pain was unrelated to the vaccine.
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| 50 | 2021-01-19 | fever |
Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling all on side of inj...
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Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling all on side of injection. All accompanied by the usual fever, body, and joint aches which subsided at 48 hours after injection. Swollen and very painful lymph nodes in neck, under arm, and upper chest swelling still present.
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| 50 | 2021-01-19 | dizziness | anxious, light headed |
| 50 | 2021-01-19 | fever, chills | chills, fever, muscle pain , nausea , |
| 50 | 2021-01-19 | headache, shortness of breath |
perioral numbness with HA. Difficulty swallowing & breathing. Pt felt it was likely due to the N95...
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perioral numbness with HA. Difficulty swallowing & breathing. Pt felt it was likely due to the N95 mask. Given procedural mask and reported improvement of symptoms. Rapid response contacted. No other intervention
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| 50 | 2021-01-20 | headache |
Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakne...
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Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakness. Stroke Code activated at clinic where she works CT head neg TPA administered, transferred to ED for CTA and stroke care CTA neg MRI pending but clinically improved
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| 50 | 2021-01-21 | chills, dizziness, fever, fatigue, headache |
Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigu...
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Approximately 15 hours after vaccine, she noticed chills, fever up to 100.6, severe headache, fatigue and nausea. About a day later she noted lightheadedness. About 1 days later she noticed soreness at the injection site and sensitivity to cold.
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| 50 | 2021-01-21 | headache | Headache, diarrhea, body aches |
| 50 | 2021-01-21 | somnolence, dizziness, fatigue |
I felt light headed immediately after the vaccine which lasted 15 minutes. At about 8-8:30pm, i felt...
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I felt light headed immediately after the vaccine which lasted 15 minutes. At about 8-8:30pm, i felt very fatigued and fell asleep. At about 11pm I experienced tachycardia that lasted one week with some palpations for another week. My hear rate was over 100. On 12-30-20 my heart rate was not coming down, so i called my nurse cardiologist and he gave me a a refill Metoprolol 6.2mg for me to take this medication only if my heart rate was over 100 to take as needed. I only took Metoprolol for one day. My PCP recommended an EKG. Today I still more fatigued than usual.
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| 50 | 2021-01-21 | dizziness, fatigue, somnolence |
I felt light headed immediately after the vaccine which lasted 15minutes. At about 8:30pm. felt fat...
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I felt light headed immediately after the vaccine which lasted 15minutes. At about 8:30pm. felt fatigued and fell asleep. then about 11:30pm i experienced tachycardia which lasted one week. My hear rate was over 100bpm. The next day on 12-30-20, my hear rate was not coming down and i spoke with my cardiologist nurse and she did a refill for Metoprolol 6.2mg. I was to only take it if my hart rate was over 100bpm.
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| 50 | 2021-01-21 | headache, fever, fatigue |
I had fatigue, fever, body aches and constant headaches. I had a rash that showed up after four or f...
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I had fatigue, fever, body aches and constant headaches. I had a rash that showed up after four or five days.
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| 50 | 2021-01-21 | sweating, dizziness | Patient became nauseous, diaphoretic, dizzy and felt as if she was going to "pass out" |
| 50 | 2021-01-21 | chills, fever, fatigue | Reported fever 101.0F, chills, fatigue, and muscle aches. |
| 50 | 2021-01-21 | fatigue, headache, dizziness |
Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shi...
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Skin burning, severe joint pain, dizziness, headache, fatigue lasted for 5 days. Missed several shifts.
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| 50 | 2021-01-21 | shortness of breath |
Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, nu...
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Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium
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| 50 | 2021-01-21 | fatigue, headache, chills |
severe headache; Muscle aches; Chills; feeling tired and rundown; This is a spontaneous report from ...
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severe headache; Muscle aches; Chills; feeling tired and rundown; This is a spontaneous report from a contactable other healthcare professional (HCP)(patient). A 50-year-old female patient received 1 dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on right arm single dose for COVID-19 immunization on 07Jan2021, 12:00PM, at 50-year-old. Medical history included: asthma. Known allergies reported as: Latex, penicillin. Concomitant medication was not reported. No other vaccine received in four weeks. The patient did not have COVID prior vaccination. The patient had muscle aches, chills, severe headache, feeling tired and rundown; all on 08Jan2021, 04:00 am. No treatment received. The patient was not tested for COVID post vaccination. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving. Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, a causal relationship between event severe headache and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-24 | chills, dizziness |
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes...
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1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
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| 50 | 2021-01-24 | throat irritation |
Employee c/o of itchy throat within 15 minutes of vaccine administration. Employee was observed a to...
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Employee c/o of itchy throat within 15 minutes of vaccine administration. Employee was observed a total of 45 minutes. After 45 minutes, states throat itchiness is gone. No other symptoms noted. Vital signs = BP 141/86, HR= 72, Puls Ox = 99%
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| 50 | 2021-01-24 | chills, fever | Pf,izer-biotech covid-19 vaccine eau Body aches, chills, fever |
| 50 | 2021-01-24 | chills, fever, headache, fatigue |
Severe headache with sharp pains in neck and head; sharp pains in neck; severe muscle and joint pain...
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Severe headache with sharp pains in neck and head; sharp pains in neck; severe muscle and joint pains entire body from feet to hands; severe muscle and joint pains entire body from feet to hands; mild chills; fatigue; mild nausea; temperature 101.7; This is a spontaneous report from a contactable Nurse reporting for herself. A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), on 12Jan2021 at 12:30 at single dose intramuscular in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Age at vaccination was 50 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140) on 22Dec2020 at 12:45PM, at single dose intramuscular in left arm. Medical history included Long QT syndrome, chronic pain, and depression. The patient has no known allergies. Concomitant medications included metoprolol, bupropion, fluoxetine, omeprazole, pregabalin (LYRICA), cyanocobalamin (VITAMIN B-12), vitamin D3. On 12Jan2021 at 08:30PM the patient experienced severe headache, with sharp pains in neck and head; severe muscle and joint pains entire body from feet to hands; mild chills, temperature 101.7; fatigue, mild nausea. The patient received the following treatments for the events: treatment medications (Metaxalone, Vicodin, Lyrica) and OTC meds (Tylenol, Advil, Aleve, vitamin B-12 & D3). The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19.
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| 50 | 2021-01-24 | chills, fever, headache, fatigue | headache muscle pain chill fever fatigue bloody nose when blew nose |
| 50 | 2021-01-25 | shortness of breath, fatigue |
Fatigue; shortness of breath; This is a spontaneous report from a contactable consumer (patient). ...
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Fatigue; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EH9899), via an unspecified route of administration, on 08Jan2021 at 10:00 AM, at single dose for COVID-19 immunisation. Vaccine location was left arm. Age at vaccination was 50-years-old. Facility type vaccine was public Health Clinic/Veterans Administration facility. No other vaccine was received in four weeks. Medical history included blood pressure high (HBP), Sjogren's syndrome, Raynauds. Concomitant medications included sambucus nigra (ELDERBERRY), fish oil, magnesium, vitamin NOS (MULTIVITAMIN). On 09Jan2011, the patient experienced fatigue and shortness of breath. No treatment was received for the event. Outcome was unknown.
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| 50 | 2021-01-25 | fever, fatigue, headache | Fever, headache, fatigue, increased heart rate |
| 50 | 2021-01-25 | dizziness, fever, headache, chills |
Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills;...
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Nausea; Headache; Body aches more in the legs; Body aches more in the legs; Low grade fever; Chills; Mild dizziness; Intermittent heart racing; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 11Jan2021 (20:00) at single dose for Covid-19 immunization. The patient received the first dose of COVID 19 vaccine (BNT162B2, lot number: EJ1685), via an unspecified route of administration (left arm) on 21Dec2020 (03:30 PM) at single dose for Covid-19 immunization. The patient's medical history included idiopathic neuropathy to bilateral feet; no known allergies. Concomitant medication included tramadol. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced nausea, headache, body aches more in the legs, low grade fever, chills, mild dizziness, and intermittent heart racing on 12Jan2021 (08:00 AM). There was no treatment received for the adverse events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 50 | 2021-01-25 | dizziness, fatigue, nasopharyngitis, fever, cough, headache |
So it started with a cough on that Sunday and then the following day I woke up cold and dizzy and I ...
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So it started with a cough on that Sunday and then the following day I woke up cold and dizzy and I had a fever 100.3F I developed Monday excruciating headache and it was difficult to see. The fever and headache lasted for about 2 days and I developed a cough again and it lasted a couple of days. Fatigue lasted for about 12-14 days. I was tested for COVID on Monday 12/28 and results came back positive on 12/29
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| 50 | 2021-01-25 | headache, somnolence |
The day after receiving the second COVID-19 vaccine, I had a massive headache, to the point where I ...
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The day after receiving the second COVID-19 vaccine, I had a massive headache, to the point where I stayed in bed and slept all day. I also noticed that my brain was foggy. The next day I was able to move to the couch, but the headache was still severe with continued brain fog. I called by PCP to see if there was anything that I needed to be doing or taking and she told me that I should start feeling better the next week. The headache remains but is mild. I have memory loss and difficulty concentrating. I am a nurse and over my weekend at work, I had difficulty doing my job because I couldn't keep track of what I was supposed to be doing and had difficulty charting. My coworkers even commented that I seemed "really different", that my memory was poor, I had personality changes (according to one person) and that my standard of care was much less than usual. One person also commented that seemed to not be able to hear her and kept asking her to repeat herself. I find myself having to concentrate harder to see when I am reading or typing something. I missed work on January 14 and 15 because of the mental fogginess and headache. I thought I was doing better, but I realized that I wasn't when I returned to work on January 23 and 24. I have spoken to my PCP on the phone once and am awaiting calls from my PCP and neurologist regarding this event.
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| 50 | 2021-01-25 | dizziness |
This is a spontaneous report from a contactable nurse (patient) and a contactable consumer (patient'...
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This is a spontaneous report from a contactable nurse (patient) and a contactable consumer (patient's son). A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ER5730, Expiry Date: Mar2021), via an unspecified route of administration on 22Dec2020 at a single dose on Left Deltoid for COVID-19 immunization. Medical history included asthma and sickle cell disease. There were no concomitant medications. She has had issues with vaccines in the past but not to this extent. Prior she experienced swelling in the arm from a pneumonia vaccination for immunization, back in 2012, she has no Lot or Expiry of this previous vaccine. She adds that she did feel dizzy after the first vaccine dose but that subsided. She has had no positive tests for COVID, and no antibody tests. The outcome of the event was recovered on an unspecified date.
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| 50 | 2021-01-25 | chills, headache |
chills; severe all over body aches especially left arm; headache; sleeplessness; This is a spontaneo...
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chills; severe all over body aches especially left arm; headache; sleeplessness; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el0142) intramuscularly at left arm on 11Jan2021 16:15 at single dose for COVID-19 immunization. Medical history included herniated disk L5 S1. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), ergocalciferol (VITAMIN D), ascorbic acid (VITAMIN C), vitamin b complex (VITAMIN B), cefixime (FLEXERIL), calcium, magnesium, curcuma longa (TURMERIC). The patient previously received first dose of bnt162b2 (lot number: ek5730) intramuscularly at left arm on 21Dec2020 15:45 at single dose for COVID-19 immunization. The patient experienced chills, severe all over body aches especially left arm, headache, sleeplessness, on 11Jan2021 23:30. No treatment received. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.
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| 50 | 2021-01-25 | headache, chills |
headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous r...
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headache; alternating feeling hot and cold; vomited; shaking chills; nausea; This is a spontaneous report from a contactable physician (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration (left arm) on 06Jan2021 09:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK5730) via an unspecified route of administration (left arm) on 16Dec2020 (09:00 AM) for Covid-19 immunization. Medical history included hypothyroidism; no known allergies. Concomitant medications included levothyroxine, macrogol 3350 (MIRALAX), docusate sodium (COLACE), and ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dihydrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, lycopene, magnesium oxide heavy, manganese sulfate monohydrate, nicotinamide, phytomenadione, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, xantofyl, zinc oxide (CENTRUM FOR WOMEN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient reported that it was the second dose of her Pfizer COVID vaccine series; 12 hours afterwards she got shaking chills and nausea (06Jan2021) and this continued overnight, no fever. The next morning, she had the worst headache of her life, and nausea and alternating feeling hot and cold, no more shaking chills and no fever. The patient reported that it continued throughout 07Jan2021, and on 07Jan2021 she vomited once. Then 08Jan2021 in the morning, she still had the worst headache of her life, she took Ibuprofen to which the headache became much diminished. But headache continued with less intensity, so she was able to go to work throughout 08Jan2021. She continued with Ibuprofen and added Tylenol. Then at 3 am on 09Jan2021, she woke with the worst headache again so severe and took both Ibuprofen and Tylenol and it got better. By afternoon 09Jan2021, she was back to herself with no more headache and a normal appetite. She did take a sick day on 07Jan2021. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 post vaccination.
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| 50 | 2021-01-25 | headache, fatigue |
upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is...
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upper respiratory infection; Fatigue; Headache; Ringing of the ears/Ringing in ears; Nausea; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date: unknown), via an unspecified route of administration on 04Jan2021 10:25 at single dose (left upper arm) for COVID-19 immunization. Medical history included asthma (diagnosed at 8 years old), covid from 2020 (she had Covid last year twice). There were no concomitant medications. The patient experienced nausea, headache, and ringing of the ears/ringing in ears on 04Jan2021; and fatigue on 05Jan2021. This went on for 2.5 days. By day 3 post vaccine (06Jan2021) got upper respiratory infection. Stated she is pre disposed because she is asthmatic. She states she took Zofran to treat the nausea, 8 mg, and that she took 1000mg Tylenol for the headache. States she received the vaccine at her employer, (healthcare center name). States the symptoms resolved after about 3 days, exact dates unknown. She wanted to know if the second vaccination is the exact same as the first. She wanted to know if Pfizer manufactures the Shingrix vaccine. Therapeutic measures were taken as a result of nausea, headache. The outcome of the event upper respiratory infection was unknown, while for other events was recovered on an unspecified date in Jan2021.
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| 50 | 2021-01-26 | cold sweat, fatigue, dizziness |
1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycard...
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1st dose on 12/31/2020. Within 5 minutes of vaccine became severely dizzy, became briefly tachycardic with diffuse warmth and claminess. EMS was called after it didn't resolve after 20-30 minutes. Blood sugar 123. BP was elevated to high 160's over high 90s. EMS transported me to the ER. 1 liter of fluids given and BP was back to normal. Head CT scan was done and was normal. Dizziness persisted for about 6 hours and I was very tired for the rest of the day with achiness noted in the evening. I was fine by the next day. 2nd dose received on 1/21/21. I had only slight dizziness after that dose and was able to leave after 30 minutes observation time. Was very tired the weekend following vaccine and have had periods of dizziness/nausea since Sunday1/24/2021. I am still feeling dizzy and nauseated 1/27/21 and was encouraged to report possible side effect to the vaccine.
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| 50 | 2021-01-26 | headache, chills, fever |
Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surfa...
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Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surface areas. About 10pm developed headache, facial flushing, painful eyes, fever 101.3, rigors, and muscle cramps in feet and legs.
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| 50 | 2021-01-26 | dizziness |
BP 144/98 HR 77 BPM SP02 98% 4L of O2 via nasal cannula. Patient stated she felt dizzy and had mi...
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BP 144/98 HR 77 BPM SP02 98% 4L of O2 via nasal cannula. Patient stated she felt dizzy and had mid chest pressure. Not radiating pain and some dizziness. No blurred vision, no nausea. Patient was placed supine and monitored for an elevated blood pressure. first BP was 180/110. HR was 101. Sat at 94% on room air. Had med history of cancer and other conditions. Normal VP baseline is usually low. Vital s taken before 2 EMTs and on-scene doctor. Patient recovered.
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| 50 | 2021-01-26 | headache, fever | Fever of 101. Very bad headache & all over body aches. |
| 50 | 2021-01-26 | dizziness, fever | Fever, Body aches, Dizziness, |
| 50 | 2021-01-26 | throat pain, fatigue, headache, fever | Headache, fever, body aches, sore throat, fatigue |
| 50 | 2021-01-26 | migraine |
Migraine, 1/19 after 2nd dose, imitrex, lasted 1hour 1/2 Migraine, 1/26 after 2nd dose imitrex l...
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Migraine, 1/19 after 2nd dose, imitrex, lasted 1hour 1/2 Migraine, 1/26 after 2nd dose imitrex lasted 2hours both relieved with imitrex
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| 50 | 2021-01-26 | headache, weakness |
Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea;...
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Tingling lips; Swollen lips; myalgia; joint pain; tachypnic; headache; Weakness generalized; Nausea; she said she was really pale, so much so, that her husband was scared for her; This is a spontaneous report from a contactable other HCP. A 50-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left deltoid on 22Dec2020 07:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. There were no relevant medical history and concomitant medications. On to 22Dec2020, she said she feels like she has had a severe reaction to the COVID-19 Vaccine, saying she was not doing so great. Reported she received her first COVID-19 Vaccine dose on 22Dec2020 at 7:00AM in her left Deltoid. She said she had a reaction after receiving the first dose of the COVID- 19 Vaccine. She said her lips were tingling slightly, clarifying her lips were swollen too. She said she took some Benadryl (she clarified she did not have the Benadryl NDC/UPC, Lot or Expiration Date), and the Benadryl took away the lip tingling and swelling. She said she was tachypneic, and developed muscle pains (clarified as myalgia), joint pain, severe headache, weakness, and nausea. She said she also was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago, Dec2020 and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID- 19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. The outcome of the events joint pain,. myalgia, tachypnic, headache, pale and nausea was recovered on an unknown date in Dec2020; the outcome of the event tingling lips and swollen lips was recovered on 22Dec2020; while the outcome of weakness was unknown. The events were assessed as medically significant and causality was reported as related.; Sender's Comments: Based on the close compatible temporal association, there was a reasonable possibility that the events were related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-01-26 | fatigue |
With the second dose I ended up with severe pain on my upper back through my neck/shoulder area and ...
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With the second dose I ended up with severe pain on my upper back through my neck/shoulder area and also had pain in my rib cages (both). I experienced joint pain in my ankles and knees (no known case of arthritis) they were off and on and extreme fatigue. I still have pain in my upper back/neck shoulder area and the fatigue. The rib cage pain and the joint pain are gone
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| 50 | 2021-01-26 | chills, weakness, headache |
involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscl...
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involuntary muscle contractions in her diaphragm; chills; cold; severe body aches; Involuntary muscle cramping; chest pain; Feels bad; severe joint aches; tremor; nausea; severe body pain in her back and knees; severe body pain in her back and knees; Weakness; Headache; This is a spontaneous report from a contactable Other HCP reported for self. This 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 07:00 on Deltoid Left at single dose (Lot # EK9231) for covid-19 immunisation. Concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 via Intramuscular at age of 50 years old on Deltoid, Left at single dose (Lot # EH9899) for covid-19 immunisation, experienced Tingling lips, Swollen lips, and the Benadryl took away the lip tingling and swelling, Tachypnea, Myalgia, Joint pain, severe headache, Weakness generalized, Nausea, she said she was really pale, so much so, that her husband was scared for her. She said the symptoms lasted for about 3 days, but the weakness lasted longer. Reported she took some Zofran disintegrating tablets for her nausea. Clarified she did have a PCR COVID-19 Virus test after she developed symptoms from receiving the first COVID-19 Vaccine dose. She said she had the PCR COVID-19 Virus test about 3 weeks ago and the test was negative. She said she thought she had the COVID-19 Virus after receiving the first COVID19 Vaccine dose because no one else she knew who had the COVID-19 Vaccine had any issues. Reported she received the second COVID-19 Vaccine dose on 12Jan2021 at 7:00AM in the left Deltoid. She said the adverse reaction she experienced after the second vaccine dose was slightly different from what she experienced with the first dose. She said about 10 hours after the COVID-19 Vaccine was administered, clarifying at around 17:00PM 12Jan2021, she started having severe body aches(disability), and involuntary muscle cramping (disability), like tetanus. She said even her diaphragm was cramping. She said she had chest pain on 12Jan2021(disability), tremors on 12Jan2021 (medically significant), and body aches, but doesn't think she had fever. She said the symptoms are still going on like with the first COVID-19 Vaccine dose, but she has more severe joint aching on 12Jan2021 (disability), weakness on 12Jan2021 (disability), and nausea on 12Jan2021 (medically significant). She said her knees feel like she was beaten severely. She said she aches so bad, it hurts having pants on. She said she does not have a headache or tremors now, but did have a headache on 12Jan2021 (medically significant) and tremors in the beginning. She said she feels the most pain in her back and knees. She said she feels really bad on 12Jan2021(disability). After the second dose on 12Jan2021, she reports severe body pain in her back and knees (disability). She reports almost feeling like she has tetanus- involuntary muscle contractions in her diaphragm on unknown date(disability), tremor, cold, chills, nausea, muscle cramps/chest pain. 'Felt like a heart attack. It was out of this world'. She still has nausea, severe pain all over my body, she can't be touched, and even wearing pants hurts. She said she is a healthy person with no chronic disease. She said she had nothing wrong with her prior to getting the COVID-19 Vaccine. Reported she hurts so bad, she can't even lift her arm. She completed a covid 19 PCR test after the first dose in Dec2020, which was negative. Treatment were received for the events severe body pain in her back and knees, involuntary muscle contractions in her diaphragm, tremor, nausea, muscle cramping, chest pain, Feels bad, more severe joint aching, severe body aches, Weakness, headache, chills, cold. Reported she has taken 1500mg of Motrin. Outcome of the severe body aches, Involuntary muscle cramping, Chest pain, severe joint aches, weakness, Nausea, Back pain, Knee pain, Feels bad was not recovered. Outcome of the event Tremor was recovered in Jan2021, Headache was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the reported events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 50 | 2021-01-26 | dizziness | lightheadness, dizziness, & hypotension |
| 50 | 2021-01-26 | chills, fatigue, malaise, headache |
nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel w...
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nausea, joint pain, muscle pain, headache, chills, insomnia, tiredness, injection pain, don't feel well
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| 50 | 2021-01-26 | fever, headache, shortness of breath |
pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache...
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pain in arm difficult breathing cant breath through mouth spine hurts lower legs hurt fever headache nausea diarrhea
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| 50 | 2021-01-26 | headache | soreness to injection site, mild headache, mild bodyache |
| 50 | 2021-01-27 | headache, fatigue, fever |
Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache t...
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Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.
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| 50 | 2021-01-28 | headache, shortness of breath |
10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient star...
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10:50am shot was given, 11am patient started to get cold and having a headache, 11:10am patient started to have hard time breathing and severely cold and BP was rising. 911 was called and patient was transported to hospital where she was admitted.
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| 50 | 2021-01-28 | fever, dizziness, headache |
Fever; Muscle pain; Joint pain; Headache; Nausea; Dizziness; This is a spontaneous report from a Non...
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Fever; Muscle pain; Joint pain; Headache; Nausea; Dizziness; This is a spontaneous report from a Non-contactable Other Healthcare Professional (HCP, also the patient). A 50-year-old female patient (not pregnant) received bnt162b2, via an unspecified route of administration on 16Jan2021 12:00 at single dose in left arm for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient's concomitant medications were not reported. The patient didn't have other vaccines in four weeks. The patient didn't have COVID prior vaccination. The patient experienced fever, muscle pain, joint pain, headache, nausea and dizziness on 17Jan2021 04:00 AM . No treatment was received for the events. The outcome of the events was recovering. COVID was not tested post vaccination. Information on lot/batch number has been requested.
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| 50 | 2021-01-28 | throat pain |
Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report re...
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Heart palpitations; sore throat; hurt when vaccination was injected; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), intramuscular in the left arm, on 15Jan2021 16:15, at single dose, for COVID-19 immunization, in a public health clinic. The patient medical history and concomitant medications were not reported. Past drug included sulfamethoxazole, trimethoprim (BACTRIM) which the patient has allergies to. The patient did not have COVID-19 prior to vaccination and is not pregnant. The patient did not receive other vaccines in four weeks. The patient experienced heart palpitations, sore throat, and hurt when vaccination was injected on 15Jan2021 at 16:15. No treatment was given for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovered on an unspecified date.
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| 50 | 2021-01-28 | headache, fatigue, chills | SEVERE HEAD PAIN, GENERAL TIREDNESS, MUSCULAR PAIN IN THE NECK, BACK AND ONE EPISODE OF CHILLS |
| 50 | 2021-01-28 | shortness of breath |
SOB with chest tightness and syncope episode with loss of consciousness. c/o elephant sitting on the...
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SOB with chest tightness and syncope episode with loss of consciousness. c/o elephant sitting on the chest. O2 92%, BP 160/ 90, AED no shock advised. EMS arrived and transported to ED
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| 50 | 2021-01-28 | dizziness, weakness, headache | feeling weak, dizzy, light headed and intense headache |
| 50 | 2021-01-28 | fever, chills, somnolence, fatigue, head discomfort |
my temperature was 101.5f to 100 f 24hrs. and 100-99.5f neck and head heaviness another 8hrs; neck t...
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my temperature was 101.5f to 100 f 24hrs. and 100-99.5f neck and head heaviness another 8hrs; neck to shoulder, chill; head heaviness; neck and head heaviness another 8hrs; still felt the pain on the injection site but not too much; fatigue; shoulder pain; sleepy; sleepy; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via an unspecified route of administration on 08Jan2021 11:00, at left arm, at single dose for covid-19 immunization. Medical history included Hx of hypothyroidism. not now, known allergies was none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration on 18Dec2020 14:00, at left arm, at single dose for covid-19 immunization and after the first dose, the patient had a pain from left side neck to elbow at next day but it was gone, she felt little sleepy the day she got vaccine. The patient received the second dose on 08Jan2021, and the patient was little sleepy so she went to sleep 8pm (20:00), from 11pm (23:00) 100f she woke up due to neck to shoulder, chill, 11:30pm (23:30) 101.3f after that she had same symptoms and her temperature was 101.5f to 100 f 24hrs, and 100-99.5f neck and head heaviness another 8hrs, she took Advil 200mg x4 in the 32hrs. She still felt the pain on the injection site but not too much. She went back to work 12Jan2021 but feel fatigue until yesterday (16Jan2021) but no more shoulder pain. No treatment was received for all events except fever. The outcome of the event fatigue was not recovered, the outcome of the event pain on the injection site was recovering, the outcome of the other events was recovered in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
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| 50 | 2021-01-31 | chills, fever, malaise, headache, fatigue |
1/28/21 at 11pm I began feeling overall unwell so I checked my temperature orally as soon as feasibl...
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1/28/21 at 11pm I began feeling overall unwell so I checked my temperature orally as soon as feasible, as I had been traveling on airplane, and I noted fever developing. Overnight I experienced increasing fever and chills, noting fever arriving and staying at 102.4 by middle of the night/very early on 1/29/21. Experienced intense headache and whole body aches. On the morning of 1/29/21 when I got out of bed I felt nauseated and vomited. I still had fever of 102, chills, intense headache and whole body aches. I went back to bed and stayed there until the morning of 1/30/21 continuing to experience all the same symptoms. By 8pm on 1/29/21, I needed relief so I took 500mg acetaminophen. I took 500mg acetaminophen again at 1am and again at 9am on 1/30/21. When I got out of bed the morning of 1/30/21 I noted I still had fever but it was lower at 100.4. On 1/31/21 fever has gone but headache, fatigue and body aches with general feeling of not feeling well.
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| 50 | 2021-01-31 | chills, fever |
My 2nd dose was given 1/18/2021. On 1/21/2021 at 2:00 am, my temp was 100.9 ( oral ). I started taki...
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My 2nd dose was given 1/18/2021. On 1/21/2021 at 2:00 am, my temp was 100.9 ( oral ). I started taking Tylenol and did not go to work. An hour before Tylenol is due, I start feeling the chills and then fever. If I skip Tylenol or Advil, my fever starts. I was cleared to go back to work today but yesterday 1/31/2021: took Tylenol close to 9 am and by 4:05 my temp is 102.6. Still not back to work.. My highest temp was 1/25/2021: 10:50 am: 104.3. I?ve been having fevers and at times chills for 11 days since the 2nd vaccine dose and still having fevers today.
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| 50 | 2021-02-01 | shortness of breath, headache, fatigue |
Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortnes...
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Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortness of breath with diarrhea/mild headache.I went to urgent care for Covid, PCR test (results negative). I had symptoms approximately 10 days before shortness of breath resolved.
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| 50 | 2021-02-10 | chills |
Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmare...
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Chills; lymph nodes swollen on chest; lump in throat; muscle aches pain at injection site; nightmares; euphoria; insomnia; waking up often red eye; Nasal Swab positive; Nasal Swab positive; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot#Ek5730, on 28Dec2020 04:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No COVID prior vaccination. On 31Dec2020 the patient tested positive for the SARS-COV-2 virus (via nasal swab). The outcome of the event was unknown. On 27Jan2021 the patent experienced chills, lymph nodes swollen on chest, lump in throat, muscle aches pain at injection site, nightmares, euphoria, insomnia and waking up often red eye. The outcome of these events was reported as recovered and no treatment received. Lab data included Polymerase chain reaction: Positive on 31Dec2020.; Sender's Comments: Based on the current available information, the events Drug ineffective and COVID-19 are unlikely related to BNT162B2 vaccine. The events occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The case will be reassessed if additional information becomes available.
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| 50 | 2021-02-10 | shortness of breath |
felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100;...
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felt near syncopal; very short of breath; heart was pounding hard; felt tachycardic; BP was 160/100; irregular HR with PVCs; HR 40; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283) on 25Jan2021 08:15 given intramuscular (left arm) single dose for COVID-19 immunization. Medical history included was reported as none. The patient was not pregnant at the time of vaccination. Concomitant medication included estradiol, testosterone, lorazepam (ATIVAN). The patient previously received ultram/ Zofran ad experienced drug allergies, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1284) on 04Jan2021 08:15 intramuscular single dose for COVID-19 immunization. The patient was not diagnosed with covid prior vaccination and the patient was not tested for covid post vaccination. On 25Jan2021 at 08:45 AM, 30 minutes after injection,-the patient felt horrible described as her heart was pounding hard and felt tachycardic. BP was 160/100 and HR 110 and felt near syncopal. Then PVCs started/ very short of breath, and HR went from 112, 69, 40, then 80. The patient went to ER. The patient was monitored and given was IVFs and O2, and labs checked. The patient was discharged 7 hours later and continued having irregular HR with PVCs. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on the available information, a possible contribution of the drug to the event syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-11 | fever |
reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day d...
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reports fever blister within 1 hour that resolved and didn't require immediate treatment. next day developed myalgias but then came into the ED due to a feeling of tongue swelling and swelling of the neck, no n/v/d, no sob/wheezing/stridor
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| 50 | 2021-02-14 | lethargy, fever, headache |
Covid positive; Covid positive; High fevers; Severe body aches; Lethargy; Severe headache; This is a...
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Covid positive; Covid positive; High fevers; Severe body aches; Lethargy; Severe headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:30 in right arm, at single dose for covid-19 immunization. Medical history included allergy to adhesive tape. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included flecainide. The patient previously took morphine, demerol, codeine, dilaudid and allergies to morphine,demerol, codiene, dilaudid, golytle (as reported). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The patient experienced severe headache on 24Dec2020 04:00, lethargy on 25Dec2020, severe body aches on 26Dec2020, high fevers on 27Dec2020, covid 19 nasal swab: positive on 28Dec2020. Seriousness criteria was reported as disabling/incapacitating. Event result in clinic visit. Treatment antibiotics and prednisone was for Covid respiratory infection. The outcome of the all events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
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| 50 | 2021-02-14 | nerve pain, sweating, headache |
Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain...
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Severe headaches; Heart palpitations; Severe joint pain/ right shoulder pain; Tremors to hands; Pain in feet; Chronic neck and right shoulder pain/mid upper back; Chronic neck and right shoulder pain/mid upper back; Severe sweats from lung region up-censation of passing out; Severe nerve pain; Insomnia; This is a spontaneous report from a contactable nurse reported for herself. A 50-years-old female patient (non pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 13Jan2021 at single dose for COVID -19 immunization. Medical history included allergies to morphine,demerol, codiene, dilaudid, golytle, adhesive tape. Concomitant medication included flecainide (FLECAINIDE). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization on 23Dec2020 and experienced severe headache, lethargy, severe body aches, high fevers, COVID positive. The patient experienced severe headaches, heart palpatations, severe joint pain, tremors to hands, pain in feet, chronic neck and r shoulder pain/mid upper back, severe sweats from lung region up-censation of passing out, severe nerve pain, insomnia in Jan2021. It was reported as serious report, seriousness criteria was disabling/incapacitating. The adverse events result in doctor or other healthcare professional office/clinic visit. The events outcome was not recovered. Information on the lot/batch number has been requested.
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| 50 | 2021-02-21 | headache, respiratory tract congestion |
05:00 pm slept 15 hours over night. Slept through 2 alarm clocks. Arrived at work on time but cogn...
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05:00 pm slept 15 hours over night. Slept through 2 alarm clocks. Arrived at work on time but cognition was significantly slower all day. Brain got tired with mild headache after 7 hours on shift and went home early, due to could not mentally function to complete work shift.
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| 50 | 2021-02-21 | fever, headache, chills |
Fever; Body aches; Headache; chills; This is a spontaneous report from a non-contactable consumer (p...
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Fever; Body aches; Headache; chills; This is a spontaneous report from a non-contactable consumer (patient) reported that a 50-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on left arm on 22Jan2021 17:00 at single dose for covid-19 immunisation. Medical history reported as none. Concomitant medication included eletriptan hydrobromide (RELPAX), atorvastatin (LIPITOR). The patient previously took first dose of BNT162B2 on 31Dec2020 at 05:00 PM for COVID-19 immunization. On 23Jan2021, patient had fever, body aches, headache and chills. The patient received treatment with TYLENOL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained
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| 50 | 2021-02-21 | shortness of breath |
Patient complained of upper left chest pressure, pain, and shortness of breath when walking back fro...
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Patient complained of upper left chest pressure, pain, and shortness of breath when walking back from bathroom after receiving 2nd dose of vaccine. Patient had been waiting in waiting area and her time was almost up. Patient's vital signs were taken by EMS and bilateral lung sounds were clear and equal. Pulses bilateral radial were normal. Patient was taken by ER in wheelchair. In ED, patient was given IV Benadryl, Solumedrol, Ativan, pepcid, and Normal Saline infusion for acute bronchospasm. Patient improved and was discharged on same day from ER.
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| 50 | 2021-02-21 | chills, headache, dehydration |
Received the 2nd shot on 2/11/2021. I started feeling a little "off" later in the evening. I woke up...
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Received the 2nd shot on 2/11/2021. I started feeling a little "off" later in the evening. I woke up at 0300 with severe joint pain, headache and chills. Nausea started shortly afterwards. The joint pain was excruciating and it was very difficult to move. By 0330, I started vomiting. Vomiting continued until approximately 0745. I felt dehydrated but was not able to hold down any water. I contacted the Nurse Advice line and spoke to a nurse. She asked me a series of questions, all relating to signs indicative of an allergic reaction. I knew I was not experiencing a typical allergic reaction. But I was experiencing a bad reaction. Based on my responses to her questions, she did not recommend that I go an Urgent Care Clinic or see a Doctor. The severe joint pain continued through 02/14/2021. I started to feel better on 02/15/2021. Even though I did not experience an allergic reaction, given the severity of my joint pain and vomiting, I still feel it is important for what I did experience to be documented. Thank you.
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| 50 | 2021-02-21 | headache, dizziness |
Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling do...
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Within one minute of vaccination, patient was flushed, light-headed, dizzy, itching, and tingling down right side. Also had mild muscle aches and a headache. Had a similar reaction on her first dose. Oxygen: 97% on room air, BP109/57 and HR 54. Pt declined Benadryl and was taken to ED for further evaluation,
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| 50 | 2021-02-21 | fatigue, runny nose, night sweats, sweating, headache, dizziness, chills |
dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, ni...
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dizziness, headache, ear pain, popping sensation ears, feeling hot and cold, chills, diaphoresis, night sweats, severe fatigue, sinus congestion, runny nose, post nasal drip, sore arm
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| 50 | 2021-02-22 | headache |
Arm burning from the inside out from injection site right after injection; headache; tingling hand a...
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Arm burning from the inside out from injection site right after injection; headache; tingling hand and feet; swelling hands feet and face; swelling face; flushed; red all over wheel down to ED; lump in throat; Low blood pressure; high resting heart rate; This is a spontaneous report from a contactable healthcare professional (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e10140), via an unspecified route of administration at the left arm on 11Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included psoriatic arthritis, and allergies to shellfish, sulfa, bees, and, kiwi. The patient was not pregnant at the time of vaccination. Concomitant medication included naproxen sodium (ALEVE) and estradiol (ESTROGEN). The patient previously took naproxen (NAPROSYN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm burning from the inside out from injection site right after injection on 11Jan2021 9:15. Seconds later the patient experienced headache, lump in throat, tingling hand and feet, swelling hands, feet, and face, flushed, red all over wheel down to Ed, low blood pressure, and high resting heart rate all on 11Jan2021. The events resulted in emergency room/department or urgent care. Treatment was received for the all the events reported as IV with added therapy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.; Sender's Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect product administration to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 50 | 2021-02-22 | runny nose, throat pain, night sweats, headache, cough, chills, weakness, fever |
Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms...
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Developed symptoms of COVID-19 and tested positive with PCR test for COVID-19 on 1-29-2021. Symptoms included cough, rhinorrhea, sore throat, sinus congestion, severe headache, weakness, body aches, N/V/D, fever, chills, night sweats, abdominal pain. Was quarantined for 10 days post symptom onset.
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| 50 | 2021-02-22 | fatigue, headache, shortness of breath |
Headache, muscle ache, fatigue. labored breathing but not severe enough to go to the Emergency Room...
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Headache, muscle ache, fatigue. labored breathing but not severe enough to go to the Emergency Room.
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| 50 | 2021-02-23 | fatigue, headache, fever |
Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administra...
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Headache; Temperature 99 - 101 F; tiredness; higher blood pressure then usual (140 X 82); administration date=02Feb2021, dose number=2/administration date=20Jan2021, dose number=1; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on her right arm, via an unspecified route of administration on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 (first dose) for covid-19 immunization. The patient experienced Headache, Temperature 99 - 101 F, tiredness, higher blood pressure than usual (140/82); all on 03Feb2021 06:00 AM. Patient received Ibuprofen 200 as treatment for the events. The outcome of the events was recovered on unspecified dates.
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| 50 | 2021-02-23 | fever, headache, chills, fatigue |
Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from ...
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Throbbing arm pain; Fever; Chills; Body aches; Headache; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), intramuscular in left arm, on 18Dec2020 at 09:00 AM, at a single dose, for COVID-19 immunization. The patient's medical history included asthma, chronic back pain (surgery and scoliosis), migraines, systemic reaction to allergy injection, and COVID-19 in Jun2020 (prior vaccination). The patient's concomitant medications included pregabalin (LYRICA), butalbital, ascorbic acid (VITAMINS C), biotin, boron/ calcium/ Cimicifuga racemosa extract/ folic acid/ Glycine max extract/ Magnolia officinalis/ nicotinic acid/ pyridoxine hydrochloride/ riboflavin/ selenium/ thiamine/ tocopherol/ vitamin B12 NOS (ESTROVEN), Linum usitatissimum seed oil (FLAXSEED OIL), paracetamol (TYLENOL ARTHRITIS), and an unspecified stool softener and D (unspecified). The patient previously took amoxicillin and cinnamon oil and experienced allergies to both. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 18Dec2020 at 08:00 PM, the patient experienced throbbing arm pain for 2 days, fever, chills, body aches, headache, and fatigue for 2 days - some of the same symptoms she had when she had COVID-19 back in Jun2020. The events were considered non-serious. Treatment was received for the adverse events including ibuprofen, paracetamol (TYLENOL), and famotidine/ ibuprofen (DUEXIS). Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from "Throbbing arm pain" and "Fatigue" on 20Dec2020, and from the remaining events on an unspecified date.
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| 50 | 2021-02-24 | chills, fever, headache, dehydration |
Started 2/15 with joint pain. On 2/20 started with high fever, chills and headache, frequent urinati...
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Started 2/15 with joint pain. On 2/20 started with high fever, chills and headache, frequent urination and dehydration. On 2/22 started to vomit continued with other systems. Went to emergency clinic. They thought it was a UTI and prescribed an antibiotic. Antibiotics not working. Admitted to hospital on 2/23. All above symptoms continues. Met with internal dr and infectious disease dr. They believe this is a bladder infection plus a virus. Have been in hospital for three days now. Dr ordered more labs and waiting on outcome.
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| 50 | 2021-02-26 | dizziness |
Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle a...
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Dizziness, that turned into a Syncopal event, resulting in a fall, that resulted in a broken ankle and concussion. Transported to nearest hospital, I had to have emergency surgery on left ankle, by Dr. A plate and screws were placed in my ankle to stabilize the break. I am being treated and monitored by my general doctor for the concussion. I am currently non-weight bearing on my ankle, for a minimum of 2-4 weeks. I am unable to work due to the ankle break and concussion, for an undetermined amount of time. I am scheduled to meet with Dr. on the 4th of March, at which time he stated he will want to begin physical therapy, once the break has reached an adequate stage of healing. I will be re-evaluated by my general Dr. for the concussion in 2 weeks.
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| 50 | 2021-02-28 | fever, headache |
sick; temperature of 101 degrees; headache/frontal type of headache; This is a spontaneous report fr...
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sick; temperature of 101 degrees; headache/frontal type of headache; This is a spontaneous report from a contactable nurse (patient). A 50-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249 and expiration date unknown), intramuscular on 26Jan2021 at 10:20 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), batch/lot number: EK9231, intramuscular injection in left upper arm on 05Jan2021 as COVID-19 immunization and only had arm pain/soreness. As a nurse, the patient has given tons of vaccines. On 26Jan2021, she was given her second dose of COVID-19 vaccine around 10:20 a.m. She didn't hurt right away, it started later on. By 6pm, she got home, so sick and had a temperature of 101 degrees. She didn't go to work as she has been running a temperature and she has taken Tylenol. She knows the vaccine works the same, but everybody acts different. The patient also asked if a high temperature of 101 degrees a common side effect and if it is a normal reaction and how long it typically last. The patient states she has never been so sick like this in her life. The patient never gets sick and wanted to know if this is a common thing. She hasn't called her primary doctor. She took Tylenol Extra Strength, 6 or 7pm, also in the middle of the night and then again at 9am the following morning. Her fever has gone down a little bit, but the headache was so bad. It's like a frontal type of headache and it hurts so bad. The headache also began around 6pm yesterday and has converted into fever. The patient wanted to know if it is common to have this type of reaction. The patient is getting so tired and declined to continue with the report, stating she just wants to lay down. The event temperature of 101 degrees was resolving while the outcome of the rest of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 50 | 2021-02-28 | shortness of breath, headache, throat pain, cough, fatigue |
tired so quickly; Headache; back pain or the area of the lungs; like my asthma is worse; back pain o...
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tired so quickly; Headache; back pain or the area of the lungs; like my asthma is worse; back pain or the area of the lungs; more like sore on the throat; Short of breath; coughing a few times; Throat pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date unknown) via unspecified route of administration on left arm, on 16Jan2021, at a single dose for COVID-19 immunisation. The patient medical history included asthma. The concomitant medication were not reported. It was reported that on 19Jan2021, she had back pain, or the area of the lungs, headaches, throat pain, like more like sore on the throat, and she wasn't having too much coughing. She reported that initially she felt fine but 3 days later (19Jan2021), she began having shortness of breath "like my asthma is worse". She was coughing a few times, sporadically, not like one day coughing like crazy on 19Jan2021. On 26Jan2021, the patient tired so quickly even in her own place doing normal stuff, like cleaning and cooking. The patient used inhaler for short of breath which she usually did not use, like for year, and she saw it had already expired, and she got nervous that she saw it was expired, so she called her doctor to see if she could go, he said he was not receiving patients, all this stuff became so horrible. She tried to go to Urgent Care and they didn't see her, they said she had to go to the hospital, and she wanted to check her blood to see if she needs to receive the second shot or not, no one gave an answer, she doesn't know what to do, her second shot of vaccination was planned on 06Feb2021. Inhaler that was expired was Albuterol: expiry was Dec2020, lot DAEO68. During a call patient stated that the only symptom that worsened was short of breath. The patient wanted to know whether she could receive her second dose of vaccine. It was also reported that patient was not accepted in urgent care locations because she "may have covid" and was instructed to go to the ER (as reported). The patient assessed the events as non-serious. The patient was recovering from the events back pain or the area of the lungs, more like sore on the throat, coughing a few times, throat pain and headache and not recovered from other events.
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| 50 | 2021-03-01 | dizziness, sweating |
almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactab...
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almost blacked out; Dizzy; sweating; turned very pale; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: LE9267, expiration date unknown) via an unspecified route of administration in the left arm on 13Feb2021, 09:45AM (at 50 years old) at a single dose for COVID-19 immunization. The patient was not pregnant when vaccinated in Other Vaccination Facility Type. Medical history included high blood pressure and allergies to Biaxin and Amoxicillin; all from an unknown date and unknown if ongoing. Concomitant medications included calcium, lisinopril, colecalciferol (VITAMIN D) which were received within 2 weeks of vaccination. At 50 years old, the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL1283, expiration date unknown) via an unspecified route of administration in the left arm on 23Jan2021, 09:00AM at a single dose for COVID-19 immunization. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and was not tested for COVID post vaccination. On 14Feb2021 09:45, the patient experienced dizzy, sweating, turned very pale, and almost blacked out. No therapeutic measures were taken as a result of the adverse events. The patient recovered from the events on an unspecified date.
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| 50 | 2021-03-01 | migraine, dizziness, malaise, fever, chills, headache |
dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purp...
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dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
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| 50 | 2021-03-02 | chills, headache |
Chills; body aches; head and neck pain; head and neck pain; sinusitis; This is a spontaneous report ...
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Chills; body aches; head and neck pain; head and neck pain; sinusitis; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in left arm on 29Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included asthma, and Covid-19 prior to vaccination. Patient was not pregnant. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and had allergy. The patient experienced chills, body aches, head and neck pain, and sinusitis on 29Jan2021. No treatment was given. Patient has not tested for Covid after vaccination. Outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 50 | 2021-03-02 | fever, chills |
Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable con...
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Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 30Jan2021 10:00 at a single dose for COVID-19 immunization in a clinic. Medical history included high blood pressure and COVID-19 prior to vaccination. The patient was not pregnant. Concomitant medication included hydrochlorothiazide, lisinopril hydrochlorthiazid, loratadine, and fluticasone propionate (FLONASE). The patient experienced injection site pain, chills, nausea, fever 99.5 on 30Jan2021 10:00. The patient did not receive any treatment for the events. The patient was recovering from the events. Information on lot/ batch number has been requested.
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| 50 | 2021-03-02 | dizziness |
dizzy; nauseas; This is a spontaneous report from a contactable consumer (patient). A 50-year-old no...
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dizzy; nauseas; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer COVID vaccine), lot no. EL1283, via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 at a single dose for COVID-19 immunization at a public health clinic/administration facility. Medical history included Gerd and allergies to tetracycline. Concomitant medications included omeprazole, cetirizine hydrochloride (ZYRTEC), ergocalciferol (VIT D), and unspecified multivitamins. No other vaccines in four weeks. No Covid prior vaccination. On 27Jan2021 10:00 AM (as reported), within 1 minute, the patient was dizzy and nauseas. The symptoms went away in10 minutes. No treatment for the events. She has not experienced any other side effects. No Covid test post vaccination. The outcome of the events was recovered on 27Jan2021 10:10.
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| 50 | 2021-03-02 | headache |
headache on right side of head; back went out from right side and cannot bend over; right leg hurts;...
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headache on right side of head; back went out from right side and cannot bend over; right leg hurts; right foot tingles; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the right arm on 29Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included patient diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 06Jan2021 for COVID-19 immunization (lot number: EK4176, administration time: 02:00 PM on left arm). The patient previously took levofloxacin (LEVAQUIN) and cefalexin (KEFLEX) and experienced allergies to medications. On 30Jan2021 10:00 PM, the patient experienced headache on right side of head, back went out from right side and cannot bend over, right leg hurts and right foot tingles. No fever. No treatment was received for the adverse events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
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| 50 | 2021-03-02 | dizziness, fatigue |
lightheaded; tired; achy; This is a spontaneous report from a contactable consumer (patient). A 50-y...
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lightheaded; tired; achy; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration in right arm on 22Jan2021 19:00 at a single dose for Covid-19 immunization. Medical history included borderline hypertension and allergies to latex. Patient was not pregnant. Concomitant medications included atorvastatin, lisinopril, and fish oil. The patient previously took morphine and had allergy. Patient reported that the day after the vaccination, she experienced lightheaded, tired, and achy at 2pm on 23Jan2021. She had these symptoms every day since. Some days it happens more often than others. It happens at different times such as lying down, walking, etc. No treatment was given. Outcome of the events was not recovered. Information regarding the lot/batch number has been requested.
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| 50 | 2021-03-09 | fatigue, fever, chills |
Chills; Fever; Tired; Rash; This is a spontaneous report from a contactable consumer reported for he...
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Chills; Fever; Tired; Rash; This is a spontaneous report from a contactable consumer reported for herself. A 50-year-old patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9629 and Expiration Date unknown) via an unspecified route of administration on 04Feb2021 03:00 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3249 and Expiration Date unknown) via an unspecified route of administration on 13Jan20210 3:15 PM at age of 50-year-old (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as stroke from Oct2019, no previous covid and no known allergy. There is no other vaccine in four weeks. The concomitant medications reported as acetylsalicylic acid (ASPIRIN) and metoprolol succinate (Toprol 25MG). Patient experienced Chills, then fever, tired, rash from 05Feb2021 06:00 PM. The outcome of events was recovering without treatment given. Information on the batch/Lot number has been requested.
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| 50 | 2021-03-09 | headache, weakness, chills, dizziness, malaise, shortness of breath |
joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection s...
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joint pain; weakness; chills; diarrhea; dizziness; minor difficulty breathing; headache; Injection site pain; malaise; muscle cramping; swollen lymph nodes; projectile vomiting; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration in right arm on 03Feb2021 15:45 at single dose for covid-19 immunisation. Medical history included diabetes, hypertension (HTN), and gastrooesophageal reflux disease (GERD). Known allergies included xylometazoline hydrochloride (SUDAFED). Concomitant medication included omeprazole (PROTONIX), metformin hydrochloride, sitagliptin (JANUMET), empagliflozin (JARDIANCE), insulin glargine (BASAGLAR), escitalopram oxalate (LEXAPRO). There was no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient experienced joint pain, weakness, chills, diarrhea, dizziness, minor difficulty breathing, headache, injection site pain, malaise, muscle cramping, swollen lymph nodes, projectile vomiting, all on 04Feb2021 09:15 with outcome of recovering. No treatment received for the events.
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| 50 | 2021-03-13 | chills, malaise, influenza like illness, headache |
Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second v...
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Transcription of a text I sent to my colleagues: Hi all--I'm not sure who has received the second vaccine, but I wanted to update as to my experience. I got sick with the first one from about 4ish hours after until the next mid morning maybe? Then I felt bad again that second night. I had my vaccine (second) yesterday at 4 PM, and I felt OK going to bed but had a pretty pitiful night. I woke up at 5 AM and I felt horrible. That felt like someone took a pair of metal cymbals and slammed them together on my head. The tinnitus was strong. I also had body aches and joint pain and felt like I had the flu. I felt a little better around 1 PM, but felt bad again around 330. Now I'm miserable again with terrible body aches and chills (this was at 7:38 PM). I'm sure I will feel better in the morning, just wanted to share my experience." Sadly, since then, I have had tinnitus with a metallic ringing in both ears along with hearing loss. I had some vertigo one day but unsure if this was related. The tinnitus makes me very sad. I am a hospitalist and am happy to have been vaccinated, still. It has been 2 months today, and it remains, unrelenting. It is worse in the morning and at night. The hearing loss is difficult.
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| 50 | 2021-03-14 | headache, fever |
Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes...
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Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes; low grade fever; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection and lot number: EL9265) via an unspecified route of administration on 03Feb2021 07:00 to Left arm at single dose for COVID-19 immunization. Patient medical history included Eosinophilia and colitis. Concomitant medications included Escitalopram, alprazolam and ibuprofen. Past drug included Wellbutrin and experienced allergy and first dose of BNT162B2 for COVID-19 immunization. On 03Feb2021 22:00 patient experienced Very large swollen lymph nodes in left armpit, neck, arm pain, headache, hot flashes, low grade fever still continues at 1 week after last dose. Seriousness was reported as non-serious. Patient did not receive any treatment for events. Outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
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| 50 | 2021-03-14 | dizziness |
more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a ...
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more intense tingling sensation around the chin area/lower mouth area; extreme dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, on left arm, on 06Feb2021 15:30 (at the age of 50-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included type 1 diabetes and Raynaud's, patient had no known allergies. No COVID prior vaccination. Concomitant medications included insulin glargine (LANTUS), insulin lispro (HUMALOG), and lansoprazole, all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration, on left arm, on 15Jan2021 15:30 (at the age of 50-year-old), at single dose, for COVID-19 immunization, and after receiving the first dose the patient experienced tingly sensation in her chin area. After receiving the second dose on 08Feb2021 13:00 (reported as "day three") patient experienced more intense tingling sensation around the chin area and extreme dizziness. Patient took diphenhydramine hydrochloride (BENADRYL) and meclozine hydrochloride (BONINE) as a result. On 09Feb2021 (reported as "day 4") patient still experienced the tingly sensation around chin and lower mouth area. Patient felt almost like a sensation of when, for example: your arm fell asleep. It was constant. No COVID tested post vaccination. The outcome of the events was not recovered.
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| 50 | 2021-03-19 | shortness of breath |
10 days after my second shot of the Covid vaccine, I was short of breath and my heart rate was eleva...
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10 days after my second shot of the Covid vaccine, I was short of breath and my heart rate was elevated. I went to the hospital and they found blood clots in both lungs and I had to be hospitalized.
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| 50 | 2021-03-21 | throat pain, weakness |
Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contac...
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Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6199), via an unspecified route of administration on 05Mar2021 15:15 in right arm as single dose for covid-19 immunisation. The patient medical history was not reported. Known allergies was no. The patient had no other vaccine in four weeks. Concomitant medications included fluticasone propionate (FLONASE); vitamin d; cyanocobalamin (VITAMIN B12). On 05Mar2021 16:00, the patient experienced weakness after vaccination, sore throat last night and today, choking when sleeping, she kept waking up from it. No treatment was received for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Outcome of events were not recovered.
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| 50 | 2021-03-21 | shortness of breath, migraine, headache, cough |
Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccin...
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Presented to ED on 3/10/21 for migraine and discharged home. Reported only sore arm following vaccination. Presented to ED on 3/7/21 with back pain, no COVID symptoms reported and was discharged home. Presented to ED on 3/10/21 with generalized body aches, nausea, vomiting, and headache for 2 days. Noted mild cough and sinus congestion and was admitted to hospital for 5 days until 3/14/21. Returned to ED on 3/15/21 with worsening shortness of breath and was admitted to hospital for another 5 days until 3/19/21.
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| 50 | 2021-03-21 | dizziness, fever, chills, throat pain, sweating |
Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and need...
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Temp now fluctuates from 95-100; Feeling delirious; Sweating; Dizzy; Left arm is numb; Pins and needles sensation all over my body; Hearing noises in my ears like a throbbing when I stand up; Barely walk to the bathroom; Chills; Everything sore; Sore throat; Began violently shaking around midnight; Fever was 103/Ran fever of 100.5-103 until this morning/Fever is below 100 today; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Mar2021 09:30 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation at a Public Health Clinic/Administration facility. Medical history included Hashimotos. The patient has no Covid prior to vaccination and not tested for Covid post vaccination. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), lisdexamfetamine mesilate (VYVANSE), venlafaxine, cyanocobalamin (B12 [CYANOCOBALAMIN]), and ergocalciferol (VIT D). The patient had no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9269) on 09Feb2021 17:30 in the left arm for Covid-19 immunization. On 03Mar2021, sore throat began around 17:30 and chills began at 21:30. Patient took Tylenol and went to sleep. Violently shaking began around midnight (Mar2021); the patient was unable to get warm, yet fever was 103 (Mar2021). It was reported that everything sore on 03Mar2021 17:50. The patient ran fever of 100.5-103 until this morning (04Mar2021). Temp now fluctuates from 95-100. Mostly all "ept" until this morning (06Mar2021) waking to drink water and take Tylenol every 4 hours. The patient was still sweating profusely and was feeling delirious and dizzy (06Mar2021). Left arm is numb and has a pins and needles sensation all over her body on 06Mar2021. It was very uncomfortable. The patient was also hearing noises in her ears like a throbbing when she stands up. Fever is below 100 today (unspecified date), after taking a shower this morning, it was 95. The patient can barely walk to the bathroom on 06Mar2021 and she hasn't left her room since this started Wednesday night. Her husband called her doctor and she say this should pass by 9:30 tonight. There were times she prayed to die; she hurts so bad. Fortunately, the pain is not this bad now. But she was suffering greatly from the 2nd shot. The events sore throat and chills were treated, while the other events were not. The outcome of the events was not recovered.
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| 50 | 2021-03-22 | cold sweat, dizziness, sweating, fever |
4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, ...
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4 to 5 hours post vaccination I began to get very dizzy or "woozy", had a pounding heart sensation, felt very "clammy", and had general ague upon any type of exertion such as walking a very short distance using my rolling walker device. This happened 3 times in approximately 2 hours on the day of vaccination. The next day (03/05/21) my blood pressure and heart rate were very elevated (BP 174/111, Heart Rate 168); I went to the emergency room where they were unable to lower my heart rate but sent me home anyway. 03/7/21 I went to ER, where I was diagnosed with atrial flutter and admitted. The atrial flutter was corrected via cardioversion and I was released 3/9/21; I was prescribed Multaq 400mg, 2X/day and take it faithfully.
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| 51 | 2020-12-31 | shortness of breath, headache, fever, cough |
*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, ...
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*12/21-22-increased soreness at site of injection...resolved Onset on 12/28 of Swollen lymph nodes, with pain, on Right side of body with increased sensitivity at Left Axillary/side of breast area. Onset on 12/30 Fever, Severe Body aches/joint pain, dry cough, chest pain with min SOB, Headache. *Exposure to 4 people on Sat 12/26 who have tested positive for Covid on 1/1/20 but their symptoms began 12/28 through 01/30.
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| 51 | 2020-12-31 | malaise, fatigue, headache |
About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and fe...
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About 40 minutes after receiving the vaccine, on the drive home, my face started getting numb and feeling tingling and maybe swollen, also, all of my regular pains in my body, ie. various mouth pains and said pains, certain things that act up in my body, were intensified and more bothersome, and I had a headache that wouldn't go away. I felt "off" that night and the next day. Probably like I was mildly sick and fatigued with body feeling sore all over and headachey. About 36 hours after getting the initial dose, I was feeling regular again.
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| 51 | 2020-12-31 | malaise |
on 12/25 all lymph nodes on the same side as the shot injection swollen, Joint Pain, not w=feeling w...
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on 12/25 all lymph nodes on the same side as the shot injection swollen, Joint Pain, not w=feeling weel. on 12/31 reported that the lymph nodes near clavicle have now swelled. The other lymph nodes have not ceased being swollen.
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| 51 | 2021-01-01 | dizziness |
Lots of dizziness and nausea. Even after a long nights rest, the dizziness does not go away. The diz...
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Lots of dizziness and nausea. Even after a long nights rest, the dizziness does not go away. The dizziness began the day of vaccine around 8pm and has not subsided.
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| 51 | 2021-01-03 | sweating, malaise |
20 minutes after receiving the vaccination the resident started to not feel well. She said she felt ...
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20 minutes after receiving the vaccination the resident started to not feel well. She said she felt very far away and just kept repeating I don't feel well. She was diaphoretic and her chest was very red and she kept scratching and rubbing it at it. I asked if she wanted IM Benadryl or epipen and she at first denied. She also said she felt like she needed to focus on her breathing. At this time we decided it was best to administer Epipen x 1 dose. Immediately after she felt better. She was observed for another 30 minutes and then went home. at 7:17pm I called and spoke with her. She said her arm was sore and that her oxygen levels were about 88-89% which is low for her but she said she felt fine and is currently working right now.
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| 51 | 2021-01-03 | chills |
Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted.; D...
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Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted.; Did have one episode of chills; This is a spontaneous report from a contactable physician. A 51-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, intramuscular on 23Dec2020 09:45 at a single dose for COVID-19 immunization in workplace clinic. Medical history included hypothyroid, allergies from bee sting, and covid-19 from Apr2020, all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient did not receive other vaccine in four weeks. On 25Dec2020, in the late evening at 11:45 PM-almost midnight, the patient experienced diarrhea, severe, without nausea or vomiting. Did have one episode of chills that resolved. Diarrhea persisted 24 hours with mucous and bloody mucous after all fecal material was exhausted. The patient had COVID-19 in Apr2020 and had positive antibodies in Jun2020 with high titers. She confirmed with their ID chief that she should proceed to receive the vaccine. Diarrhea resolved in 24 hours. Some lingering increased GI activity. No fever (temp 99.0F) (Dec2020). The patient recovered from events without treatment in Dec2020. The events were reported as non-serious. The patient was not tested for COVID-19 post vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diarrhea, severe cannot be excluded, considering the plausible temporal relationship and the known adverse profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 51 | 2021-01-03 | fever | Fever |
| 51 | 2021-01-03 | chills, headache, fever | Fever, chills, headache,body aches |
| 51 | 2021-01-03 | shortness of breath |
On Dec. 24th I started to develop pain with breathing. No other symptoms. I was unable to take deep...
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On Dec. 24th I started to develop pain with breathing. No other symptoms. I was unable to take deep breaths and felt SOB because of that. I was evaluated in the emergency room on Mon 28th. Full workup completed, cardiac and PE. Work up negative and Covid test negative. I was diagnosed with pleurisy.
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| 51 | 2021-01-03 | dizziness | Patient felt lightheaded for approximately 15 minutes |
| 51 | 2021-01-03 | chills, shortness of breath, fever |
Patient has a presumed fever (shaking chills) and increasing shortness of breath that started this m...
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Patient has a presumed fever (shaking chills) and increasing shortness of breath that started this morning (1/4/2021)
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| 51 | 2021-01-03 | headache, chills |
Staff member at nursing home vaccinated at mass vaccination event on 12/18/2020 for residents and st...
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Staff member at nursing home vaccinated at mass vaccination event on 12/18/2020 for residents and staff. Developed headache, chills, diarrhea- muscle aches, joint aches on 12/29/2020 and tested positive for COVID-19 on 12/30/2020. Uneventful course isolating at home.
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| 51 | 2021-01-04 | headache | Headache, Anaphylaxis, UrticariaPruritus & NauseaVomiting |
| 51 | 2021-01-04 | migraine |
Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contact...
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Migraines for several days, nausea on day three; nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL0140), via intramuscular route of administration in the left arm on 18Dec2020 at 09:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included fibromyalgia and history of migraines. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 21Dec2020 at 13:00 the patient experienced migraines for several days, nausea on day three. The patient did not receive any treatment for the events. The clinical outcome of the migraines for several days, nausea on day three was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-04 | headache |
Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to sever...
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Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; This is a spontaneous report from a contactable nurse (patient herself). This 51-year-old female nurse received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 28Dec2020 at 16:00 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included type 2 diabetes. No known allergies. Relevant concomitant medications included metformin, pravastatin and paracetamol (TYLENOL). The patient was vaccinated at hospital, age at vaccination was 51-year-old. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed On 28Dec2020 at 17:00, the patient had mild headache within first hour relieved some with paracetamol (TYLENOL). 12 hours after injection, awoke to severe headache, and nausea. Unrelieved with TYLENOL after one hour. She took ibuprofen, 'CLARITIN' and ondansetron hydrochloride (ZOFRAN). Eventually relieved 1.5 hr after that. The patient recovered from both events in Dec2020.
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| 51 | 2021-01-04 | headache, chills, fatigue |
achy, chills, fatigue, headache starting a few hours after vaccine. Resolved with sleep, tea and ov...
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achy, chills, fatigue, headache starting a few hours after vaccine. Resolved with sleep, tea and over the counter Sudafed 4 hour night time with ibuprofen.
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| 51 | 2021-01-04 | chills, dizziness |
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/...
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lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
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| 51 | 2021-01-04 | fatigue |
tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands...
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tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands and feet are cold/She felt cold; This is a spontaneous report from a contactable nurse (patient). A 51 years old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Dec2020 10:00 at single dose in the arm left for covid-19 immunisation. Medical history included change in taste, altered taste. Concomitant medications were none. Caller reported she was having side effects with the COVID vaccine she received yesterday (28Dec2020) morning at 10am. The patient experienced paresthesia, tingling in hands and feet and they are cold, said she "felt cold" and has soreness in the injection site on 28Dec2020 17:00. Caller confirmed the above details. Her hands got really cold and tingling to them and she was wondering what this is and went to her other half and asked him to take a look. It passed and lasted about 10-15 minutes and just thought it was unusual. Did a 5:00pm check-in and she was doing okay and everything was fine so she didn't mention it. At 7:00pm she got tired and laid down and started feeling the tingling in the fingers and her hands. Upon waking this morning when her feet met the ground it was intensified, the tingling, and she went to walk it out it got better, but she is still having the tingling in both fingers/hands and feet. Stated unsure of seriousness criteria for the tingling in hands and feet and coldness. Wondered if it is something she needs to worry about that is why she called. Is it something that could go away or worse like with Guillain-barre syndrome. It's not disabling, but it is concerning. Unable to provide the NDC or expiry for COVID vaccine given. Stated she can't understand the writing on the card provided for her with product details. Does see on card Pfizer, X40113 and stated the lot number looks to be either "ES1685 or EJ1685 or E51685". Unable to provide the dose/strength. Received this vaccine at her workplace. Mentioned in past she had flu vaccine with the additive of mercury and experienced changes in taste, altered taste. It was reported to her primary care provider. This was between 6-8 years ago, unable to provide name of vaccine, NDC, Lot, or expiry. Since then she only receives single dose vials instead of multidose vials. They were looking for a list of side effects and wanted to know if she should seek care for her symptoms, it's unusual. Wanted to know if the side effects she is having is something Pfizer has been seeing and will it go away and when. Previous transfer agent sent her to safety. It is difficult to navigate the website. Outcome of event fatigue was unknown, while outcome of other events was not recovered. Causal relationship between vaccine and events "paresthesia, tingling in hands and feet" "hands and feet are cold" "soreness in injection site" were related by agency and Primary Source Reporter. Information about Lot/Batch number has been requested.
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| 51 | 2021-01-04 | headache, dizziness |
waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - fe...
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waves of nausea for 2 days after; Dizziness; headache; difficulty with higher thought processes - feeling "zoned out"; difficulty with higher thought processes - feeling "zoned out"; This is a spontaneous report from a contactable other healthcare professional (patient). A 51-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number unknown due to not available/provided to reporter at the time of report completion), intramuscular at left arm on 23Dec2020 09:00 at single dose for COVID-19 immunization at a "Nursing Home/Senior Living Facility". The patient's medical history included Gluten and FODMAP food allergy. Concomitant medications received within 2 weeks of vaccination: dietary supplements. No other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had been tested for COVID-19 post the vaccination. COVID-19 test post vaccination on 23Dec2020 result was negative. It was reported that on 23Dec2020 09:30, the patient experienced dizziness, headache, difficulty with higher thought processes - feeling "zoned out", and "waves of nausea for 2 days after". No treatment was taken for the above events. The outcome of the events was recovered in Dec2020. Information on the lot/batch number has been requested.
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| 51 | 2021-01-05 | dizziness |
15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but ...
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15 minutes after the immunization I felt a little lightheaded. It was mild so I tried to leave, but then felt presyncopal. Sat down, drank water and ate a cookie. The feeling did not subside. After about another 20 minutes, felt tingly all over. After about 5 minutes of that, the tip of my tongue started too tingle. I alerted the staff and they checked my pulse (nl in the low 60s) and my BP (normal SBP 112). They gave me liquid Benadryl 25 mg and the tingling immediately stopped but I still felt lightheaded. They transported me to the ED. I was given 1 L of fluid and monitored and rested for about an hour, then I felt fine. No other tests or meds given
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| 51 | 2021-01-05 | cough, throat irritation |
COUGH, TOUNGE TINGLING , SCRATCHY THROAT 15 MIN POST VACCINE. EPI AND BENADRLY GIVEN IN CLINIC EME...
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COUGH, TOUNGE TINGLING , SCRATCHY THROAT 15 MIN POST VACCINE. EPI AND BENADRLY GIVEN IN CLINIC EMERGENCY DEPT GAVE DECADRON
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| 51 | 2021-01-05 | fatigue, somnolence |
Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Eyes start...
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Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Eyes started swelling, around my eye the left one, it is more around the eyes it's worse; Swelling around mouth; Aching in my mid back; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Batch/Lot number: EL1284), via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history was not reported. Concomitant medications included montelukast, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); colecalciferol (vitamin D), and bumetanide (BUMEX). The nurse stated that she got the Pfizer COVID Vaccine yesterday (28Dec2020) and she didn't know if she should report the side effects but she didn't yesterday and she was going to today (29Dec2020). It didn't happen right away, it was like throughout the day, her eyes started swelling around them, she had swelling around her mouth, she still has it actually. She didn't have any breathing issues but there was a lot of aching in her mid back which was gone now, the aching part, but it was the swelling that concerned her. They were around her eye, the left one. She had a question herself though because this was just her first vaccine. She meant it wasn't bad enough that she had breathing issues because she monitored it and it's already in there now. She asks if it would it be okay to get the next one. As treatment, the patient took Tylenol and a Benadryl. The patient also mentioned that she has been extremely tired too. What she meant was she was sitting at her desk at work yesterday and she was nodding off. According to her, it was just offered through work and they went to a hospital to get it. The patient said that she did not have to seek medical treatment for it, so it was not like life threatening. When clarified if the swelling around eyes was still there, the patient stated that it was not as prominent, it was more around the eyes it's worse. She further stated that it has improved, she was still tired but the swelling had improved. The patient was also asked regarding the route of administration and she stated that she believes it was long enough to be, it looked like IM, she was not sure. It might have been a SubQ but she means it wasn't like a huge long needle but it wasn't like the real short ones either. Outcome of the events "Eyes started swelling, around my eye the left one, it is more around the eyes it's worse", "Swelling around mouth", "Aching in my mid back", was recovering/resolving; for the event 'Fatigue' was not recovered, while for 'Somnolence' was unknown. Causality assessment of the reporter between the events 'eye swelling', 'swelling around mouth', 'aching in my mid back', and 'I have been extremely tired too. I was sitting at my desk at work yesterday and I was nodding of' and BNT162B2 was reported as related.
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| 51 | 2021-01-05 | headache, fatigue |
Gastro problems, diaherra , muscle aches, my whole body hurts, nausea, headache, very very tired...I...
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Gastro problems, diaherra , muscle aches, my whole body hurts, nausea, headache, very very tired...I have taken a tums and just slept since 1/5/2021 at 4:00p. I have no appetite.
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| 51 | 2021-01-05 | headache, malaise, dizziness, nasal congestion | Headache, light headed, instant nasal congestion and malaise |
| 51 | 2021-01-05 | skin warm |
Little ball size in the beginning. Left inner upper arm, warm to touch, very tender. Now about the s...
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Little ball size in the beginning. Left inner upper arm, warm to touch, very tender. Now about the size of a quarter. Seems to be getting larger with the warm compresses, per Dr's orders.
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| 51 | 2021-01-05 | headache, dizziness |
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse Al...
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Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 1/6/2021  Date: 1/6/2021  Subjective Patient is a 51 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination.  She denied any history of previous adverse reactions to vaccines.  She was given the Pfizer vaccination in the left deltoid muscle.  During her 15 minute waiting period after the injection, the patient began to experience dizziness, flushing and HA. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, facial swelling, lip swelling and tongue swelling.  This provider was notified of patient reaction and she was then assessed in the emergency bay area.  Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, skin changes, tongue swelling and vomiting.  Hx: pt has history of breast CA and is on oral chemotherapy.   ALLERGY REVIEW OF SYSTEMS: All other systems negative    Objective  Vitals Vitals:  01/06/21 1415 01/06/21 1427 01/06/21 1443 BP: (!) 168/89 (!) 154/94 (!) 154/84 Pulse: 87 85 72 SpO2: 99% 98% 99%  Physical Exam Vitals signs and nursing note reviewed. Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic. Right Ear: External ear normal. Left Ear: External ear normal. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal.    Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.  Pt was given Food and water and started to feel better. For her headache she was given Tylenol 1000 mg orally. Pt left clinic at 2:45 pm.    Electronically Signed 1/6/2021 2:44 PM  Â
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| 51 | 2021-01-05 | dizziness, headache |
c/o lightheadedness and light headache. Cold pack applied to nape of neck, head down, felt better an...
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c/o lightheadedness and light headache. Cold pack applied to nape of neck, head down, felt better and returned to work Narrative: c/o lightheadedness and mild headache. resolved and returned to work
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| 51 | 2021-01-05 | fatigue, headache, cold sweat |
caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vacc...
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caller couldn't hear properly; got the Covid vaccine last 18Dec2020/her second dose of COVID-19 Vaccine was scheduled on 06Jan2021; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020; Nausea; Headache; Body aches; fatigue; Cold sweat; This is a spontaneous report from a contactable other health professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number reported as either EK5730, ER5730, or EX5730), via an unspecified route of administration on 18Dec2020 16:00 at single dose at left deltoid for COVID-19 immunisation. Medical history and concomitant medications were none. The patient previously had shingles shot in Sep2020, previous shingles shot either three months or six months prior to the one in Sep2020 (2020), both for immunization, and severe myalgia and fever that lasted for two days after the second shingles shot (adverse events followed prior vaccinations). It was reported that did a callback as caller couldn't hear properly. Caller got the Covid vaccine last 18Dec2020 and was tested positive, 29Dec2020. Want to know if it's safe for her to get the second dose. The patient received Pfizer COVID-19 Vaccine on 18Dec2020 at 16:00. Patient had a couple days worth of symptoms. Now patient had COVID. Patient believed most likely got COVID from her son who was home from college. She was in between dosages of COVID-19 Vaccine. Looked like from research her quarantine would be done on 05Jan2021 and her second dose of COVID-19 Vaccine was scheduled on 06Jan2021. Everything she had read stated if her symptoms were gone to go ahead and get the second COVID-19 Vaccine. Patient wanted to know if Pfizer was doing any studies regarding people who test positive for COVID after receiving the COVID-19 Vaccine. Not sure if Pfizer would be interested in doing antibody studies. Declined obtained COVID-19 Vaccine through work Clarified caller's days worth of symptoms as: Headache the same evening as vaccination. Body Aches: began overnight on 18Dec2020. Fatigue that lasted all week, began overnight on 18Dec2020. Cold sweats: Lasted two days and began overnight on 18Dec2020. Nausea: began on 21Dec2020, not sure if it was related to COVID-19 Vaccine or not. The reporter considered the events weren't serious, but felt like she was having an immunological response. Diagnosed with COVID Seriousness: As of now, not serious. Is having a recurrence of all of those same symptoms as the COVID-19 Vaccine and then some. Lot number provided from patient card. Stated she was unable read it accurately. would take picture in case Pfizer wanted it. Stated lot number was either EK5730, ER5730, or EX5730. A sample of the product was not available to be returned. Vaccination facility type was Hospital, not administered at military site. No additional vaccines administered on same date of Pfizer suspect. No adverse events required a visit to. No prior vaccinations received within 4 weeks. The outcome of the event "Cold sweat" was recovered on 20Dec2020. The outcome of the other events was unknown. The reported considered the events Headache, Body aches, fatigue, Cold sweat, Nausea were related to the suspect drugs. Information on the lot/batch number has been requested.; Sender's Comments: The reported COVID test positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
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| 51 | 2021-01-05 | dizziness, malaise, influenza like illness, fatigue, weakness, cough |
felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling ...
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felt like she had the flu/ kind of like flu symptoms; dry cough; stated that her arm hurt; tingling going down arm/ tingling down to her fingers; A little nausea/nauseated; real tired/ exhausted; muscle aches, just achy feeling; a little dizzy; sinus congestion; feel bad enough; didn't have enough energy; swollen lymph node; its like a little bitty lump in her throat; lymph node's a little bit tender; stated that her head feels congested almost like sinus pressure; stated that her head feels congested almost like sinus pressure; This is a spontaneous report from a contactable nurse reported for self. This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an 29Dec2020 15:15 at single dose for covid-19 immunisation. Medical history included migraine, stated that the pressure triggers migraines and she was not going there. Concomitant medications were not provided. Past drug history included stated she took Excedrin migraine because she has history of migraines. She stated it felt like she had the flu, didn't have a temperature and never had a temperature. The first symptom was a dry cough and arm hurt so bad it was tingling going down arm/ tingling down to her fingers and now it felt much better and was able to move. A little nausea/ nauseated, kind of like flu symptoms, was real tired/ exhausted, muscle aches, just achy feeling. She was going to get up and go to work but felt the same symptoms but a little dizzy. Right now, she was feeling a little better but she had this like sinus congestion and the dry cough. She felt bad enough and didn't have enough energy to attend her aunts funeral and was fine yesterday. She also had a little bit of a swollen lymph node. She was not having difficulty breathing or anything like that. She was trying to eat something and its like a little bitty lump in her throat and her lymph node's a little bit tender." She stated she was starting to feel tired. Stated right now head feels congested almost like sinus pressure. Stated she does not have a headache. Stated that she does not have a temperature. Stated that she feels like crap. Stated that she called the nurse at the hospital and she stated that with the vaccination some people are testing positive for Covid. Stated that she was told that if she was having symptoms that she should go get a Covid test. Wanted to know if she should get a Covid test. Wanted to know if she should get the rapid test or 3 day. Outcome of the events felt like she had the flu/ kind of like flu symptoms, dry cough, arm hurt, tingling going down arm/ tingling down to her fingers, nausea, real tired/ exhausted, muscle aches, just achy feeling, a little dizzy, was recovering. Outcome of the event sinus congestion, feel bad enough, didn't have enough energy, swollen lymph node, its like a little bitty lump in my throat, lymph node's a little bit tender, her head feels congested almost like sinus pressure was unknown. Information on the Lot/batch number has been requested.
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| 51 | 2021-01-05 | dizziness | lightheadedness, spontaneous resolution |
| 51 | 2021-01-06 | dizziness, chills |
AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. ...
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AT 7:45 AM ON SATURDAY, 01/02/2021, I STARTED HAVING DIZZINESS, LIGHT-HEADEDNESS, AND PALPITATIONS. THE MORNING OF 01/05/2021, I DEVELOPED CHILLS WITHOUT FEVER. WENT TO MY FAMILY PRACTICE, LIFETIME MEDICINE, AND WAS SEEN BY NIDA ARIF, PA FOR ABOVE PERSISTING SYMPTOMS. AN EKG WAS DONE IN THE OFFICE RESULTING IN NORMAL SINUS RHYTHM. AS OF 01/06/2021, CHILLS, DIZZINESS AND LIGHT-HEADEDNESS RESOLVED. PALPITATIONS CONTINUE TO PERSIST AS OF 01/07/2021 WHEN THIS REPORT WAS FILLED OUT AND SUBMITTED.
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| 51 | 2021-01-06 | sweating, dizziness |
Dizziness Narrative: Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration ...
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Dizziness Narrative: Pt received the vaccine at 9:28am. Approx 15-24 mins after the administration began to feel lightheaded, sweaty and flushed. Pt states this is not uncommon for her, has history of this after shots and occurs spontaneously throughout the day. Pt's face was flushed but did not develop any tongue or lip swelling, denied sob or respiratory difficulty. On exam op clear, no swelling to lips, tongue, no stridor, lungs cta bil, no wheezing, cor rrr s1s2 no m/g/r, abd soft nontender, ext no c/c/e, left upper ext injection site without redness or swelling. Vital signs were T 97.5, bp 154/97 p 95, o2 sat 97%, bp 146/80, p98, 100% 148/05 p 102 99%, 163/92 p83 o2 99%. Pt was observed for the next approx. 15-20 mins, given water and improved. Walked around the clinic with the pt who felt comfortable to be discharged. She was instructed to monitor her symptoms, follow up with her primary md regarding pretreatment prior to second vaccine and to go straight to the ED if her symptoms progress or worsen. Pt understood and agreed with instructions. Pt works in the facility and will be around medical personnel until 8pm.
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| 51 | 2021-01-06 | chills, headache, fever | Fever, severe chills, headache |
| 51 | 2021-01-06 | throat pain, fatigue | Had body aches and fatigue for 4 days. Sore throat developed after second day. |
| 51 | 2021-01-06 | headache, fever, migraine, fatigue |
Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That nig...
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Headache, Fever, fatigue, muscle spasms 12/29 received the vaccine. Woke up tired on 12/30. That night woke up with muscle spasms all over her body and took her temp which was 101. The muscle spasms stopped at 0300 on 12/31. After that she developed a migraine. Headache last 22 hours and then just went away. She was tired the following day 1/1. All symptoms resolved on 1/2. She received the first vaccine in the ED and is scheduled to receive the second one in the ED as well. She has h/o anaphylaxis to food and bugs.
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| 51 | 2021-01-06 | fever, headache | Headache, Myalgia, Fever, Rash & Urticaria Pruritus |
| 51 | 2021-01-06 | nasal congestion, fever, malaise, fatigue |
I woke in the morning with nasal congestion. Around 0800 I started with fatigue and malaise. At 1000...
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I woke in the morning with nasal congestion. Around 0800 I started with fatigue and malaise. At 1000 I had a temperature of 100.4, took Tylenol 500 mg, and laid down. I got up an hour later feeling fine. Around 1600 hours I felt malaise again and warm. I checked my temperature and it was 100.2. I took Tylenol 500 mg again. I went to bed at 2030 and woke Friday morning feeling completely normal. All of the symptoms had resolved.
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| 51 | 2021-01-06 | headache, fatigue |
Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walkin...
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Patient experience severe headache, welts, nausea, extreme fatigue, and reported feeling like walking on broken bones. All over body pain.
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| 51 | 2021-01-06 | fever, cough, shortness of breath |
Patient had her first dose of Pfizer covid 19 vaccine. She was observed for 30 minutes, 15 minutes ...
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Patient had her first dose of Pfizer covid 19 vaccine. She was observed for 30 minutes, 15 minutes longer than normal as a precaution, due to her allergies. Patient continued to moniter her oxygenation saturation and did not report a drop in oxygen saturation, however, she reported a funny feeling in her throat, difficulty swallowing and shortness of breath. She was escorted to the emergency department via wheelchair for further observation and treatment.
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| 51 | 2021-01-06 | fatigue, headache |
Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/20...
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Patient started experiencing extreme fatigue and headache on 1/6/2021. She arrived at work on 1/7/2021 and was experiencing extreme fatigue, severe headache, welts, naussea, and feeling of walking on broken bones. Patient was advised to go home from work.
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| 51 | 2021-01-06 | throat swelling |
Pfizer-BioNTech COVID-19 Vaccine EUA swelling in throat approximately 30 minutes after injection. T...
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Pfizer-BioNTech COVID-19 Vaccine EUA swelling in throat approximately 30 minutes after injection. Took oral Benadryl 50mg and symptoms began to subside about 15-20 minutes later with full resolution in about 1 hour.
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| 51 | 2021-01-06 | chills | chills and severe body aches |
| 51 | 2021-01-06 | fever | fever 102F aches |
| 51 | 2021-01-06 | sweating, chills, headache |
had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had ...
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had, headache, body aches, chills ,GI upset, heartburn, sweats the next day. then 2 days later had loose stools, day 3 swollen lymph nodes in my next. day 4 rash on my back that was red, itched, burned . went away about 12 hours after they came.
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| 51 | 2021-01-07 | nasal congestion, shortness of breath |
Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl an...
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Facial swelling, shortness of breath, nasal stuffiness, tachycardia >150, IV solumedrol, Benadryl and Pepcid Relief in symptoms upon discharge at 2330
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| 51 | 2021-01-07 | cough, fever, fatigue, chills |
Fever >101, rigor, chills, 15 hours post administration Cough from 6-18 hours post administration Fa...
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Fever >101, rigor, chills, 15 hours post administration Cough from 6-18 hours post administration Fatigue from 6 - 20 hours post administration Muscle aches from 15 - 36 hours post administration Joint pain from 24 - 36 hours post administration
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| 51 | 2021-01-07 | fever, headache | Fever and body aches 12 hours after vaccine. Fever 104.1 during the night, body aches, headache |
| 51 | 2021-01-07 | fatigue, headache |
Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous rep...
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Headache; nausea; tiredness; site injection swelling; site injection pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 28Dec2020 at 14:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Dec2020, the patient experienced headache, nausea, tiredness, injection site swelling and injection site pain. Treatment was not received for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events headache, nausea, tiredness, injection site swelling, and injection site pain were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 51 | 2021-01-07 | fatigue, sweating, shortness of breath |
Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild...
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Muscle pain; Shortness of breath; Tiredness; Nausea; Sweating; Mild soreness at infection site; Mild soreness at infection site; This is a Spontaneous report from a contactable Other HCP (patient). A 51-year-old female patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number=EH9899), on 30Dec2020 12:00 PM, Intramuscularly at single dose (first dose), (vaccine location=Left arm) for COVID-19 immunization. Medical history included Covid; Hypertension; Diabetes Type 2. Concomitant medications were not reported. Patient was no Known allergies. Patient experienced Muscle pain, shortness of breath, tiredness, nausea, sweating, mild soreness at infection site on 02Jan2021 09:00 AM. Patient did not receive any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was not recovered. This case was assessed non-serious by reporter. And the events did not result in Death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
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| 51 | 2021-01-07 | chills | Myalgias and chills |
| 51 | 2021-01-07 | headache, fever, chills |
On January 5,2021, developed chills, muscle ache, headache, joint pain ,fever and left arm pain. Tak...
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On January 5,2021, developed chills, muscle ache, headache, joint pain ,fever and left arm pain. Taken Acetaminophen
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| 51 | 2021-01-07 | weakness, fever |
Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches ...
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Patient received second Pfizer vaccine on 1.5.21. On 1.7.21 at 2:40pm the patient experienced aches and weakness that evening, took tylenol with relief. 1/8/21 patient woke up in the middle of the night with fever, blister on the inside of her lip, and her right cheek twitching. 1/8/21 patient went to PCP to be checked out. Discovered redness and bruising at the injection site. Patient has had relief with tylenol and zyrtec.
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| 51 | 2021-01-07 | shortness of breath |
Patient received vaccine at 13:30. She started feeling anxious after receiving vaccine but went back...
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Patient received vaccine at 13:30. She started feeling anxious after receiving vaccine but went back to work. Patient received 50 mg of diphenhydramine at 14:30, she then started experiencing hives and shortness of breath. She was administer 0.3 mg of epinephrine into the thigh and EMS was called.
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| 51 | 2021-01-07 | chills, headache |
Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache,...
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Soreness in left arm at injection site similar to receiving flu vaccine. On 1/7/21 I had a headache, stiff/achy neck and shoulders and some chills. Upon waking on 1/8/21 my left armpit is sore and swollen.
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| 51 | 2021-01-07 | fatigue |
Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achine...
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Tinnitus, generalized fatigue, muscle- specifically mid back, achiness, neck muscle/trapezius achiness, soreness at injection site
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| 51 | 2021-01-07 | fatigue, chills, dizziness, headache |
Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s. Also, hea...
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Today at about 10:20 am began feeling lightheaded, dizzy, with palpitations, HR 100-120s. Also, headache, mild muscle aches, chills. After about 2 hours, did not improve therefore was directed to the ED. EKG was normal. CBC, CMP, TFTs all normal. Was monitored for a couple hours and HR improved. At home it took until 17:40 for HR to consistently be 100 or less.. still feel fatigued, headache, and achy.
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| 51 | 2021-01-07 | headache | headache, body aches, & joint pain |
| 51 | 2021-01-08 | headache, fatigue | Fatigue sudden. Headache. Took tylenol every 4 to 6 hours. |
| 51 | 2021-01-08 | shortness of breath, dizziness | Hypotension 90/60 experienced; Dizziness; almost passed out; rapid heart beat and unable to breath |
| 51 | 2021-01-08 | shortness of breath | Patient developed tachycardia, vomited and trouble breathing |
| 51 | 2021-01-08 | dizziness |
Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "differ...
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Within five minutes after the vaccine administration the pt reported R arm tingling, feeling "different" and spotty non-confluent erythema and pruritis over affected arm, upper chest, posterior neck. She reported feeling faint and began to have mild hyperventilation. Vital signs remained stable and WNL, lungs were clear with good air movement and there was no mucosal involvement. Pt was treated with PO bendryl. Over the course of 45 minutes her rash faded and her sense of pruritis also lessened. She was able to return to work with no further symptoms
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| 51 | 2021-01-08 | dizziness | c/o dizziness, near-syncope 10 minutes post-vaccination |
| 51 | 2021-01-09 | fatigue, migraine |
1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and...
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1. Migraine headache that will not go away with Ibuprofen. 2. Body aches 3. Fatigue 4. Numbness and tingling in the arm the vaccine was administered in
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| 51 | 2021-01-09 | shortness of breath, malaise, headache |
1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 13...
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1/7/2021 at 1230 I began experiencing SOB, assumed it was asthma, 2 puffs of albuterol taken. At 1330 still SOB with chest pressure/tightness, no change, no cough, no feeling appropriate, 2 puffs albuterol. At 1415 reported to the vaccination clinic and told them of symptoms, SOB with movement, and general pressure in the chest. 2 Tylenol taken. I was required to check into the ER for Observation. oxygen saturation checked for 2 hours. no change in symptoms, no worsening. I then left work in the ER and went home. At approx. 1800 ate dinner, no real taste, but needed to eat. At 1830 showered, 2000 to bed, just feeling malaise. continued pressure in the chest and general soreness. 2 Tylenol Through the night I slept very poorly, tossed and turned, woke frequently. Body and joints with extreme pain everywhere it touched the mattress. I have a screw in my left foot, it felt like it was on fire at some point during the night. My left leg ached up into my hip. On the morning of January 8, woke approx 0800 with a temperature of 99.9, pain in all my joints, back and up into neck, headache, and nausea. Took 2 Tylenol, 3 ibuprofen, and 4 mg Zofran. 1200 symptoms began to lessen and felt like I had the flu, still sore, but less severe. 1300 - 2 Tylenol Slept better, just sore January 8 night. January 9 - 2 Tylenol in the morning, sore everywhere, right arm site sore, headache, eye pain, intermittent nausea. 2 more tylenol around 1800 January 10, 2 tylenol 0900, remain sore but lessening, headache and eye pain continues, intermittent nausea
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| 51 | 2021-01-09 | chills, malaise, headache, fatigue, fever |
1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever ...
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1st vaccine dec 18th : arm pain for 3 days , felt sick within 2 hours with headache and fever and chills temp at that time 100 degrees , : fever 100 to 101 degrees on day 1 , 2 , 3 , 100 degrees on day 4 , day 5 , myalgia , body aches and headaches daily week 1 and fatigue week 2 was bed bound for 2 days and then could not work for 3 days after that 2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
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| 51 | 2021-01-09 | fever, headache, chills |
2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tin...
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2nd vaccine om 1/8/21 : left arm pain within 5 to 10 mins of injection with burning , pain and tingling , headache and feverish feeling and chills started within 2 hours , severe myalgia and body ache and headache day 1 and day 2 , on round the clock tyelenol every 6 hours , temp max recorded 100.6
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| 51 | 2021-01-09 | headache |
4 Raised bumps around injection site, in the shape of a ring around the site. Mild itching at site. ...
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4 Raised bumps around injection site, in the shape of a ring around the site. Mild itching at site. No redness Headache
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| 51 | 2021-01-09 | headache, shortness of breath |
Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left b...
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Allergic reaction 10 minutes after injection. High BP 171/110, chest tightness, eye swelling, left back of shoulder, neck, face pain , moderate severe headache. SOB.
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| 51 | 2021-01-09 | fever, fatigue, chills |
Low grade fever 100.2, severe body aches, fatigue, started around 8:00 pm 1/7/21, worsened throughou...
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Low grade fever 100.2, severe body aches, fatigue, started around 8:00 pm 1/7/21, worsened throughout the night. Intense fatigue and body aches continued throughout 1/8/21. 1/9/2021, Fatigue , intermittent chills subside.,mild generalized body aches continue.
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| 51 | 2021-01-09 | headache |
Lymph nodes along left neck swollen, soreness bilateral arm pits, and soreness at symphysis pubis ar...
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Lymph nodes along left neck swollen, soreness bilateral arm pits, and soreness at symphysis pubis area. General headache.
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| 51 | 2021-01-09 | fatigue |
Pfizer-BioNTech COVID-19 Vaccine EUA I woke on the 18th with extreme fatigue and nausea, fell asleep...
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Pfizer-BioNTech COVID-19 Vaccine EUA I woke on the 18th with extreme fatigue and nausea, fell asleep twice during the day while sitting on the couch. Lessened and became just tired by Sunday Dec 19.
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| 51 | 2021-01-09 | migraine |
Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm...
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Severe migraine 24 hours after the second vaccine Very swollen lymph nodes in the arm pit of the arm that received vaccine
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| 51 | 2021-01-09 | headache |
Tachycardia almost immediately after injection 100-110s. Slight tightness of chest, but I was tryin...
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Tachycardia almost immediately after injection 100-110s. Slight tightness of chest, but I was trying not to panic. Tachycardia increased to 130s for 2 minutes then came down to 100s, BP 140/86, a little nausea and slight headache. Better at 4:45 thought I was good to leave. Then BP spiked to 180/110s, HR 136, transported to ER for monitoring. Tachycardia and HTN would continue to cycling elevate over next 2hours before being discharged with HR of 100s and BP 150/86
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| 51 | 2021-01-10 | headache, chills, fever, headache, fever, chills |
12/19-Chills at 1000, Body aches and headache at 1230, fever 101.5. Pt reported fever increased to ...
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12/19-Chills at 1000, Body aches and headache at 1230, fever 101.5. Pt reported fever increased to 106 at which time she went to the ER. ER reports fever on arrival of 100.8. IV Zofran and IVF admin in ER and d/c. F/u 12/20 1130-pt improved and at home.
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| 51 | 2021-01-10 | chills, fever |
36 hours of intense pain all over , fever , rigors, visible swelling of joints , swollen lymph node ...
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36 hours of intense pain all over , fever , rigors, visible swelling of joints , swollen lymph node in armpit of left arm
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| 51 | 2021-01-10 | fever, headache, fatigue |
Body aches. Headache. Extreme fatigue. Shot site pain. Fever 100.4 All continued overnight. In a.m....
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Body aches. Headache. Extreme fatigue. Shot site pain. Fever 100.4 All continued overnight. In a.m. next day all continued except fever, down to 98 - 99. Pain in my arm is worse, not able to use arm much.
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| 51 | 2021-01-10 | cough, chills, fatigue, headache, malaise, nasal congestion |
Chills; Headache; Coughing; Tiredness; Nasal congested; Feels like her sinus were blocked; Body ache...
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Chills; Headache; Coughing; Tiredness; Nasal congested; Feels like her sinus were blocked; Body ache; feeling sick; Sneezing; This is a spontaneous report from a contactable nurse (patient, front line health care worker). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EH9899) via an unspecified route of administration in the left arm on 28Dec2020 (at 10:30 or 11:00 AM) at single dose for COVID-19 immunization. Medical history included hypertension, diabetes, and stroke, all reported as family history (her parent). There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer suspect. The patient did not have prior vaccinations within 4 weeks. The patient had body ache (reported as medically significant) on 01Jan2021 with outcome of recovering, had been sick for a week/ very ill on 28Dec2020 with outcome of unknown, sneezing on 28Dec2020 with outcome of not recovered, chills on 01Jan2021 with outcome of unknown, headache on 01Jan2021 with outcome of recovering, coughing on 01Jan2021 with outcome of not recovered, tiredness on 01Jan2021 with outcome of unknown, nasal congested on 01Jan2021 with outcome of not recovered, feels like her sinus were blocked on 01Jan2021 with outcome of unknown. Treatment was received for the events. Reported she had a lot of sickness, by evening that day (28Dec2020) she got sneezing and feeling sick. Then the next day was the same, then the third day. She became very ill with chills, body ache, headache, coughing, and tiredness on 01Jan2021 (also reported as 3 days later vaccination). And she had no fever, but stated she had been sick for a week. Added the headache and body ache were a little better but still she felt so congested. Clarified she had nasal congested that feels like her sinus were blocked. She treated herself with acetaminophen, once daily 500 mg by mouth starting 01Jan2021. Added the body ache pain was still on the back of her chest but her legs and arms were better. She used steam inhalation for the congestion. She was not scheduled for the next dose yet, she was just waiting. The patient was wondering if she should do a test for COVID 19. Mentioned she had been healthy all through this year and digging in the COVID 19 all the time but then after the vaccine she got so sick. This was the first day she could get up and did anything. Advised caller to consult her HCP.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the body ache. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-10 | headache, dizziness, fatigue | DIZZINESS, HEADACHE AND TOTAL EXHAUSTION FOR 2 DAYS. |
| 51 | 2021-01-10 | headache, dizziness | Dizzy, Headache, unsteady on feet, chest feels heavy, nauseated |
| 51 | 2021-01-10 | headache, dizziness |
Felt immediately dizzy, lasted several hours, somewhat nauseous and slight headache now 9 hours late...
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Felt immediately dizzy, lasted several hours, somewhat nauseous and slight headache now 9 hours later and still currently active with these symptoms.
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| 51 | 2021-01-10 | headache |
Had muscles aches headache and some neck pain 15 mins after vaccination. Patient is still currently ...
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Had muscles aches headache and some neck pain 15 mins after vaccination. Patient is still currently having these symptoms. Headaches and body aches have worsened.
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| 51 | 2021-01-10 | chills, headache, fatigue, sweating |
I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction...
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I am a health care professional and received my first vaccine 12/17/20. I had the my first reaction on 12/19/20. Horrible fatigue, body aches. My second dose was given on 1/7/21. After 6 hours, I felt myalgias, arthralgias, skin sensitivity to anything that touched me. Severe fatigue and headache. Took Tylenol with no relief. The worst day hit at 1/8/21 at 3:00 a.m. I could not move without extreme pain. Sweating and chills. No appetite. Had to be assisted to toilet. Tried to go into hospital to do vaccine clinic today, 1/11/21 and had to return home as I was extremely fatigued and excessive sweating.
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| 51 | 2021-01-10 | dizziness, chills, fatigue, headache, fever |
On dec 29 I began fever, chills and bad headache. Tested negative for covid and flu. Also fatigue. ...
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On dec 29 I began fever, chills and bad headache. Tested negative for covid and flu. Also fatigue. Then dizzy and just didn?t feel good. Tested negative again on January 4. But still dizzy and fatigue.
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| 51 | 2021-01-10 | throat irritation |
Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms ...
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Received dose 2hours post dose, itching throat, ears. facial swelling. Bendryl 50mg taken. Symptoms continued for the day of shot and day after shot. Day 2 additional Bendryl total 200mg taken before relief of symptoms. My PCP is aware of reaction and will place allergy on chart.
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| 51 | 2021-01-10 | shortness of breath |
Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Ac...
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Shortness of breath Arm pain Lump under left arm pit Pain goes across chest and down arm No fever Achy all over Left arm down to fingers and up the arm and across the chest to swollen arm under arm pit is in pain
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| 51 | 2021-01-10 | fatigue, fever, headache, chills |
Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sle...
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Started having chills at 11pm, took tylenol 650mg. However, the symptoms not relieved, could not sleep the whole night. fever went up to 101F. Also feeling extreme fatigue, not able to get up from the bed, took another dose 1000mg tylenol, completely lost appetite, body ache. Low grade ever lasted up to 1/8/21. Even now still feeling fatigue and frequent headache. The injection site felt fine two days following injection. But started feeling inlamed and painful on 1/8/21. On 1/9/21, the pain of the site expanded towards the armpit and left upper shoulder and back.
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| 51 | 2021-01-10 | fever | Tmax of 102.3 at hour 18, fever x 24 hours. |
| 51 | 2021-01-10 | chills, headache |
Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience seve...
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Vaccine recipient reported that in the afternoon after receiving their vaccine, they experience severe headache and nausea. They also developed chills, body ache, and arm pain at night. On a follow up call on 1/11/2021, they reported that their symptoms resolved on 1/8/2021.
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| 51 | 2021-01-11 | fatigue |
10 hours later after received vaccine developed Left arm pain . During the night wake up due to seve...
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10 hours later after received vaccine developed Left arm pain . During the night wake up due to severe left axillary pain irradiated to left scapula, left breast, also has adenopathy, bone ache and fatigue. Taken acetaminophen
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| 51 | 2021-01-11 | chills, fever | Body aches, chills, fever |
| 51 | 2021-01-11 | fever |
Body aches, fever of 100.9 the morning after the vaccination. Took one Naprosyn and about an hour l...
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Body aches, fever of 100.9 the morning after the vaccination. Took one Naprosyn and about an hour later (~1:00pm ) symptoms completely resolved.
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| 51 | 2021-01-11 | chills |
COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/...
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COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; COVID-19/Caller received the first dose of the vaccine and she tested positive with Covid; arm pain; she felt like crap the night; chills; This is a spontaneous report from a contactable pharmacist (patient). A 51-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899, expiration date Mar2021), intramuscular on left arm, on 18Dec2020 at 0.3 mL, a single dose for vaccination. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she tested positive with Covid. She received the Pfizer Covid vaccine on 18Dec2020. She was exposed to the virus through close personal contact right around this same time-frame and did develop the virus herself. She wanted to know if there were any recommendations regarding her needing to get the second dose in series. She stated that her husband, who was not vaccinated, had the virus and developed more serious symptoms than she did. She is concerned about worsening side effects with the second dose and stated that she felt like crap the night after her first dose with chills and arm pain. The patient tested positive for COVID-19 on 26Dec2020. Specific test name was unknown, but she knows it was not a rapid test. She is scheduled to get the second dose of the Pfizer COVID-19 Vaccine on 08Jan2021. She called to ask if she should or should not get the second dose relative to the COVID-19 diagnosis. She has not been able to find the information she is asking about. The outcome of the event of Covid-19 was recovering while other events was unknown. The Covid-19 was assessed as unrelated to the suspect drug.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment. COVID-19 antigen test positive.
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| 51 | 2021-01-11 | headache |
Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Sy...
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Developed pain, redness and swelling (injection site) about 8-9 hrs. after receiving the vaccine. Symptoms increased day 2 with swelling as big as a lemon fruit. Day 3 - aside from pain & swelling at the injection site, I developed Left axillary lymphadenopathy. Day 4 - severe headache lip numbness & body ache Took Ibuprofen 400 mg each day
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| 51 | 2021-01-11 | headache, chills, fatigue | Extreme chills lasted approx 6 hrs. Muscle & joint pain, fatigue, headache lasting approx. 36hrs. |
| 51 | 2021-01-11 | fatigue, malaise, chills, dizziness |
Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pai...
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Fatigue; Dizziness, Light-headed; nausea; diarrhea; swelling of face; muscle pain; chills; joint pain; Overall feeling of unwell; This is a spontaneous report from a non-contactable other HCP (patient). A 51-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on 31Dec2020 at single dose on arm right for COVID-19 immunisation. Medical history included fibromyalgia and known allergies: Rose hip tea and Diclofenac. No COVID prior vaccination. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included zolpidem tartrate (AMBIEN) and duloxetine hydrochloride (CYMBALTA). The patient experienced fatigue, dizziness, light-headed, nausea, diarrhea, swelling of face, muscle pain, chills, joint pain, overall feeling of unwell; all on 01Jan2021. No treatment received for the events. Outcome of events was not recovered. Since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-01-11 | chills, headache, fever |
Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness ...
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Fever/temperature 99.9-100.2/feverish/They were not high readings; rigors/chills; Achiness/achiness all over; Neck is also really sore; head hurt/headache was in the occipital area; mild pain at the injection site; Her whole arm is swollen and sore/Sore upper arm/arm achy; Her whole arm is swollen and sore/Sore upper arm; whole arm felt warm/warm to the touch; This is a spontaneous report from a contactable Nurse(patient). A 51-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization(reported as for work). She worked in the hospital. She just got it at work. She didn't have a prescribing doctor. Her first dose was 3 weeks before today. Her first vaccine was a Pfizer vaccine with lot:13551. She got the 2nd dose 20 days later. She got the second dose on 05Jan2021. Medical history and concomitant medications reported as none. Also reported she did have other medical conditions, but she got the go ahead to get the vaccine from her rheumatologist. Patient received her second dose of vaccine 05Jan2021 and was experiencing fever, chills, achiness during the night last night on 06Jan2021. She was asking if she was experiencing adverse events or Sars-COV-2 symptoms. At first, she had mild pain at the injection site, but then in the middle of the night, her whole upper arm became sore and swollen. Not just at the injection site. Onset date of sore upper arm was 05Jan2021. She developed rigors/chills. She had achiness all over. She checked her temperature a half an hour to 45 min ago, and it was 99.9-100.2. She usually runs 96-97. It was around 3-4 am that she felt chilled, but not feverish. She was just chilled/ had rigors. It was a couple hours later at 7 am that she felt feverish. They were not high readings. In the past 10 minutes, her head had started to hurt. Her neck was also really sore. Her headache was in the occipital area. It had only been 10 mins that this had came on, and it was about the same. It really hurt. Onset date of headache/ neck pain was 06Jan2021. Her whole arm was swollen and sore. It was warm to the touch. Her whole arm felt warm and achy. She had used an ice pack, and it did help some. She was assuming this was just an expected immune response. She just didn't want to put anyone at risk. She was always very careful. She mostly worked from home, but she was in the office yesterday with two masks and a face shield. She also used a lot of spray and hand sanitizer. The outcome of events fever, achiness, "Her whole arm is swollen and sore/Sore upper arm/arm achy" and headache, neck pain was not recovered, of chills was recovered in Jan2021, of other events was unknown. Sore upper arm was reported as worsened.
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| 51 | 2021-01-11 | headache, fatigue |
Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left ...
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Headaches, body aches, pain at injection site (left arm sore) and exhaustion. lymph nodes in left armpit became swollen and painful to the touch starting on 1/8/21 until 1/11/21.
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| 51 | 2021-01-11 | dizziness | Nausea, body aches, dizziness, mouth/tooth pain |
| 51 | 2021-01-11 | headache |
Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pa...
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Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pain alternating down left arm, right leg, and across chest and head
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| 51 | 2021-01-11 | shortness of breath, migraine |
Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; S...
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Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Vaccination site cellulitis, shortness of breath, stridor and migraine, due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | headache, fever |
Vaccine 2 only: severe arm pain began 2 hours after shot. Within 8 hours I had severe pain all over...
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Vaccine 2 only: severe arm pain began 2 hours after shot. Within 8 hours I had severe pain all over my body and fever 103F. Still have severe headache 36 hours late and fever 100F.
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| 51 | 2021-01-11 | dizziness, headache |
achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactab...
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achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, expiration date: Mar2021), via an unspecified route of administration at the left arm on 05Jan2021 12:10 at a single dose for COVID-19 immunization in the hospital. The patient has not had any vaccines in four weeks. The patient has no medical history. There were no concomitant medications. The patient received the COVID vaccine on 05Jan2021 and confirmed that it was the first dose she received of the COVID vaccine. She clarified that she started to have dizziness, disorientation, nausea, achiness and headache. The dizziness, disorientation and nausea started about 8 hours after she received the vaccine, 05Jan2021 20:10. She stated that she was just trying to push through with the side effects. She woke up in the morning, 06Jan2021, feeling both achy and with a headache. She stated that she had the achiness that was regular and knew would normally come along with it. However, she also had a headache. The outcome of the events was not recovered.
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| 51 | 2021-01-11 | cough, chills, headache, fever, dizziness, throat pain |
anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry...
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anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-01-11 | fatigue |
body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contacta...
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body aches (just legs ache); very mild sore arm; fatigue; This is a spontaneous report from contactable nurse (patient) from a Pfizer-sponsored program. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 28Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included possible exposure to COVID-19 patient on 22Dec2020 to 23Dec2020 (patient's patient tested positive on 24Dec2020 and saw the patient on 22Dec2020 and 23Dec2020). The patient's concomitant medications were not reported. The patient experienced fatigue on 28Dec2020, very mild sore arm on 29Dec2020, and body aches (just legs ache) on 02Jan2020. The clinical course was reported as: The patient felt fatigue on the day of vaccination and very mild sore arm the next day. The patient experienced body ache (just legs) on 02Jan2021, but it was less on 03Jan2021. The clinical outcome of fatigue and very mild sore arm was unknown and of body aches (just legs ache) was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
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| 51 | 2021-01-11 | discomfort |
erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round ar...
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erythematous swollen thick raised sores with vesicles; 2 swollen erythematous maculopapular round areas on the left side of neck; feel more inflamed; burning feeling to the touch; Is getting slightly painful; Discomfort; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 27Dec2020 05:30 at a single dose for COVID-19 immunization. Medical history included atopic dermatitis. Patient previously took DUPIXENT, last dose was 18Dec2020 (due to a lack of knowledge about DUPIXENT) and the COVID vaccine, patient have not taken next due dose of DUPIXANT on 01Jan2021). Patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 31Dec2020 02:00 (reported as day 4 after the injection), patient developed 2 swollen erythematous maculopapular round areas on the left side of neck that were sore and slightly have a burning sensation (not pins/needle) to the touch also described as 2 very large erythematous swollen thick raised sores with vesicles on the left side of neck. Patient showed photos to internist a couple days later when they did not go away. As of this reported, it was now day 10 and they are not bigger but they feel more inflamed and have more of a burning feeling to the touch. The small vesicle on each sore had disappeared. Patient stated she had a history of atopic dermatitis but looked and felt nothing like it. Initially had little vesicular areas in the center but the vesicles aren't there today. Discomfort remains. No associated fever or headache. Patient had read of zoster developing with COVID-19 infection, but not associated with the actual vaccine. She was asking if this might be a weird varicella zoster reaction to the vaccine and any data about this. This did not seem to be going away and was getting slightly painful (though so far tolerable) though does not seem to be spreading at this point. Outcome of the events was not recovered. No treatment was received for the events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information on the lot/batch number has been requested.
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| 51 | 2021-01-11 | malaise |
she does not feel well; This is a spontaneous report from a contactable consumer (patient). A 51-yea...
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she does not feel well; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EU9231), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient does not feel well on 06Jan2021. Outcome of the event was unknown.
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| 51 | 2021-01-11 | cough, fever, nasal congestion |
sneezing; coughing; congestion; fever; This is a spontaneous report from a contactable consumer (pat...
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sneezing; coughing; congestion; fever; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in left arm (triceps muscle) on 30Dec2020 10:30 at single dose for covid-19 immunization. Medical history included seasonal allergy from 1995 and ongoing, seasonal asthma from 1995 and ongoing. The patient had no concomitant medications. The patient experienced fever on 31Dec2020, congestion on 02Jan2021, sneezing and coughing on an unspecified date. Time the vaccination was given around 10:30 a.m, but she known she was okay to leave by 10:45 a.m. No additional administered vaccines. The adverse event was not required a visit to emergency room or physician office. Prior Vaccinations (within 4 weeks) was none. Relevant tests were none. Certified nursing assistant works in hospital where she cares for Covid patients. She received the vaccine on 30Dec2020 and by the next day, she had fever and congestion. The fever has gone away but she was still congested and was sneezing and coughing at home. The caller stated she was a CNA calling on behalf of herself in regard to the Pfizer COVID vaccination. She stated she received the vaccine on 30Dec2020. She had like a fever and everything over the weekend- starting Thursday night, Friday and then part of Saturday. She also had this congestion ever since she got the shot. The caller confirmed she received her first COVID vaccine on 30Dec2020. Late Thursday night, 31Dec2020, she woke up and had a fever. She had her husband check her temperature. She confirmed she recovered completely from the fever. She hadn't a fever since Saturday (02Jan2021), probably around 8pm. She didn't have a fever at all on Sunday. The congestion really didn't start until Saturday morning, 02Jan2021. She stated the congestion was still persisting at this point. Caller stated, " it honestly feels like a sinus infection" The caller was able to provide the Lot number off of her patient card. Caller made the comment the card also had the date she had to go back for her second vaccine. The patient underwent lab tests and procedures which included body temperature: recovered completely from the fever. The outcome of events for fever was resolved on 02Jan2021, for congestion was not resolved, for other events was unknown.
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| 51 | 2021-01-12 | cough, throat pain, headache, fatigue | 1/3/21 Sinus pressure, loss of smell, cough, SOA with exertion, HA, fatigue, sore throat, ear pain |
| 51 | 2021-01-12 | shortness of breath, cough, fatigue, headache, throat pain | 1/3/21 sinus pressure, loss of smell, cough, SOA with exertion, HA, fatigue, sore throat, ear pain |
| 51 | 2021-01-12 | chills, fatigue, respiratory tract congestion | 1/8/21 fatigue, chills, cough, congestion, diarrhea. 1/8/21 Dx'd with Acute viral syndrome |
| 51 | 2021-01-12 | influenza like illness, fatigue, malaise, dizziness, chills |
Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies;...
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Chills; Joints were sore; Left upper arm is sore; Nausea; Light-headed; Tired; allergies; allergies; Body was not feeling well, she felt like she was getting the flu; Body was not feeling well, she felt like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E10142), via an unspecified route of administration on left upper arm at 10:40 AM on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hip replacement from Aug2020 (Right hip replaced in Aug2020, she was a runner and this is due to wear and tear), allergies, family history included diabetes and high blood pressure. Concomitant medication included cetirizine hydrochloride (ZYRTEC). Additional Vaccines Administered on Same Date of the Pfizer Suspect: none. The patient previously received flu vaccine for immunization. The patient was having symptoms, nothing life threatening but she wanted to report them. Weight: 150lb-152lb. She was in healthcare but not a healthcare provider, she work in a outpatient clinic. Her first shot was on 05Jan2021. That day she experienced nausea and was light headed in the evening on 05Jan2021. She thought it was her allergies. She was really tired and went to bed really early that night. She got chills last night on 06Jan2021 and her body was not feeling well, she felt like she was getting the flu. Her joints were sore and her head started to hurt. The nausea, light headedness and tired feeling got worse last and she went to bed even earlier that night. She took her temperature this morning, she didn't take it last night as she knew she would get some symptoms from the shot, and she had no fever. Sometimes got light symptoms from the flu vaccine that she got every year, she had no product name, NDC, Lot, or Expiry for that product. When she woke up her head was still killing her but felt sickly. She went to work, she just thought she would power through it but she felt like she could go home and go right to sleep. The day of the shot she took a One a Day Women for 50 and over and a Zyrtec. Yesterday morning she took the Zyrtec but not the vitamin and she didn't take either this morning due to her stomach. She was told she should take Tylenol so maybe she would take that today. It was also noted that her left upper arm was sore where she got the shot on 05Jan2021, it had gotten better today. The outcome of events feeling unwell and flu-like illness was unknown. The outcome of event pain in arm was recovering, the outcome of rest events was not recovered.
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| 51 | 2021-01-12 | fever | Developed a fever of 100.0 |
| 51 | 2021-01-12 | headache |
Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to ...
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Employee received Dose 1 of COVID19 vaccine. Approx 30mins later employee complained of tingling to right toe, right jaw lock, and headache on right side 4/10 pain.
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| 51 | 2021-01-12 | skin warm |
Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 d...
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Extreme erythema covering entire abdomen. Painful, burning, and itchy. Hot to the touch. Lasting 6 days. Treated with steroid injection and Benadryl. Treatment started January 4, 2021.
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| 51 | 2021-01-12 | discomfort |
Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to ...
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Flushing of face and rash all over chest. Swelling to eyes, nausea, stabbing pain and heaviness to left neck and under arm, chest pressure, vomiting, and loose stools
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| 51 | 2021-01-12 | nasal congestion, throat pain, fatigue | I had what felt like a sinus infection, sore throat, stuffy nose, body aches and fatigue. |
| 51 | 2021-01-12 | chills, fatigue | Left arm pain, armpit pain, body aches, shaking chills, nausea, extreme tiredness |
| 51 | 2021-01-12 | shortness of breath |
Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt f...
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Pt received COVID vaccine on 12/27/2020 at 1421 and tolerated well. By 1700 that same day, pt felt flushed in her hands and face. She felt a little short of breath. She started to get fluid-filled blisters on bilateral palms. This is a milder form of the reaction pt has to flu vaccines (she was advised by PCP not to receive flu vaccines because of the blistering). Pt took diphenhyramine 25 mg PO x 1 and the fluid-filled blisters resolved within a few hours. 12/28 around 0330, pt awoke and felt like her right carotid was "pulsating." Pt drank water, did not go back to sleep. "Pulsating" resoved within an hour. No other symptoms develped. In the morning, pt called employee health RN who instructed her to contact PCP and report the reaction. Pt called PCP who advised pt not to get second dose of vaccine due to her reaction to COVID and the flu vaccines.
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| 51 | 2021-01-12 | body temperature increased, dizziness, malaise |
Received her 2nd Covid Vaccine from Pfizer on 1/7/2021. She stated that she developed side effects ...
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Received her 2nd Covid Vaccine from Pfizer on 1/7/2021. She stated that she developed side effects about 2am reporting elevated temp of 101, dizziness, muscle aches all over, nausea, and just didn't feel well. She states she developed a knot on her arm at injection site with redness and itching. She reports this knot was hard initially but next day was better. She reports these side effects lasted all weekend.
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| 51 | 2021-01-12 | throat irritation | Scratchy throat and metallic taste in mouth 10 min following injection |
| 51 | 2021-01-12 | headache |
Severe pain at site starting by 1800 01/11/2021. 01/12/2021 Severe pain at site kept me awake most t...
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Severe pain at site starting by 1800 01/11/2021. 01/12/2021 Severe pain at site kept me awake most the night, headache, nausea, joint pain starting at 0615 01/12/2021 which continued to get worse through out the day. Left work early 01/12/2021. Woke 01/13/2021 with slight headache still.
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| 51 | 2021-01-12 | body temperature increased, nasal congestion, chills, fatigue |
The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I ...
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The day after receiving the vaccine I woke up with slight soreness of the arm. At work at 10:00am I began to get fatigued chills overall body aches but was afebrile. I also had nasal congestion and sneezing for 4 hrs. that resolved. At 12 noon I felt progressively worse and had to leave work. I got home and my temp was 100.2 and took more Ibuprofen at 1 PM. At 2PM the body aches and chills were pretty severe- my temp rose to 103.2. I took more Ibuprofen and alternated with TYLENOL and it returned to normal at 10 PM. I notified my Drs office and had a telemedicine visit with Dr at 4PM who thought it was a normal immune response but suggested getting a COVID Test in the meantime before returning to work. I woke up this morning afebrile with no issues notified employee health got a referral and had my COVID test completed at 09:30am. The urgent care MD strongly urged me to report to VAERS, not just CDC as I had yesterday. My COVID tests are still pending.
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| 51 | 2021-01-12 | fever | developed a fever no other symptoms |
| 51 | 2021-01-12 | fever | developed a fever of 100.0 |
| 51 | 2021-01-12 | dizziness, headache |
dizziness; flushing; HA (Headache); This is a spontaneous report from a non-contactable healthcare p...
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dizziness; flushing; HA (Headache); This is a spontaneous report from a non-contactable healthcare professional. A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, then the second dose (lot number: EK9231, expiry date not reported) via intramuscular route of administration the left deltoid muscle on 06Jan202, both at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience dizziness, flushing and HA (headache). She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, and lightheadedness. No therapy/ treatment was given. Events were non-serious. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 51 | 2021-01-12 | dizziness, headache |
gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a co...
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gut wrenching nausea; stomach ache; flushed; dizzy; Headache; This is a spontaneous report from a contactable other HCP(patient). A 51 years old female patient received first dose BNT162B2(lot number EL0140), via an unspecified route of administration on 29Dec2020 08:00 at the 51 years old at Arm Left at single dose for COVID-19 immunization. The patient medical history was none. The concomitant medications were none. The patient had her first dose on 29Dec2020, she had no fever or chills and she got it at 8AM, and she woke up on 30Dec2020, and for the last 9 days when she wakes up, she was gut wrenchingly nauseated. It lasted like up to sometimes until noon, she still had a little nausea now, and it is almost noon there, and this comes along with being so nauseated. She was having a pretty moderate stomach ache on 30Dec2020, especially after eating, then she was really felt flushed and dizzy on 30Dec2020, but she thought because the nausea was so bad. She had a headache on 30Dec2020 and lasted for 5 days. She was not sick prior to the COVID vaccine. The outcome of the event Headache was recovered on 04Jan2021, the other events was not recovered.
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| 51 | 2021-01-13 | fatigue |
Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , g...
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Bone pain all over for 15 min and then to the lower legs, constant 12/23 1AM, at 0530 goes to ER , given morphine, Valium,zofran, dexamethasone and norco and discharge home. No relief with med. lower feet noted trace of swelling, jaw pain and epigastric discomfort. Leg pain subside after 3 days but with muscular pain esp the upper arms. Extreme fatigue and mild tenderness on the back of head. It?s been 3 weeks now and I have the fatigue, epigastric discomfort, loss 10 lbs of wt. muscle easily get sore.
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| 51 | 2021-01-13 | fatigue, throat irritation |
Brief (less than 2 minutes) itching in throat. Sore left arm for 2 days. On day 2, inability to lif...
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Brief (less than 2 minutes) itching in throat. Sore left arm for 2 days. On day 2, inability to lift arm for about 1 hour, improved after ibuprofen. Significant fatigue for 2 days. By day 3, all symptoms resolved.
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| 51 | 2021-01-13 | chills | Chills, Arm Sore |
| 51 | 2021-01-13 | headache, fatigue, chills | Extreme fatigue, body aches, intermittent chills and headaches for 30 hours |
| 51 | 2021-01-13 | headache, dizziness, chills |
Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no se...
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Hot flash, dizziness, nausea, cold chills, headache. Right side of body numbness and tingling, no sensation of hot/cold.
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| 51 | 2021-01-13 | chills, headache, fever |
I had a fever of 101.6 and chills, body aches and headache. It ran for 4 days. I went back to work ...
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I had a fever of 101.6 and chills, body aches and headache. It ran for 4 days. I went back to work on 12/28/2020. I received dose 2 on 01/12/2021.
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| 51 | 2021-01-13 | chills, weakness, headache, fatigue, influenza like illness |
Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and f...
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Initial injection area hurt for 2 days. Began feeling overall sluggish, upset stomach, nausea and flu like symptoms. Next day the symptoms progressively got worse to include chills, body aches and joint pain and headaches, sluggish and no energy. Had to leave work early due to feeling tired, no energy and went home slept rest of day throughout night, unable to eat. Symptoms stayed the same throughout a Friday Jan 8th still with chills, aches, joint pain and headaches, nausea started to subside finally ate some soup and drank liquids , again was sluggish no energy still and went to bed early. Saturday January 9ththe headaches subsided and I started to feel better... Saturday January 9ththe headaches subsided and I started to feel better, but still did not feel like myself, all over less aches and pains but still not feeling well, still tired and Sunday the same but was able to have an appetite. Monday went into work still not 100% but was able to function. Started feeling like myself by wednesday 1/13.
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| 51 | 2021-01-13 | throat irritation |
Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ea...
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Itchy tingling sensation in mouth and throat, hives on torso and spreading, itchy eyes and inside ears, swollen lymph nodes in neck and groin area
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| 51 | 2021-01-13 | fever, fatigue |
Please note: I had documented symptomatic COVID19 infection March 2020. Recovered fully without lo...
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Please note: I had documented symptomatic COVID19 infection March 2020. Recovered fully without long term symptoms. SARS-COV2 Ab testing was positive on 12/6/20 Dose #1 Vaccine was received 12/22/20 at 3:30pm - on 12/23 I woke up at 5:30am with fever, body aches and fatigue - fever went up to 103F and I spent the day in bed - symptoms resolved approximately 12hr later (around 5:30pm) I then felt fine until 1/2/21 (10 days later) when I awakened with fever, generalized body aches and fatigue - this time fever was lower to 100.4. I again spent much of the day in bed and symptoms resolved after 8 hrs
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| 51 | 2021-01-13 | headache, chills | Reported headache, chills, greater than 6 loose stools overnight. Symptoms have resolved. |
| 51 | 2021-01-13 | headache | Same day as vaccination ee had comiting, diarrhea, nausea, severe headache lasted for 10 days. |
| 51 | 2021-01-13 | fatigue, headache |
Severe headache middle of night first night accompanied by nausea Moderate headache next 48 hrs Fat...
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Severe headache middle of night first night accompanied by nausea Moderate headache next 48 hrs Fatigue Aches first 24 hrs more unusual reaction => starting on day 2, hives/rash over most of the body for <24hrs
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| 51 | 2021-01-13 | headache | Soreness at the injection site, Headache. Treatment: Tylenol, Outcome: No improvement. |
| 51 | 2021-01-13 | headache, chills | Sudden onset of splitting headache with nausea, chills |
| 51 | 2021-01-13 | malaise |
Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left a...
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Swelling on left neck chest collarbone. Swollen lymph nodes. Redness pain. Only on left side. Left arm was injection site. Malaise. Have appt today 1/14/2021 at 230 at doctor's office.
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| 51 | 2021-01-13 | fever, headache |
Vaccine on Monday 01/11/2021. Tuesday 01/12/21 morning got up with muscle ache, headache, fever 100...
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Vaccine on Monday 01/11/2021. Tuesday 01/12/21 morning got up with muscle ache, headache, fever 100.8.
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| 51 | 2021-01-13 | fever, malaise | fever, body ache, malaise. called in sick to work. |
| 51 | 2021-01-13 | fever, chills, cough, discomfort, shortness of breath, headache |
received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breath...
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received my shot at 8:15 am, within approximately 45min I felt a very slight heaviness to my breathing something similar to allergy season belreathing, and a slight headache on my rr temple. This was nothing that stopped me or slowed me down that day. At approx 10:30pm I awoke from a deep sleep with SHARP chest pains, at 11pm chills, 1am fever and discomfort, 2am muscle aches. I slept on my left side to keep blood circulating to my heart which seemed to ease some of my discomfort. My first night was rough. I awoke Thurs (12/24) with a swollen left foot and leg. some rt leg pain, joint pain in my left knee. I pushed myself to get up and move and go about my day. Friday, I still had a little left foot foot swelling and pain, knee pain, but kept pushing. The handout says if symptoms persist for longer than 24-48 to seek medical care, I have not. Friday, (12/25/20)was Christmas and much of the day was non eventful. At approx 530pm. I felt a bulging not in the center of my chest which was tender to the touch. This concerned me. I gently messaged the area, rested a bit but continued to move up and down the stairs. That discomfort and the bulge decreased within a few hours. Saturday, (12/26) 4:am and I have notice much of the swelling in my foot and legs has decreased, however, I now have bruising. The sore arm is gone, and I am hopefully, all is well. I forgot to mention, I have had intermittent persistent cough with slight sob, something similar to the start of allergy season, but it is brief. I have been coughing at night. I have a history of whooping cough. And gastric bypass.
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| 51 | 2021-01-14 | headache, chills, sweating, fatigue |
24 hours waves of nausea and sweats started, then a short time later a bad headache and about 40 min...
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24 hours waves of nausea and sweats started, then a short time later a bad headache and about 40 minutes later diarrhea and chills. Also very fatigued and just feeling off.
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| 51 | 2021-01-14 | chills, fever, weakness, body temperature increased, headache, influenza like illness, malaise |
2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen...
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2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen as a rock, hot to touch and sore. 1/15/21 injection site redness, swollen as a rock, hot to touch and sore; skin temp taken 100.0 at injection site, localized in area, not feeling well, weakness, neck stiffness, headaches Midrin taken for intense headache. Pt has been resting all week, off work returned today no fever. 1st dose: no ae to report
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| 51 | 2021-01-14 | malaise, cough, dizziness, fatigue, headache, fever, runny nose, weakness |
Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, ...
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Fever, sensation of heart pounding in my chest, dizziness and weakness, fatigue, severe joint pain, body aches, skin sensitivity, headache, chest tightness and burning on inspiration, runny nose, unproductive cough, just felt horrible with all of this for two days fever ran between 99.7 and 100.6. Symptoms began to resolve and no fever by day three. Every day after continued to improve but joint pain, weakness with a general malaise through Thursday. It is now the following Friday and I am still experiencing fatigue and just a general feeling of not being quite 100%.
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| 51 | 2021-01-14 | fatigue, fever, chills | Fever, shivers, nausea fatigue. Treatment: Tylenol outcome: complete resolution of symptoms. |
| 51 | 2021-01-14 | fatigue, chills, fever, headache |
Fever; chills; muscle aches; headache; fatigue; This is a spontaneous report from a contactable nurs...
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Fever; chills; muscle aches; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). This 51--year-old female nurse reported for herself received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EL1283/expiration date: unknown), via unknown route of administration, on 07Jan2021at 12:00 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 immunization at workplace clinic. Relevant medical history included chronic Fatigue. The patient have known allergies to penicillin (PCN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ferrous sulfate 65 mg, daily. The patient previously received the first dose of BNT162B2 (lot number: EJ1685/expiration date: unknown) on 17Dec2020 at 01:00 PM (at the age of 51 years old) as a single dose in the left arm via unknown route of administration for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Jan2021 at 12:00 AM, after the second dose, the patient experienced fever, chills, muscle aches, headache, fatigue. No treatment was received for the events fever, chills, muscle aches, headache, fatigue. The outcome of the events fever, chills, muscle aches, headache, fatigue was unknown. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-14 | shortness of breath, fever, throat irritation, cough | Itch in throat Cough Fever 99.6 F Body aches Short of breath |
| 51 | 2021-01-14 | shortness of breath, fever, cough, headache, throat irritation, shortness of breath, cough, throat irritation, fever, headache | Itch in throat Cough Fever 99.6 F Body aches Shortness of breath Headache |
| 51 | 2021-01-14 | headache, fever |
Pain, swelling to injection site, pain, aches all over, fever and headache started approx 10 hours a...
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Pain, swelling to injection site, pain, aches all over, fever and headache started approx 10 hours after injection, lasting approx 29 hours. Approx 48 hours after injection swollen, tender area approx size of golf ball under left arm ( injection arm) and conintues to be there on 3rd day
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| 51 | 2021-01-14 | shortness of breath |
Patient felt a sense of fullness and tingling in throat shortly after vaccination (10 minutes), and ...
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Patient felt a sense of fullness and tingling in throat shortly after vaccination (10 minutes), and was transferred to urgent care for closer monitoring. She did not experience any dyspnea, and vital signs remained stable until she was cleared to discharge. No other complications noted during the 2 hours patient was observed in urgent care.
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| 51 | 2021-01-14 | headache, fatigue, chills |
R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is...
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R arm pain--at site of injection; significant nausea; headache; body aches; chills; fatigue; This is a spontaneous report from a contactable Physician (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL6142), via an unspecified route of administration on 07Jan2021 14:45 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Medical history included hypothyroidism, hx of Hodgkins from 1994, breast cancer from 2005. Concomitant drug included levothyroxine sodium (SYNTHROID). The known allergies included Bactrim, bacitracin, non-ionic contrast. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Right arm pain - at site of injection, significant nausea, headache, body aches and chills. fatigue on 07Jan2021 20:00 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
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| 51 | 2021-01-14 | dizziness, fatigue |
Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling...
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Reactions: Injection site pain Injection site swelling Injection site redness Sever fatigue Swelling face/eyes Muscle pain - legs Muscle weakness - legs New onset hypertension Dizziness
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| 51 | 2021-01-14 | shortness of breath, fever |
Received vaccine on 1/6, mild fever/achiness on 1/7. On 1/8 had some chest pain and SOB. This cont...
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Received vaccine on 1/6, mild fever/achiness on 1/7. On 1/8 had some chest pain and SOB. This continued to get worse on Friday. By Saturday, patient felt she could not get comfortable and was more short of breath. She went to the ER and after multiple tests they found multiple pulmonary emboli. Of note, patient took a long flight on 1/6 and is on hormone replacement therapy.
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| 51 | 2021-01-14 | headache, malaise |
Severe Headache; body ache/pain; malaise; nausea; This is a spontaneous report from a contactable co...
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Severe Headache; body ache/pain; malaise; nausea; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 16Dec2020 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history was none. The patient had no known allergies. The patient's concomitant medications were not reported. It was unknown if other vaccine was administered in four weeks. On 07Jan2021, the patient experienced severe headache, body ache, malaise, pain and nausea fit for 30 hours. Prior vaccination the patient had no COVID. It was unknown if the patient was COVID tested post vaccination. No treatment received for the events. The patient recovered from the events on unspecified date in Jan2021. Information on the batch number has been requested.
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| 51 | 2021-01-14 | shortness of breath, headache, fatigue |
Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my...
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Shortness of breath; Joint pain; fatigue; headache; ribs pain; chest pressure; burning feeling of my eyes; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 04Jan2021 03:45 PM (at the age of 51 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient did not have any known allergies to medications, food, or other products. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021, at 05:00 AM, the patient experienced shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes. Treatment received for the events included an inhaler and acetaminophen (TYLENOL). The outcome of the events shortness of breath, joint pain, headache, fatigue, ribs pain, chest pressure and burning feeling of her eyes was recovering. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
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| 51 | 2021-01-14 | throat irritation |
Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness...
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Slight allergic reaction; itchiness immediately after the injection in the injection area; itchiness spread to parts of patients body like the back of her throat and tongue; itchiness spread to parts of the patients body like the back of their throat and tongue; itching to the area of the leg, the face, the head; This is a spontaneous report from a contactable consumer (patient). The 51-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (upper left arm), on 21Dec2020, at a single dose, for COVID-19 immunization/ prophylaxis. Relevant medical history included root canal. The patient has no concomitant medications. The patient previously took thimerosal (preservative) and experienced allergy. Patient knows the vaccine is preservative free. The patient received the first dose on 21Dec2020. She had a slight allergic reaction where she experienced itchiness immediately after the injection in the injection area (itching in the arm) and the itchiness spread to parts of her body like the back of her throat, tongue, area of the leg, the face, the head. She took three Benadryl as treatment for these events. The patient recovered completely that same evening (on 21Dec2020) before she went to bed around 10 or 11 that night after her third Benadryl. She was due to go back to get her second dose between 11Jan2021 and 13Jan2021, next week. She is concerned about getting the second dose since she had somewhat of a reaction with the first dose. She had to have a root canal and she was taking an antibiotic which she clarifies as a Z-pack, azithromycin. States her last antibiotic pill is due to be taken on Monday, 11Jan2021. She was asking if she can get the second dose. She is also concerned about how she may react to the 2nd dose of the vaccine while taking Azithromycin. They were informed at work that the 2nd dose of the vaccine should be administered between days 21 and 23 after the first one. Information about lot/batch number has been requested.
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| 51 | 2021-01-14 | fatigue, chills, headache | Tiredness, Body aches, Headache, Chills started 1/14 at 1500 . I am still having symptoms today. |
| 51 | 2021-01-14 | malaise |
positive for covid19; positive for covid19; got or felt sick; This is a spontaneous report from a co...
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positive for covid19; positive for covid19; got or felt sick; This is a spontaneous report from a contactable physician reported for self and consumer. This 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 at single dose for covid-19 immunisation. As soon as patient got vaccine she got or felt sick in Dec2020 and had the test and finds out she was positive, so she stays home two weeks and doesn't have no symptom at all and wants to know when has to take a test. The day after the patient developed symptoms thought it was the vaccine, but the symptoms continued for 2-3 days, the 3rd day the patient got herself tested. The patient was positive for covid19 at the time had the shot/ as soon as she got vaccinated she became positive. The patient hasn't had any symptoms for the past 2 weeks. The patient was scheduled to get retested. The patient was scheduled for 2nd dose of vaccine. The patient asked if there are any risks since developed covid the day after getting the vaccine. What if miss today. The patient wanted to know time after having no symptoms past two weeks, when she has to take a test. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Test positive for covid19 found as soon as following the vaccination, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
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| 51 | 2021-01-14 | fatigue |
soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel li...
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soreness at the injection site; I slept off and on from 8:00pm to 12:00am - I did not really feel like moving from the couch, but got up to go to bed; my entire left arm felt "odd" - not painful, just different than my right arm; very tired; joints/muscles on my left side (neck, leg, arm) started to ache; joints/muscles on my left side (neck, leg, arm) started to ache; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration (left arm), on 08Jan2021 at 12:00, at a single dose for COVID-19 immunization. The patient's medical history included stomach flu (about 2 years ago), pneumonia (14 years ago), and oral surgery (recently). Concomitant medications included lisdexamfetamine mesilate (VYVANSE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), calcium, ergocalciferol (VIT D) and red yeast rice. The patient previously received influenza vaccine. The patient has no known allergies. Patient's body mass index (BMI) was 32.5. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the pharmacy or drug store. About 30 min after vaccination on 08Jan2020, the patient's entire left arm felt "odd" not painful, just different than my right arm. About 6 hours after the shot, the patient started getting very tired, and my joints/muscles on my left side (neck, leg, arm) started to ache. She slept off and on from 20:00 to 12:00 and she did not really feel like moving from the couch, but got up to go to bed. She checked for fever around 19:30 and 12:00 but had none. She took one of my left over 600 mg ibuprofen (from a recent oral surgery) as treatment, then went to bed and woke up feeling much better. Today, she only has soreness at the injection site (as she normally did with a flu vaccine). She decided to be proactive and took another 600 ibuprofen around 15:00 and felt consistent all day. Patient stated that how she felt the evening of the vaccine was not painful; just "different" than she experienced before. Outcome of the events was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
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| 51 | 2021-01-15 | night sweats, headache, fever |
1st day- Body aches, headache, mild fever 100.1, night sweating when sleep 2nd - Body aches, headac...
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1st day- Body aches, headache, mild fever 100.1, night sweating when sleep 2nd - Body aches, headache, mild fever 99.9 3rd day - body aches only
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| 51 | 2021-01-15 | headache |
Headache moderate joint and muscle pain all lasting approximately 16-18 hours which I treated with 8...
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Headache moderate joint and muscle pain all lasting approximately 16-18 hours which I treated with 800 mg ibuprofen every 6 hours
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| 51 | 2021-01-16 | headache |
01/17/2021 @11:41 am Covid Vax in Left Deltoid @12:03 pm stated tongue was ?tingly? and had a headac...
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01/17/2021 @11:41 am Covid Vax in Left Deltoid @12:03 pm stated tongue was ?tingly? and had a headache 5/10. She took 1000mg Tylenol. Given history of allergies, I gave her 50mg oral diphenhydramine ? liquid. She also took an Ativan 1mg. She was nervous and upset, but no further reaction except ?tingly tongue?. No rash, examined arms, torso, face, lips. 12:15pm BP 152/82, admitted to some anxiety 12:30 ?feels good?, still some tongue tingling 12:36 BP 140/80 tongue/mouth nothing remarkable I advised her not to drive and sister came to pick her up at 1:30. No further incidents I advised her to talk to her dr about 2nd vaccine and consider an allergist due to prior allergies.
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| 51 | 2021-01-17 | migraine, headache |
BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe ...
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BNT162B2 first dose 18Dec2020, second dose 06Jan2021; Severe sharp headache behind left eye; Severe nausea (but could be from headache).; Possible migraine; Mild photophobia; Mild photophobia; This is a spontaneous report from a contactable Physician who reported for herself. A 51-year-old female patient received her second single dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EL3249) at left arm at 17:30 06Jan2021 for Covid-19 immunization in a hospital. She had her first injection at 07:15 PM 18Dec2020 and experienced mild photophobia within 5-10 min. The patient had a medical histroy of allergic rhinitis and was allergic to cashews. Concomitant medications included fexofenadine, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12). The patient did not receive any other vaccines within 4 weeks prior to her first COVID vaccine. Within 5-10 minutes of 2nd injection, the patient had mild photophobia (also after 1st injection but patient did not recognize the symptom at that time). About 20 hours after 2nd injection, the patient developed severe sharp headache behind left eye, severe nausea (but could be from headache/ possible migraine). The patient stated that she had no prior history of migraines or frequent headaches. Three days after 2nd dose, the patient's lingering intermittent mild left-sided headache persisted. The patient self-administered OTC oral analgesics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events headache, nausea, migraine, photophobia at the time of last observation was resolving. The patient considered that the events were non-serious.
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| 51 | 2021-01-17 | malaise, headache, fatigue, fever, chills |
Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fati...
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Got my second dose of Pfizer, 12 hrs later developed fever (103 F), chills, myalgia, headache. Fatigue, bilateral orbital pain. No visual problems. Took Tylenol every 4 hrs and fever (101. 5)returns in 1-2 hrs. Pulse ox remained normal, 98%, but pulse was 99/min. Usually my resting pulse ox is 55/minutes. Was unable to go to work and see patients. Had these symptoms for 48 hrs even though stayed in bed, took Tylenol around the clock and drank plenty of fluids (2-3 liters of water in addition to natural orange and apple juices). Never lost appetite either, do eating my vegetables and fish diet. Ice cream help between Tylenol?s. Completely resolved after 72 hrs. Now still have LEFT injection site tender deltoid and left axillary tender nodes, improving as well. All along breathing fine, no cough or congestion or sore throat. No anosmia or dysgeusia. This was after my second Pfizer dose. After the First dose only had tenderness on the RIGHT deltoid muscle injection site and tender axillary node, resolved by now.
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| 51 | 2021-01-17 | headache |
Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue ti...
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Mucus membranes burning/inflamed sensation. Vaginal area swollen, red, inflamed. Lips and tongue tingling. Started having symptoms a couple of hours after 2 dose of vaccine. Feels like nerves are burning in these areas. Intense headache 24 hrs after shot. Took Tylenol 500 mg with no relief. Took naproxen 550 mg Tuesday night around 10 pm. Resolved headache but not burning sensation around mucus membranes. Got progressively worse. Saw MD on Friday who did pelvic exam. Confirmed vaginitis. Prescribed Medrol dosepak, refresh vaginal lubricant and topical desitin. Currently on day 4 on Medrol dospak with some relief. Burning sensation now comes and goes and is not constant. Again, the burning sensation feels like the nerves in the areas of mucus membranes are inflamed.
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| 51 | 2021-01-17 | malaise, chills, fatigue, headache | Nausea;headache;chills;muscle pain;tiredness Feel unwell. |
| 51 | 2021-01-17 | chills |
Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right ar...
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Stiffness on the right arm where she got the vaccine shot that is painful; Stiffness on the right arm where she got the vaccine shot that is painful; Cold chills; Body aches; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: SJ1865), via an unspecified route of administration on 06Jan2021 10:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included ongoing Diabetic- Started 4-5 years ago. Concomitant medication included ongoing metformin for diabetic. The patient clarified the side effects she experienced were cold chills, body aches, and stiffness on the right arm where she got the vaccine shot and there was pain. The cold chills started late afternoon on 06Jan2021 around 1:00 PM or 1:30PM. She confirmed these have gone away and she has recovered completely. The body aches started around this same time as well. The stiffness on the right arm where she got the vaccine shot is painful. She noticed the stiffness and pain about 30 minutes after she got the vaccine, it was like 10:30 AM when she noticed this. She is no longer hurting and the stiffness has gone away. It went away on Saturday late in the evening like 7:00PM or 8:00 PM. The outcome of the events was recovered on 09Jan2021.
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| 51 | 2021-01-18 | fever, malaise, fatigue, chills |
9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 we...
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9 to 36 hours. Lymphnode swelling , pain left axilla. Fever, chills ,muscle aches, brain fog. 1 week post Facial paralysis, fatigue, vocal cord weakness, feeling of unwell.
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| 51 | 2021-01-18 | fatigue | Fatigue, wheezing, soreness, palpitations |
| 51 | 2021-01-18 | fever, headache, chills | Headache, chills, low grade fever developed 24 hours after receiving vaccine - resolved in 2 days. |
| 51 | 2021-01-18 | malaise |
Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; ...
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Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; kidneys were hurting; body aches; tested positive; tested positive; The arm wasn't swollen it was just burning.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. At first, she thought she was having a reaction, but then she started feeling sick so she got tested. She was positive so she wasn't having a reaction. She was scared from the pain of COVID. She experienced sickness. Her stomach was still weirded out. She did experience arm pain from the vaccine. Her doctor told her it was fine that it needed to air out. She left the bandage on too long. She didn't have a prescribing doctor. She received the vaccine on the 29Dec2020. She tested positive 02Jan2020. The arm wasn't swollen it was just burning. She was sick to her stomach when she got the stomach. The sick to the stomach lasted maybe two days, but then she got COVID. The burning was around the arm. It wasn't that bad. It lasted for a day. It started the day she got the shot (on the 29Dec2020). On 07Jan2021, she went to the hospital because her kidneys were hurting. The doctor said her kidneys were good. They did labs which were good. She was still going through body aches. She was told she was currently in the worst part of the virus. She still had a sour stomach going on from the virus as well. The outcome of the body aches and sour stomach was not recovered, for other events was unknown.
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| 51 | 2021-01-18 | cough, chills, runny nose, productive cough, migraine, malaise, headache |
Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sne...
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Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Information of lot/batch number has been requested.
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| 51 | 2021-01-19 | shortness of breath |
Abnout 5 minutes after getting her vaccine she began to feel short of breath, tightness, and palpita...
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Abnout 5 minutes after getting her vaccine she began to feel short of breath, tightness, and palpitation. In the ED, patient was given IM epi x 1, IV benadryl & solumedrol. Patient states that she felt better. Patient has had a similar allergic rxn in the past to shrimp, beta blockers and lisinopril (cough). Pt has never had to use epinephrine for her allergic reactions in the past. Patient has an epi-pen at home for her son (peanut allergy).
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| 51 | 2021-01-19 | headache, dizziness, chills, fever |
Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , D...
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Back pain,fever,chills,muscle aches, headache, diarrhea, upset stomach , nausea, severe head fog , Disiness, feels like electrical currents in head and ears. These symptoms have been all 7 days.
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| 51 | 2021-01-19 | fever |
Fever of 99.6 and 99.4 which likely began overnight (but first logged at 5:00 am) and ended by after...
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Fever of 99.6 and 99.4 which likely began overnight (but first logged at 5:00 am) and ended by afternoon of 1/19/21. Arm pain and body aches resolved around same time. Significant left jaw pain which began evening of 1/19/21 and continue into 1/20/21. All symptoms alleviated by ibuprofen.
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| 51 | 2021-01-19 | dizziness |
Patient presents back to the COVID clinic approximately one hour post vaccine with chief complaints ...
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Patient presents back to the COVID clinic approximately one hour post vaccine with chief complaints of total body urticaria and light headed
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| 51 | 2021-01-19 | chills | Stomach cramps, diarrhea, slight chill |
| 51 | 2021-01-19 | dizziness, cough |
Vaccine administered at 4:40 PM. At 4:50 PM patient reported sudden onset cough, dizziness, and thro...
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Vaccine administered at 4:40 PM. At 4:50 PM patient reported sudden onset cough, dizziness, and throat closing. Onsite nurses attended to patient immediately. Vital signs stable. 911 called. EMS transport at 5:00 PM to hospital.
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| 51 | 2021-01-19 | headache, chills | chills, headache, achy |
| 51 | 2021-01-19 | headache, fatigue |
immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday mornin...
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immediate massive headache, bad taste/metal-pepper about 15 mins after shot, fatigue Saturday morning 1.9.21; foggy mind body aches Symptoms subsided Tuesday morning 1.12.21
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| 51 | 2021-01-21 | dizziness |
0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Para...
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0805 Felt confused , heart pounding, lightheadness. BP 180/102 0809 911 called 0810 160-90 0816 Paramedics arrived, Hx of panic attacks that precipitate ED visit, not on any meds.
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| 51 | 2021-01-21 | chills, fever, headache, throat pain |
1/21/2021 - 9pm, slight aches in neck muscles 1/22/2021- 3am, fever 102.8 F (forehead) and 102.1 F (...
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1/21/2021 - 9pm, slight aches in neck muscles 1/22/2021- 3am, fever 102.8 F (forehead) and 102.1 F (ear), chills, body aches, joints achy, headache, slight sore throat, couldn't sleep. Took 2 butalbital and drank Pedialyte; forehead temp was 100.1 F by 5 am, and 99.7 F by 6 am 7:30 am (1/22/2021) fever returned and was 102.2 F (forehead) and 101.4 in ear. All other symptoms remain the same. Took 2 butalbital and drank more Pedialyte Called doctor and left voicemail with nurse to put these notes in my chart It should be noted that I had Covid-19 from onset of symptoms on 11/13/2020 and had symptoms through 11/29/2020. I had two visits to urgent care for fluids and medication (11/20/2020 & 11/29/2020). Exposure came from my husband who presented with symptoms on 11/12/2020 and contact tracing revealed his exposure was on 11/09/2020
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| 51 | 2021-01-21 | dizziness, headache, discomfort |
An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tyl...
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An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tylenol as soon as I got home due to symptoms getting worse. That night I went to bed at 10pm and didn?t wake up till 7:45am (I was dead tired, I didn?t even hear my alarm). Jan/19/21. Soon as I got up, I experienced headache, vertigo, and this time with mild body aches/heavy feeling and mental fog (Tylenol helped relieved symptoms). Towards the afternoon, I also felt mild burning sensation in my eyes and somehow I felt hot flashes around my face only. Been taking my temperature with normal results. Jan/20/21 Still experiencing off/on headaches and light headedness, otherwise feels okay. All symptoms gone by end of the day.
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| 51 | 2021-01-21 | chills, headache, fever | CHills Fever Body Aches Headache |
| 51 | 2021-01-21 | headache, fever |
Developed a fever and bad body aches around 9:00 pm the evening of the shot. My stomach was very up...
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Developed a fever and bad body aches around 9:00 pm the evening of the shot. My stomach was very upset and couldn?t eat. Had bad headache.
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| 51 | 2021-01-21 | fever, chills | Fever chills body aches |
| 51 | 2021-01-21 | headache, chills, fatigue, fever | Fever, chills, headache, fatigue |
| 51 | 2021-01-21 | migraine, fever, chills |
HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVE...
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HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVER THE FIRST 24 HRS AND THEN STARTED TO DISSIPATE AFTER ABOUT 36 HRS AND WERE COMPLETELY GONE IN 48 HRS. TOOK ADVIL. SLEEP.
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| 51 | 2021-01-21 | throat pain, fatigue | Injection site pain, body aches, fatigue, throat pain. Resolved. |
| 51 | 2021-01-21 | shortness of breath, sweating |
Received the Pfizer COVID-19 vaccine this morning and, while walking back to work, experienced hyper...
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Received the Pfizer COVID-19 vaccine this morning and, while walking back to work, experienced hypertension, tachycardia, diaphoresis, shortness of breath, anxiety and chest discomfort. Code Blue was called; she received supplemental oxygen and was given Aspirin 81 mg. Emergency Medical Services (911) were contacted and arrived at 11:45 AM. She was assessed and an intravenous line was inserted. She was transported to an emergency room and left this facility at 12:20 PM. Update: The employee was assessed and treated at Hospital. She was not admitted; she was directed to follow up with her primary care provider and to seek a referral to a cardiologist.
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| 51 | 2021-01-21 | sweating, shortness of breath |
received the Pfizer COVID-19 vaccine this morning and while walking back to work, experienced hypert...
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received the Pfizer COVID-19 vaccine this morning and while walking back to work, experienced hypertension, tachycardia, diaphoresis, shortness of breath, anxiety and chest discomfort. Code Blue was called; she received supplemental oxygen and was given Aspirin 81 mg. Emergency Medical Services were contacted and arrived at 11:45 AM. She was assessed and an intravenous line was inserted. She was transported to an emergency room and left this facility at 12:20 PM. Update: was assessed and treated at Hospital. She was not admitted; she was directed to follow up with her primary care provider and to seek a referral to a cardiologist.
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| 51 | 2021-01-24 | headache, fatigue, dizziness, chills, fever |
I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chi...
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I felt light headed on the way home from the vaccine 1/23/21. At around midnight, I woke up with chills. At 2am, I woke with more chills and a splitting headache. I took Tylenol which decreased the symptoms. All day on Sunday, I had a horrible headache, a fever of 101F, body aches (muscles and joints), cramping, nausea, terrible fatigue. I took Tylenol every 4 hours which did help some. Today, I feel fatigued, fever is gone, I feel nauseated.
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| 51 | 2021-01-24 | fever |
I received dose 2 on tuesday 1pm, after 12 hours the fever kicked in and lasted 24 hours through lat...
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I received dose 2 on tuesday 1pm, after 12 hours the fever kicked in and lasted 24 hours through late wednesday night rendering me fairly useless. But that's not the event I'm reporting. On saturday, my period started, and it's literally the heaviest period that I've ever had in my life (and it's still going). I'm perimenopausal, and haven't had a period in 5 months, so at first I chalked it up to that, but the timing is suspicious so I asked around - there seems to be a lot of women who have been having off-schedule, very-heavy periods after their vaccinations. I'm a research scientist and I think this is worth investigating to see if it's truly a vaccine effect and what the implications are, especially knowing that covid affects clotting. I've also submitted this info on pfizer's site.
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| 51 | 2021-01-24 | headache, chills, fever, throat pain, throat swelling |
I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7...
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I started with sore throat,feeling like it was swelling and no difficulty breathing around 5pm. At 7 pm started exp chills, fever 101.9, the highest it got over next 2 days 100.5. The pain in my legs cause me to not be able to walk and severe headache. Due to the pain in my legs exp bruises in both legs of calf muscles. I felt as if I had Covid therefore I went to the doctor 4 days.
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| 51 | 2021-01-24 | shortness of breath, headache, fever |
Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fir...
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Within 5 minutes, throat closing and generalized itchiness, tongue swelling, joint ache, skin on fire, short of breath. 2 doses of PO Benadryl at clinic, transferred to ED where she received epinephrine and 4 days of prednisone and allergy consult. Nausea began evening of 1/21/21 with headache. Fever 100.6 began 1/22/21. Headache and nausea still remain, not fully recovered.
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| 51 | 2021-01-24 | headache, fever | pain at site, joint pain, headache, fever and nausea |
| 51 | 2021-01-24 | dizziness, shortness of breath |
short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do...
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short of breath; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; lightheaded, dizzy, like pre-syncope as I felt like I could pass out but did not do so; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) via an unspecified route of administration in the left arm, on 03Jan2021 at 10:00, at a single dose, for covid-19 immunization. Medical history included known allergies (unspecified). The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a doctor's office/urgent care. The patient experienced 3 "waves" or what her many coworkers were describing as "whooshes". The first two occurred minutes apart approximately 4-5 minutes post vaccine-last less than one minute each. The 3rd wave occurred after lunch approximately 3 hours later-lasted approximately 2 hours but not as intense as the first times. The patient further described the symptoms as "felt like a rush" (unspecified) experienced when receiving epinephrine. She was short of breath, lightheaded, dizzy, like pre-syncope as she felt like she could pass out but did not do so. The events occurred on 03Jan2021. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date. The patient has not been tested for COVID-19 since vaccination.
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| 51 | 2021-01-25 | headache, shortness of breath, dizziness, fatigue |
about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. ...
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about 15 to 17 minutes after vaccine I got a warmth thru my whole body and my heart started racing. I also had a headache. I was taken back to medic area and was assessed. My oxygen was good but my pulse and BP were high. I layed down and after 10 minutes felt better and my pulse recovered. Shortly later I was told I could go home. I sat up and felt briefly dizzy then my heart started racing again (pulse 137). I layed back down and EMS was called. By the time they arrived my pulse had slowed to normal but I still had a headache. This was about 45 min after vaccine. They performed an EKG and monitored my vitals as I sat up and then stood up. I did not have any incidents of my heart racing but my BP was 157/98 so I was told they could take me to EC for monitoring or to my doctor. I chose to go to my doctors. I arrived at my doctor an hour later and still had elevated BP and headache . He chose to monitor me. I had another incident where my heart started to race so he gave me liquid Benadryl and let me rest. I think I had one more milder incident of my heart racing but it was not as strong. After about 3 hours I went home and was told to monitor for Anaphylaxis. I went home and slept 3 hours and woke up feeling fine. I was fatigued for next 3 days but not issues with heart. About day 5 I was working and had a couple of incidents where I felt my heart pick up a little bit and I couldn't catch my breath. After that I feel like I was fine and don't remember any more incidents.
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| 51 | 2021-01-25 | fever, pneumonia |
diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; F...
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diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; Fever; Body aches; swollen lymph nodes under left armpit; Exposed to COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a 51-year-old female patient received the first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 08:30 in left arm at single dose for covid-19 immunization. The patient medical history was none. Family medical history was no. Patient had been taking vitamin supplements. No vaccinations were taken within 4 weeks. Patient received first COVID-19 Vaccine on 21Dec2020 around 08:30. Between that three weeks period, patient was diagnosed with COVID. Patient was exposed the following weekend. Took four tests to finally test positive within a four-day-span. Patient was exposed to COVID on 26Dec2020. On 28Dec2020, patient experienced swollen lymph nodes under left armpit. Progressively got more sensitive on 29Dec2020. Patient thought maybe it was a side effect of the COVID-19 Vaccine. Wednesday morning, 30Dec2020, around 10:00 patient noticed body aches. Around 12:00 patient noticed a fever. On 30Dec2020, patient had a 24-hour lab test to check for COVID. All other COVID tests performed were rapid tests. First COVID test was on 30Dec2020. Patient had another COVID test on 31Dec2020, and two COVID tests on 02Jan2021. Patient was tested positive for COVID on 02Jan2021. COVID test that resulted positive was a rapid test in the emergency room. Patient was diagnosed with Covid-19 after the 1st dose. Patient was in the emergency room with pneumonia which occurred on 02Jan2021. It was confirmed patient was discharged from the emergency room six to seven hours after arrival. Lot number from patient card was either EJ1685 or ET1685. Caller unable to confirm lot number from patient card. Chest X-ray was what sent her to emergency room labs and blood work done on 02Jan2021 in emergency room. Labs were done in clinic a couple days before flu and strep test both negative on an unspecified date. Patient didn't remember all tests and results. Outcome of all events were unknown. Caller would like to know whether she should take the 2nd dose or not. Information on the lot/batch number has been requested.
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| 51 | 2021-01-25 | fatigue, nasopharyngitis | nausea, tiredness and cold |
| 51 | 2021-01-25 | headache |
warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and t...
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warmth in the chest; heart began to race and BP elevated. started to feel discomfort in chest and tightness in throat but did not close up. Was given Benadryl and Steiroid. chest x ray given which was normal. EKG taken which was abnormal but told was consistent with an older EKG. Was feeling better and about 90 minutes later felt warmth over my heart, my lips and mouth became tingly and both arms went numb and uncertain if my heart monitor showed abnormal. Was admitted overnight for observation. About 10 hours later had warmth in my chest, heart started beating fast, numbness in arms and around mouth and slight tightness in throat. Benadryl administered and heart calmed after couple of minutes, numbness went away after couple of minutes and tightness in throat went away after an hour. Again about 13 hours later the warmth in chest and heart racing only symptoms. Given another dose of Benadryl. The symptoms only lasted a couple of minutes. I also saw a cardiologist who ordered an echocardiogram just to rule out anything with my heart. It was normal. I was sent home with instructions to use Bendryl oral for 3 days every 12 hours. I was told it could be from vaccine and I was to follow symptoms for 2 weeks and if not better to see cardiologist to look at other reasons. I have taken the Benadryl for 3 days every 12 hours and did not have any other episodes with my heart. I am on day 6 now and I have joint pain and headache.
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| 51 | 2021-01-26 | fever, dizziness, fatigue, chills, headache | Dizziness, nausea, fever, chills, HA, muscle aches, fatigue |
| 51 | 2021-01-26 | chills, cough, shortness of breath, malaise |
Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, d...
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Forty five minutes after administration the patient felt scratchy throat, persistent cough, vomit, difficulty breathing, swollen face, rash on the neck , torso and arms, itchiness of the eyes, chills . Took some benadryl, cream and pills. Next day malaise, swollen hands, body aches.
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| 51 | 2021-01-26 | fatigue, fever | Nausea, fever, bodyaches, headache, fatigue, rash |
| 51 | 2021-01-26 | dizziness |
Noticed heart rate elevated on day of vaccine (1/26/21) w/ slight dizziness. My heart rate is rangin...
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Noticed heart rate elevated on day of vaccine (1/26/21) w/ slight dizziness. My heart rate is ranging from 130s-180s, becoming more elevated with activity. At rest it's varying from 90s to 130s. It is now 1/27/21 at 8:50am and symptoms have continued.
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| 51 | 2021-01-26 | cough, throat pain, fever, headache, fatigue |
Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the...
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Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; Fever; headache; bodyaches; cough; tiredness; sore throat; This is a spontaneous report from a contactable physician (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 05Jan2021 at 08:15 AM at a single dose for COVID-19 immunization in a hospital. Medical history included known allergies to mold, dust mites, grass and tree pollen, cockroaches. Concomitant medications included hydroxyzine, ergocalciferol (VITAMIN D), vitamin c, calcium, and glucose (GLUCOS). The patient experienced fever, headache, bodyaches, cough, tiredness, sore throat on 10Jan2021 at 08:30 AM. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received zinc, vitamin D, ibuprofen, and Tylenol as treatment for the events. Since the vaccination, has the patient been tested for COVID-19: Yes. The patient has no COVID prior to vaccination and she was tested for COVID post vaccination (nasal swab; COVID-19 Ag test) with COVID test result as positive on 12Jan2021. The patient did not receive other vaccine in four weeks. Outcome of the event "Since the vaccination, has the patient been tested for COVID-19:Yes" was unknown, while recovering for the remaining events. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for COVID test based on the known safety profile. However the short duration since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
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| 51 | 2021-01-26 | weakness |
metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went t...
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metallic taste in throat; mid chest tightness and weakness; flushed feeling in body and legs; went to the emergency room since she didn't feel any better; mid chest tightness and weakness; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730, expiration date: Mar2021), via an unspecified route of administration on 30Dec2020 12:00 at single dose on deltoid left for COVID-19 immunisation. Medical history included patient was working in healthcare and around Covid positive patients daily. There were no concomitant medications. 10 minutes after getting bnt162b2, patient noticed side effects. Patient had a metallic taste in throat and a few more things. Right after getting it she had a flushed feeling in her body and legs, similar like IV contrast. 10 minutes after that so about 20 minutes later she had mid chest tightness and weakness that was gone after about 40 minutes to an hour. Patient was unable to provide any seriousness criteria, stating it was scary for a moment and she didn't know what it was, but the mid chest tightness could have progressed to something more serious. That was how she felt at that moment, but after it was all gone, it was not serious. She did not know why or what the reason was or if she was lucky or what. Patient was sitting for 10 minutes after receiving Pfizer COVID vaccine and was doing something on her phone when she started experiencing these symptoms unexpectantly. Eventually the nurses observing her after a half hour took her to the emergency room since she wasn't feeling any better. Patient had emergency room visit for all events. Outcome of events was resolving.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported mid chest tightness and the administration of the COVID 19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 51 | 2021-01-26 | throat irritation |
nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressu...
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nausea, vomiting, burning in the stomach, itching in the throat., I couldn't talk. high blood pressure. I was administered solumedrol intravenous, Benadryl intravenous, Pepcid intravenous and Zofran sublingual and NSS 0.9 to 10 ml per hour.
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| 51 | 2021-01-27 | headache |
slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuf...
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slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff; slight tingling and numbness of her face and cheeks/little tingling numbness in her face; slight tingling and numbness of her face and cheeks/little tingling numbness in her face/tingly stuff/she has not had symptoms for years, potentially initiated by being vaccinated; Headache; Diarrhea; Stomach upset; warm flushed feeling; heavy metallic taste to her mouth; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 07Jan2021, at single dose, for COVID-19 immunization. Medical history included ongoing multiple sclerosis (MS) from 2012 (she has not had symptoms for years), tingly stuff/tingling and numbness (MS symptoms). There were no concomitant medications. The patient experienced metallic taste in her mouth, a slight tingling and numbness of her face and cheeks. The patient reported that she also has a history of MS that has been controlled and she has been without symptoms for years. She stated the tingling could be a symptom of MS, potentially initiated by being vaccinated. She stated that the tingly stuff concerned her, she got a little panicky because that can be a symptom of MS and she did not have symptoms for years. The patient clarified that on 07Jan2021, she took the vaccine. On 07Jan2021, she experienced heavy metallic taste to her mouth two hours after the injection, headache, diarrhea, stomach upset, and warm flushed feeling. On 08Jan2021, she experienced little tingling numbness in her face. She stated that she has MS prior to the vaccine and reported that numbness and tingling can be MS symptoms. She has not had symptoms for years. The patient did not receive treatment for the events. The outcome of "heavy metallic taste to her mouth" was recovering (reported as "improved but persisting"); paraesthesia and hypoeasthesia were recovering; headache, diarrhea, stomach upset, and warm flushed feeling were resolved on 09Jan2021.
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| 51 | 2021-01-28 | malaise |
Given 2nd dose of Covid vaccine on 1/9/21 and felt immediate jolt of pain in left shoulder and scapu...
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Given 2nd dose of Covid vaccine on 1/9/21 and felt immediate jolt of pain in left shoulder and scapula region and complained of not feeling well. Per ED note, mild facial swelling, no evidence of any other symptoms, given Benadryl, Steroids and Pepcid, monitored for 4 hours and discharged.
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| 51 | 2021-01-28 | throat irritation |
Patient reported tongue numbness and throat itching sensation within three minutes of vaccine admi...
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Patient reported tongue numbness and throat itching sensation within three minutes of vaccine administration. BP 131/87, HR 80, O2 97%. Patient then developed macular rash on bilateral arms and described sensation of generalized warmth about 15 minutes after vaccine administration. presented to vaccine clinic for consult, patient was then transferred to ER via stretcher.
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| 51 | 2021-01-28 | headache |
Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain;...
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Sore arm; weird taste in mouth; tingling lips; feeling very cold; pain ache under armpit; neck pain; headache moving around and off and on; tingling legs; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) via intramuscular on right arm on 17Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included depression, anxiety, attention deficit hyperactivity disorder (ADD). Concomitant medication included celecoxib (CELEXA), dexmethylphenidate hydrochloride (FOCALIN), ibuprofen, paracetamol (TYLENOL). No other vaccine in four weeks. The patient had no COVID prior vaccination. The patient had no COVID tested post vaccination. The patient previously took cefixime (FLEXERIL) and experienced drug hypersensitivity, naproxen and experienced drug hypersensitivity. On first day after vaccine the patient experienced sore arm, weird taste in mouth, tingling lips, feeling very cold, pain ache under armpit, neck pain, headache moving around and off and on, tingling legs, all on 17Jan2021 08:45. No treatment received for the events. The outcome of the events was unknown.
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| 51 | 2021-01-28 | fatigue, dizziness |
cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble...
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cold frostbite like hands and feet; dizziness when warmed up too quickly; racing heart rate; trouble finding words; extreme fatigue; nausea; achiness at joints; swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient herself). A 51-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (vaccine location: left arm), on 23Dec2020 17:00, at single dose, for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes - all on 24Dec2020. These symptoms never left up until day 21 when the patient received her next shot. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination, and had not been Covid-tested post vaccination. It was unknown if treatment was received for the adverse events. The patient was recovering from the events.
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| 51 | 2021-01-28 | dizziness |
vertigo; dizzy; nauseated; This is a spontaneous report from a contactable consumer, the patient. A ...
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vertigo; dizzy; nauseated; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249), via an unspecified route of administration in the left arm on 16Jan2021 at 15:30 PM (at the age of 51-year-old) as a single dose for COVID-19 vaccination. Medical history reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN), sertraline hcl (ZOLOFT), zolpidem tartrate (AMBIEN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jan2021 at 07:00 AM, the day following her vaccine, the patient had severe vertigo. It lasted most of the day. She was extremely dizzy and felt nauseated. She did not throw up, however. The patient did not receive any treatment for the events. The clinical outcome of the events vertigo, dizzy, and nauseated was recovered on unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 51 | 2021-01-30 | dizziness, cough | Throat closing, palpitation, lightheadedness, cough with bronchospasm |
| 51 | 2021-01-31 | chills, headache, fatigue |
1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and ...
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1st shot on 1/5/2021 felt really tired and fatigued. Woke up at 5:30am on 1/6/2021 with chills and a headache. Some light swelling and soreness at the injection site on the left arm. 2nd shot on 1/26/21 @ 4:15pm. Right arm swollen, muscle very sore and tight feeling. Some bruising. Half dollar sized knot at the inject site.
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| 51 | 2021-01-31 | chills, fatigue, headache |
diarrhea; tired; headache; chills; This is a spontaneous report from a contactable other HCP (patien...
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diarrhea; tired; headache; chills; This is a spontaneous report from a contactable other HCP (patient). A 51-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration in left arm on 16Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing Diabetes, Type 2 (Caller was diagnosed with this about 10 to 15 years ago), patient states that she has noticed that her blood sugars have gone up a bit. Patient states that she thinks that her sugars are up just because of stress on the body, because she had cancer and when she was going through her cancer, her sugars were all out of whack. Patient states that any time her body is stressed her sugars will go up. There were no concomitant medications. Patient states that she got the COVID Vaccine on Saturday 16Jan2021, and since then on 17Jan2021, she has been really tired, has a headache, and has chills; but caller states that all that is normal side effects that she read about. Caller states that the side effect she is concerned about is diarrhea, and she is wondering if that is a known side effect of the product. Caller received the vaccine on Saturday 16Jan2021, and her symptoms all started the next day on 17Jan2021. Caller confirms all symptoms are still ongoing but they have all improved. Caller confirms that she received no other vaccines on the same day as the COVID vaccine. The outcome of the events was recovering.
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| 51 | 2021-02-01 | fatigue, malaise, chills |
Developed chills with aching long bones (thighs, low back, upper arms) early evening after injection...
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Developed chills with aching long bones (thighs, low back, upper arms) early evening after injection. Profound malaise and fatigue with same pain and chills next day and continuing until 2/1/2021.
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| 51 | 2021-02-01 | headache |
Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instruc...
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Systemic: Headache, Systemic: Other- Staff Member complained of metallic taste and headache. Instructed to lay down, BP was elevated, continued to rise. Contacted 911, patient transported to hospital, admitted and disharged next day. Symptoms lasted 1 day
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| 51 | 2021-02-02 | headache, fever |
On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my n...
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On Friday, 1/29, after receiving the vaccine, I experience a headache, sharp right side pain in my neck, jaw, and ear. On Saturday, 1/30, I woke up, and the right side of my face was numb, and my right eye would not blink. I went to ER. When they took my vitals, I had high blood pressure and fever. They did a CT scan of my head and admitted me. I was diagnosed with Bell's Palsy. I was discharged on Sunday, 1/31, with medications: Valacyclovir 1 gram three times a day and Prednisone 20 mg three times a day. I was instructed to followup with a neurologist, immunologist, ophthalmologist, and my primary care physician.
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| 51 | 2021-02-03 | dizziness, chills, headache, fatigue, discomfort |
chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm...
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chills; headache; could not sleep; dizzy; nausea; she is very, very tired; feeling bad; her left arm is killing her; pain was in her body/whole body was killing her; not able to walk; whole body joint pain; feeling cold and warm; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248, expiry date not reported), intramuscular on the left arm on 19Jan2021 10:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiry date not reported), intramuscular on the left arm on 29Dec2020 10:15 for COVID-19 immunization and experienced arm was sore and hurting. The patient reported that she just got the second dose of the vaccine yesterday (19Jan2021). She had a really bad side effects. With the first dose only her arm was sore and hurting, states it was nothing, she did not have side effects. With the second dose her left arm is killing her on 19Jan2021. She clarifies the side effects that she is experiencing are whole body joint pain and muscle pain on 19Jan2021, chills on an unspecified date, nausea on 20Jan2021, headache on an unspecified date, and she is very, very tired on 19Jan2021. She received the second dose of the vaccine around 10:15 am yesterday and she went to work and she was ok. About 12 hours later on 19Jan2021 she started feeling bad, by 10-10:30pm her whole body was killing her and she was not able to walk. Around 11:15pm she had to talk to her supervisor since she was not able to work. She was experiencing the whole body pain and muscle pain. She did not have nausea or dizziness last night. She could not sleep last night, she was not comfortable in bed since she was in pain, her pain was in her body. She started feeling dizzy and nauseous this morning (20Jan2021) when she was getting out bed. States she could not even drive, she wish she had someone that could have picked her up from work since it was horrible. She reported all night she was feeling cold and warm, yesterday she felt warm and she thought she had a fever and when she checked her temperature she did not have a fever. Her temperature this morning was 97.5. Right now she feels freezing, the chills. The patient underwent lab tests and procedures which included body temperature: 97.5 on 20Jan2021. The patient did not recover from her left arm is killing her, whole body joint pain, feeling cold and warm, muscle pain, nausea, very tired, and dizziness while the outcome of the rest of the events was unknown.
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| 51 | 2021-02-08 | fatigue, migraine, headache, sweating, fever, chills, dizziness |
yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 10...
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yesterday started a flare up but she is not sure if this is related to the vaccine use; fever/was 105.00 with Tylenol; increased dizziness/light-headed; body aches; severe headache; nausea; chills; sweating/sweats; Fatigue; feeling crappy; blood pressure tends to be low but was 95/81 at the time she got the shot; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 25Jan2021 this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration on 19Jan2021 17:45 at single dose on the left arm for COVID-19 immunization. Medical history included ongoing severe Crohn's disease, pneumonia, allergy to eggs/anaphylactic reactions to eggs, anaphylactic with bee stings on 2020 (this has happen twice in 2020), collapsed her lung (reaction to anesthesia that collapsed her lung), high fever, anaphylactic reactions. Concomitant medication included sertraline (SERTRALINE), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took Hep B and experienced fever, flu like symptoms, achy, and lethargic (no issue with the first 2 doses but with the 3rd dose she had a high fever); MMR and had an adverse reaction. It was reported that the shot was given on 19Jan2021. She experienced the following severe dizziness which started that day (17:45) and lasted 3 days. It has resolved. Nausea which started that day (17:45) and stayed constant for 3 days. Now it has only been happing in the late afternoons or evenings. Light headed which started that day and last 3 days. Headache (17:45), the initial headache felt like her whole head was going to explode into a 1000 piece. Now it just starts about 4-5pm in the evening. It was better and not as severe but like a migraine with nausea (17:45), feeling crappy (17:45), and body aches. Body aches which started on the day of the shot (17:45) and lasted 3 days. Fatigue which started on the day she got the shot (17:45) and was ongoing in the evening now chills and sweats which started on the day she got the shot and was ongoing. Her husband asked about if this was being related to the change of life but she doesn't think so. Fever which happened on the day she got the shot (17:45) but not at the site, later that night and was 105.00 with Tylenol. It has resolved. She noted that her blood pressure tends to be low but was 95/81 at the time she got the shot (17:45). The patient has not taken her blood pressure and does know if this has resolved. It was relayed that she took Tylenol and Benadryl before the shot due to her history and was still taking it as treatment for the symptoms. She has a lot of drug and other allergies, the only that was anaphylaxis was bees and egg. This was why she brought 2 EpiPens when she had the shot. She didn't have to use her EpiPen and was really proud of that but did have some reactions. The patient reported she did not go to the doctor. At this point she was somewhat expected that she had a not great reaction so the fact that she could still breath after getting it was a good thing. She also noted she could not have driven home due to dizziness. The patient was not brought to the emergency room and did not went to a physician's office. The patient has an ongoing medical history of Crohn's disease and reported that yesterday (as reported) started a flare up but she was not sure if this was related to the vaccine use. The patient recovered from fever on 23Jan2021; was recovering from dizziness, body aches, severe headache, nausea, chills, sweating, and fatigue; while outcome of blood pressure tends to be low, feeling crappy and Crohn's flare up was unknown.
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| 51 | 2021-02-10 | headache, dizziness, throat irritation |
2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch...
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2 hrs after 2nd injection, felt like i was burning from inside out; skin red; flushed; rash; scratch throat; body aches; dizziness; headache; lymp nodes tender; eye swelling; blurred vision; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; blisters on the trunk of my body as well as lips and gums; tooth pain; jaw pain; i also had leg and bilateral foot pain x 4 days; all my mucos membranes were red, irritated and blistered; all my mucos membranes were red, irritated and blistered; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 19Jan2021 10:45 at a single dose on left arm for COVID-19 immunization. Medical history included allergies: sulfa. Concomitant medication included bupropion (BUPROPION). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient experienced 2 hrs after 2nd injection, 'felt like I was burning from inside out', Skin red, flushed, rash, scratch throat, temp, body aches, dizziness, headache, lymph nodes tender, eye swelling, blurred vision, 'blisters on the trunk of my body as well as lips and gums', tooth pain, jaw pain. All of these symptoms lasted 3 days (as reported), blisters and gum issues lasted 4 days (as reported). Patient also had leg and bilateral foot pain x 4 days. All mucous membranes were red, irritated and blistered. The adverse events were experienced on 19Jan2021 12:30. Therapeutic measures were taken as a result of the events which included Benadryl, steroid injection. The outcome of the events was recovering (as reported). Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 51 | 2021-02-14 | weakness |
Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up t...
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Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.
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| 51 | 2021-02-19 | throat swelling |
Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treate...
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Itching began about 12 hours after the second injection. Followed by moderate patchy hives. Treated with OTC Benedryl, Pepcid, and Zyrtec. Had a decrease in itching and mild improvement in the rash. At about 26 hours post-vaccination itching and severe hives developed a sought treatment in the emergency department for severe hives, severe itching, throat swelling, and hoarseness in voice. Was treated with solu-medrol, Pepcid, and Benedryl. Sent home with steroids and Benedryl. Then on 2/20/2021 began to develop throat swelling and voice hoarseness again. Sought the emergency room again for the same treatment list above.
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| 51 | 2021-02-21 | headache |
Difficulty swallowing within minutes of vaccination. no progression of this symptom and also develo...
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Difficulty swallowing within minutes of vaccination. no progression of this symptom and also developed a mild headache to base of skull. chest feels a little tight. 12.5 mg of Benadryl given about 30 minutes in to observation. After another 50 minutes, headache gone, chest pressure less, and swallowing improved. patient advised to return to ED if symptoms returned or worsened.
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| 51 | 2021-02-21 | headache, sweating, weakness, influenza like illness, fever, fatigue, chills |
Flu-like. Headache, sweats/chills, fever (100.1), tired, body aches - for 2 days Body aches/tired ...
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Flu-like. Headache, sweats/chills, fever (100.1), tired, body aches - for 2 days Body aches/tired - continuing for 1 week Tired/low energy - for 2 weeks.
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| 51 | 2021-02-21 | weakness, dizziness, shortness of breath |
Lightheaded, dizziness. Weakness on the side of the injection. No energy and shortness of breath wit...
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Lightheaded, dizziness. Weakness on the side of the injection. No energy and shortness of breath with activity ongoing. Patient normally very active and has not chronic conditions
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| 51 | 2021-02-21 | discomfort |
Mild discomfort; This is a spontaneous report from a contactable consumer, the patient. A 51-years-o...
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Mild discomfort; This is a spontaneous report from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received the first dose of bnt162b2 (BNT162B2, lot number: EL-1283) , via an unspecified route of administration in the left arm (at 51 years of age) on 22-JAN-2021 at 13:00 as a single dose for Covid-19 Vaccination. Medical history included hypertension and Hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID), hydrochlorothiazide, losartan potassium (HYZAAR). The patient had no known allergies. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 22Jan2021 at 14:30, the patient experienced mild discomfort. No treatment was given for the event. The clinical outcome of the event mild discomfort was unknown.
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| 51 | 2021-02-21 | headache, migraine |
Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. Th...
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Ten minutes after, I had sharp pain on my left temporal and they took my vitals. BP was elevated. They asked me what are my allergies and medical history. I couldn't remember - so had brain fog at that time. My left ear, face, and neck (left side of head) is numb at that time. The symptoms were the same for two hours. Memory remained fogged. An hour or so after the incident - I called the advice nurse from medical clinic and I did remember the doctor's name. Pain on head and numbness remained for days. My auto-immune system was stimulated my doctor said. Everything kept cascading down - now I'm on post surgery 9 days and I'm on disability. I went to ER on January 18, I was complaining of left sided numbness, vomiting, headaches. Facial numbness (left), mild headaches. Left sided headache progressed to (similar to prior migraine headaches) migraine like. January 29, I emailed my physicians (in between the 17th and 29th). On the 29th, I went to see the doctor - joints - really swollen and painful and I cannot walk. I was given steroid shots. February 2, - appt with neurologist. February - with Dr. - for painful swollen feet; Feb 10 - appt with Rheumotologist - Feb 10 with Dr - a Specialist - , as well. Right foot is swollen as well as the left foot at this time. Dr. - axperatated the right ankle -he said it was infected. February 11, Dr said I have infected joints and need surgery. They did surgery on February 13th. Dr. the surgeon . Had surgery at medical facility for infected ankle. February 15 - discharged home. Appt with surgeon on the 16th. Appt with Primary on the 19th. Appt with my Rheumotologist today. Discharged - with Home Health care; Physical and Occupational therapist and nursing. I have been on bedrest since discharge. I need maximum care. Tomorrow I have a appt with surgeon to hopefully remove cast and sutures on surgical site.
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| 51 | 2021-02-21 | fatigue | The day after felt very fluish. Very fatigued and had swollen lymph node above right collar bone. |
| 51 | 2021-02-22 | chills, fatigue, headache, sweating, fever |
A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headac...
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A little over 24 hours after my second dose I started to feel muscle aches, a fever of 102.4, headache, chills, fatigue, diarrhea, sweating, injection site pain, stomach pain and upset. I have been taking Tylenol and Ibuprofen to help with the aches and pains and NyQuil at night to help with fever and aches. It is helpful. I have been eating a BRAT diet and drinking a lot of vitamin water with 0 sugars.
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| 51 | 2021-02-23 | fatigue |
Exhausted; Night terrors; This is a spontaneous report from a contactable consumer, the patient. Thi...
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Exhausted; Night terrors; This is a spontaneous report from a contactable consumer, the patient. This 51year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), DOSE 1, single dose via unknown route of administration in the left arm on 25Jan2021 about 3:45pm (at the age of 51 years-old) for COVID-19 vaccination. Medical history included ongoing severe asthmatic onset date unknown, probably during childhood but worsened with age and became really bad after hurricane, ongoing irregular heartbeat, ongoing menopause, ongoing food allergies includes banana peppers, jalepenos and nuts; anything spicy; these cause anaphylactic reactions where her throat is itching and swells, ongoing Hashimoto's disease, thyroid, endocrine abnormality and compromises immune system, to keep her brain going through menopause, seizure disorder and high blood pressure. Past drug events included Demerol-Vistaril: ate part of her leg away, top layer of her leg just fell off; she had all the skin done and had plastic surgery to repair this in 1988; Lot/NDC/Expiry: Unknown, does not have product, anaphylactic reactions to: penicillin: Lot/NDC/Expiry: Unknown, does not have product; clindamycin: Lot/NDC/Expiry: Unknown, does not have product; sulfa: Lot/NDC/Expiry: Unknown, does not have product; Darvocet: Lot/NDC/Expiry: Unknown, does not have product; Ceclor: Lot/NDC/Expiry: Unknown, does not have product. There was no family medical history relevant to events, night terrors and exhausted. Concomitant medications included atenolol 12.5mg taken once daily (1/2 of 25mg tablet) for irregular heartbeat, levothyroxine 125mcg taken once daily for thyroid, bupropion (WELLBUTRIN) 300mg taken once daily for menopause, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 20mg extended release taken once daily to keep her brain going through menopause, topiramate (TOPAMATE) 25mg taken once daily for seizure disorder and lisinopril 10mg taken daily for high blood pressure. On 26Jan2021, the patient had night terrors where she started screaming in her sleep at midnight and was exhausted at 05:00 and ongoing. There were no relevant tests. The night terrors and exhausted did not require a visit to the physician's office or emergency room. The clinical outcome of night terrors was recovered with sequel and not recovered for exhausted. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None.
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| 51 | 2021-02-23 | fatigue |
joint pain; muscle ache; fatigue; This is a spontaneous report received from a contactable consumer....
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joint pain; muscle ache; fatigue; This is a spontaneous report received from a contactable consumer. A 51-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 04Jan2021 (lot number and expiry date unknown), at single dose; then received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 25Jan2021 (lot number and expiry date unknown), at single dose, for COVID-19 immunization. Medical history included type 2 diabetes mellitus (reported as "t2dm"). The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in four weeks. The patient experienced joint pain, muscle ache and fatigue in Jan2021. Treatment for the events included APAP. The patient was tested for COVID-19 post vaccination in Jan2021 thru nasal swab with unknown results. The patient was recovering from the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
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| 51 | 2021-02-25 | chills, headache |
Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea...
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Body aches; Joint pains; Chills; Right arm injection muscular pain radiating to elbow; Slight nausea; Slight headache; Right arm injection muscular pain radiating to elbow; This is a spontaneous report from a contactable Nurse. This 51-year-old female Nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3246), intramuscular at right arm on 25Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included HTN, cholesterol, known allergies: sulfa. Historical vaccine included the first dose of BNT162B2 (lot number=EJ1686) on 04Jan2021 13:00 via intramuscular at left arm for COVID-19 immunization. Concomitant medication included amlodipine, rosuvastatin calcium (CRESTOR), clonazepam. On 26Jan2021 12:00, patient had body aches, joint pains, chills, right arm injection muscular pain radiating to elbow, slight nausea, slight headache with outcome of unknown. No treatment was received. The patient underwent lab tests included COVID-19 virus test (nasal swab): negative on 10Jan2021. Patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination.
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| 51 | 2021-02-28 | dizziness |
Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Numb...
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Stomach cramps; arm soreness; severe vertigo; nausea; unable to get up or walk; dizziness; Dose Number 2, Date of start of drug 21Jan2021/ Dose Number 1, Date of start of drug 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 51-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249, expiration date: unknown), via an unspecified route of administration on the left arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: unknown) in the left arm on 29Dec2020 at 15:00 (3:00PM) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jan2021 at 04:00, the patient experienced stomach cramps and arm soreness for two days. On the same day, the patient experienced severe vertigo with nausea and was unable to get up or walk. The following day, 24Jan2021, vertigo was slightly less. On the fifth day, the patient was still having some dizziness and nausea. No treatment was administered for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The events stomach cramps and arm soreness resolved in 25Jan2021, and the events nausea, unable to get up or walk and dizziness had not resolved, while the event severe vertigo was resolving.
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| 51 | 2021-03-02 | shortness of breath |
51 y/o female, no chronic health problems. 14 days following first COVID Pfizer vaccine, I felt unab...
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51 y/o female, no chronic health problems. 14 days following first COVID Pfizer vaccine, I felt unable to take a deep breath, on day 15 following the vaccine, I became short of breath,; on day 16 I was having mild chest pain with inspiration and shortness of breath; day 17 following vaccination I became significantly short of breath, with moderate to severe chest pain with inspiration and tachycardia (heart rate in the 140's). I called my PCP who ordered an EKG, CXR, COVID swab, a metabolic panel, a CBC, and a D-dimer. My D-dimer was elevated and he called me to go directly to the emergency department, which I did and had a CTA chest. I was diagnosed with multifocal pulmonary emboli in my right lung with a slight pleural effusion on my left lung. I had a duplex ultrasound of my legs which was negatve for DVT, and an echocardiogram which was within normal limits. I was finally diagnosed with acute unprovoked pulmonary embolism, given a Heparin bolus and started on a Heparin IV infusion. Ultimately, I transitioned to Eliquis PO and was discharged from the hospital within 24 hours.
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| 51 | 2021-03-02 | fever, chills, headache |
Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a ...
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Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264, expiration date was not reported), via an unspecified route of administration on the left arm on 30Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Sulfa allergy, penicillin allergy, COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol. The patient experienced fever over 100, headache, chills, joint soreness and arm soreness on 31Jan2021 at 04:00 am. No treatment was given in response to the events. Outcome of the events was unknown.
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| 51 | 2021-03-02 | chills |
I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administratio...
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I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration; left arm soreness onset evening of vaccine for about 1.5 days; This is a spontaneous report from a contactable nurse (also the patient). A 51-year-old female (also the age at vaccination) patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3248), via an unspecified route of administration at the left arm on 07Jan2021 14:40 (also reported as 02:45 PM) at SINGLE DOSE for Covid-19 immunization. The patient was vaccinated at a Hospital. The patient is not pregnant at the time of the report. Medical history included Environmental allergies: some trees and grass (also reported as Known allergies: No). The patient had no COVID prior to vaccination. Th patient was not COVID tested post vaccination. No other vaccine in four weeks. Concomitant medication included (reported as Other medications in two weeks) bupropion hydrochloride (WELLBUTRIN), loratadine, pseudoephedrine sulfate (CLARITIN-D), montelukast sodium (SINGULAIR), diphenhydramine hydrochloride (BENADRYL), vitamin d nos (VITAMIN D NOS) and MVM (exact meaning unspecified). It was reported that: "Administration time on my paperwork was documented incorrectly; I received 07Jan2021 dose at 2:40pm and not the 1:40pm time that is documented. I experienced Abdominal cramping, chills, and diarrhea onset within 3 hours of vaccine administration (reported as 5:30 PM), lasting about 2 hours and resolved; left arm soreness onset evening of vaccine for about 1.5 days." The patient was not treated for the events. The outcome of the events was recovered.
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| 51 | 2021-03-04 | chills |
Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several ho...
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Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; Muscle soreness at injection site. Chills starting 18 hours after injection & lasting for several hours.; This is a spontaneous report from a non-contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL3248), via an unspecified route of administration in the right arm 02Feb2021 08:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure. She had her first dose of bnt162b2 (lot EL3248) in the right arm and she had muscle soreness at injection site. Concomitant medications included lisinopril, amlodipine and potassium. The patient experienced muscle soreness at injection site and chills starting 18 hours after injection & lasting for several hours on 02Feb2021, no treatment reported. The outcome of events recovered. No follow up attempts are possible. No further information is expected.
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| 51 | 2021-03-07 | fever, headache |
Fever; aches and pains; headache; This is a spontaneous report from a contactable consumer (patient)...
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Fever; aches and pains; headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (brand=Pfizer), via an unspecified route of administration (right arm) on 02Feb2021 08:30 at a single dose for COVID-19 immunization at a workplace clinic. Medical history included allergies to macadamia nuts. There were no concomitant medications. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (brand=Pfizer) on 14Jan2021 07:30 AM (vaccine location= left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced fever, aches and pains, headache on 03Feb2021 05:00 AM. No treatment received for the events. The events were reported as non-serious (did not result to death, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, and not congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 51 | 2021-03-16 | fever |
4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. ...
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4-6 hours post vaccine, mild fever, pain at injection site left arm, itchiness and bumps all over. Ibuprofen and Benadryl 50mg taken. Symptoms resolved. 5 days later, tinnitus in right ear occurs and has been ongoing since then.
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| 51 | 2021-03-18 | headache, fatigue, shortness of breath |
Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flu...
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Headache; her whole left arm and left hand are sore; allergic reaction; left arm started feeling flushed; her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm; upper part of her left arm started turning pink, and then red; burning feeling in her left hand fingers; her left hand got numb and tingly; her left hand got numb and tingly; her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers; the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey"; blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021; she looked like she had hives; rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist; there is a flush color around the vaccine injection site, but not on the vaccine injection site; Injection site pain/injection site is sore; left shoulder is warm to the touch around her COVID-19 Vaccine injection site; she looked completely wiped out, and pale; looked completely wiped out/Tiredness; Short of breath; her pulse was 101; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 21Feb2021), via an unspecified route of administration in the left arm, on 17Feb2021 15:40, as single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from 2012 to (diagnosed with Type 2 Diabetes Mellitus almost 9 years ago), neuropathy in her feet/nerves and reported that she only turns pink if she gets overheated. There were no concomitant medications. The patient did not receive any prior vaccinations within 4 weeks. Historical vaccines included influenza vaccine (reported as flu vaccine) which she gets every year and pneumococcal vaccine (reported as pneumonia vaccine) which she gets every 5 years. The patient reported that she received her first Pfizer COVID-19 vaccine on 17Feb2021 and had an allergic reaction. She said she was at a podiatry appointment, and her podiatrist told her the pharmacy had an extra COVID-19 Vaccine available. She said the pharmacy staff came to her podiatrist's office to administer her COVID-19 Vaccine. She said about 5 minutes after she received the COVID-19 Vaccine injection, on 17Feb2021 15:45, her left arm started feeling flushed, her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck. She said 20 minutes later, she walked from her podiatrist's office to a nurse's station to be monitored further. She said while she was at the nurse's station, a doctor came by twice to evaluate. She clarified the upper part of her left arm started turning pink, and then red. She said her podiatrist asked her if that was a normal reaction for her. She said she told her podiatrist she only turns pink if she gets overheated. She said her left hand got numb and tingly. She said the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were "twingey". She said her podiatrist and his nurse felt both her arms, and said her left arm was much warmer than her right arm. While she was at the nurse's station being monitored, she felt short of breath. She said she wasn't sure if she was short of breath because of her nerves. She said her oxygen level was checked and it was at 99%. She said her pulse was 101, her blood pressure was 118/76, and her blood glucose finger stick test was 128. She said she was told by the staff monitoring her, she should expect her blood glucose number to skyrocket because there is a steroid in the COVID-19 Vaccine shot. She said the staff also mentioned she can expect blood glucose spikes as the COVID-19 Vaccine's steroid goes through her system. Her fingers in her left hand became itchy while she was at the nurse's station being monitored. It was a deep down itch in her left hand fingers. She said she asked for an ice pack to put on her left hand because she uses ice packs for neuropathy in her feet, and she felt an ice pack would help with the itch and burning feeling in her left hand fingers. The doctor came to look at her again and wanted to give her IV Benadryl. Then the doctor decided against the IV Benadryl because she would be too sleepy to drive home but the doctor did eventually give her an intramuscular injection of Benadryl 25mg (clarified as Diphenhydramine 25mg in a syringe) in her upper right arm. Within 5 minutes the itching in her left hand fingers calmed down, and the redness in her left arm calmed down to a pink color. She said 20 minutes later her left arm was still pink and warm. She said she was told by the doctor if her reaction moved out of the localized area of her left arm, to go to the Emergency Room, and to use an icepack, again, on her left hand. When she arrived home, her husband said she looked like she had hives and a rash going down her left arm. Her left arm was not itchy though. She clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist. She reported that while she was at her podiatrist's office her left arm was a solid pink. She then mentioned that when she goes out in the sun and gets overheated, she turns pink. She said from her left shoulder to left elbow was warm to the touch. She said by the COVID-19 Vaccine injection site there is a flush color around the vaccine injection site, but not on the vaccine injection site. She said the COVID-19 Vaccine injection site is sore and her left shoulder is warm to the touch around her COVID-19 Vaccine injection site. She reported there were no blotchy, red marks on her left arm on 18Feb2021. She said her left arm is a pretty normal on 18Feb2021. The nurse who monitored her after the COVID-19 Vaccine shot said she needed to report her allergic reaction. She was told she needs to let the COVID-19 Vaccine staff know of her reaction before she gets her second COVID-19 Vaccine injection, so she can be monitored closely. She took no other treatment after she returned home from receiving her COVID-19 Vaccine. She reported she had a headache on 18Feb2021, clarifying her whole head hurts, and the headache has been persisting all day. She said she experienced tiredness, as well. She said the tiredness started on 17Feb2021 and can be partially attributed to the Diphenhydramine 25mg injection she was given. Her husband told her she looked completely wiped out, and pale when she got home after getting her COVID-19 Vaccine on 17Feb2021. She said she remembers being tired when she got home because her eyes were squinty. She reported feeling more tired on 18Feb2021 and her whole left arm and left hand are sore. She clarified her blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021. The patient recovered from the events "her fingers in her left hand became itchy/it was a deep down itch in her left hand fingers" on 17Feb2021; from "upper part of her left arm started turning pink, and then red" and "rash going down her left arm/clarified the blotchy red marks go in a line from the inside of her top left elbow down to her left wrist" on 18Feb2021; from "her left hand got numb and tingly", "the muscles in her left arm between the inside of her left elbow down to the inside of her left wrist were twingey", short of breath, "burning feeling in her left hand fingers" and "she looked completely wiped out, and pale" in Feb2021; was recovering from "left arm started feeling flushed"; has not recovered from "her left arm started getting hot, and the hot sensation traveled down her left arm to her left hand, and up to her left shoulder and neck/her left arm was much warmer than her right arm", "blood glucose was at 295 when she checked before bedtime of 17Feb2021, and at 185 before breakfast in the morning of 18Feb2021", "there is a flush color around the vaccine injection site, but not on the vaccine injection site", "Injection site pain/injection site is sore", "left shoulder is warm to the touch around her COVID-19 Vaccine injection site", "looked completely wiped out/Tiredness", "Headache" and "her whole left arm and left hand are sore". The outcome of the events allergic reaction, "her pulse was 101", "she looked like she had hives" was unknown.
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| 51 | 2021-03-18 | shortness of breath |
difficulty breathing had to be rushed to the ER.; COVID (nasal swab/rapid) tested post vaccination w...
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difficulty breathing had to be rushed to the ER.; COVID (nasal swab/rapid) tested post vaccination was positive; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204), via an unspecified route of administration, on right arm, on 08Mar2021 15:45 (at the age of 51-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included allergies to latex, lactose, gluten; celiac disease, lactose intolerant, and had COVID prior vaccination. Concomitant medications included levothyroxine sodium (LEVOXYL), omeprazole (PROTONIX), tramadol, diclofenac and benzoate. No other vaccine in four weeks. Past drug included morphine and had allergies. On 09Mar2021 15:00 (also reported as "24 hours next day"), The patient experienced difficulty breathing had to be rushed to the ER (emergency room), and resulted in emergency room/department or urgent care and life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures, which included on 09Mar2021 COVID (nasal swab/rapid) tested post vaccination was positive. Therapeutic measures were taken as a result of event "difficulty breathing" and included treatment with "IV drip of vaccine" (as reported). The outcome of the event "difficulty breathing" was recovering, of event "COVID (nasal swab/rapid) tested post vaccination was positive" was unknown.
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| 51 | 2021-03-21 | shortness of breath |
Burning sensation started in my left chest area through to the back of the left shoulder blade. Then...
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Burning sensation started in my left chest area through to the back of the left shoulder blade. Then a light of tightness and hard to breath in the middle of my chest near my throat. then a later that day into the next day burning sensation in the very middle of my chest.
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| 51 | 2021-03-21 | dizziness | c/o of dizziness after the vaccine was administered |
| 51 | 2021-03-21 | dizziness | c/o of dizziness after vaccination during the post vaccine observation period. |
| 51 | 2021-03-21 | shortness of breath |
chest was a little tight; short of breath; 04Mar2021 7 am patient felt heart palpitation which woke ...
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chest was a little tight; short of breath; 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes/patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150; This is a spontaneous report from a contactable Nurse (patient herself). A non-pregnant 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: E16198), via an unspecified route of administration, administered at Right arm on 02Mar2021 15:00 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history included: Diabetes, hypertension, asthma, vitamin D deficiency, known allergies: Serevent inhaler. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included lisinopril, cefixime (FLEXERIL), colecalciferol (VITAMIN D). On 04Mar2021 7 am patient felt heart palpitation which woke her up. Patient's heart rate was jumping from 50-70 lasting 15 minutes. Then at 15:00, the patient felt heart was racing and patient used the pulse OX which showed heart jumped back and forth from 140-150, chest was a little tight and short of breath. No chest pain. Patient went to hospital. The patient was hospitalized in Mar2021 for all events. Patient still get heart racing on and off. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for all events. The outcome of the events was Not recovered.; Sender's Comments: Pending the investigational results and clinical diagnosis, the company does not attribute the events palpitation, chest tight and short of breath to BNT162B2. The underlying hypertension, diabetes and asthma are considered as risk factors for developing the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 51 | 2021-03-22 | shortness of breath, dizziness |
Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/2...
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Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/21
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| 52 | 2020-12-31 | discomfort |
10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ...
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10MINS AFTER THE VACCINATION LEFT SIDED FACIAL NUMBNESS . HIGH B/P 172/112 O2 SAT 98% HR 72, RR18. ANXIETY. SMILE SYMETRICAL PROTRUDING TOUNG CENTERED. @10:45AM B/P 153/93 @10:58 AM B/P 146/89 @11:15AM EMERGENCY SERVICES WERE OFFERED SEVERAL TIMES BY RPH ( PATIENT REFUSED) . PCP WAS NOTIFIED BY FNP - B C . MEDICAL DIRECTOR DR SPOKE TO PATIENT OVER THE PHONE DIRECTLY. NO PARLYSIS WAS DETERMINED. PATIENT COULD FEEL A PINCH IN THE AFFECTED AREA. PATIENT STATED THE REACTION ABATED BEFORE THE END OF THE CLINIC @12:30PM
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| 52 | 2020-12-31 | malaise, sweating, dizziness |
Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my thr...
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Flushing, sweating, increased heart rate proceeded to feel difficulty swallowing and clearing my throat. I was taken to the ER. The symptoms progressed to feeling dizziness, difficulty speaking, and chest pressure with increased SBP/DBP. General nausea and feeling very unwell.
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| 52 | 2020-12-31 | discomfort, headache | Tinnitus, worse in left ear. Heavy feeling all over. Headache, Tylenol 500mg q6h. |
| 52 | 2021-01-01 | fever, chills, fatigue, headache |
12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2...
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12/29/2020 (date of injection) soreness at injection site, Headache & increased Heart Rate. 12/30/2020 Headache, Chills, Body Aches, Fatigue. 12/31/2020 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/1/2021 Headache, increased Chills, increased Body Aches, increased Fatigue, feeling Feverish (not able to do ADL's). 1/2/2021 All symptoms are getting better, still slightly there.
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| 52 | 2021-01-01 | chills, fatigue, headache | headache, chills, fatigue, nausea starting 1-2 hours after vaccine dose and lasting 7 days |
| 52 | 2021-01-02 | shortness of breath |
About 5 mins after vaccine was received patient started wheezing, felt like her throat was closing. ...
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About 5 mins after vaccine was received patient started wheezing, felt like her throat was closing. Difficulty breathing
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| 52 | 2021-01-02 | shortness of breath |
Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for ...
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Pfizer-BioNTech COVID-19 Vaccine EUA Slight chest pain and slight difficulty taking deep breath for a few seconds it - did not go past 15 minute observation. Felt nauseated for a brief time - did not go past the 15 minutes. About 25 minutes after the tip of my tongue, section of my bottom lip and sides of my tongue were tingly. The tip of my tongue continues to be like that day #2 after and there is a small blood blister underneath the tip of my tongue. Parts of my body feel a little itchy an hour after vaccine and continues very infrequently at this time and it disappears in seconds.
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| 52 | 2021-01-03 | fatigue | Arm pain, extreme fatigue, muscle spasm (charley horse) in left inner thigh, shin and foot. |
| 52 | 2021-01-03 | headache | Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face) |
| 52 | 2021-01-03 | fever |
I started to develop a fever 2-3 days after the first vaccine. My fever continued for 9 days straigh...
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I started to develop a fever 2-3 days after the first vaccine. My fever continued for 9 days straight, even though i was taking antipyretic
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| 52 | 2021-01-03 | fever, dizziness, fatigue |
Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The...
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Initially I had sore arm and very tired , which all resolved with in 24 hours of the vaccine. The morning of the 26th (day 3 after vaccine) , I woke up and felt great.. I took my normal 4- 5 mile run. I felt a little dizzy , & hungry when I ran (not my normal) , got home had diarrhea 1 x , then for next two days very faint GI discomfort and I had fever for two days , temp range 99-100
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| 52 | 2021-01-03 | fatigue, fever, headache, chills | Nausea, headache, muscle ache, exhaustion, chills, low grade fever, and pain at the injection site. |
| 52 | 2021-01-03 | fever | Temperature of 103 F, nausea, vomiting, diarrhea for 3 days |
| 52 | 2021-01-03 | cough, chills |
injection site was red and had a rash achy chills extreme joint pain on left side, hip, knee and ank...
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injection site was red and had a rash achy chills extreme joint pain on left side, hip, knee and ankle cough
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| 52 | 2021-01-04 | somnolence, headache, dizziness, nasal congestion, cold sweat, chills, fatigue |
1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received...
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1/4/21 around 10am became extremely nauseated, clammy, dizzy and hot. No temp and had just received COVID POC test and was negative. Left to go home and had loose stool then chills, body aches, hot spells, and extremely tired. Could not stay awake and was in brain fog. Slept all day, all night and all day on 1/5/21. No appetite, stuffy nose, headache, chills and hot spells, no fever, Again unable to stay awake.
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| 52 | 2021-01-04 | dizziness, cold sweat |
Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and c...
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Approximately 10 minutes after vaccine administration, patient developed chest pain, skin cool and clammy. Felt like heart racing. Dizzy. Radial pulse 88 and regular. BP 116/72. Patient declined going to the Emergency Department and was observed for approximately another 30 min, Chest discomfort subsided. Her husband ( an MD) came in and took her to his office for further observation.
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| 52 | 2021-01-04 | shortness of breath, fever, weakness, chills |
Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see prov...
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Chest tightness and minimally SOB; weakness, chills generalized feeling of being yucky; did see provider and CXR and EKG normal. States low-grade fever lasted couple of days.
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| 52 | 2021-01-04 | malaise, cough, fatigue, shortness of breath, fever |
I went home and took my daily nap. I was really tired and not feeling well. The next morning, I woke...
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I went home and took my daily nap. I was really tired and not feeling well. The next morning, I woke up with a fever and I had fatigue. I was also coughing and had SOB. The doctor said I needed to go to urgent care. I had a breathing tx and a steroid injection. I was told I also had a respiratory infection. I was also given steroid pills, antibiotics and pump. Still have a lingering cough.
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| 52 | 2021-01-04 | headache |
Mild to severe headache behind her eye and sinus area; Mild to severe headache behind her eye and si...
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Mild to severe headache behind her eye and sinus area; Mild to severe headache behind her eye and sinus area; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 21Dec2020 at 10:15 AM, at single dose, for COVID-19 immunisation. Medical history included peanut allergy, penicillin allergy and nut allergy (unknown if ongoing). Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient experienced mild to severe headache in Dec2020, days after the COVID-19 injection. Main complaint was headache behind her eye and sinus area. The event required physician office visit on 29Dec2020. It was unknown if the event required any treatment. The events was considered as non serious. The patient was unsure if this was related to the vaccine but informed the reporter. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 52 | 2021-01-04 | dizziness, fatigue, headache | Nausea, lightheadedness, headache, fatigue, sore/swollen arm |
| 52 | 2021-01-04 | thirst |
Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toe...
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Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
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| 52 | 2021-01-04 | throat swelling |
Tingling in throat; throat swelling; This is a spontaneous report from a contactable nurse (patient ...
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Tingling in throat; throat swelling; This is a spontaneous report from a contactable nurse (patient herself). A 52-year-old female patient received first dose of BNT162B2 (lot number: EH9899; expiry date: 31Mar2021), via an unspecified route of administration, on 28Dec2020 10:00 am (left arm), at a single dose, for COVID-19 vaccination. Relevant medical history included hypertension and seasonal allergies. Concomitant medication included levocetirizine dihydrochloride (XYZAL). The patient previously took losartan, sulfa, ultram, morphine, codiene, and lisinopril and experienced allergies. On 28Dec2020, at 10:15 a.m., the patient experienced tingling in throat and throat swelling. The patient received Benadryl as treatment for the events. Outcome of the events was recovering.
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| 52 | 2021-01-04 | somnolence, cough |
Wheezing; Cough; Profound sleepiness; This is a spontaneous report from a contactable other healthca...
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Wheezing; Cough; Profound sleepiness; This is a spontaneous report from a contactable other healthcare professional (HCP). A 52-year-old female patient received the first dose of bnt162b2 (lot number: EK9231), intramuscular on the left arm on 24Dec2020 at 11:30 at a single dose for immunization. Medical history included HBP, asthma, radicular pain and migraines. The patient's concomitant medications were not reported. The patient previously took tetracycline and experienced drug allergy. The facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19. On 26Dec2020 at 05:00, the patient experienced wheezing, cough and profound sleepiness, and was prescribed Proair Inhaler as treatment for the events. The outcome of the events was not resolved.
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| 52 | 2021-01-04 | headache, fever, fatigue |
chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a c...
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chest tightness; 103.8; Fatigue; body aches; headache; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). This 52-year-old female HCP reported for herself that she received 1st dose of BNT162B2 intramuscular at left arm on 28Dec2020 08:30 AM for Covid-19 immunization. Medical history included COVID-19 and concomitant drugs were not provided. The patient did not realize vaccine should be taken 90 days after a covid infection tested positive on 12Jan2020. The patient received vaccine on 28Dec2020, she experienced 103.8, fatigue, body aches, headache, nausea, and some chest tightness on 29Dec2020 at 09:00 AM. No treatment was received. The outcome of the events was resolving. The events were reported non-serious. Information about lot/batch number has been requested.
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| 52 | 2021-01-04 | headache, fatigue |
within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was m...
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within 20 of the injection I strted to salivate and feeling nauseated. returned to clinic and was monitor there. my blood pressure was noted to be low at 115/41. HR 74. reepat BP was 121/48 which is much lower than my usal BP. i was observed for about 1 hrs. the sx's did not go away but the BP improved a little to 130/64 standing. I went home develop injection site pain, fatigue, headache and the pesistent salivation did not go away. after 1 wk it decreased in frequency but still present today. I can not do my normal activity as this worsen the symptom. and my blood pressure has not normalized. still run in 110's/60's. the headaches and fatigue are becoming a burden.
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| 52 | 2021-01-05 | throat pain, fatigue, headache | Fatigue, severe headache, muscle aches. slight sore throat |
| 52 | 2021-01-05 | malaise, headache, chills, fatigue, fever | Feeling unwell, tiredness, fever, chills, joint pain, headache. muscle pain. nausea |
| 52 | 2021-01-05 | dizziness, shortness of breath, fatigue, headache, cold sweat, influenza like illness, throat pain |
Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in ...
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Felt dizzy Racing heart with chest pressure Some difficulty breathing Clammy palms Placed me in supine position Observation maintained until vitals returned to normal
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| 52 | 2021-01-05 | shortness of breath, fever, fatigue |
Fever of 103 F two nights in a row. Aches as bad as when I had Covid-19 in October. Shortness of bre...
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Fever of 103 F two nights in a row. Aches as bad as when I had Covid-19 in October. Shortness of breath. Fatigue.
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| 52 | 2021-01-05 | headache, fever | Fever, body aches, severe headaches, the vaccine site is hot and swollen and painful |
| 52 | 2021-01-05 | weakness, fever, fatigue |
Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER ...
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Fever, pain below the injection site, fatigue/weakness, facial swelling; her PCP sent her to the ER for IV fluids and oral Tylenol.
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| 52 | 2021-01-05 | fever | Fever- tmax 101.2. Duration approx. 10-12 hours |
| 52 | 2021-01-05 | throat pain, night sweats, malaise, headache, cough, chills, runny nose, fever |
Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, n...
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Headache, chill, body aches, fever, malaise, runny nose, sore throat, loss of taste, night sweats, nausea, diarrhea, chest tightness, dry cough
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| 52 | 2021-01-05 | headache |
Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (p...
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Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) via an unspecified route of administration on 30Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol and asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC), hctz (HCTZ), metoprolol succinate (TOPROL XL), omeprazole (OMEPRAZOLE) and pravastatin (PRAVASTATIN). The patient previously took diphenhydramine (BENADRYL) and experienced drug allergy. The patient experienced headache and sore arm on 30Dec2020 13:00. Outcome of events was recovering.
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| 52 | 2021-01-05 | fatigue, headache, fever |
High fever; headache; myalgia ; inbility to smell or taste; fatigue on 22nd; hAD THOSE SYMPTOMS FOR...
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High fever; headache; myalgia ; inbility to smell or taste; fatigue on 22nd; hAD THOSE SYMPTOMS FOR ABOUT A WEEK; tested positive for COVID on Dec 26. haven't recovered inablity to smell or taste; fatigue - still have that, too;
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| 52 | 2021-01-05 | dizziness, chills |
Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated p...
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Immediate after injection- tingling, numbness, dizziness, confusion, vision disturbance (dilated pupils), loss of BP, rapid heart rate, uncontrollable rigors/trembling. Rushed down hall to ED via stretcher. Received IV fluids, IV steroids, IV benedryl, IV pepcid, IV ativan.
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| 52 | 2021-01-05 | dizziness |
PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PA...
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PARKING LOT ATTENDANT CAME RUNNING INTO CLINIC STATING CLIENT WAS COMPLAINING OF DIZZINESS, HEART PALPATIONS, AND APPEARED PALE. CLIENT STATED HISTORY OF LOW BLOOD PRESSURE. BLOOD PRESSURE TAKEN ABOUT 1420. 120/90. EMT NOTIFIED THAT THEY MAYBE NEEDED. EPINEPHRINE BROUGHT TO CAR. ENCOURAGED CLIENT TO TAKE SLOW, DEEP BREATHS. AFTER 10 MINUTES, STATED FELT MUCH BETTER. PARKING ATTENDANT STATED CLIENT'S COLOR HAD RETURNED. ENCOURAGED TO WAIT FOR ANOTHER 10 MINUTES BEFORE DRIVING AWAY.
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| 52 | 2021-01-05 | headache, chills, fatigue | Pain and swelling on injection site, Cold chills, headache and fatigued |
| 52 | 2021-01-05 | fatigue, chills |
Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on star...
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Right shoulder (injection site), right back, HA 12/24/20-12/27/20. Right-sided back tingling on starting 12/24/20. Fatigue and chills 12/28/20. Occasional right back tingling resolved 12/31/20.
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| 52 | 2021-01-05 | headache | mild headache |
| 52 | 2021-01-05 | sweating, shortness of breath, chills, cough, throat pain |
the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; t...
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the top of her stomach felt swollen and gassy; Diarrhea/had diarrhea that was like liquid-y water; top of her stomach had a bad burning sensation; Vomiting; she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing; sore throat with a mild cough, like she needed to be clearing her throat; sore throat with a mild cough, like she needed to be clearing her throat; got a chill; food was not tasting right; arm was sore; could not raise her arm; her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unspecified route of administration on 21Dec2020 on left upper arm at a single dose for COVID-19 prevention. Current medical history included a lung disease called asthma and allergies, diagnosed in her late 20's; Diabetes Type 2, diagnosed about 10 years ago and High Blood pressure, diagnosed when she was in her 30's. Caller also wanted to include that she did have COVID before, she had COVID in Jul2020. Current concomitant medications included salbutamol (ALBUTEROL) at 2 Puffs via inhalation, twice daily for asthma; Unspecified Blood Pressure Medication One pill, once daily by mouth in the morning; Unspecified Nasal Spray 1 spray in each nare, once daily via nasal inhalation; montelukast sodium (SINGULAIR) at 1 pill via oral, once a day for allergies; metformin at 1 pill, daily, by mouth for Diabetes Type 2. The patient stated that her place of employment did not give her the card that has the lot number on it, they said they would give it to her with her second injection. The patient did not know the dose received, just that it was the first in the series. The patient had no other vaccines on the same day as the COVID vaccine. The patient reported that her weight on 21Dec2020 when she got the vaccine, was 200.6, but her weight today, was 196.0 pounds. The patient received the vaccine on 21Dec2020, and as soon as she got the shot, her arm was sore like a flu shot. When she got the shot, she could not raise her arm past her shoulder without pain, but now she can raise her arm again. On Thursday, 24Dec2020, patient got a chill, and later that same night, food was not tasting right. On 25Dec2020, the chill continued, and she had a little bit of a sore throat with a mild cough, like she needed to be clearing her throat. On 26Dec2020 morning, the patient experienced vomiting when she woke up, and the top of her stomach had a bad burning sensation, and she had diarrhea. The patient stated that while she was vomiting, she got choked on some saline and sweat ran down her face, and she had to concentrate on breathing. But the patient stated that she vomited, had diarrhea, and the burning sensation, the whole day on Saturday. The patient stated that on 27Dec2020, it calmed down, and she did not vomit at all. The patient stated that she felt like she needed to vomit, but she did not. The patient states that on Sunday, she still had the chills a little, and the top part of her stomach was still burning. The patient took some Pepto-Bismol and that helped calm down the caller's stomach. The patient stated that she could feel the Pepto-Bismol cooling her stomach off, like it had been hot, and patient stated that the top of her stomach felt swollen and gassy. The patient stated that later Sunday night, things calmed down, but she still has the burning sensation and she did not feel like she needed to vomit anymore. This morning, patient reported that she still has some burning sensation, but now, it is coming and going like labor pains. The patient stated that she did go to the bathroom once this morning and had diarrhea that was like liquid-y water. The patient stated that during all this over the last few days, each and every time that she tried to eat, she couldn't eat much because her stomach would burn more with eating. But yesterday, the patient had some fried fish and stated that the fried fish did not burn as much as the rest of the food she tried eating. The outcome of the events vomiting and the top of her stomach felt swollen and gassy was recovered on 27Dec2020, arm was sore and could not raise her arm was recovered on 26Dec2020, chills, top of her stomach had a bad burning sensation was recovering, Diarrhea/had diarrhea that was like liquid-y water was not recovered and other events was unknown. Information about batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vomiting and Foreign body aspiration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-06 | sweating |
Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon re...
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Approximately 10 minutes after receiving vaccine patient complaint of itchy eyes and hands. Upon review, patient eyes red and swollen, palms of hands red and sweaty, chest rashy, ears red. Injection site WNL.
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| 52 | 2021-01-06 | fatigue |
Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was t...
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Approximately 20-30 minutes after receiving the vaccine I noticed around my eyes and upper lip was tingling and felt numb. I continued to close up my desk to leave work for the day thinking it would just go away in few minutes. When I got to my vehicle I took two Benadryl capsules and drank a bottle of water and waited nearby the hospital emergency department parking area for 30 - 40 minutes. The numbness had eased and I drove home. Tuesday and today (Wednesday) I have felt very tired and fatigued.
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| 52 | 2021-01-06 | chills, headache, cough, fever | Body aches Chills Fever of 101.3 F Joint pain Headache Dry cough |
| 52 | 2021-01-06 | dizziness |
Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B...
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Dizziness, HYPOtension, blurred vision Narrative: Reaction at 30 min- Dizziness, blurred vision, B/P dropped to 95/55- She stayed in ER until 11am, No Sxs of breathing issues or SOB. She was NOT admitted, just observed until B/P went up. Vaccine was given in the ED- reason not given.
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| 52 | 2021-01-06 | fever |
Patient with low grade fever (tmax 99.6), body aches, and pain at injection site. Taking motrin wit...
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Patient with low grade fever (tmax 99.6), body aches, and pain at injection site. Taking motrin with some relief.
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| 52 | 2021-01-06 | shortness of breath |
Reported difficulty breathing, rash at injection site, throat closing. Used Epi pen ( history of all...
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Reported difficulty breathing, rash at injection site, throat closing. Used Epi pen ( history of allergies). Transferred to ED
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| 52 | 2021-01-06 | shortness of breath | Shortness of breath and wheezing |
| 52 | 2021-01-06 | chills, body temperature increased | Temp 101, Oral Chills, body aches. |
| 52 | 2021-01-06 | chills, dizziness, fatigue, headache, body temperature increased, weakness |
Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest...
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Temperature 103.1, chills, muscle and joint pain, fatigue, weakness dizziness, headache, nausea rest and fluids, acetaminophen started at 0400 am on 1/6 symptoms started to resolve by 2000 (8pm) on 1/6
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| 52 | 2021-01-07 | fatigue, fever, malaise, chills |
After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mout...
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After the vaccine, my arm went numb. I ended up having fatigue, fever, and metallic taste in my mouth. My bones hurt, and my neck hurt really bad. that lasted for three days. I developed chills and a fever, I felt really sick. I had a COVID test and was positive.
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| 52 | 2021-01-07 | dizziness |
C/O: DIZZINESS. 1140: VS: 184/98, P: 92; 02 SAT: RA: 98%; 1152: VS: 167/88, P: 70; 02 SAT:...
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C/O: DIZZINESS. 1140: VS: 184/98, P: 92; 02 SAT: RA: 98%; 1152: VS: 167/88, P: 70; 02 SAT: RA: 98%
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| 52 | 2021-01-07 | headache, fever, weakness, chills | Chills, vomiting, fever 104, upset stomach, low energy level, headache |
| 52 | 2021-01-07 | chills |
Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer ...
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Chills; Shaking; Patient was bad and cold; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231, Expiration Date: 30Apr2021), via an unspecified route of administration in left arm, on 31Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included blood pressure. The patient had unspecified concomitant medications. The patient took this shot on 31Dec2020 at her job at medical center (EDF, environmental service; it's housekeeping). The patient was fine during the daytime. The patient made it to her home and now she got the chills and was shaking on an unspecified date. When the patient was asleep, that is when she started feeling chills and the shake. The patient was bad and cold, and she got a bad chill. The patient wanted to report and asked if it was going to go away. No treatment was administered for the events. The outcome of the events was unknown.
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| 52 | 2021-01-07 | dizziness, fatigue, headache, malaise |
Dizziness, Headache, Myalgia & Diarrhea Narrative: Vaccinated in the morning 12/20. Fell asleep ear...
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Dizziness, Headache, Myalgia & Diarrhea Narrative: Vaccinated in the morning 12/20. Fell asleep early due to fatigue. Woke up not feeling well: headache, body aches, dizzy. Unable to go to work that day. By Tuesday able to return to work though experiencing loose stools.
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| 52 | 2021-01-07 | fever, chills, headache | Fever 101.5, aches, chills, headache |
| 52 | 2021-01-07 | chills, fever | Fever, chills, nausea, lymph node enlargement with pain |
| 52 | 2021-01-07 | dizziness |
First dose of Pfizer COVID-19 vaccine administered to this individual. She reported dizziness and h...
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First dose of Pfizer COVID-19 vaccine administered to this individual. She reported dizziness and head feeling "fuzzy". Had patient drink water and juice. VS were BP 137/90 HR 91. She stated her HR routinely runs in the 90s. Observed her for greater than 30 minutes. Symptoms didn't worsen. She was awake, alert with a steady gait. Patient was released to home.
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| 52 | 2021-01-07 | malaise, dizziness | General Malaise, Light Headed, Palpitations & Nausea |
| 52 | 2021-01-07 | fatigue, headache, weakness |
HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSE...
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HEADACHE, NAUSEA, VOMITING, SYNCOPE, JOINT PAIN, WEAKNESS, EXTREME FATIGUE. STARTED ON 1-1-21, NAUSEA AND VOMITING STOPPED ON 1-2-21 BUT RETURNED ON 1-8-21.
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| 52 | 2021-01-07 | fatigue, headache | Injection site pain Muscle pain Headache Fatigue |
| 52 | 2021-01-07 | weakness | LEFT AXILLARY PAIN AND EDEMA, GENERALIZED WEAKNESS AND MUSCLE PAIN WAS UNABLE TO GET OUT OF BED |
| 52 | 2021-01-07 | chills, headache, fever | Low grade temp, chills, body aches, nausea and diarrhea, headache |
| 52 | 2021-01-07 | dizziness |
Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins ...
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Patient felt warm with palpitations 5 minutes after vaccine administered. was monitored for 30 mins & then returned to work. on 12/30/2020 patient was at work in Presurgical testing dept & experienced near syncope, dizziness & elevated BP. reported to ED & was admitted to telemetry unit.
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| 52 | 2021-01-07 | weakness, fatigue |
SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO...
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SEVERE FATIGUE AND WEAKNESS, LEFT AXILLARY PAIN AND EDEMA, HOT TO TOUCH, SINCE 1/8/2021 UNABLE TO GO TO WORK DUE TO SYMPTOMS
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| 52 | 2021-01-07 | shortness of breath, cold sweat, chills, weakness, fever, nasopharyngitis, headache |
Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Ski...
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Severe pain in arm with bump from shot. Clamy, cold chills, Then started getting hot with fever. Skin is sore from the fever. Headache, temp 100.3. Weak and loopy, slept all day. Hurts under the arm. SOB.
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| 52 | 2021-01-07 | body temperature increased, headache | Temp 102.3 ,Severe headache, whole body muscle aches, felt like I was on fire from the inside out. |
| 52 | 2021-01-07 | dizziness | c/o light headedness, ems evaled pt. declined further treatment. or eval symptoms resolved. |
| 52 | 2021-01-07 | fever, nasal congestion, headache, fatigue, dizziness, chills, throat pain |
dizziness; muscle aches; chills; fatigue; subjective fever; sore throat; headache; congestion; This ...
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dizziness; muscle aches; chills; fatigue; subjective fever; sore throat; headache; congestion; This is a spontaneous report from a non-contactable consumer, the patient. This 52-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration from 30Dec2020 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included depression from an unknown date and unknown if ongoing and dyslipidaemia from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included citalopram (CITALOPRAM) and atorvastatin (ATORVASTATIN). On 30Dec2020, the patient experienced dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat. The adverse events resulted in a doctor or clinic visit. Therapeutic measures included Tylenol and Nyquil. The clinical outcome of dizziness, muscle aches, chills, fatigue, subjective fever, headache, congestion and sore throat was not resolved. It was also reported that since the vaccination, the patient was tested for COVID-19 on 04Jan2021 via nasal swab, results pending. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 52 | 2021-01-07 | fever, headache |
fever 99.7; Body ache; Headache; This is a spontaneous report from a contactable nurse reported for ...
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fever 99.7; Body ache; Headache; This is a spontaneous report from a contactable nurse reported for self. This 52-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Jan2021 at single dose (LOT# EL1284) for covid-19 immunisation. The patient got vaccine yesterday (01Jan2021) and had a side effect. The patient had a fever 99.7, body ache, headache on 02Jan2021 and wanted to know if can take anything. Outcome of the events was unknown.
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| 52 | 2021-01-08 | chills, fever, headache |
Body aches, headache, shaking chills and fever (102.6). Treated with Tylenol, rest and fluids. Sympt...
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Body aches, headache, shaking chills and fever (102.6). Treated with Tylenol, rest and fluids. Symptoms lasted 60 hours.
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| 52 | 2021-01-08 | headache, fever, chills, night sweats, fatigue, cough, headache, night sweats, fever, chills, cough, fatigue | Headache, Myalgia, Fever, chills, arm pain, nausea, cough, fatigue, night sweats |
| 52 | 2021-01-08 | chills, fever, headache, fatigue |
Headache, chills, fever 100.6 °F, fatigue; acetaminophen 500mg; symptoms abated 24h after vaccinati...
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Headache, chills, fever 100.6 °F, fatigue; acetaminophen 500mg; symptoms abated 24h after vaccination
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| 52 | 2021-01-08 | fatigue |
Nausea, fatigue, hallucinations? Was under observation, emt was called, vitals were normal. Recove...
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Nausea, fatigue, hallucinations? Was under observation, emt was called, vitals were normal. Recovered within 3 hours with no further intervention.
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| 52 | 2021-01-08 | dizziness, throat irritation |
Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was h...
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Tongue became swollen and itchy, throat was scratchy and felt constricted. High blood pressure was high, dizziness and ringing in the ears
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| 52 | 2021-01-08 | dizziness |
after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofra...
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after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofran 4mg, gave one dose epi-pen, and 50mg Benadryl. patient still complained of chest pain and was dry heaving. she was then transported by ems to the hospital at 4pm.
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| 52 | 2021-01-09 | nasal congestion, dizziness, fatigue, lethargy |
1. Light headedness. Treated with extra fluids. Began 30 minutes after vaccine and lasted about 4...
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1. Light headedness. Treated with extra fluids. Began 30 minutes after vaccine and lasted about 4 hours. 2. Fatigue and lethargy. Treated with rest and fluids. Began 24 hours after vaccine. Duration 12 hours. 3. Nasal congestion. No treatment necessary. Began 24 hours after vaccine. Duration 4 days.
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| 52 | 2021-01-09 | headache, fatigue, dizziness, nasopharyngitis, fever |
Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night t...
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Extreme fatigue on Friday during the day, by 5pm I was running a low grade fever through the night that was 100.9 . Body aches, cold, headache, dizziness. Saturday ran fever off and on that never got above 100.9. Which broke Sunday am. Sunday just fatigue, sore arm that is warm to the touch, but not red.
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| 52 | 2021-01-09 | fever, fatigue | Extreme fatigue, muscle aches, slight fever (99.0) and right arm soreness |
| 52 | 2021-01-09 | fatigue, dizziness, shortness of breath, headache |
Headache hour after vacation, then as day progressed, continued headache, approx 4pm pounding heada...
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Headache hour after vacation, then as day progressed, continued headache, approx 4pm pounding headache, nausea, lightheaded, fatigue and just feeling bad. Next day dizziness, fatigue, headache and body aches. Symptoms continued with some shortness of breath. Nyquil taken at approx 5-6pm. 3rd day woke up had dizzy spell fell on the floor. Still having some fatigue lightheadedness and nausea.
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| 52 | 2021-01-10 | fatigue, fever, malaise |
"Pfizer-BioNTech COVID-19 Vaccine EUA" woke up feeling generally unwell, fever of 100.5 and fatigue....
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"Pfizer-BioNTech COVID-19 Vaccine EUA" woke up feeling generally unwell, fever of 100.5 and fatigue. Resolved by the next morning of 1/2/2021.
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| 52 | 2021-01-10 | cough, respiratory tract congestion, runny nose, headache |
1/10 developed running nose, headache, cough, congestion, headache. no fever. last nasal covid test ...
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1/10 developed running nose, headache, cough, congestion, headache. no fever. last nasal covid test 1/9, pending result.
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| 52 | 2021-01-10 | dizziness |
30 minutes after vaccine, developed dizziness. This progressed and also developed tachycardia and h...
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30 minutes after vaccine, developed dizziness. This progressed and also developed tachycardia and headache, worsening over next 15 minutes, with skipped beats. Heart rate was 115 and decreased 93 with breathing exercises for relaxation. Blood pressure was steady at about 190/110 ( she states she stopped her blood pressure medication 3 days prior). she was taken to ED for further evaluation and treatment
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| 52 | 2021-01-10 | dizziness, fever |
52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccin...
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52 y.o. female presented to provider visit on 1.11 in response to a reaction to the 2nd COVID vaccine received on 1.6. Patient has not worked since 1/6. Her symptoms started 1/7. She showed the provider a photo from her phone from 1/9 where her face was diffusely swollen and erythematous. She has not had dyspnea. She reports low grade fever off and on since vaccination. No n/v. She had stomach cramps for a whole, but those have fully resolved. At the visit on 1.11, her main symptoms are puffy eyes, and somewhat swollen and flushed face. Patient also reports dizziness, and still feels unsteady. Patient received a dexamethasone and depo-medrol injection in clinic on 1.11. Patient given return instructions. Provider will follow up in a few days to check on the patient.
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| 52 | 2021-01-10 | headache, fever |
ABOUT 10 HOURS AFTER SHOT RECEIVED I STARTED SHAKING VIGOUROUSLY AND DID NOT STOP FOR ALMOST 2 HOURS...
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ABOUT 10 HOURS AFTER SHOT RECEIVED I STARTED SHAKING VIGOUROUSLY AND DID NOT STOP FOR ALMOST 2 HOURS. THEN I DEVELOPED A SLIGHT FEVER - 100-101 - BAD HEADACHE, MUSCLE ACHES, BODY ACHES. TOOK TYLENOL REGULARLY, FINALLY EXCEDRIN FOR HEADACHE AND ICE PACKS FOR BACK OF NECK AND FOREHEAD. DIBILATING FOR THE NEXT DAY, THEN FEVER BROKE AND FELT BACK TO NORMAL.
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| 52 | 2021-01-10 | weakness, fatigue, somnolence |
Approximately 5 minutes after receiving the vaccine patient began to feel very weak and drained and ...
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Approximately 5 minutes after receiving the vaccine patient began to feel very weak and drained and sleepy. Arms felt weak. Pain in the back of the neck. At 3:05pm, BP 155/88 HR=66 Temp 98.4F O2=95% Glucose=160. Patient reports taking Tylenol prior to receiving the vaccine. At 3:10pm, BP=148/95 HR=68, O2=95%. Patient was released from clinic at 3:17pm. Patient reports having similar symptoms following 1st dose of Pfizer Covid-19 vaccine occurring 1 hour after receiving the dose. Patient reports being very sleepy and fatigued. Fatigue lasted for 3 days. Per patient, symptoms resolved with Tylenol and rest.
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| 52 | 2021-01-10 | chills, fatigue, headache, dizziness | Chills, muscle and joint pain, fever, headache, fatigue, light headed, difficulty concentrating |
| 52 | 2021-01-10 | fever, headache, chills |
Headache/Body Aches/chills/ fever of 100.9. Lasted approximately 6 hours. Symptoms were similar to w...
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Headache/Body Aches/chills/ fever of 100.9. Lasted approximately 6 hours. Symptoms were similar to when I had Covid.
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| 52 | 2021-01-10 | migraine, headache |
Migraine headache began the next morning about 7am and increased as the day progressed including nau...
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Migraine headache began the next morning about 7am and increased as the day progressed including nausea and light sensitivity. Waves of nausea and headache continued into the next day. I had not had a migraine in over 2 years prior to this event. Treated with OTC Excedrin at first on Jan 10th, then when that was ineffective took butabital at lunch time and when that was ineffective took Maxalt with phenergan about 5p. The next day on Jan 11th, thought I was better but by 630a nausea returned in waves and headache began building again. Took Maxalt with phenergan about 930a and again at 9p.
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| 52 | 2021-01-10 | headache, fever, chills |
Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Start...
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Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work Started 12 hours after second dose of covid vaccine. No reaction to first dose.
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| 52 | 2021-01-10 | shortness of breath, fever, cough |
Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortn...
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Symptoms started 1/4/21 @ 1800 with dry heaving, body aches, fever, then started coughing and shortness of breath that night. Next day still had fever, severe body aches and cough got worse with shortness of breath. I did home nebulizer several times and started prednisone 40mg. 1/6/21 shortness of breath worsened to the point I couldn't talk, chest tightness with burning. Went into ED at hospital where they gave me another breathing treatment x 2, magnesium sulfate, IV solu medrol. They were going to admit me but I decided against it with all the covid patients.
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| 52 | 2021-01-10 | fever, chills |
sore arm after the first 6-8 hours that lasted maybe 8 hours. At approx. 30 hours post vaccination,...
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sore arm after the first 6-8 hours that lasted maybe 8 hours. At approx. 30 hours post vaccination, woke with fever, chills, rigors; took Tylenol and Benadryl and symptoms subsided after about 3 hours.
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| 52 | 2021-01-11 | chills |
Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eye...
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Approximately 45 minutes post injection, started wheezing slightly and having itchy watery eyes. Eyes swelled. Significant scleral edema bilaterally but mostly left eye. Sudden chills and felt freezing in extremities. Face became tingly. Took 50 mg Benadryl, Claritin and rescue inhaler (2 puffs albuterol). Within 1.5 hours felt better and able to rest. Still Itchy but wheezing was better. On 1/12 woke with swollen eyes. Took 25 Benadryl and Claritin. Walked 1 mile and began to wheeze. Took albuterol and rested.
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| 52 | 2021-01-11 | chills, fever, cough, fatigue, headache, shortness of breath, malaise |
Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injecti...
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Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; difficulty breathing; she has a bad cough; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Jan2021, the patient reported all of the symptoms on the sheet including injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The reporter also stated that the patient had difficulty breathing, she stated that every few words she has to catch her breath and she has a bad cough. The outcome of the event was unknown. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
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| 52 | 2021-01-11 | fever, chills, headache |
Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at th...
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Headache; muscle soreness; general all over the body soreness; her arm was very sore/ This was at the injection site; a low grade fever/ a fever of 101.0; chills; This is a spontaneous report from a contactable registered nurse (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, Expiry Date: Mar2021), via an unspecified route of administration in the left biceps of her arm on 05Jan2021 07:15 at single dose for COVID-19 immunization. Medical history included positive on 19Dec2020 for the COVID virus. She had no allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported a side effect she experienced after having the shot. Afterward her arm was very sore. The patient got it at 7:15 am and it didn't feel the sore until about midway through the day (05Jan2021). This was at the injection site. When she got home she had chills and a low grade fever (05Jan2021) so she took Tylenol. The morning (06Jan2021) she woke up with headache and a fever of 101.0. She still had the muscle soreness, it was more at the administration site but there was some general all over the body soreness too. The patient explained she was positive on 19Dec2020 for the COVID virus and felt like these were the same symptoms she had with the virus. When asked about a seriousness criteria, she stated she reported that her fever improved with the Tylenol and she was feeling better now. The outcome of soreness at injection site was not recovered, of fever, headache was recovering, of the other events was unknown. No emergency room or physician office was involved. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
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| 52 | 2021-01-11 | chills, fatigue, fever |
I woke up with chills and fever 12.5 hours after the vaccine. Fever lasted for 36 hours and went as ...
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I woke up with chills and fever 12.5 hours after the vaccine. Fever lasted for 36 hours and went as high as 102.4. Intermittent nausea and very tired.
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| 52 | 2021-01-11 | headache, throat irritation |
Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - fir...
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Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.
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| 52 | 2021-01-11 | chills, headache |
Mildly sore arm at injection site. Headache and chills. Redness and rash with terrible itching on ...
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Mildly sore arm at injection site. Headache and chills. Redness and rash with terrible itching on upper arm near injection site and across chest, collar bone, neck and chin. Took Benedryl , Allegra, and Tylenol for 24 hours. Symptoms mostly resolved by 4:00pm on 1/8/21.
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| 52 | 2021-01-11 | sweating, cold sweat |
Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated sh...
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Patient started to become flushed within 5 minutes of receiving injection. At 9:20 she the stated she was hot and her hands were sweaty. after 15 minutes post injection patient was red going down her neck. She was then evaluated by the EMTs. She stated she felt a little better by 9:45 but we continued to observe. By 10:05 patient was still flushed and was getting cold hand . Gave Benadryl 25 mg po at 10:17 AM. By 1035 Patient was very cold but her face was still flushed and felt hot to her. Her hands were clammy and cold. EMT transported to hospital at 10:45. This was her second dose of Pfizer.
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| 52 | 2021-01-11 | headache, fatigue |
injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness ...
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injection site hot and swollen, itching on left arm belly and face, tingling on upper lip, numbness on tong, headache, pain on back of neck, body pain down the back, diarrhea, stomach cramps, very tired, nausea, stomach bloating
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| 52 | 2021-01-11 | fatigue, sweating, chills | nausea fatigue sweaty chills sore lymph nodes in neck |
| 52 | 2021-01-11 | fever, fatigue |
woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/...
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woke up at 4 am the day after vaccination with pain in injection site arm 8/10. Had general muscle/joint pain that made it difficult to get out of bed. Nausea and low grade fever. Unable to go into work. Felt I was not able to get out of bed to even take medication. Fianlly took 600mg of ibuprofen at 1:30 p.m. Was able to sleep and at 4pm was able to get out of bed. Still felt very fatigued. Slept well then next night and felt 90% better the next morning. Feeling much better today. No s&s.
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| 52 | 2021-01-12 | shortness of breath |
After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face b...
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After about 20 minutes, the patient stated she felt short of breath, chest tightness, and her face became red. The nurses took her vitals which showed hypertension and tachycardia. She was lowered to the ground and given some juice while a code was called. When the code team arrived, the patient was alert and oriented within the vaccination clinic, she was then transferred to the ER by nursing staff and hospital security.
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| 52 | 2021-01-12 | dizziness |
Dizzy, cloudy, burning sensation of right side of neck. BP is ordinarily 11/62, but was 135/85. Obse...
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Dizzy, cloudy, burning sensation of right side of neck. BP is ordinarily 11/62, but was 135/85. Observed, issues resolved at 12:46 pm/
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| 52 | 2021-01-12 | fatigue, headache |
I had a mild headache the evening of the shot, I had a headache the next two days that was relieved ...
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I had a mild headache the evening of the shot, I had a headache the next two days that was relieved by Advil. I had a very sore arm at the injection site Friday and Saturday after the shot was given. The arm pain was gone Sunday morning. I was very tired on Saturday especially and slept through the morning and early afternoon on and off until about 3:00 pm. On Friday during the day, I noticed my right ear starting to feel unusual and uncomfortable. On Saturday, the ear issue continued, I felt like I had some hearing loss and a constant buzzing and ear fullness feeling. On Sunday, the ear issued continued with the hearing loss, buzzing and fullness and has through today and hasn't stopped. I tried some nasal decongestant on Sunday afternoon, but it didn't have any effect. I made an appointment with the ENT doctor on Monday morning for Tuesday. I had a hearing test on Tuesday and saw the ENT doctor on Wednesday. He prescribed prednisone and ordered an MRI. I will be starting the prednisone later today (Wednesday) when the pharmacy has the prescription ready.
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| 52 | 2021-01-12 | fever, headache | Insomnia, headache, fever, aches, skin pain |
| 52 | 2021-01-12 | chills, headache, fever |
Patient reports arm and leg pain (aching), extreme pain along with chills and low grade fever, mild ...
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Patient reports arm and leg pain (aching), extreme pain along with chills and low grade fever, mild headache.
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| 52 | 2021-01-12 | headache, fatigue |
Symptoms - EE reports beginning on Saturday PM she felt fatigued and HA. Sunday and Monday worseni...
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Symptoms - EE reports beginning on Saturday PM she felt fatigued and HA. Sunday and Monday worsening HA and fatigue. EE report she called off of work Monday and Tuesday and RTW on Wedneday. EE reports complete resolution of symptoms today. Last day of work and shift - ? at work today Home remedies? - rest and tylenol Any improvement? ? yes, resolution of symptoms Recommendation? EE encouraged to continue to monitor her symptoms and to follow the guidelines outlined in the Workplace Policy. EE denied COVID-19 exposure without proper PPE and denied travel. EE verbalized back understanding and denied further questions at this time.
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| 52 | 2021-01-12 | headache, dizziness, fatigue | developed headache, light headedness, nausea and fatigue |
| 52 | 2021-01-12 | headache, dizziness | dizziness with perceived palpitations; facial flushing and headache |
| 52 | 2021-01-13 | shortness of breath |
About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I fel...
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About 10 to 12 minutes after the injection, I started feeling like my throat was constricted. I felt pain in my temple and I also felt like my ears were clogged. My tonugue was tingling and I had pain across my chest. I had trouble swallowing and taking a deep breath. The medical providers assessed me and since my heart was not racing and I did not have a rash all over my body, deemed I was okay. When I went home, I noticed a rash on my chest from my collarbone to my sternum and alongside my ears on my neck. My sister is an ER Doctor and I did a video conference with her. She had me take Benadryl. I have never had any reaction to any vaccine nor have I ever had to take Benadryl.
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| 52 | 2021-01-13 | shortness of breath |
After vaccination, patient started to experience trouble breathing within 2 and a half minutes. I in...
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After vaccination, patient started to experience trouble breathing within 2 and a half minutes. I injected the patient with 1 Epipen and patient started feeling better. Emergency services soon came and brought her away. At that time patient was alert and had no difficulty breathing.
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| 52 | 2021-01-13 | shortness of breath |
During post vaccine monitoring after patient received initial COVID vaccine patient reported feeling...
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During post vaccine monitoring after patient received initial COVID vaccine patient reported feeling tightness in her chest and feeling harder to breath. Pt reports that this has occurred in the past with other allergic reactions. VS assessed 136/74, HR 105, SPO2 97. Pt transferred to ER for continued monitoring. Patient given dexamethasone, diphenhydramine, famotidine, ipratropium, and ondansetron
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| 52 | 2021-01-13 | headache |
I received the Pfizer #EL3246 Vaccine, exp 4/30/2021 on Jan 12, 2021 through the Health Department a...
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I received the Pfizer #EL3246 Vaccine, exp 4/30/2021 on Jan 12, 2021 through the Health Department and developed severe facial swelling, primarily around the right eye. The left eye has slight swelling. Please note: I had a previous reaction to Tetanus many years ago that included swelling. In addition, I have had headaches and gastrointestinal symptoms.
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| 52 | 2021-01-13 | dizziness, fever |
Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/...
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Individual initially felt fine after receiving the vaccine with just sore arm. 24-hours later on 12/29 around noon she started feeling tachycardic (resting heart rate was 107-125 bpm). She vomited and felt anxious. Developed fever of 101.8 and was very achy. Day 2: low grade fever treated with ibuprofen. Day 3: fever free but dizzy feeling. Day 4: symptoms resolved. Of note, patient was 30 days out from having had COVID-19 at the time of vaccination. Patient states her course of COVID was "serious" but did not require hospitalization.
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| 52 | 2021-01-13 | headache, dizziness |
Loose bowels; headaches; dizziness; loose stool; upper back pain where the lungs are/Upper back pain...
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Loose bowels; headaches; dizziness; loose stool; upper back pain where the lungs are/Upper back pain; Sudden head rush; This is a spontaneous report from a two contactable Other Health Professional (one of which patient) received via Medical Information Team. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: 30Apr2021), via an unspecified route of administration in arm left on 30Dec2020 at single dose for COVID-19 immunization. The patient medical history included fibromyalgia from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine at 10 mg and rosuvastatin calcium at 20 mg, both from an unknown date and ongoing. The patient experienced headaches, dizziness, loose stool, upper back pain where the lungs are/upper back pain, all on 02Jan2021. The patient also experienced loose bowels on 03Jan2021 and sudden head rush on 30Dec2020. The patient underwent lab tests and procedures which included COVID-19 test which resulted negative on 06Jan2021. The patient outcome of headache, dizziness, loose bowels was recovering, the outcome of loose stools was unknown, the outcome of back pain and sudden head rush was recovered.
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| 52 | 2021-01-13 | headache, chills, fever, malaise |
Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of bu...
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Nausea, headache, body aches and pains, fever of 100.7 orally and chills, chest pain, feeling of burning at surgical scar site, malaise starting around 18 hours post injection and lasting about 14 hours. Minimal to zero relief with Ibuprophen, or Acetaminophen. No medical treatment required. Headache continues to persist but chronic headaches are part of normal history.
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| 52 | 2021-01-13 | throat pain, head discomfort, dizziness | None stated. |
| 52 | 2021-01-13 | fatigue, headache |
Received 2nd dose Pfizer lot EL0142 on 1-13-2021 on right arm. Has body aches, joint pain, muscle a...
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Received 2nd dose Pfizer lot EL0142 on 1-13-2021 on right arm. Has body aches, joint pain, muscle ache, head ache, fatigue, and arm pain.
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| 52 | 2021-01-13 | chills, headache, fever |
headache; high fever; chills, shivering; body ache; This is a spontaneous report from a non-contacta...
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headache; high fever; chills, shivering; body ache; This is a spontaneous report from a non-contactable Other HCP reporting for herself. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number K9231), intramuscular, in left arm, on 06Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 52 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history and did not receive concomitant medications. She had no known allergies to medications, food, or other products. On the first and second day the patient experienced high fever, chills, shivering, body ache; headache the third day with chills. No treatment was given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The events were resolving. No follow-up attempts are possible. No further information is expected.
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| 52 | 2021-01-14 | cough |
1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor ...
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1435 vaccine given 1440 tingling in tongue, lump in throat - no swelling, no SOB, no rash - monitor as she was anxious prior to receiving vaccine 1444 states sxs are getting worse, still no swelling or SOB noted 1445 States she now feels like tongue is swelling and lump in throat is worse, cough noted. 99.5F, 97% RA, 102HR, 22 Resp, 146/99 BP 1448 Hoarseness in voice noted as associate getting into wheelchair 1449 Turn over care to ED
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| 52 | 2021-01-14 | dizziness |
About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of...
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About 10 min after receiving vaccine, patient began to experience lightheadedness and parethesias of distal arm. Vital signs within normal limits. Patient improved.
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| 52 | 2021-01-14 | fever, headache, chills |
About 14 hours after my 2nd dose I experienced headache, fever, chills, body aches for about 12 hour...
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About 14 hours after my 2nd dose I experienced headache, fever, chills, body aches for about 12 hours; What is concerning is that my Vsafe app asked if I received the 2nd dose and then never checked back for side effects. This is when most people are experiencing side effects and the monitoring parameters that are set forth by the CDC are failing
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| 52 | 2021-01-14 | dizziness, dehydration |
Before receiving vaccine, patient was visibly anxious and fearful of the shot. Within 5 minutes of ...
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Before receiving vaccine, patient was visibly anxious and fearful of the shot. Within 5 minutes of receiving vaccine, patient complained of lightheadedness. Vital signs showed slight hypotension which improved with hydration.
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| 52 | 2021-01-14 | headache, fever, skin warm, fatigue |
Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of b...
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Exactly 12 days after the vaccine I reported a fine rash with small blisters covering the backs of both of my hands with itching and warm redness in them both (I have pictures) Within an hour it began feverish red itching and slight burning on both of The undersides of my forearms. I was advised by the pharmacists on duty in the covid clinic site to use topical Benadryl cream and or take Benadryl by mouth if it worsened. I was told to seek emergency dept help if any signs of breathing issues presented. The next morning the itching was gone the redness subsided and the rash was markedly better but still raised in the tops of my hands. By 1030am on 1/12/21, I could not detect taste or smell at all. I was advised then to report to employee healthline for further instruction. I was told to leave work and proceed to our employee Covid swab testing drive thru facility for Covid testing and remain home for results the following morning on 1/13/21. At approximately 10am 1/13/21 I was confirmed positive for COVID-19 via the swab results. I was told to quarantine and given a return to work date of 1/24/21 as long as my symptoms were resolved. I am currently in home quarantine still suffering no taste or smell, muscle cramps in legs, thighs and back. Fatigue, Loss of appetite, sinus pressure and headache not relieved with medications.
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| 52 | 2021-01-14 | fever, fatigue |
I got my 2nd dose on Wednesday and felt fine all night. On Thursday, I started to have a low grade ...
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I got my 2nd dose on Wednesday and felt fine all night. On Thursday, I started to have a low grade fever with body aches and tiredness. On Thursday night about 6pm, I developed severe swelling under my left arm and down the left side of my ribs.
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| 52 | 2021-01-14 | fever |
I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began ...
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I had no side effects after my vaccine on 12/24/20 until 1/8/21. On Friday, 1/8/21 at 830pm I began with severe abdominal pain, low grade fever, nausea and loss of appetite. My abdominal pain persisted and worsened over the next 24-36hours. I presented to the ER on Sunday, January 10, 2021 at 8am with severe right lower quadrant pain, pelvic pain, nausea and low grade fever. I was promptly diagnosed with appendicitis and taken to the OR at approximately 2pm on the same day. In the OR my appendix was gangrenous, there was pus in the pelvic area nd fluid in my peritoneum. My appendix was not ruptured. My appendix was removed as well as part of the omentum. I remained in the hospital on IV Metronidazole and Ciprofloxacin for 2 days and was discharged on 1/13/21 at 9pm. I am continuing to recvoer at home on the same 2 antibiotics in oral form. I have a JP drain that is still in place. Of note I had two negative COVID 19 tests on 1/9/21 and 1/10/21. Both were PCR tests.
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| 52 | 2021-01-14 | chills, fever |
Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge b...
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Nauseous; threw up a little; she keeps falling down, has had 3 falls; hit her head; she has a huge bump on her face that is very painful; she cannot walk straight or without assistance anymore; Vertigo; Weakness in the muscles; a little arm soreness; Body aches; Chills; Could not sleep; Fever; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine), Batch/lot number: EK9231, Expiry Date: 31Mar2021, via an unspecified route of administration on 06Jan2021 09:00 at single dose in deltoid right for COVID-19 immunisation. Medical history included heart attack from Jul2019. Concomitant medication included diltiazem from 2019 and ongoing at 120mg tablet taken daily for abnormal heart rhythm she did not know of until had heart attack, acetylsalicylic acid (BABY ASPIRIN) from 2019 and ongoing at 81 mg tablet taken daily for heart attack. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 17Dec2020 for COVID-19 immunisation; she got the Flu vaccine every year and got shingles vaccine in Mar2020 for immunization. She did totally fine after receiving Flu vaccines and the Shingles vaccine. She had no side effects from the Flu vaccines except maybe a little arm soreness; she had arm soreness for a couple of days after the shingles vaccine; maybe a slight fever and took it easy. This Emergency Room Nurse (patient) received her second dose of Pfizer BioNTech COVID-19 Vaccine on 06Jan2021 around 9:00am. She went back to work, worked around 6-8 more hours that day and was fine. She went home and around 8-10 hours after she got the second dose on the evening of 06Jan2021 she had a little arm soreness and body aches. Last night all night she had chills; she could not sleep; fever. This morning: 07Jan2021 she was so nauseous that she got up and tried to get to the bathroom where she threw up a little. She reported as of 07Jan2021 she kept falling down: She fell in the bathroom this morning first when she was trying to get to the bathroom to throw up; During the second fall she was going on the stairs and fell, and hit her head; she had a huge bump on her face that was very painful now that she thought was from that second fall; and she had the third fall this evening; she cannot walk straight or without assistance anymore, she had been on the couch all day. She has had vertigo all day and weakness in the muscles. Chills was described as unbearable, heavy chills that she could not control. Fever: Temperature of 102-102.4 degrees Fahrenheit. The high fever hit around 3:00am on 07Jan2021. When her high fever hit around 3:00am she thought she would go to the emergency room but she did not want to scare her family so she stayed home and tried to pull through it. Today she took a Tylenol after she threw up this morning just to get through the day. Since she cannot walk without assistance or walk straight today that's the only lingering symptom that really worries her; she may go to the emergency room tonight if she did not get any better. She just did not want to scare her family and the emergency room was another copay cost so she really did not want to go to the emergency room at her workplace; but she may go there tonight and be kept overnight under observation. Prior to taking this second dose of Pfizer BioNTech COVID-19 Vaccine she was completely fine. She expected to have body aches, chills and fever; but she never thought the Pfizer BioNTech COVID-19 Vaccine would put her into a place where she is falling like this with the nausea and vertigo; she has never in her life had vertigo or falling like this. She reported she had no other vaccinations on the same date as Pfizer BioNTech Vaccine second dose. Has had no other vaccines in the recent past. She had never felt like this before with any other vaccines; she had never felt so weak in her muscles and never fallen down like this with any other vaccines. Seriousness criteria and outcome of all events unknown. The reporter considered all events were related to Pfizer BioNTech COVID-19 Vaccine.
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| 52 | 2021-01-14 | headache |
Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination....
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Severe burning in injection site immediately. Severe headache starting 3-5 hours since vaccination. Still experiencing as of 1/15/2021. On 1/14/2021 experienced throbbing under ear to jaw bone.
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| 52 | 2021-01-14 | malaise |
THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD ...
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THAT EVENING BETWEEN 10-11 PM HAD A GRAND MAL SEIZURE AND WAS UNRESPONSIVE. TAKEN TO ER WHERE BLOOD WORK WAS DONE AND CT SCAN. SENT HOME AROUND 6:30 AM ON JAN 1ST. (I DO NOT REMEMBER MUCH JUST WHAT MY FAMILY HAD TOLD ME) . I DO REMEMBER BEING SEVERLY SICK WITH VOMITING IN THE ER. CURRENTLY FOLLOWING UP WITH MY FAMILY MD AND HAVE MRI AND EEG TESTS SCHECULED WITHIN THE NEXT COUPLE OF WEEKS.
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| 52 | 2021-01-14 | fatigue, sweating, chills |
Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate f...
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Woke up with moderate fatigue, nausea, more severe arm pain than day before; Woke up with moderate fatigue, nausea, more severe arm pain than day before; Felt sweaty/chills, neck lymph glands tender; Felt sweaty/chills, neck lymph glands tender; neck lymph glands tender; Moderate arm pain that night; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), intramuscularly on 04Jan2021 16:30 at single dose for COVID-19 immunization. Anatomical Located at Arm Right. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication which the patient received within 2 weeks of vaccination included colecalciferol (VITAMIN D), tocopherol (VITAMIN E), magnesium, ibuprofen, paracetamol (TYLENOL). The patient previously took amoxicillin and experienced allergy. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient experienced Moderate arm pain that night on 04Jan2021 19:00 and woke up with moderate fatigue, nausea, more severe arm pain than day before on 05Jan2021. At 23 hours post injection on 05Jan2021, the patient also felt sweaty/chills, neck lymph glands tender. All symptoms gone at 48 hrs post injection. The patient did not receive any treatment for the reported events. The outcome of the events was recovered in Jan2021. This case reported as non-serious.
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| 52 | 2021-01-14 | headache, dizziness, shortness of breath, fever | light headed, fever, nausea, head ache, trouble breathing |
| 52 | 2021-01-14 | fever |
neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder a...
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neck sore to left shoulder and over to right ear; Fever; right ear ache/neck sore to left shoulder and over to right ear; left arm sore; neck sore to left shoulder and over to right ear; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number EK4176, Expiry Date: Mar2021, via an unspecified route of administration on 21Dec2020 at a SINGLE DOSE then via an unspecified route of administration on 07Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's husband was calling for his wife that had the second shot. He stated that she was a nurse. He stated that she came home from work with her arm and neck sore. He stated that the neck soreness was causing ear ache. He stated that her fever was 102.9 and stated that they put a cool rag on her head. He stated that she had the shot yesterday and stated that she had her first shot 21Dec2020. They stated that arm sore at 1:00 in morning and stated sore neck at 11:30 this morning. Fever started at 11:30 and was 99.7 and about 15 minutes later was 99.9 and stated that was with having three Aleves. She stated that it is back up to 102.9 and stated that the right ear ache started at 11:00am today. The patient underwent lab tests and procedures which included body temperature: 102.9 on 08Jan2021, 99.7 on 08Jan2021 and 99.9 on 08Jan2021. Therapeutic measures were taken as a result of fever (pyrexia). The outcome of events was not recovered.
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| 52 | 2021-01-14 | chills | onset same day of vaccine, c/o chills, no fever, pain in hips and legs and low BP 80/52 |
| 52 | 2021-01-15 | skin warm, dizziness |
11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms ...
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11:40 am - receives the 1 dose of the Pfizer Covid vaccine 0.3mg IM 11:50 am - reports the symptoms of tingling, warmness, pressure, burning on her upper left chest. Nausea and dizziness 11:58 am - takes diphenhydramine 50mg, (2 capsules of 25mg) by mouth 12:02 pm - receives 1 dose of EpiPen autoinjector 0.3mg IM. 911 call 12:05 pm - reports feelings of tightening in her throat and receives 2nd dose of EpiPen autoinjector 0.3mg IM 12:10 pm - reports that tightening in her throat is relieving 12:15 pm - EMS arrives and is transporting her to the ER
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| 52 | 2021-01-16 | body temperature increased, malaise, fatigue |
101.8 temp, malaise, fatigue. Tyl and Motrin only gets temp down to 100.5. Soreness at injection sit...
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101.8 temp, malaise, fatigue. Tyl and Motrin only gets temp down to 100.5. Soreness at injection site.
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| 52 | 2021-01-16 | fatigue, headache, chills |
Headache Chills Pain / redness in injection site Fatigue several hours after injection Headache las...
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Headache Chills Pain / redness in injection site Fatigue several hours after injection Headache lasted 3 days , chills intermittent for several days fatigue still have
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| 52 | 2021-01-16 | throat swelling |
I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. Th...
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I waited 15 per protocol walked back to my unit and noticed my face was puffy and lips felt numb. The Np on my unit looked in my throat and noticed my throat was red and swollen. No difficulty with breathing. Oxygen 100 on RA. Benadryl and additional Pepcid taken. Swelling in throat decreased, facial swelling dissipated as well. Lips were tingling for hours and dissipated after additional Benadryl taken.
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| 52 | 2021-01-16 | headache, fever, chills, fatigue | headache, muscle ache, fever, chills, fever, lymphadenopathy, injection site pain, tiredness |
| 52 | 2021-01-17 | headache, chills, fatigue, fever |
Headache the next day, chills, low grade fever less than 100.3, body aches, fatigue, pain/soreness u...
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Headache the next day, chills, low grade fever less than 100.3, body aches, fatigue, pain/soreness under arm/side of breast.
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| 52 | 2021-01-17 | chills, skin warm, fever, headache, fatigue |
Headache, chills, fever (101.6), muscle and joint pain and fatigue that started approximately 30 hou...
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Headache, chills, fever (101.6), muscle and joint pain and fatigue that started approximately 30 hours after vaccination. Treated with acetaminophen and ibuprofen. On 1/14/2021, forty-eight (48) hours after the vaccine administration, rash appeared on trunk and neck. Rash was red, warm not itchy and was treated with diphenhydramine oral and topical hydrocortisone. Rash persisted for 24-36 hours.
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| 52 | 2021-01-17 | shortness of breath | SHORTNESS OF BREATH DURING 15MIN WAITING PERIOD AFTER RECIEVED VACCINE. SENT TO THE ED |
| 52 | 2021-01-17 | headache, nasal congestion, fatigue, fever |
Symptoms started at 3:00 AM on 01/05/2021, complains of headache, body aches, temp 100.4, congeston,...
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Symptoms started at 3:00 AM on 01/05/2021, complains of headache, body aches, temp 100.4, congeston, fatigue. Took Tylenol for fever.
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| 52 | 2021-01-17 | shortness of breath | shortness of breath during 15 min waiting period sent to the ed |
| 52 | 2021-01-18 | headache |
Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side...
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Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation . The patient medical history was not reported. Concomitant medication included fluticasone propionate (FLONASE), pantoprazole. The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.
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| 52 | 2021-01-19 | fatigue, fever, headache | 99.9 fever. body aches. Joint pain. Headache, nausea, fatigue |
| 52 | 2021-01-19 | dizziness |
Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed ...
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Approximately 15 minutes after receiving second vaccine dose, patient reported feeling light-headed and a subjective swelling of her left cheek. Patient was tachycardic and hypertensive; taken to ER for observation. Received a dose of oral diphenhydramine 50 mg. Was ultimately discharged home in stable condition.
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| 52 | 2021-01-19 | fatigue |
Began experiencing body aches, extreme fatigue and joint pain shortly after receiving first dose of ...
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Began experiencing body aches, extreme fatigue and joint pain shortly after receiving first dose of the vaccine. Taking OTC tylenol/motrin. Joint pain has resolved. Body aches and extreme fatigue remain.
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| 52 | 2021-01-19 | fatigue, dizziness | DIZZY, CHILLS, FATIGUE |
| 52 | 2021-01-19 | headache, influenza like illness |
Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to...
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Had flu like symptoms along with the most extreme headache with tunnel vision and vertigo. Unable to pick head up off pillow for 2 days. Unable to eat or drink as well.
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| 52 | 2021-01-19 | headache, fatigue, chills, fever |
I woke up with a horrible headache the day after my second dose of the vaccine. It progressed to a l...
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I woke up with a horrible headache the day after my second dose of the vaccine. It progressed to a low grade fever of 100.4, and at one point was 102 degrees. I had chills, muscle aches, and I was extremely tired. Tylenol brought the fever down.
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| 52 | 2021-01-19 | malaise, dizziness |
Patient reported feeling unwell, dizzy, dry heaving. Patient was watched monitored and charge RN wa...
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Patient reported feeling unwell, dizzy, dry heaving. Patient was watched monitored and charge RN was notified. No additional intervention.
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| 52 | 2021-01-19 | fever |
RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FE...
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RASH, SWELLING LEGS AND SEVERE PAIN INABILITY TO GO UP STAIRS, BREAKOUT IN MOUTH ,FAST HEARTBEAT, FEVER
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| 52 | 2021-01-20 | fatigue, headache, fever, cough |
Fever; Headache; Achy Bones; Tiredness; Cough; Start Date/Time: 22Dec2020 04:00 AM; Dose Number:1/St...
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Fever; Headache; Achy Bones; Tiredness; Cough; Start Date/Time: 22Dec2020 04:00 AM; Dose Number:1/Start Date/Time: 08Jan2021 08:45 AM;Dose Number:2; This is a spontaneous report from a contactable other HCP reporting for herself. A 52-years-old female patient received the second dose of bnt162b2 (BNT162B2) vaccine , on 08Jan2021 08:45 in the left arm at single dose for Covid 19 immunization. Medical history included drug hypersensitivity Concomitant medication included lisdexamfetamine mesilate (VYVANSE), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), ergocalciferol (VIT D). The patient received the first dose of BNT 162B2 vaccine on 22Dec2020. On 08Jan2021, the patient received the second dose of BNT162B2 vaccine earlier than expected. On 09Jan2021 the patient experienced fever, headache, achy bones, tiredness, and cough The reported events were considered non serious and their outcome was recovering No follow-up attempts are possible: information about lot/batch number cannot be obtained. No further information is expected.
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| 52 | 2021-01-20 | fatigue |
Heart attack / she had a MI / diagnosed as a NSTEMI; This is a spontaneous report from a contactable...
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Heart attack / she had a MI / diagnosed as a NSTEMI; This is a spontaneous report from a contactable healthcare professional (patient). This 52-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 07Jan2021, for COVID-19 vaccination. Medical history included autoimmune thyroiditis (Hashimoto's thyroiditis) from 1998 and vitiligo from 1988. She was overweight. She had really no other risk factors. Concomitant medications were not reported. On 08Jan2021 the patient experienced heart attack and she had a MI, then a cardiac catherization that was normal and a normal echo as well. She said it was diagnosed as a NSTEMI and not a large MI, the smaller version. These events required hospitalization from 08Jan2021 to 12Jan2021. MI occurred after she finished clinic and she was not standing or doing anything, just sitting and she had chest pain. Her office was right next to the ER, so she received treatment within an hour and they were able to help her. She said that her hospital couldn't do a cardiac cath, so on 11Jan2021 they moved her to an hospital which was another treatment facility. When she had her MI they gave her acetylsalicylic acid (ASPIRIN) and sublingual nitroglycerin. They tested her troponin and did an EKG which was abnormal on an unspecified date in Jan2021. On 08Jan2021 troponin was increased. When they treated her with nitroglycerin and Aspirin, two hours later her EKG was normal and her troponin came down overnight on 09Jan2021, which was when they said for sure that she had a heart attack. The patient said it was very scary to have a heart attack, but thankfully there was not a lot of damage done and she was able to get treatment quickly. She did not think the event was disabling since they did not see much damage to her heart muscle, it was a near miss kind of thing. She said it was life changing in that she will now be on medication forever, she will be on at least a baby Aspirin and probably something like a statin for the rest of her life. She was recovering, it was unknown what the lasting effects may be, she felt normal but tired from her hospital stay. Heart attack resolved on 08Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event acute myocardial infarction cannot be excluded. The contributory role of the patient age and background of obesity cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 52 | 2021-01-21 | fatigue, fever | 26 hours after injection fever, fatigue,muscle ,aches |
| 52 | 2021-01-21 | chills, fever, headache |
52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today d...
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52 yo female vaccinated 1-8-21 with Pfizer. No reaction. Then had massage yesterday and then today developed chills and fever. 101.5 now. Also has rash on breast and stomach. Flushed. Headache, nausea and myalgias.
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| 52 | 2021-01-21 | fever, chills, fatigue, headache |
Fever/chills /body aches Fatigue /headache Feel like lightning goes throughout my body Muscles and ...
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Fever/chills /body aches Fatigue /headache Feel like lightning goes throughout my body Muscles and bones extreme pain Extremely thirsty Couldn?t walk properly because of fatigue
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| 52 | 2021-01-21 | shortness of breath, fever |
GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATI...
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GENERALIZED RASH WITH PRURITUS. SHORTNESS OF BREATH. EDEMA IN EXTREMITIES, FACE, NECK . FEVER. PATIENT TOOK BENADRYL. SYMPTOMS RESOLVED NEXT MORNING
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| 52 | 2021-01-21 | weakness, chills, headache, fever, fatigue |
Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Aro...
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Vaccine was administered around 4-pm into right arm and bleeding occurred after administration. Around 3 am, I awoke with chills and low grade fever. Tmax 103.8F, chills, pressure headache, neck/back pain, and fatigue that lasted ~30 hours. Still have mild pressure headache with mild back/neck pain and weakness.
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| 52 | 2021-01-21 | cough, fatigue, throat pain |
after the first vaccine shot my muscles started aching with general fatigue. this lasted about a day...
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after the first vaccine shot my muscles started aching with general fatigue. this lasted about a day and felt like it came and went very quickly. the injection site was still hard and edematous after about 2 weeks. After the second vaccine I became slightly achy the same day I got the shot but pre-emptively took ibuprofen, which worked well. it wasn't until the day after my shot (towards the end of my work day) that I became incredibly fatigued and muscles ached. Later in the evening I developed a sore throat and slight cough, I did not take my temperature but felt I had a slight temperature increase. the 2nd and 3rd day post shot I was incredibly fatigued with a slight sore throat. by 4th day post shot I was feeling back to my normal self.
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| 52 | 2021-01-21 | fatigue, headache |
hives 2 hours post injection at injection site and above arm, shoulder, neck and chest and head. ...
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hives 2 hours post injection at injection site and above arm, shoulder, neck and chest and head. Itching. later feeling fatigue, body aches and headache.
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| 52 | 2021-01-24 | pneumonia |
Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and ...
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Pneumonia; Left Arm Swelling / her arm and shoulder became swollen; Left Arm Swelling / her arm and shoulder became swollen; she also has something else going on in her shoulder; achy all over in her neck, arm, and shoulder; achy all over in her neck, arm, and shoulder; Felt sick to her stomach; her arm was sore that evening; This is a spontaneous report from a Pfizer Sponsored Program made from a contactable consumer (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK5730) at single dose on left arm on 23-Dec-2020 for COVID-19 immunization. Medical history included sleep apnea; high blood pressure; COPD (chronic obstructive pulmonary disease). Concomitant Medication was nothing new, her normal medication, she took vitamins, and high blood pressure medication. She had had no positive test for Covid prior to the vaccine, she had had no antibody test, she had had no issues with vaccine in the past. The patient experienced left arm swelling in Jan2021 and pneumonia on 08Jan2021. The patient worked in a hospital and received her first dose on 23Dec2020 and she was supposed to get the second dose today but she was not at work today. She was wanting to know if she should go ahead and take the second dose because her arm was still swollen. The product was the Covid vaccine. She stated that her arm was still swollen, when she got shot she was fine, her arm was sore that evening (Dec2020) and then nothing, then a weekend after new years her arm and shoulder became swollen (Jan2021) and she had been to the ER and the doctor thought the swelling was because of the shot, but she also had something else going on in her shoulder (Jan2021). So in the meantime she went to the ER and they took X rays, and they told her that she was starting to develop pneumonia. She was going back to work tomorrow, being that she was on the antibiotics now, still had swelling in the arm, and had pneumonia, should she still get the 2nd shot. She noticed the swelling Saturday after New Years. She was also achy all over in her neck, arm, and shoulder (Jan2021). She felt sick to her stomach, this was all the first Week of Jan2021. She went to the ER, she was not admitted and came home the same day. She went to the ER on 08Jan2021. 08Jan2021 was also when the pneumonia was diagnosed. The name of antibiotic she was prescribed was doxycycline. She started it on Saturday 09Jan2021, she was prescribed 100 mg 2 pills a day for 10 days. When they did the X ray, they said that the pneumonia had showed up, or she was just starting to get pneumonia. Patient stated that she didn't believe because they made a comment about the way she was laying however she had been taking the medication and feeling better. She was schedule for the second dose today. She did reschedule for Friday, and wanted to know if she should still get it. In the ER, they said it could have been a blood clot and so they did a scan to find blood clots but it was negative. The outcome of event pneumonia was resolving; events left arm swelling and shoulder became swollen was not resolved. The outcome of rest evens was unknown..
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| 52 | 2021-01-24 | headache, dizziness | Reported blurry vision, dizziness, and severe headache. |
| 52 | 2021-01-24 | chills, fever, headache |
Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Musc...
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Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Muscle aches; Fever finally broke at 3pm on the next day 17 hours after symptoms began; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on the left arm on 09Jan2021 at 11:00, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 22Dec2020 at 11:00 for COVID-19 immunization. On 09Jan2021, the patient had shot at 11am with no reaction then at 10pm when started shaking/shivering violently for 2 hours and then developed very bad headache, muscle aches. The patient's fever up to 101 then the fever finally broke at 3pm on the next day (10Jan2021) 17 hours after symptoms began. As treatment, patient took Tylenol and Excedrin for headache, muscles aches and fever. No treatment was reported for the events shaking/shivering. The outcome of the event fever was recovered on 10Jan2021 15:00 while the rest of the events was recovered on Jan2021.
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| 52 | 2021-01-24 | fatigue, body temperature increased |
Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provide...
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Went to receive my second shot on 1/23/2021 by mistake instead of scheduled appt 1/30/2021. Provider informed me I was there on the wrong day but told me she would fit me in so I would not have to come back. After receiving the 2nd dose and waiting the 15 minutes, I realized that the time between shots were 14 days instead of 21. The HCP was contacted and was to reach out to vaccine provider. 1/23/2021 = date of receiving shot = no symptoms 1/24/2021 = 3:10 am woke with 102.1 fever, sore arm, body aches, and my skin hurt. Woke again at 8:00am with fever of 101.3 and the same symptoms. Alternated Tylenol and Ibuprofen every 2 yours. Fever went away around 10:00am but went still had body and skin aches and tired. 1/25/2021 = woke with no fever, but arm still hurt and so does the gland in my armpit. Still have body & skin aches. I am tired and I feel slightly off. My eyes are very tired.
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| 52 | 2021-01-24 | fever | body aches, low grade fever - total duration approx 36 hrs |
| 52 | 2021-01-24 | shortness of breath, fever, headache, fatigue |
fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue...
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fever/102.3 temperature; headache; achy all over; Within 3 minutes had tingling pins in mouth tongue and throat; Within 3 minutes had tingling pins in mouth tongue and throat; had hard time breathing; O2 sat were at 91; i had High BP 148/92; severe fatigue; This is a spontaneous report from a contactable Other HCP (patient). This 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EJ1686), via an unspecified route of administration on 05Jan2021 07:00 at single dose on the left arm for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), asthma, depression, irritable bowel syndrome (IBS), known allergies included bacitracin, penicillin, levofloxacin (LEVAQUIN), metronidazole (FLAGYL), oseltamivir phosphate (TAMIFLU), Bees, Hornets. Patient took other medications in two weeks. No other vaccine received in four weeks. Patient was not pregnant. Facility type vaccine was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Jan2021 07:03, within 3 minutes patient had tingling pins in mouth tongue and throat, had hard time breathing. The nurses gave her 50 mg of diphenhydramine hydrochloride (BENADRYL). The doctors checked her O2 sat were at 91, and she had High BP 148/92. After 40 minutes (05Jan2021 07:43) after the medication her symptoms seem to go away and she could breath better. She went home and went to bed because she work night shift. She got the vaccine when she got off work, then about six hours later (05Jan2021 13:00) she had bad headache and achy all over, 12 hours later (05Jan2021 19:00) she had 102.3 temperature and took paracetamol (TYLENOL) every 4 hours and fever finally broke 26 hours later (06Jan2021 21:00). She continued to have a headache for about 5 days and severe fatigue. Adverse event resulted in life threatening illness (immediate risk of death from the event). Patient was recovered with lasting effects.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported life threatening events including tingling pins in mouth tongue and throat, had hard time breathing, PO2 decreased, blood pressure increased, bad headache, achy all over, fever, and severe fatigue, and the administration of the COVID 19 vaccine, BNT162B2, considering the plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 52 | 2021-01-24 | headache, shortness of breath |
headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petec...
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headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting 3days. now 17 day later petechiae on abdomen abd burning pain (lymph nodes) in right underarm.
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| 52 | 2021-01-24 | fever, chills, headache | headache, fever, chills, body aches, nausea |
| 52 | 2021-01-25 | dizziness |
At 11:55 pm, Covid-19 vaccine administered to client. 11:57 am, client escorted to vaccination obser...
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At 11:55 pm, Covid-19 vaccine administered to client. 11:57 am, client escorted to vaccination observation room. 12:01 pm Client asked observer "Is it normal to feel light headed?"; Observer had client lie on the floor and elevate her legs; Observer radios for assistance 12:02 pm Assistance of RN arrived in the room. 12:03 pm Observer monitored B/P 146/98, pulse 66 Skin color good. Client verbalizing coherently. 12:05 pm Pulse oximeter applied 97%, pulse 77 12:10 pm B/P 122/66, pulse 84 Oximeter 97% 12:15 pm B/P 124/66 pulse 78, oximeter 97% Client assisted to sitting position. 12:27 pm B/P 124/66, pulse 78, oximeter 97% 12:30 pm Client release from clinic. Escorted to first floor and client then left the building.
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| 52 | 2021-01-25 | dehydration, fatigue |
Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Pati...
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Extreme fatigue followed by swelling of lymph nodes, swelling of tongue, difficulty swallowing. Patient took Benadryl 50mg and drank lots of water. Patient states she was severely dehydrated. Patient stated that she "should have probably gone" to the hospital but she did not. She did have an Epipen on her person if needed at the time but decided not to use it.
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| 52 | 2021-01-25 | headache |
On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and war...
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On same day of injection, recipient developed a headache, swollen lymph nodes under arm, red and warm swollen injection site area
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| 52 | 2021-01-25 | fever, weakness, chills, fatigue, headache |
had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous ...
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had fever max 100.8; chills; severe body aches; headaches; weakness; fatigue; This is a spontaneous report from a contactable other hcp (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 4176), via an unspecified route of administration on the left arm on 12Jan2021 13:15 at a single dose for covid-19 immunisation. Medical history included PCN allergy from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications included multivitamins, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) and fish oil (FISH OIL). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1685) on 22Dec2020 13:00 on the left arm for covid-19 immunization and stated that had no issues after first vaccination. On 12Jan2021 21:00, the patient had fever max 100.8 (no unit reported), chills, severe body aches, headaches, weakness, and fatigue. The patient underwent lab tests and procedures which included body temperature: max 100.8 (no unit reported) on 12Jan2021 21:00. As treatment, patient received OTC NSAIDS. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 52 | 2021-01-26 | shortness of breath, dizziness |
11:15 reported chest tightness - used her inhaler b/p 12/80 heart rate 86. reported slightly light h...
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11:15 reported chest tightness - used her inhaler b/p 12/80 heart rate 86. reported slightly light headed had two masks on placed in private room so she could remove masks. 11:21 breathing better masks removed 11:35 b/p 130/90 heart rate 94 breathing easy. Informed to only wear one mask. Instructed to Call 911 for further breathing difficulty.
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| 52 | 2021-01-26 | dizziness |
Following first dose of COVID-19 vaccine patient stated that she felt "faint". Patient was given two...
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Following first dose of COVID-19 vaccine patient stated that she felt "faint". Patient was given two ice packs, juice and a private room to recover in.
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| 52 | 2021-01-26 | sweating, shortness of breath |
Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had ch...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Shortly after receiving the vaccine patient stated they had chest pain, shortness of breath, nausea, back pain, and sweating. On evaluation a mild systolic murmur and irregular heartbeat were noted. Patient was transferred to the emergency department where initial vitals were within normal ranges except for blood pressure 145/104 mmHg. No wheezing, vomiting, respiratory distress, or anaphylaxis noted. Patient administered aspirin, morphine, acetaminophen, diphenhydramine, ibuprofen, and ondansetron and symptoms resolved. Repeat vitals were within normal ranges and patient discharged to home stable.
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| 52 | 2021-01-26 | dizziness |
Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a ...
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Reports usual chest pressure related to lupus condition but after getting Covid vaccine it is now a sharp pain, reports dizziness 6/10 and "different". Increased pain with deep breaths. denies nausea. Taken to ED with RR
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| 52 | 2021-01-26 | malaise, fatigue |
States started with side effects that evening around 6pm. Symptoms include fatigue, nausea, tirednes...
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States started with side effects that evening around 6pm. Symptoms include fatigue, nausea, tiredness, body aches, feeling unwell. Calling for follow-up because it has been over 48 hours since the vaccine and she still has symptoms. Now having sinus pain and congestion. Advised to follow-up with PCP. Placed order for COVID. COVID test on 1/19/21 resulted negative.
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| 52 | 2021-01-26 | headache, chills, runny nose | Swollen arm, redness, hot Headache Chills Body aches Runny nose Sneezing |
| 52 | 2021-01-26 | headache, fatigue, sweating | headache, body aches, sweats, fatigue |
| 52 | 2021-01-27 | fatigue |
Lymphadenopathy; mild fatigue; Myalgia; This is a spontaneous report from a contactable physician (p...
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Lymphadenopathy; mild fatigue; Myalgia; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), intramuscular in the left arm on 12Jan2021 at 16:30 as a single dose to prevent COVID. The patient's concomitant medications were not reported and it was reported that she had no relevant medical history. The patient previously received the first dose of BNT162B2 on 22Dec2020 at 14:00. The patient did not receive any other vaccine/s on the same date as BNT162B2, did not have prior vaccination within four weeks of receiving BNT162B2, and did not experience any adverse event following prior vaccinations. The patient experienced mild fatigue and myalgia on 13Jan2021, and lymphadenopathy on 14Jan2021. Seriousness for the events was reported as serious (medically significant). The patient received her second dose of the Pfizer Covid Vaccine on 12Jan2021 at 16:30. She experienced mild fatigue and myalgia after 24 hours which has improved. She clarified that the mild fatigue and myalgia resolved by this morning. She felt lymphadenopathy in her lower neck and supraclavicular area. Stated it was almost fullness she can feel, there was no redness and it was not tender. She was hoping this was related to the vaccine that she got in her left upper arm. She went to the CDC and Pfizer website and saw that lymphadenopathy was mentioned but it was a small percentage. The patient declined any treatment. The events did not require a visit to the Emergency Room of Physician's office. Outcome of the events fatigue and myalgia was recovered on 15Jan2021, while for the event lymphadenopathy was not recovered. The reporter's causality assessment between the events and BNT162B2 for the events fatigue and myalgia was related, while for the event lymphadenopathy was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events fatigue, myalgia and lymphadenopathy are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-01-28 | fatigue |
Petechia; felt fatigued; This is a spontaneous report from a contactable physician. A 52-years-old f...
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Petechia; felt fatigued; This is a spontaneous report from a contactable physician. A 52-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular on deltoid left from 05Jan2021 to 05Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood cholesterol increased/high cholesterol and allergy to sulfa drugs. Concomitant medication included ongoing rosuvastatin calcium (CRESTOR) for blood cholesterol increased. The reporter stated that about 5 days later she noticed petechiae on her hands (10Jan2021). The patient also felt fatigue on Jan2021. She went to see her primary care doctor. She had lab work, blood count, clotting factors, and CMP done and states her labs were ok and the other test had unknown results on an unspecified date. The patient's weight ranges from 140-145 lbs. The petechiae has slowly faded. Outcome of the event petechia was recovering while outcome of the event fatigue was unknown.
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| 52 | 2021-01-31 | migraine, fatigue |
39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), di...
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39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), diarrhea, nausea, had temp of 99.5F for one day, fatigue.
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| 52 | 2021-01-31 | shortness of breath |
Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest...
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Anaphylaxis, tongue swelling, difficulty breathing, & hives, Ambulance transported pt to the nearest ER, required Epinephrine injections 1mg IM X3, IV Methylprednisolone 50mg and IV Benadryl 50mg, pt had to be transferred to higher level of care due to ongoing symptoms and was kept until 1/24/21. Pt said staff at the ER told her they knew they should report the reaction to someone but didn't know how to report it.
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| 52 | 2021-01-31 | fever, fatigue, weakness |
fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous ...
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fever between 103 to 103 F; Severe body aches; fatigue; generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231 and expiration date not provided), via an unspecified route of administration in the left arm on 07Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included Meniere's disease, and allergies to Latex. The patient previously took cefalexin (KEFLEX) and codeine and experienced allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 17Dec2020 17:30 in the left arm for COVID-19 immunization. The patient is not pregnant. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications. On 08Jan2021 03:00, about 10 hours post vaccine, the patient experienced fever between 103 to 103 f, severe body aches, fatigue, and generalized weakness which lasted until about 60 hours post vaccination. The patient has not undergone COVID testing post vaccination. The outcome of the events was recovered on 10Jan2021 15:30.; Sender's Comments: Based on a compatible temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-02-01 | chills, fever |
passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-co...
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passed out; hit chin on the sink; vomited; Fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 at single dose on unspecified date for covid-19 immunization. Patient had one of the worst nights, fever/chills on 18Jan2021. Got up at 1:30 on 19Jan2021 to use the bathroom, passed out and hit chin on the sink. Then vomited. Still low fever. Patient didn't receive treatment for events. Outcome of all events was recovering. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. The report was considered as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 52 | 2021-02-02 | headache |
Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain;...
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Bleeding/ gastro intestinal bleeding; Bleeding/ gastro intestinal bleeding; woke up with chest pain; tachycardia; body ache; headache; This is a spontaneous report from a contactable other HCP reported for self. A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1686), via an unspecified route of administration at left arm on 13Jan2021 12:00 PM (that is 14Jan2021 00:00) at SINGLE DOSE for COVID-19 immunization. No Covid prior vaccination. Medical history included allergy to shellfish and Iodine, Kidney and pancreas transplant 10 years ago. Concomitant medications in two weeks includes mycophenolate sodium (MYFORTIC), Tacrolimus, Prednisone, Trazodone. The patient previously received first dose of BNT162B2 (Lot number: EJ1686), at left arm on 24Dec2020 14:30. No Other vaccine in four weeks. On 14Jan2021 09:30 AM, patient woke up the next morning with chest pain, tachycardia, body ache, headache, bleeding. Symptoms lasted from Thursday to Monday. A total of 5 days. Patient have never suffered from a headache and as of 20Jan2021, patient still had it. Every day got better and no longer have the other symptoms. The only other one is the gastro intestinal bleeding. Patient only see few spots of blood when go to the bathroom. She believed that is gastrointestinal because almost never had a period as a teen. No treatment received. Not tested covid post vaccination. Outcome of "Bleeding", "Gastrointestinal bleeding" was not recovered, of "headache" was recovering, of other events was recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events haemorrhage and gastrointestinal haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 52 | 2021-02-03 | cough, fever, headache |
tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVI...
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tested for COVID and result came out positive/ body ache, fever, headache and cough; tested for COVID and result came out positive/ body ache, fever, headache and cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration, on 24Dec2020 at single dose as first dose, on left deltoid on 14Jan2021 as second dose at single dose to protect patient from COVID. Medical history included prediabetes and blood pressure high. Concomitant medication included metformin for prediabetes, losartan for blood pressure high. The patient's second vaccine (COVID 19 Vaccine) was just past this 14Jan2021. Then she had a lot of symptoms on 14Jan2021, the patient had like body ache, fever, headache and cough. The patient started to have suddenly with the side effects from the vaccine and then it was fine until yesterday and then she had to go in and get tested for COVID because she had never tested positive and her result came out this morning positive in Jan2021. The patient received Tylenol as treatment. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.
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| 52 | 2021-02-04 | throat swelling, headache, dizziness |
throat was getting somewhat tight, some swelling; throat was getting somewhat tight, some swelling; ...
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throat was getting somewhat tight, some swelling; throat was getting somewhat tight, some swelling; slightly lightheaded; mild headache; This is a spontaneous report from a contactable other health professional (patient). A 52-year-old female patient received first dose of BNT162B2 (lot no. and expiry date were not reported), via an unspecified route of administration into left arm on 20Jan2021 13:30 at single dose for Covid-19 immunization. The patient is not pregnant. Medical history included allergies to shrimp and lobster, mild asthma and high blood pressure. Concomitant medication included diltiazem, benzoyl peroxide (BP), cetirizine hydrochloride (ZYRTEC), loratadine, paracetamol (TYLENOL) and vitamins. The patient had allergies to past blood pressure medications which included amlodipine besilate (NORVASC), irbesartan (AVAPRO) and lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. After taking first dose about 20 minutes on 20Jan2021 at 13:50 the patient felt slightly lightheaded and had mild headache, no real concern. Left observation area to go home after 45 minutes. No other symptoms at that point. Light headedness went away. While driving and running errands a few hours later the patient noticed her throat was getting somewhat tight, some swelling on 20Jan2021 at 16:30; this is similar to when she used to have shrimp/lobster allergic reactions. The patient took 1 tab of Benadryl before it got too bad and it subsided after about 30 min. No shortness of breath or any more symptoms so she went home and went to sleep after a few hours. She woke up and her throat had still some swelling. She called her doctor and she was recommended to take more allergy meds throught out the day and to report event to facility and to monitor. The swelling has not gone but much better. She was concerned about 2nd shot if it can be given where she was observed and monitored for a day. The patient recovered from slightly lightheaded on unspecified date. The outcome of headache was unknown and the remaining events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association and drug's safety profile, the events throat tightness and throat swelling are possibly related to suspect vaccine BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-02-06 | shortness of breath | patient started feeling as though her throat was closing and short of breath |
| 52 | 2021-02-07 | fatigue |
Feeling tired; Discovered she was Covid 19 positive; Discovered she was Covid 19 positive; This is a...
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Feeling tired; Discovered she was Covid 19 positive; Discovered she was Covid 19 positive; This is a follow-up spontaneous report from a Pfizer-sponsored program Pfizer. A contactable consumer reported that a 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunisation. Medical history included Allergies from an unknown date and unknown if ongoing, bad back aches from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]), mometasone furoate (FLONASE [MOMETASONE FUROATE]). On 16Jan2021, she had her first dose of COVID vaccine, and two hours later she had a positive COVID test done. She is wondering when she can get the second dose, her doctor said she had to wait 3 months for the second, dose, she is questioning that, and wants to know, should she be retested for COVID, since she thinks it may be a false positive, since she has no symptoms of COVID. She states she didn't really have any symptoms other than feeling tired. The outcome of event fatigue was unknown, while the outcome of the other events was not resolved. Information about lot/batch number has been requested.
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| 52 | 2021-02-07 | dizziness | complained of dizziness; refused to stay to be observed extra 15 minutes; no other problems. |
| 52 | 2021-02-08 | throat irritation |
lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from...
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lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 22Jan2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, morbid obesity, anemia, arthritis, allergic to fish (shell & fin) and all nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but it was reported that the patient took other medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Jan2021, at 16:15 (also reported as after 15 minutes), the patient's lips became numb and the throat started to sound very scratchy and itchy. This resulted in a doctor or other healthcare professional visit. Treatment for the events included the patient taking her own diphenhydramine (BENADRYL), epinephrine (EPIPEN) and albuterol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of lips became numb and the throat started to sound very scratchy and itchy was resolved with sequel on Jan2021. Information on the batch/lot number has been requested.
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| 52 | 2021-02-10 | fatigue |
the second injection caused my flare to worsen; fatigue; multiple joint pain; This is a spontaneous ...
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the second injection caused my flare to worsen; fatigue; multiple joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EK9231), via an unspecified route of administration in right arm on 08Jan2021 10:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included psoriatic arthritis, sub clinical hyperthyroidism and allergy to bees. She had her first dose of bnt162b2 (lot EK5730) on 18Dec2020 in her right arm. No other vaccine in four weeks and no Covid prior vaccination. Concomitant medications included methimazole, meloxicam (MOBIC), apremilast (OTEZLA), atenolol and melatonin. She previously took Ceclor and Biaxin and had drug hypersensitivity. Her psoriatic arthritis was starting to have a flare prior to her first injection. She believed the second injection caused her flare to worsen to the point she had difficulty working due to fatigue and multiple joint pain on 10Jan2021. Tramadol was given as treatment. The events were reported as serious- disability or permanent damage. The outcome of events was not recovered.
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| 52 | 2021-02-14 | fever, discomfort, dizziness |
At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; ...
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At approximately 16:00 started shaking; extremely cold; Both arms as well as pectoral muscles hurt; Both arms as well as pectoral muscles hurt; Very dizzy; fever up to 102.1 Fahrenheit; uncomfortable like I needed to get something out my body; This is a spontaneous report from a contactable nurse reported for herself. A 52-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 29Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included HTN (hypertension). Concomitant medication included losartan and hydrochlorothiazide (HCT) received in two weeks. There was no other vaccine received in four weeks. At approximately 29Jan2021 16:00, the patient started shaking and extremely cold. The patient experienced both arms as well as pectoral muscles hurt. The patient experienced very dizzy and uncomfortable like she needed to get something out her body. This lasted for over 24 hours with fever up to 102.1 Fahrenheit. All events occurred on 29Jan2021 16:00. The events resulted in congenital anomaly or birth defect (pending clarification). No treatment received for the events. The patient was no pregnant. The patient had no COVID prior vaccination. The patient had not been tested for COVID-19 post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-02-17 | headache |
Enlargened lymph node in mouth; headache in temples; This is a spontaneous report from a contactable...
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Enlargened lymph node in mouth; headache in temples; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: E13302) solution for injection, via an unspecified route of administration in left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included lower back pain. Concomitant medications: patient received medications two weeks prior to vaccination. The patient had the first dose of the vaccine on 22Dec2020 at 1pm (lot/batch number: El0140) in left arm. Patient reported that after 2 days (13Jan2021), at around 3pm she got a headache in her temples that would not go away. She went to the urgent care Covid test done which was negative. Had ER visit for headache then with continued headache, then 2 weeks later another ER visit. She also had enlarged lymph node in mouth that was found 2 days ago (03Feb2021). Patient visited ER for the events. As treatment, patient was given Rocephin IV, migraine cocktail, morphine and Dilad. The patient underwent lab tests which included Nasal swab: negative on 16Jan2021 (Rapid test). Prior to vaccination, patient was not diagnosed with Covid-19. Outcome of the events was not recovered. No follow-up activities are needed. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 52 | 2021-02-17 | discomfort, headache |
I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfor...
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I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfort; blood in my urine; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Jan2021 at 10:30 AM as a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient ha d no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, has not been tested for COVID-19 since the vaccination, and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine and also did not receive any other medication within two weeks of vaccination. The patient had a headache on 22Jan2021 for 5 days. She also had stomach bloating and pressure and discomfort on 22Jan2021. It was reported that when she saw blood in her urine, she went to a walk-in and was diagnosed with a UTI on 22Jan2021. She did 7 days of an antibiotic. Then on 30Jan2021, she had an abscess tooth that became infected. It was reported that the patient received antibiotics for both infections. It was reported that the events result in a doctor or other healthcare professional office/clinic visit and an Emergency room/department or urgent care. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
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| 52 | 2021-02-21 | body temperature increased, chills |
16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 s...
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16 hours after injection, had chills, temp 99.8, body aches that lasted about 16 hours. Then had 2 small nosebleeds that lasted less than 1 minute-one about 48 hours after injection and one about 72 hours after injection. About 79 hours after injection, noticed petechiae on bilateral lower legs only . . Notified my PCP the next day. No nosebleed on day 4 after injection and petechiae stable - maybe spread a little but still below the knees. ( Had previous COVID-19 infection that symptoms started around 11/29/2020)
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| 52 | 2021-02-21 | shortness of breath |
Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mi...
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Patient arrived for 2nd dose of Pfizer vaccine. Administered with no difficulty. Approximately 20 mins after receiving vaccine, patient began to report shortness of breath and chest tightness and rash to chest, that continued to worsen. She was brought into the urgent care (on-site) and was evaluated by MD and urgent care team. Intravenous access was established, placed on cardiac monitoring and supplemental oxygen was administered. Benadryl, Pepcid, Epinephrine (2 doses), Solumedrol, normal saline intravenous transfusion was administered. SOB and chest tightness resolved, rash improved. Monitored in urgent care for additional 5 hours, discharged home with prednisone and epi-pen.
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| 52 | 2021-02-21 | skin warm, influenza like illness, somnolence, head discomfort |
Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the to...
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Within 15 minutes, left arm got got really cold - like ice. Lasted about 2 hours. The arm to the touch was warm but it felt like it was in ice bucket. They kept me for 2 hours. Started to resolve in those two hours but didn't go away completely. By evening it was mostly returned to normal. Next day, I woke up with flu-like symptoms - felt like I had the flu. Every hair on my head hurt; wanted to sleep; no appetite. Three in afternoon - I felt much better. As quickly as it came on, it went away quickly.
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| 52 | 2021-02-22 | shortness of breath |
"10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal...
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"10min after vaccine, experiencing chest tightness and feeling SOB, BP 124/82 HR 44-86 with abnormal heart rhythm on auscultation O2 sat 100% temp 36.8 . She expresses tingling to the tips of her fingers, left shoulder pain radiated to her neck. DR in urgent care immediately notified and arrived . EKG ordered "
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| 52 | 2021-02-22 | fatigue, dizziness, fever, sweating |
I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER w...
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I had light headedness,breaking out severe sweats, nausea and vomited (1). I was transported to ER with a 103.5 fever lasted for 10 days, Covid test, Epipen,swollen lymph nodes(right arm) painful,increased fatigue.During the 10 day period I had went to the ER again 5th day got tested for Covid and rechecked symptoms.
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| 52 | 2021-02-22 | shortness of breath, fatigue, headache |
Patient is a 52 year old female who presents with concerns of headaches, nausea, fatigue, hives/itch...
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Patient is a 52 year old female who presents with concerns of headaches, nausea, fatigue, hives/itching, and SOB since receiving her Covid-19 vaccine 3 weeks ago. Got the Pfizer vaccine at the Center on 1/17/21 around 12:30PM. She had no side effects during the 15 minutes she was kept for observation after receiving the vaccine. She did develop a headache and fatigue approximately 1.5 hours after she got the vaccine and then later that day developed nausea. SOB developed the following day. She developed hives on her chest approximately 2-3 days after the vaccine. States she cannot recall the exact date that the hives started. Hives have appeared like pink raised plaques. Largest plaque was 1 inch in diameter she estimates. The hives have continued to come and go from different areas of her body including her shoulders, buttock, upper legs. SOB is present at rest and with exertion. She has had no chest pain/pressure/tightness/wheezing , palpitations, or feeling of her throat closing. States her exertion capacity is reduced.
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| 52 | 2021-02-22 | chills, dizziness, headache | Strong headache, in the left arm and all over the body. Nauseas Chills Dizziness |
| 52 | 2021-02-22 | sweating, fever, headache, fatigue |
exhaustion, fever of 102, bone pain, chills, muscle/joint aches, headache, sweating, lump (size of s...
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exhaustion, fever of 102, bone pain, chills, muscle/joint aches, headache, sweating, lump (size of small apple) in my left armpit. All symptoms subsided by Wednesday except exhaustion and lump.
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| 52 | 2021-02-22 | fatigue, headache |
nausea, fatigue, headache used otc acetaminophen 500mg 2tabs q 12hours & headache gone morning 2 ....
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nausea, fatigue, headache used otc acetaminophen 500mg 2tabs q 12hours & headache gone morning 2 ... night 3 of nausea, took ondansetron 4mg i had from old RX once and otherwise, tolerated the little nausea left until gone night 4..brain fog for 4 days- remained without remaining headache
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| 52 | 2021-02-23 | fatigue, dehydration |
Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swal...
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Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.
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| 52 | 2021-02-23 | fatigue | I exp fatigue, arm soreness, body ache and flare of Psoriasis lasting 48 hours, |
| 52 | 2021-02-23 | chills, runny nose, throat pain, nasopharyngitis, fatigue, shortness of breath, cough |
Tiredness, out of breath after a few normal activities. Five days later cold/sinus symptoms started...
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Tiredness, out of breath after a few normal activities. Five days later cold/sinus symptoms started with a sore throat, severe dryness of throat, nose, then congestion, runny nose, chills, NEVER a fever. A week later still tire, a little congestion, cough, some white liquid flem.
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| 52 | 2021-02-23 | fever |
fever; body aches; mild vertigo; The first dose was received on 02Dec2020 and the second dose was re...
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fever; body aches; mild vertigo; The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021; This is a spontaneous report from a contactable Other Health Professional reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration (left arm) from 16Jan2021 17:30 (05:30 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Keflex and sulfa from unspecified date. Patient is not pregnant. No other vaccine was given in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medication included botulinum toxin type a (BOTOX), and ibuprofen (MOTRIN) from an unspecified date for an unspecified indication (medications in two weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on 02Dec2020 07:45 AM, Left arm. The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021. The patient experienced fever, body aches, mild vertigo on 17Jan2021 12:00. Treatment was not given. Outcome of the events was recovered in 2021. Information about lot/batch number has been requested.
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| 52 | 2021-02-28 | dizziness |
Increased pain with deep breaths; dizziness 6/10 and "different"; a sharp pain/Increased pain; This ...
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Increased pain with deep breaths; dizziness 6/10 and "different"; a sharp pain/Increased pain; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3302), intramuscular from 25Jan2021 16:00 at SINGLE DOSE in left arm for COVID-19 immunization. Medical history included allergic rhinitis, depression, hypertension, and lupus. Concomitant medications included salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), bupropion, hydroxychloroquine, olmesartan, colecalciferol, folate sodium, magnesium, omega-3 fatty acids, pyridoxine hydrochloride, vitamin b12 nos, vitamin e nos (SUPER OMEGA 3 [COLECALCIFEROL;FOLATE SODIUM;MAGNESIUM;OMEGA-3 FATTY ACIDS;PYRIDOXINE HYDROCHLORIDE;VITAMIN B12 NOS;VITAMIN E NOS]), curcuma longa rhizome (TURMERIC CURCUMIN [CURCUMA LONGA RHIZOME]). The patient previously took codeine and experienced Known allergies, hives, itching, throat swells. The patient had first dose of BNT162B2 on 04Jan2021 15:15 at 52-years-old. It was reported that the patient experienced usual chest pressure related to lupus condition but after getting Covid vaccine it is now a on 25Jan2021 16:00, sharp pain, reports dizziness 6/10 and "different". Increased pain with deep breaths. denies nausea. Taken to ED (Emergency department) with RR. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included investigation: 6/10 on 25Jan2021, respiratory rate: unknown results on 25Jan2021. The outcome of the events was unknown.
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| 52 | 2021-03-02 | headache, fever, somnolence, fatigue |
I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasm...
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I slept all day; I could not eat; I could not get out of bed, I hurt so bad/Body aches; Muscle spasms; Headache; Tired; I had a 100.4 temperature for 2 days; This is a spontaneous report from a contactable consumer (reporting for herself). A 52-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unspecified indication. On 30Jan2021, the patient stated that "I slept all day, I could not eat, I could not get out of bed, I hurt so bad and has body aches, muscle spasms, headache, tired and I had a 100.4 temperature for 2 days." The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Nov2020. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 52 | 2021-03-04 | influenza like illness, chills, fatigue |
aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that...
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aggravated and upset; she is angry; is miserable everyday/ felt like she was in a car accident, that is how bad she felt; cold chills; she runs low like 96.6 to 96.8 and she took her temperature/ she was 95.5; joint pain/joint hurting; restless leg syndrome; fatigue; she got sick; nauseous; threw up; flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included seasonal asthma diagnosed when she was a child and has a rescue inhaler she only uses once in a while if she needs it; she stated her thyroid was giving her problem, she takes a thyroid medicine; and stated weight was thanks to menopause. Concomitant medications included ascorbic acid (VITAMIN C), fish oil (OMEGA 3), and curcuma longa (TURMERIC). The patient reported that she was aggravated and upset on an unspecified date. She reported that she was not feeling bad before taking the shot and nobody was telling her what to do about it. She was asking what she should do about her symptoms of joint pain, restless leg syndrome and fatigue after getting her first vaccination on 22Dec2020. She was crying and stated that her boss can't tell her anything, she doesn't want to go to her doctor because, what was he going to tell her. She doesn't want to waste a copay. She reported taking Advil and Tylenol for her joint pain without relief and asked what else she should do. She stated she wanted directions, she doesn't want people reading off of a card. She stated she shouldn't have to pay a copay and she doesn't want more medicine to mask her symptoms, she wanted an answer. Additionally, the patient was calling about Pfizer COVID shot, she took first dose 22Dec2020, had a reaction, 35 minutes after she sat for 30 minutes, she works at a hospital, and she walked out to her car, she got sick and nauseous, then after the shot, she had flu like symptoms that lasted, and the next day was terrible, it lasted another week and a half, then she took the second shot 11Jan2021, to this day, she still has restless leg syndrome, fatigue, and her joints were hurting her. She had the same thing before, but this hurts a lot worse, and it was not going away, she was taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she was taking Omega 3, vitamins, she was 52 years old, she does Spartan races, Cross fit, she does paleo and keto eating, if one looks at her they wouldn't know she was 52, and she was hurting everyday and doesn't know what else do to, and doctors weren't knowledgeable, she doesn't want a stupid answer. She called work, the CDC knows about it, now VAERS, and they said to call Pfizer, when she calls her doctor she doesn't want to pay a copayment and get an idiotic answer. She got this because she works at a hospital and she was trying to protect herself and everyone else, she doesn't like feeling this way, it was to the point she was getting angry, not at Pfizer, but she gets up and runs, with her dog, she was busy all the time, she has 3 boys in the military, and she meets up to do obstacles with them, but she doesn't feel like doing crap and was miserable everyday. She was a CNA in nursing school. She doesn't know if she even wanted to see her doctor, she doesn't want to get an idiotic answer. She hasn't seen him in while, she switched insurance, been primary for years. Stated this was her first day speaking to DSU before she decides what else to do after this, she was angry. Stated about 35 minutes after the first shot, after 30 minutes they said she could go, she said ok, she walked out to her car, was nauseous and threw up and didn't eat that morning, and the next day, she felt like she was in a car accident, that was how bad she felt, she had cold chills, flu like stuff that night before, she runs low like 96.6 to 96.8 and she took her temperature, she got in a blanket and went to bed that night, she was 95.5, and didn't bother taking another temperature, she took a bunch of Advil and went to bed, and Benadryl to go to sleep. This all started on 22Dec2020, and it took about 2 weeks, she just had joint pain, not like now, but those days she didn't feel good, but by the third week she was ok, and she went to take the second shot next time, and all hell broke loose. The second shot was 11Jan2021, and that night it she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed, she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day, she felt like the first time, that like she got it an accident, feeling terrible, that night, and she can lay on the couch to relax, but with the restless leg syndrome, and her joints all day long, she just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. Restless leg syndrome depends, sometimes it was better than other time. Joint pain was not improving, she was so aggravated about that, she was not feeling 100%, people look at her and say she doesn't look like she feels good, she doesn't, and she was ready to bite their heads off, she was very active, always in the gym or something, she has 3 kids in the military, and was always meeting up with them to do military runs and just this was ridiculous. Stated she took a picture of the vaccine card, as she sent it to a few people. This was definitely the Pfizer vaccine, she has told many people, many people know do not take this, she was so irritated, it's not even funny. The case was reported as non-serious. The outcome was not recovered for the events joint pain, restless leg syndrome and fatigue; and unknown for the rest of the events.
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| 52 | 2021-03-04 | fatigue |
feel tired/more tired; mind felt foggy; feel achy throughout body; This is a spontaneous report from...
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feel tired/more tired; mind felt foggy; feel achy throughout body; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration (at the age of 52-years-old) on 01Feb2021 12:30 at a single dose in left arm for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Bactrim and clarithromycin and experienced allergies. The patient experienced feel tired/more tired, mind felt foggy, feel achy throughout body all on 01Feb2021 14:30 with outcome of recovering. The patient reported that "Approximately 1 hr (as reported) after receiving the vaccine, I started to feel tired, and my mind felt foggy. A few hours later, I began to feel achy throughout body and more tired. Next morning continued to feel achy but not as tired." No treatment received for the events. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious.
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| 52 | 2021-03-04 | chills, fatigue, malaise |
she was very annoyed the next day; felt like the first time that like she got it an accident; feelin...
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she was very annoyed the next day; felt like the first time that like she got it an accident; feeling terrible; Restless leg syndrome/same thing before, but this hurts a lot worse, and it not going away; Restless leg syndrome/same thing before, but this hurts a lot worse, and it not going away; Fatigue; Her joints are hurting her/Fatigue/same thing before, but this hurts a lot worse, and it not going away; Cold chills; didn't get very much sleep; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE/PFIZER COVID SHOT; lot number: EL1284; expiration date: unknown) at vaccination age of 52-year-old via an unspecified route of administration in the left arm on 11Jan2021 at a single dose for prevention, she works in a hospital (covid-19 immunization). Medical history included seasonal asthma, cross fit (exercise adequate), and paleo and keto eating, thyroid is giving her problem, menopause. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE/PFIZER COVID SHOT; lot number: EH9899) at vaccination age of 52-year-old via an unspecified route of administration on 22Dec2020 at a single dose for prevention, she works in a hospital (covid-19 immunization) but got sick and was nauseous, flu like symptoms, restless leg syndrome, fatigue, joints are hurting her, she doesn't feel like doing crap and is miserable everyday, threw up, felt like she was in a car accident, that is how bad she felt, cold chills and anger. Concomitant medications included fish oil (OMEGA 3), ascorbic acid (VITAMIN C), Apple Cider Vinegar, thyroid medicine and vitamins. She reported that she took the second shot 11Jan2021 (to this day), she still has restless leg syndrome, fatigue, and her joints are hurting her. She had the same thing before, but this hurts a lot worse, and it not going away. She is taking Turmeric, everything, and everyone says to just keep taking Tylenol or Advil but she can't keep taking it because now it was upsetting her stomach, or like arthritis medicine, she is taking Omega 3 and vitamins. She added that she went to take the second shot next time, and all hell broke loose. That night (11Jan2021), she noted her joints were starting all over again, and she had restless leg syndrome, cold chills and everything, so she went to bed. she didn't have Benadryl, so she got up, and that night took Tylenol, she didn't get very much sleep, and she was very annoyed the next day (12Jan2021). She felt like the first time that like she got it an accident, feeling terrible that night, and she can lay on the couch to relax but with the restless leg syndrome, and her joints all day long. She just went yesterday to buy Advil Arthritis, and she never had arthritis before or anything. She mentioned that the restless leg syndrome outcome depends, sometimes it is better than other time, as for the joint pain, it was not improving, she is so aggravated about that, she is not feeling 100%, people look at her and say she doesn't look like she feels good (she doesn't) and she is ready to bite their heads off since she is very active, always in the gym or something. She started Turmeric since she is desperate, this has been going on since 11Jan2021, anything she is doing now is not doing anything. She does not know what to do as every doctor will say maybe she should see this doctor, but she didn't feel like this before this shot. She was tired of feeling this way, she didn't feel this way before the shot, and if anyone met her, they know it. The outcome of the event restless leg syndrome was recovering, arthralgia was not recovered while the outcome of the other events was unknown.
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| 52 | 2021-03-06 | throat irritation |
After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With i...
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After receiving the shot about 30 seconds later I felt a gush of warm heat overcoming my body.With in a minute my throat got scratching and had a hard time Swallowing. My Tongue Swelled and my lips felt Numb.A Medic doc was called over to me. I was immediately taken to a tent with other Doctors. The doctor immediately gave me a Epipen in my right upper thigh. With in a few minutes EMS was there they tried to put a IV IN me but was unsuccessful. The EMT gave me a shot of Benadryl in my right arm. EMT rushed me to Emergency room. At the ER they put an IV in and gave me Dexamethasone and Pepcid. I was closely watched and was released after around 5 hours.
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| 52 | 2021-03-09 | cough, fever |
glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side...
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glands were swollen and when swallows; glands were swollen and when swallows, sharp pain on one side; vaccines were given in the left arm because she was left-handed; Back pain; spasms; fever; she felt like the inside of her eyes were on fire; She had a moist cough; spine pain; nausea; vomiting; She had numbness and tingling around the outside of mouth; She had numbness and tingling around the outside of mouth; She had pain in the arm at the injection site; knees would buckle; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; injection site was about a silver dollar size and was red and warm to touch; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302) at single dose on 27Jan2021 via an unknown route in left arm for Covid-19 immunization. She was diagnosed diabetes six years ago (as of 23Feb2021), and her last A1C was 6.1 in Dec2020, had chronic edema since her last child was born 26 years ago. Concomitant drugs included furosemide (LASIX) 400 mg twice daily, potassium 10 meg three times daily, omeprazole (PRILOSEC) 40 mg once daily, and metformin hydrochloride (METFORMIN ER) 1000 mg twice daily, all ongoing. She did not feel like the medication she takes are relevant because she had been taking them for a very long time. Historical Vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140) intramuscular injection in left arm on 04Jan2021 for Covid-19 immunization and experienced back pain, diagnosed with COVID in between the first and second vaccine, headache, arm pain at the injection area, severe back spasms in the thoracic and lumbar (AER 2021200627). Patient experienced back pain 2-3 days after the first dose, headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given Voltaren and Flexeril. She was taking 1 gram of Tylenol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. The reporter assessed headache, arm pain at the injection area, back pain, severe back spasms in the thoracic and lumbar were related to suspect vaccine. After the 2nd dose of the vaccine, patient experienced back pain in Jan2021, sharp, stabbing, crushing pain and spasms in Jan2021, fever for a couple of days in Jan2021, knees would buckle in Jan2021, glands were swollen and when swallows, sharp pain on one side on 09Feb2021, felt like the inside of her eyes were on fire in Jan2021, moist cough in Jan2021, spine pain in Jan2021, nausea and vomiting in Jan2021, numbness and tingling around the outside of mouth in Jan2021, pain in the arm at the injection site in Jan2021, injection site was about a silver dollar size and was red and warm to touch in Jan2021. The event clinical course was as follows: The second dose was given on 27Jan2021. She was getting over COVID and had to wait until the 27Jan2021 to get second dose. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021 with results of her PCR test on 13Jan2021. She was diagnosed with COVID in between the first and second vaccine due to an exposure not the vaccine. At hour 25 after receiving the second dose symptoms started. Severe back pain in the entire spine. It was sharp, stabbing, crushing pain and spasms. When the back would spasm her knees would buckle. She had a fever for a couple of days. 102 fever and she felt like the inside of her eyes were on fire. She has never had that before. She had a moist cough and still has a moist cough. The spine pain was better, but it is not gone away yet. Normally she does not have back pain. At first the pain was an 8 out 10 now (as of 23Feb2021) it was 5 out of 10. Also had nausea and vomiting. She had numbness and tingling around the outside of mouth. That lasted for two days. She had pain in the arm at the injection site. The injection site was about a silver dollar size and was red and warm to touch. She had pain at the injection site and pain in the arm. Both vaccines were given in the left arm because she was left-handed. She thought she would be using that arm more. She did go to Urgent Care after the second dose as well. They gave her a shot of Toradol and another prescription for Voltaren twice a day and Flexeril at bedtime because she can't stay awake when she takes it. She has missed work because of this. The back pain and cough was almost a month now (as of 23Feb2021). She reported no matter what she did she did not get it to go away. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of Tylenol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She has been taking 1000mg Tylenol three times a day and now she was taking it two times a day. She used Tylenol and generic, SunMark Acetaminophen (Lot number: OLE2349B, expiry: Sep2022). Regarding seriousness of headache, made a different in the vision. It was throbbing. for back pain: it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor. for arm pain at the injection area: gripping was not easy and moving her arm was painful. She is left handed. Heat worked better than ice. Ice made things worse. for cough: it had not been disabling. it was irritating because it had been almost 30 days. She knows it was different than the COVID cough because it was moist and when she had COVID it was a dry cough. Regarding seriousness of nausea and vomiting: it was debilitating and she couldn't go anywhere because she was throwing up with every move she made. The pain made it worse. The reporter assessed moist cough, nausea and vomiting, arm pain at the injection area were related to suspect vaccine. No investigation assessment performed. Outcome of fever, inside of her eyes were on fire, pain in the arm at the injection site was resolved. Outcome of back pain, moist cough was not resolved. Outcome of spine pain was resolving. Outcome of the other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the back pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including spine CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-09 | headache |
she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at ...
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she was diagnosed with COVID in between the first and second vaccine; she had headache; arm pain at the injection area; severe back spasms in the thoracic and lumbar; made a different in the vision, it was throbbing; back pain; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL0140), intramuscular on 04Jan2021 at single dose at left arm for covid-19 immunization. Medical history included diabetes (diagnosed six years ago. Her last A1C was 6.1 in Dec2020), chronic edema since her last child was born 26 years ago. Concomitant medications included ongoing furosemide (LASIX), ongoing potassium, ongoing omeprazole (PRILOSEC), ongoing metformin, and paracetamol (TYLENOL). Caller received the Pfizer-BioNTech COVID-19 Vaccine first dose on 04Jan2021 and second dose on 27Jan2021. Caller reported to have experienced back pain 2-3 days after the first dose, and a sharp stabbing back pain with moist cough for almost a month now after the second dose. Caller was diagnosed with COVID-19 in between. With the first vaccine she had headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar. It was sharp, stabbing, crushing pain then she would have spasms. She went to urgent care and was given diclofenac (VOLTAREN) and cefixime (FLEXERIL). She was taking 1 gram of paracetamol every 8 hours. That lasted two to three days. That started on the 06Jan2021. She thought she was doing great and then on the sixth was when it started. By the morning of the ninth it was over. Seriousness criteria for back pain, it was seven out of 10. It was disabling. She had to miss work and could barely walk across the floor; for event arm pain at the injection area, gripping was not easy and moving her arm was painful. She was left handed. Heat worked better than ice. Ice made things worse; for event headache, made a different in the vision, it was throbbing. She did a zoom call with her doctor because of COVID symptoms and because she took vaccine. She took 1000mg of paracetamol prior to receiving both doses and thought maybe it wouldn't hurt and would keep her from getting a fever. She had been taking 1000mg paracetamol three times a day and now she was taking it two times a day. She was taking cefixime at bedtime because she can't stay awake when she took it. She can't take it and work. She had missed work because of this. She was taking diclofenac twice a day. Patient didn't have the first bottle of paracetamol she used because she had gone through it. Current bottle of Tylenol was the generic, SunMark Acetaminophen. She had to get her glasses to read the lot number. It was made by (Pharmacy name), Lot number: OLE2349B, expiry: Sep2022. She didn't feel like the medication she took were relevant because she had been taking them for a very long time. COVID symptoms started on 11Jan2021. She had PCR test on 12Jan2021. She got the results of her PCR test on 13Jan2021. Outcome of event back pain was not recovered, outcome of events headache, arm pain at the injection area and severe back spasms in the thoracic and lumbar was recovered in 2021, and outcome of other events was unknown. Relatedness of drug to reaction(s)/event(s): Events headache, arm pain at the injection area, back pain and severe back spasms in the thoracic and lumbar: source of assessment: primary source reporter; Method of assessment: global introspection; Drug result: Related.; Sender's Comments: Event back pain represents an intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 52 | 2021-03-15 | shortness of breath |
Patient woke with severe chest pain and difficult to take deep breaths. Chest pain extended over he...
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Patient woke with severe chest pain and difficult to take deep breaths. Chest pain extended over her shoulder and around her neck. Pain worsened during the day, went to ER, found to have positive troponins and subsequent ecg were abnormal. Echo was negative and angiogram showed no blocked arteries. Cardiologist diagnosed her with pericarditis
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| 52 | 2021-03-17 | dizziness |
ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper...
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ACC Note: ADULT EMREGENCy retrived from the COVID vaccine tent. Pt states lightheadedness and upper chest/throat discomfort. TENT NOTE: PT. COMPLAINED OF TIGHTNESS IN UPPER CHEST AND FEELING FLUSHED. ASSISTED TO GURNEY AND ADULT EMERGENCY CALLED
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| 52 | 2021-03-18 | cough, nasopharyngitis, throat pain, fever, fatigue |
Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; l...
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Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation . Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen on 23Feb2021 07:00 with outcome of recovering , fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen on 23Feb2021 07:00 with outcome of recovering , feels like a head cold on 23Feb2021 07:00 with outcome of recovering , earache on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms on 23Feb2021 07:00 with outcome of recovering , sore throat on 23Feb2021 07:00 with outcome of recovering , slight cough on 23Feb2021 07:00 with outcome of recovering. Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use. Follow up information has been requested.
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| 52 | 2021-03-21 | throat swelling | c/o chest tightness, throat swelling and flushing |
| 52 | 2021-03-30 | headache, fever |
Fever over 100; Injection site rash and swelling; Injection site rash and swelling; Severe headache;...
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Fever over 100; Injection site rash and swelling; Injection site rash and swelling; Severe headache; Lower body jont pain; This is a spontaneous report from a contactable Other Health Professional, the patient. A 52-year-old non-pregnant female patient, received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL 3248), via an unspecified route of administration in the left arm on 26Jan2021 at 02:00 PM (at the age of 52-years-old) as a single dose for covid-19 immunisation. Medical history included gadolinium contrast (allergies to medications, food, or other products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On 27Jan2021 at 05:30 AM the patient exepreienced fever over 100, severe headache, lower body joint pain, injection site rash and swelling. The event were assessed as non-serious by the reporter. No treatment was received for the events. Outcome of the events were recovering.
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| 53 | 2021-01-03 | shortness of breath |
At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minut...
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At pre-vaccine screening patient reported no contra-indications so had the vaccine. Roughly 45 minutes later patient reported shortness of breath, not feeling good and not being able to hear properly. Blood pressure was taken immediately at 1.38pm - 189/96mmHg and pulse -88bpm, and again at 1.43pm -180/90mmHg. Emergency services were contacted and came immediately within 3-5mins. After assessing patient they took her to hospital.
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| 53 | 2021-01-03 | dizziness |
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness,...
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Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given. Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
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| 53 | 2021-01-03 | runny nose, chills, respiratory tract congestion |
I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tende...
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I developed a raised rash on my left arm at injection site , had chills and nausea and lots of tenderness at injection site at 3 am (1/1/21) following injection. The nausea had resolved when I woke up, the rash subsided throughout the day as did the chills. The most distressing event began on 1/1/2021 , that being sneezing, runny nose and watery eyes which continued and got much worse over the next two days, despite taking sudafed as often as possible. No other cold or flu symptoms were present and it felt like allergies although I have never had any sort of seasonal allergies. I finally took Zyrtec for it the evening of 1/3/21 and the symptoms stopped. Congestion, light sensitivity remain. I am reluctant to take another dose due to drowsiness side effect. Hoping symptoms will all be gone by tomorrow.
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| 53 | 2021-01-03 | shortness of breath, dizziness, fever |
With in five minutes I stared to itch around my face and eyes. Got dizzy and blurry vision when I st...
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With in five minutes I stared to itch around my face and eyes. Got dizzy and blurry vision when I stood up. My lips began to swell. Was given 50 mg Benadryl PO and watched for one hour. Never had difficulty breathing. Itchy continued for five days going away with Benadryl. Lymph nodes in arm pit of arm vaccine was in swelled and hurt for two days. Spiked a fever the second day twice that was controlled with Tylenol.
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| 53 | 2021-01-03 | fatigue |
pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 ...
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pounding heart and shakiness within an hour; fatigue, neck pain, muscle aches, low grade temp by 16 hours after vaccine. Resolved in 5 days.
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| 53 | 2021-01-04 | dizziness | Dizzy, altered, stridor. No oral swelling observed. |
| 53 | 2021-01-04 | dizziness, headache | Headache, nausea, light-headed. Mostly resolved after 30 minutes of observation. |
| 53 | 2021-01-04 | headache |
Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her l...
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Immediately after receiving vaccine, she felt pain in her left deltoid, followed by a spasm in her left trapezius, and headache. She experienced a warm sensation travelling down her left arm. She described a feeling of muscle spasms in her left upper and lower extremity and was unable to bear weight on her left lower extremity due to the altered sensation. She endorsed acute nausea and vomiting. She was transferred from vaccine clinic to emergency department at 1420. Patient received diphenydramine 12.5mg IV @ 1722, prochlorperazine 10mg IV @1733, Lactated Ringers 250mL IV bolus @ 1733, ondansetron ODT 4mg @1445. Patient was diagnosed with an acute anxiety attack in the setting of a novel vaccine administration. She was discharged at 1854.
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| 53 | 2021-01-04 | chills |
Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Withi...
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Received the COVID vaccine at work in her left deltoid 40 minutes prior to arrival to the ER. Within 5 minutes of receiving it, serial blood pressure readings began rising, her arm felt heavy, and she developed an uncontrollable tremor primarily in her left arm with what appears to be generalized shivering. Associated with significant anxiety. She has never had an allergic reaction before. No associated shortness of breath or wheezing. No lip tongue or throat swelling. No pruritus or hives. No nausea or vomiting. She was treated for possible dystonic reaction initially with two doses of Benadryl 25mg IV, then 1mg of IV lorazepam, and finally 125mg solumedrol. Symptoms improved significantly with Benadryl, and then resolved entirely after lorazepam. She was discharged home to complete 4 more days of 50mg prednisone.
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| 53 | 2021-01-04 | dizziness, headache, shortness of breath |
Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received firs...
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Shortness of breath; heaviness in chest; headache; dizziness; nausea; The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 53-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 29Dec2020 11:30 at single dose for COVID-19 immunization at a hospital. The patient also received first dose of unspecified other vaccine on the same day of COVID vaccine (29Dec2020) at left arm. The patient's medical history included diabetes type 2, arthritis, known allergies to Shrimp and penicillin. The patient's concomitant medications received within 2 weeks of vaccination included unspecified medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took lisinopril and experienced drug hypersensitivity (Known allergies: Lisinopril). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 post the vaccination. On 29Dec2020 11:30, the patient experienced shortness of breath, heaviness in chest, headache, dizziness and nausea. Treatment for above events included antihistamine. The outcome of the events shortness of breath, heaviness in chest, headache, dizziness and nausea was recovered in Dec2020. The events were reported as non-serious by the reporter. Information on the lot/batch number has been requested.
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| 53 | 2021-01-04 | weakness, fatigue, headache |
The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for ...
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The next day 12/18 felt weak, fatigue and had to rest in between my activities. I exp headaches for 2 days and on 12/20 feeling 100 ft walk was tired. Then on 12/21 started my exp body ache lasted 2 days. I spoke with my PCP and had a appt on 12/28. On 12/31 it felt as of my symptoms was subsiding. I started feeling better on 1/2/21. I missed 6 days of work.
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| 53 | 2021-01-04 | chills, influenza like illness, headache |
The next day a rash appeared on my forearms and now is on my ankles, calves and scalp.; Severe heada...
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The next day a rash appeared on my forearms and now is on my ankles, calves and scalp.; Severe headache; chills; flu like symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at left arm on 18Dec2020 at 14:00 at single dose for covid-19 immunization at workplace clinic. Medical history included hypolipidaemia, allergic to sulfa drugs (hives), allergy to adhesive (severe skin blistering). There was non other vaccine in four weeks and no other medications in two weeks. The patient previously took naproxen (NAPROSYN) and amoxicillin clavulanic acid (AUGMENTIN ) and was allergic to both drugs, and experienced anaphylaxis for naproxen. The patient experienced severe headache, chills and flu like symptoms the night after the shot on 18Dec2020. The next day on 19Dec2020 at 10: 00 AM a rash appeared on her forearms and was on her ankles, calves and scalp at time of the report. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
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| 53 | 2021-01-04 | headache |
This RN received the COVID 19 vaccine 12-17-2020 at 1730 . Called manager at 1040 to report nausea, ...
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This RN received the COVID 19 vaccine 12-17-2020 at 1730 . Called manager at 1040 to report nausea, vomiting and terrible headache. No fever noted.
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| 53 | 2021-01-04 | headache, shortness of breath, throat pain | Tingling lips Sore throat Burning in chest Rash Headache Neck stiffness SOB |
| 53 | 2021-01-04 | fatigue, malaise, headache |
a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced s...
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a day after vaccination, felt fatigue and "under the weather". 2 days after injection, experienced sharp pain in left ear radiating down to jawline and left shoulder and upper arm. Pain also caused severe headache relieved with high dose Tylenol. Symptoms lasted 24hrs. Headaches became mild lasted thru day of report reaction (1/4).
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| 53 | 2021-01-04 | headache |
feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on th...
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feeling tingling on right side of tongue and part of inside of mouth; Felt some light tingling on the Right side of shoulder and up into neck and ear; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; but few hours after the shot, have pain in right shoulder and back of neck into back of head.; pain in right shoulder and back of neck into back of head; This is a spontaneous report from a contactable nurse for herself. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK9231), intramuscular on 30Dec2020 10:15 at single dose on right arm for covid-19 immunisation. Medical history included hypothyroid, migraines and sulfa allergy. Concomitant medications included propranolol, topiramate (TOPAMAX), levothyroxine, bupropion hydrochloride (WELLBUTRIN) and levocetirizine dihydrochloride (XYZAL), all from unknown date for unknown indication. At 10:30 on 30Dec2020 (also reported as "about 5 minutes after shot"), patient started feeling tingling on right side of tongue and part of inside of mouth. Felt some light tingling on the Right side of shoulder and up into neck and ear. The tingling resolved, but few hours after the shot, have pain in right shoulder and back of neck into back of head. No treatment was received for the events. Action taken in response to the event was not applicable. Outcome of feeling tingling on right side of tongue and part of inside of mouth, felt some light tingling on the Right side of shoulder and up into neck and ear was resolved. Outcome of pain in right shoulder and back of neck into back of head was unknown.
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| 53 | 2021-01-04 | headache, fatigue, chills, fever, malaise |
fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This ...
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fever; Diarrhea; headache; chills; feeling unwell; Joint pain; injection site pain; tiredness; This is a spontaneous report from a contactable consumer. A 53-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot EK5730), intramuscular (Dose number 1, Arm left) on 23Dec2020, 13:45 at single dose for COVID-19 immunization. Medical history included diabetic, thyroidectomy, hysterectomy, tonsillectomy, and Known allergies: Sulfa. Concomitant medication included zolpidem, levothyroxine, and pantoprazole from unspecified dates for an unspecified indication. The patient experienced fever, diarrhea, headache, chills, feeling unwell, joint pain, injection site pain, and tiredness on 23Dec2020 13:45. No treatment for AE was given. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. Outcome of the events was not recovered. Events were reported as non-serious.
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| 53 | 2021-01-04 | headache, fever | headache, low grade fever, body aches, nausea |
| 53 | 2021-01-04 | dizziness, shortness of breath, nasal congestion |
heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrena...
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heart began racing; dizziness/lightheaded; felt foggy; became winded/short of breath; felt an adrenaline rush; Nasal congestion started after 30 min; within 3 min after injection, became flushed; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 19Dec2020 07:30 AM at left arm, at single dose for covid-19 immunization. Medical history included Type 1 diabetes, hx of anaphylaxis to allergy shots and allergies to Latex, avocados, fluorescein dye (anaphylaxis), cats/dogs, environmental. Concomitant medication included ascorbic acid (VIT C), ergocalciferol (VIT D), fexofenadine hydrochloride (ALLEGRA), insulin lispro (HUMALOG), tocopherol (VIT E). The patient was not pregnant at the time of vaccination. Within 3 min after injection, the patient became flushed from 19Dec2020 07:33 AM; heart began racing, dizziness, lightheaded, felt foggy, became winded/short of breath and felt an adrenaline rush, was observed by med personnel x 30min from 19Dec2020 08:00 AM. Nasal congestion started after 30 min on 19Dec2020 08:00 AM. No treatment was received for all events. These events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 53 | 2021-01-04 | sweating |
it made me turned flushed, really almost purple/ My face was red, arms were red, my neck was red; Sw...
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it made me turned flushed, really almost purple/ My face was red, arms were red, my neck was red; Sweating; The initial case was missing the following minimum criteria: adverse event nos. Upon receipt of follow-up information on (27Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient herself). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899, expiry date not reported), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol, hydrochlorothiazide, and lisinopril; all from unspecified dates for blood pressure high. The patient verbalized, "I had the vaccine on last Monday be 21st. I had an issue and ended up in the ER. It made me turned flushed, really almost purple, no anaphylactic nothing, just sweating, my face was red, arms were red, my neck was red but that is it. They gave me Pepcid and Benadryl in ER and watched me in the ER for about 40 minutes. I work at the hospital and I got it from them. I was fine the rest of the week, Thursday, my son came by to pick up a couple of holiday gifts only saw him for 5 minutes. He has now tested positive for COVID. We had masks on. I hugged him on his way out. He took the gifts and left. He is at home now. He got tested yesterday positive for COVID. My question is am I still at risk of getting it from that meeting after I only had one shot?" On an unspecified date, the patient underwent lab tests and procedures which included blood pressure measurement: 133/85 and body temperature: 97.9. Therapeutic measures were taken as a result of the events that included Pepcid and Benadryl. Clinical outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-01-05 | headache |
Bad Headache, lasting 6 hours or longer. Took 2 pills Equate Acetaminophen 500mg at time of onset a...
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Bad Headache, lasting 6 hours or longer. Took 2 pills Equate Acetaminophen 500mg at time of onset and helped ease some but did not take it away. Went to bed early and woke up next morning fine. no more headache.
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| 53 | 2021-01-05 | fever, headache, chills |
Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, he...
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Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; Chills, muscle/joint pain, headache, injection site pain, fever 103.9; This is a spontaneous report from a contactable Nurse (Patient). A 53-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ej1685) , via an unspecified route of administration on 22Dec2020 11:00 at first single dose at arm left for covid-19 immunisation . Medical history included iodine allergy. Concomitant medication included fish oil. The patient experienced Chills, muscle/joint pain, headache, injection site pain, fever 103.9 on 22Dec2020 21:00. Therapeutic measures were taken as a result of events was Ibuprofen. The outcome of events was recovered with sequelae. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination
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| 53 | 2021-01-05 | dizziness |
Dizziness Lightheadedness Nausea Monitored for 30 minutes total; no intervention required and releas...
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Dizziness Lightheadedness Nausea Monitored for 30 minutes total; no intervention required and released to home.
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| 53 | 2021-01-05 | fever |
FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 m...
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FEVER, BODY ACHES, AND FACIAL SWELLING started at 1200 on 01/06/2021. took 400 mg po motrin and 25 mg po bendaryl. At 4am took and additional 25 mg Benadryl po. and at 1000 took third dose of benadryl po 25 mg. Pt. states that he left eye is watering. Pt. states that she has a little bit of facial swelling still at 1023 am on 1/6/2021.
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| 53 | 2021-01-05 | chills, dizziness, fever, headache | Fever Woozy Headache chills |
| 53 | 2021-01-05 | headache, fever, chills |
Fever since 5 hours after injection. Chills, body ache, headache Fever as high as 102.6 at morning o...
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Fever since 5 hours after injection. Chills, body ache, headache Fever as high as 102.6 at morning of the next day and 100.8 24 hours late
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| 53 | 2021-01-05 | headache | Headache |
| 53 | 2021-01-05 | headache, nasal congestion |
I started having nausea, headache and nasal congestion at 2:54 pm on 12/19/2020. This lasted until ...
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I started having nausea, headache and nasal congestion at 2:54 pm on 12/19/2020. This lasted until 12/21/2020 at 9:23 pm. I had tried Sprix, Zomig 5mg and Promethazine 12.5mg. The nausea went away, but the headache persisted. I had originally thought it was a migraine and treated it as such, but my rescue medications did not work, so I thought it could be a side effect of the vaccination.
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| 53 | 2021-01-05 | headache |
In the end of December she developed right wrist pain and some mild swelling, then pain in both arms...
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In the end of December she developed right wrist pain and some mild swelling, then pain in both arms from elbows to hands, and then it started in the back on her thighs in hips bilaterally and her right ankle. She still has the headache that is unchanged x 1 month, but the other symptoms were new, and she had never had them before. She still has it and it is 1/6/21.
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| 53 | 2021-01-05 | fever, chills |
Muscle pain; Got little ache in the back; Joint pain; Fever; Chills/felt like chills like when you f...
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Muscle pain; Got little ache in the back; Joint pain; Fever; Chills/felt like chills like when you feel cold; arm be sore from the shot; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Nursing Home. Medical history included Blood pressure high. Concomitant medications included metoprolol for Blood pressure high, potassium. The patient had got her COVID-19 Vaccine yesterday (29Dec2020) and now (30Dec2020) she had a little muscle pain, guess from the arm. She got the shot in her muscle yesterday. Today (30Dec2020), spiked a little fever, and she got a little muscle pain, joint pain. She felt good, she just got little ache in the back. She took some Tylenol, it has all worked today. The patient also experienced "arm be sore from the shot". She got a little chill that's why she took the Tylenol. she had a little fever, she caught fever or felt like chills like when feel cold. Therapeutic measures were taken as a result of ache in the back, fever, and chills included Tylenol. The outcome of the events was unknown.
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| 53 | 2021-01-05 | dizziness, headache |
PATIENT C/O DIZZINESS, HEADACHE, NAUSEA WITH DRY HEAVING, BP 184/90 AT 7:40AM. EPI 0.3MG ADMINISTER...
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PATIENT C/O DIZZINESS, HEADACHE, NAUSEA WITH DRY HEAVING, BP 184/90 AT 7:40AM. EPI 0.3MG ADMINISTERED AT 7:50AM. SYMPTOMS IMPROVED, BP 179/79 HR 114 AT 7:53AM. PATIENT REFUSED AMBULANCE OR FURTHER MEDICAL TX. STAFF MEMBER OBSERVED FOR AN HOUR UNTIL FAMILY ARRIVED.
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| 53 | 2021-01-05 | fatigue, fever, headache | Pt started with fever, Fatigue and headache at 1/6/2021 @3:00 AM |
| 53 | 2021-01-05 | malaise, fever, weakness, runny nose, dizziness, cough |
Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and w...
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Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; Tested positive for COVID after receiving the vaccine/runny nose and felt achy/coughing/ dizzy and weak. It was affecting her legs and she had no taste; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable consumer (patient) reported a 53-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown, did not see this information on the vaccination card), via an unspecified route of administration in the left arm on 20Dec2020 at single dose for covid-19 immunization (certified nurse assistant in healthcare). Other products, patient history and investigation assessment was No. There were no concomitant medications. The patient was vaccinated with the COVID Vaccine on 20Dec2020 but tested positive afterwards on 27Dec2020. The patent thought she had COVID in the vaccine and COVID in her body. She was scheduled for next dose on 10Jan2021 and would like to know if she should get the scheduled dose or if she needs to wait longer and re-schedule it. She was now a COVID patient and sick. She was waiting to get better. Before the vaccine she tested negative and felt great. Then she got the vaccine. She had a runny nose and felt achy. She asked her coworker, and her coworker felt the same. She thought if it continued that maybe it was a side effect. Caller confirmed her symptoms were runny nose, feeling achy, and coughing. She took Tylenol and the aches went away. They then came back, and she had more aching and she was wondering why. Caller clarified that these symptoms did not start the next day after receiving the vaccine. Achiness/body aches was started on 23Dec2020 when she was at work. It would wake her up at night. She did have aches right now, but her fever had lowered down. She was also dizzy and weak. It was affecting her legs and she had no taste. She was not eating but needs to eat. If she did, she eat something sweet. Runny nose was started on 24Dec2020. She went back to work on 26Dec2020 but told them she could not work because she had symptoms of COVID. She went to her second job where they do COVID testing and asked her boss for a test. She tested positive on 27Dec2020. Dose was unknown. She said she thought she got 1 vial. The whole thing. The outcome of events "tested positive for COVID after receiving the vaccine" was not recovered. Information on lot/batch number has been requested.
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| 53 | 2021-01-05 | chills, fever |
Woke in middle of night with chills fever and severe body aches that lasted until 2100 on 12/29/2020...
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Woke in middle of night with chills fever and severe body aches that lasted until 2100 on 12/29/2020. Arm at injections site red swollen, hot to touch and itchy.
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| 53 | 2021-01-06 | headache |
Approximately 2 hours after the vaccine she reported a "spot on her arm" where the vaccine had been ...
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Approximately 2 hours after the vaccine she reported a "spot on her arm" where the vaccine had been given, a headache and back ache. She did go to the chiropractor on 1/4, but states it did not help. She saw an allergy specialist on 1/5. As of 1/7/20 0830am she still had a headache.
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| 53 | 2021-01-06 | chills | Chilling and body aches |
| 53 | 2021-01-06 | headache, weakness |
Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and se...
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Headache Weakness, Myalgia, Arthralgia, Weakness, Nausea, Palpitations Narrative: Medication and self-care instructions: drink plenty of fluids, take motrin if needed.please return if symptoms worsen or persist.
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| 53 | 2021-01-06 | runny nose, weakness, chills, dizziness, fatigue, headache, fever |
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injectio...
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Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure. Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day. Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped. Will try Benadryl.
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| 53 | 2021-01-06 | fatigue |
Very achy and tired the following day. very tender at injection site for three days following inject...
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Very achy and tired the following day. very tender at injection site for three days following injection. Bruising at injection site.
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| 53 | 2021-01-06 | fever, headache, chills |
fever, headache, chills, body aches--alternating tylenol and Ibuprofen, rest, staying hydrated x 2...
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fever, headache, chills, body aches--alternating tylenol and Ibuprofen, rest, staying hydrated x 2 days
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| 53 | 2021-01-07 | body temperature increased, fatigue |
1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with di...
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1/6/21: Received vaccine without any immediate reaction around 12:20pm. Took ibuprofen 400mg with dinner that evening anticipating some body aches (which i had for 24h after dose 1). 1/7/21: Woke in the early AM with severe arthralgia, myalgia, restlessness, mild R arm swelling. Ate a small snack and took ibuprofen. All day 1/7/21: fatigue, myalgia, arthralgia (all of my large and small joints, my long bones, my intercostals, my large muscles stiff/ ached), and increasingly swollen R axillary lymph node(s) about the size of a large egg, extending into my upper chest. Food aversion at breakfast - could not tolerate eating more than a few bites. Slept almost all day except to re-dose ibuprofen and take a warm shower. Tolerating bland diet by evening. Tmax 99.3F forehead As of now 10:30am 1/8/21, myalgias are improving. Fatigue continues but is less. R axillary and chest lymph nodes are painful and swollen, up into my lower neck. Continuing to take ibuprofen with some food 3x per day
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| 53 | 2021-01-07 | dehydration, cold sweat, dizziness |
After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Pat...
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After second dose of Pfizer COVID-19 vaccine, patient started "feeling weird" and "washed over". Patient denied dyspnea, nausea, DM/hypoglycemia issues, known heart issues, swelling/itchiness, adverse event with first vaccine, and no adverse event to previous other vaccines. Patient had eaten lunch, but just come off of a shift and thought she might be dehydrated. Water was provided to the patient. Patient stated that she had intermittent lightheadedness/dizziness. Patient denied performance of vasovagal maneuver. Patient also experienced tachycardia and was clammy. Cool pack was provided to patient. Clinical course below: 1530 145/81, 105, 97%, 15 1535 119/81, 88, 96% 1540 126/75, 87, 96% 1542 pt felt another wave of lightheadedness, HR 103 1546 126/79, 90, 96% 1551 128/80, 91, 96% 1555 140/60, 79, 96% 1559 110/84, 87, 97% 1600 pt reports new scratchy throat 1602 25 mg Benadryl administered by RN 1603 discussed with Pharm D 1605 131/77 91, 97% 1611 145/79, 95, 98% Pt finished 12 oz of water and 4 oz of juice 1615 pt reports throat feeling better 1615 118/62, 69, 96% 1630 109/95, 99, 97% Pt stuck out tongue, no evidence of edema 1621 127/72, 84, 97% Â At 1642, patient was discharged to family's care and taken home.
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| 53 | 2021-01-07 | sweating |
Associate stated anxious to needles at 1400 and had flu vaccine anxiety in past. at 1403, felt swea...
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Associate stated anxious to needles at 1400 and had flu vaccine anxiety in past. at 1403, felt sweaty and asked to lie down. 1405 had cold compress, 15 ounces apple juice, sat 40 minutes post vaccine. At 1440 ambulated to bathroom with assistance and stated she felt better at that time. Associate left to her work environment ( Lab) at hospital as she stated she was fine.
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| 53 | 2021-01-07 | skin warm |
Developed a fine rash across her forehead and chest. Cheeks were firey red and warm to the touch. ...
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Developed a fine rash across her forehead and chest. Cheeks were firey red and warm to the touch. Rash lasted a couple of days.
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| 53 | 2021-01-07 | shortness of breath |
Entered post-monitoring area at 1750, notified RN of prior itching and hives post first dose COVID-1...
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Entered post-monitoring area at 1750, notified RN of prior itching and hives post first dose COVID-19 vaccination. Reported that she had taken Benadryl 50mg PO after first vaccination. Pt reported today 1/7/20, she took medication prior to COVID-19 vaccination: Pepcid 40mg PO at 1626. Benadryl 25mg PO at 1626. 1810: pt c/o scalp itching, visible redness to itchy area on scalp. BP 158/84 (101), HR 82, regular rhythm, SpO2 97%, RR 18, Temp=97.5F 1812: 25mg Diphenhydramine HCL oral solution given PO for itching to scalp. 1818: BP 159/93 (108), HR 78, regular rhythm, SpO2 98%, RR 17, Temp =98 F 1822: Splotchy redness noted to pt's L lower arm, no itching. Redness noted to L upper chest with pt c/o itching to L upper chest area, R neck, nose and R toes itching. Pt denies difficulty breathing, swallowing. SpO2=98% 1830: BP 172/84 (105), HR 82, regular rhythm, SpO2 100%, RR 16, Temp=97.5 F Pt denies any new areas of itching, scalp, R toes, R neck and R chest area still itchy. No c/o difficulty swallowing or breathing. No throat clearing. 1837: pt notes improvement in scalp and nose itching. Redness to L arm and chest improved. 1845: BP 165/80 (102), HR 85, regular rhythm, RR 16, SpO2=99%, Temp =98.2 F Pt c/o itching again to R side of scalp with redness noted to scalp. 1850: 25mg Diphenhydramine HCL oral solution given PO for itching and redness to scalp. 1900: BP 153/87 (104), HR 85, regular rhythm, RR 12, SpO2=98%, Temp=97.6 F Pt reports mild scalp itching with some improvement since second dose of diphenhydramine. No other itching or redness noted. 1915: BP 171/86 (107), HR=80, regular rhythm, RR 12, SpO2=99%, Temp=97.4 F pt reports mild itching to L scalp and L chest, no significant redness noted. 1930: Pt denies worsening symptoms, no additional itching or redness. Gave pt discharge instructions to not exceed 100mg of Diphenhydramine in a 4 hour period. Recorded times and amounts of diphenhydramine given during post vaccine monitoring period. Pt denies feeling drowsy and is comfortable driving home. Directed patient to call emergency services from home with any worsening of rash or trouble breathing, feeling faint, or any other concerning symptoms. Pt's husband will be at home with pt, aware of additional monitoring needed post vaccine.
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| 53 | 2021-01-07 | headache, fever | Headache & Fever Narrative: |
| 53 | 2021-01-07 | dizziness, headache |
Headache and lightheadedness 15 min post vax Observation, fluids, food Sxs resolved after 10 mins of...
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Headache and lightheadedness 15 min post vax Observation, fluids, food Sxs resolved after 10 mins of close monitoring NKA
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| 53 | 2021-01-07 | headache | Headache, Arthralgia, foggy feeling, back ache Narrative: |
| 53 | 2021-01-07 | headache |
Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (...
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Headache; Sore arm; Swelling of the feet; This is a spontaneous report from a contactable consumer (patient herself). This 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 23Dec2020 at single dose for COVID-19 immunisation. She was working as a receptionist in a nursing home. Age at vaccination was 53-year-old. No relevant medical history and concomitant medications were provided. On unknown date after vaccination, the patient developed headache, sore arm, and swelling of the feet. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 53 | 2021-01-07 | headache |
Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities...
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Myalgia bilateral leg and right ankle pain, reports calf tightness and cramping to lower extremities Narrative: developed bilateral leg pain, tightness of calf muscles within one hour of receiving vaccine. Headache on 12/23/2020
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| 53 | 2021-01-07 | headache, chills, malaise, fever |
Symptoms - ? EE woke up this am with body aches, chills, headache (endorses hx of migraine), and fev...
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Symptoms - ? EE woke up this am with body aches, chills, headache (endorses hx of migraine), and fever (Tmax 101.8). Last day of work and shift - ? supposed to work tonight but called off due to feeling ill Home remedies? - Tylenol at 0740 and sleep Any improvement? ? mild improvement Recommendation? EE educated to continue to monitor symptoms and call vaccine support with further concerns or questions. EE educated of changes in RedCap Survey and educated will need to be fever free for 24 hours before returning to work. EE reports she called off of work tonight as she is not feeling well. EE educated to continue to manage her symptoms and to follow the guidelines outlined in the TCH Illness in the Workplace Policy. EE denied COVID-19 exposure without proper PPE and denied travel. EE verbalized back understanding and denied further questions at this time.
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| 53 | 2021-01-07 | chills | chills, nausea, arm sore |
| 53 | 2021-01-07 | chills, fatigue, fever, malaise |
felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; ...
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felt really tired; sore arm/ arm was sore to touch and to lift it up/ hurt to touch; chills; fever; body aches; snoring bad; freezing/ can't get warm; shaking; felt terrible; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the right arm on 28Dec2020 13:15 at a single dose for COVID-19 immunization. She has had the Coronavirus before and wanted to know if previously having the virus might make her side effects worse. She had COVID 19. She got her positive result on 06Aug2020. Her husband had it too. She knows what it is like. She didn't have to go to the hospital, but she had a severe enough case. She had the fever, dry cough, body aches, nausea, and poops. She has been getting body aches after having COVID really intense. She gets tired very easily. She had fibromyalgia was diagnosed more than 10 years ago and ongoing, before the year 2000; acid reflux was diagnosed five or six years ago; high blood pressure was diagnosed back in 2007; high cholesterol; wheezing for a couple of years and depression. The patient was also taking a water pill. Concomitant medication included omeprazole ongoing for acid reflux, hydrochlorothiazide (HYDROCHLOROTH, 25 mg) ongoing, losartan 100 mg ongoing, desvenlafaxine 75 mg ongoing for depression, montelukast 10 mg ongoing for wheezing, atorvastatin calcium ongoing for cholesterol. When asked for the lot number the patient said that she thinks it is EL1284 but it could possibly be ELI284. On 28Dec2020, the patient felt really tired, has a sore arm with chills, fever and body aches. The same day she got the vaccine she had felt fine. She came home and did a few things. She sat down for a minute and then it was like wham. She told her husband she was done. She went to sleep fast and slept for a couple of hours. She went to work the next morning and her arm was sore to touch and to lift it up. Sometimes when you get the flu shot it is like that too. She does not have any red marks where it was injected. She only knows where it was because it hurt to touch. She got really tired at work about 11:30AM. Her body started aching. She was being tested twice a week for Corona COVID. She had just been tested on 28Dec2020 morning before the vaccination and was negative. On an unspecified in Dec2020, she was freezing and shaking. She cannot get warm. It was like that for a couple of hours. Usually her temperature runs low. It was up to 100.1 degrees Fahrenheit which is high for her because she usually is on the lower end. She felt really ugh.The symptoms after the vaccine reminded her of when she had COVID. She had a low fever and body aches and felt terrible. Her boss wanted to know if she had the flu. The patient does not think so because it would be ironic the day after she gets the shot. She was assuming it was the side effects from this. She further clarified wham as that she was really tired and it came over her really quick. She sat in the chair and got a blanket. Her husband said she was snoring bad (28Dec2020). Two hours later the dogs woke her up and she thought it was the middle of the night. It wasn't it was early. On unspecified date in Dec2020, she had a bout and her body started aching. A day after, she does not feel that bad, does not have fever and her body was not aching. That night when she got home she could not sleep on her arm because it was sore. The next day was when it was hard to lift it. She had the injection in the right arm, which is the arm she uses. It was still sore to touch. She has fibromyalgia. She is not sure if that is why she is aching. She is not sure if that kicked it in high gear. The vaccine was administered in a Long Term Care Center. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The events did not result to emergency room nor physician visit. The outcome of the event fever and body aches recovered on an unspecified date in Dec2020; outcome for all other events was unknown. Information on the lot number has been requested.
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| 53 | 2021-01-07 | chills, fatigue, malaise, headache |
mild pain at the injection site; tiredness; chills; headache; feeling unwell; This is a spontaneous ...
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mild pain at the injection site; tiredness; chills; headache; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received bnt162b2 (BNT162B2; Pfizer-Biontech Covid-19 Vaccine also reported as vaccine A (Pfizer Ultracold); lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 22Dec2020 09:15 at a single dose for covid-19 vaccination. Medical history included anxiety and depression. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had other medications received within 2 weeks of vaccination. The patient most recent COVID-19 vaccine was administered a hospital. It was reported that 7 hours after vaccination (22Dec2020 04:15 PM [reported as 04:00PM]), the patient experienced mild pain at the injection site, tiredness, chills, headache, and feeling unwell. All resolved within 12 hours after sleep (23Dec2020 04:15). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 23Dec2020 04:15.
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| 53 | 2021-01-07 | fever, fatigue |
neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and s...
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neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-08 | sweating, fever, headache, chills |
1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes...
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1/6/21 - Started with a headache that night and then 1/7/21 had severe headache, swollen lymph nodes left inguinal, fever of 102.3F, diaphoresis, chills, flushed face, change of taste and baseball sized swelling to injection site.
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| 53 | 2021-01-08 | headache, fever, fatigue, weakness |
12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before...
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12 hours post injection- fever of 101.8, body aches, headache, fatigue. Lasted about 23 hours before fever was back to normal. Still have fatigue and weakness
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| 53 | 2021-01-08 | throat irritation |
Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer note...
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Customer rec'd COVID-19 vaccine at 1208pm and transferred to post vaccine observation. Customer noted to be frequently rubbing her eyes, initially denies feeling any symptoms. Symptoms of itching eyes persistent followed by customer clearing throat repeatedly. Continues to deny symptoms related to vaccine. States that she has anxiety. Customer noted to be hypotensive at 1226 98/68. Refuses epinepherine, transport to ED for monitoring. Customer accepts Benadryl 50mg PO @ 1227. O2 sat ~94-95%, pulse 79-84. Customer monitored at site, escort and significant other, at chairside. Customer persistent with her request to leave throughout observation, states she is fine. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer does not have resolution with dry throat symptoms but does not wish to remain in observation any longer. Vitals at 1307 consistent with baseline as documented previously in chart. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1315, ambulating independently with steady gait, no obvious s/sx of distress
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| 53 | 2021-01-08 | fatigue | Diarrhea Fatigue for 24 hours post vaccination. Loose stools were for 3 days |
| 53 | 2021-01-08 | malaise |
HYPERtension Narrative: 0930- Pt complained of not feeling well, VS taken, BP 182/85, HR 92, O2Sat ...
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HYPERtension Narrative: 0930- Pt complained of not feeling well, VS taken, BP 182/85, HR 92, O2Sat 100%; Pt was placed on observation. 0944- VS taken again,BP 177/89, HR 94, O2Sat 100% 1000- Pt stated she was feeling better and event was probably due to anxiety; Pt declined going to ED; VS taken again, BP 149/83, HR 85, O2Sat 100%; Pt discharged home.
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| 53 | 2021-01-08 | fatigue, headache | Headache, Myalgia, Fatigue |
| 53 | 2021-01-08 | fever, chills, shortness of breath, headache, fatigue |
Muscle pain, joint pain, fever, chills, shortness of breath, headache, fatigue, starting the morning...
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Muscle pain, joint pain, fever, chills, shortness of breath, headache, fatigue, starting the morning after the vaccination that was provided around 4:30 in the afternoon, used Tylenol for the pain and fever. Better the next day but still not well. Missed work
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| 53 | 2021-01-08 | influenza like illness |
Significant burning with admin of first shot. Approx 3.5 hours after shot I could not move my arm at...
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Significant burning with admin of first shot. Approx 3.5 hours after shot I could not move my arm at the shoulder. This was more than muscle soreness but being unfamiliar with Covid vaccine, I just rode it out. This lasted 2 days. Since then, my shoulder joint has not been the same with sl limited ROM and persistent pain. This improved signif over the 3 weeks until my 2nd Covid vaccine 1/7/21. This is what tipped me off that the first shot was not correct. #2 did not burn at all with administration or cause any limited ROM. Typical deltoid soreness sl more than a tetanus shot, and general "flu like sxs" that lasted < 24 hours.
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| 53 | 2021-01-08 | headache | at 12 hours post vaccine I had Headeaches and Body Aches for the next 20 hours |
| 53 | 2021-01-09 | fever, fatigue | Fever Chills Aches Fatigue |
| 53 | 2021-01-09 | cough, chills, fever |
I took the vaccine dose at 1030 a.m, I started feeling chills and fever by 9 pm same day, still hav...
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I took the vaccine dose at 1030 a.m, I started feeling chills and fever by 9 pm same day, still having low grade fever and some cough and not too much chills. I am taking Advil two tablets OTC.
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| 53 | 2021-01-09 | headache, dizziness |
Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midn...
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Multiple episodes of dizziness, coming and going. Arm hurt upon movement starting shortly after midnight after received and still hurting, joint pain and headache began early AM 01/09/21. All have ended except pain at injection site and joints still achy.
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| 53 | 2021-01-09 | headache, sweating, fever | Pain at injection site, fever, sweating and worsening headache |
| 53 | 2021-01-10 | headache, fever |
(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (t...
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(1) First vaccine - slight effects of Covid symptoms. (2) Second vaccine - Headache, slight fever (took tyenol) -Sat am - swollen tongue when I woke up. Took benydril, swelling went down. tongue bled - (brush teeth, scrap tongue) -Sun - semi swollen tongue, rash lower abdomin. R am front area by under arm.
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| 53 | 2021-01-10 | chills, fever, headache, weakness, fatigue |
1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever...
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1/8/21 AM headache over the eye, injection site sore arm; PM body aches, chills and shivering, fever 107., joint pain --over the counter ibuprofen no relief, weakness in legs. 1/9/2021 body aches and fever resolved. Fatigue, weakness and joint pain, Tylenol --some relief. Swollen lymph nodes in left armpit and soreness; low back pain, shooting hip pain.
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| 53 | 2021-01-10 | chills, fever, lethargy, headache |
5am on 1/7 woke up with chills, bodyaches, fever, lethargy and headache. Lasted through day, temper...
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5am on 1/7 woke up with chills, bodyaches, fever, lethargy and headache. Lasted through day, temperature up to 101.5. On 1/8, temperature resolved, still bodyaches. On 1/9, symptoms resolving, but at 12:00pm temperature of 99.9 and fatigue. On 1/10 right deltoid where vaccine was administered, sight is warm to touch and swollen, painful.
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| 53 | 2021-01-10 | nasal congestion |
At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, ...
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At 8:00 pm, approximately 36 hours after my second COVID - 19 vaccine injection in my left deltoid, my left upper lip began swelling. I took a Benadryl as I was already on prednisone. I had no problems during the night except a stuffy nose. On the following morning my face was swollen, more on the left. I took two more Benadryl during the day and on Sunday morning the swelling was gone. I had not other symptoms or complications.
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| 53 | 2021-01-10 | fever, headache | Body Aches, Headache, F - resolved 24 hrs |
| 53 | 2021-01-10 | chills | Body aches, chills, injection site soreness |
| 53 | 2021-01-10 | weakness, headache, chills | Chills and shakes without fever, weakness, and headache |
| 53 | 2021-01-10 | fever, chills, fever, chills | FEVER, CHILLS, RIGORS |
| 53 | 2021-01-10 | dizziness, fatigue, headache, fever, chills |
Fever 101, chills, H/A , tiredness, lower back pain, body aches. Felt slightly dizzy at times. Star...
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Fever 101, chills, H/A , tiredness, lower back pain, body aches. Felt slightly dizzy at times. Started 1/7/21 @2220. Slept most of 1/8. Medicated with Advil every 4-6 hrs for fever. Continued until 1/9/21 at 0100. Woke with H/A am 1/9 but no fever. Took last Advil for it.
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| 53 | 2021-01-10 | fever, fatigue, headache |
Low grade fever, HA, fatigue, pain and swelling at the injection site. Tylenol and Motrin with impr...
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Low grade fever, HA, fatigue, pain and swelling at the injection site. Tylenol and Motrin with improvement.
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| 53 | 2021-01-10 | chills, fever, headache | Muscle aches, chills, fever,joint pain, headache. |
| 53 | 2021-01-10 | headache |
POST VACCINATION SHOT- APPROX. 17 MINUTES- C/O FRONTAL AND TEMPORAL HEADACHE (4:10 PAIN SCALE LEVEL...
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POST VACCINATION SHOT- APPROX. 17 MINUTES- C/O FRONTAL AND TEMPORAL HEADACHE (4:10 PAIN SCALE LEVEL). DOES NOT USUALLY GET A HEADACHE. DENIES ANY OTHER COMPLAINTS AT THIS TIME. EMS AND RN ON SCENE, ASSESSMENT MADE . 0957: VS: BP: 111/76; P: 79; 02 SAT: 97 % ON ROOM AIR; 1003: VS: BP: 110/78; P: 77; 02 SAT: 96% ON ROOM AIR.
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| 53 | 2021-01-10 | shortness of breath, skin warm |
Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red...
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Started as a red raised rash under my arms and my waistline; rash turned to hot to touch; raised red large hives all over my body including my face/head; numbness to my hands/feet/chest area; the SOB started; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU9231), via an unspecified route of administration in the left arm on 30Dec2020 at 08:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism and chronic low back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), and etodolac (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took miconazole nitrate (MONISTAT) on unknown dates for an unknown indication and experienced drug allergy. On 31Dec2020 at 10:00, the patient started with a red raised rash under her arms and waistline and as the day progressed the rash turned hot to touch with raised red large hives all over her body including her face/head. By 23:00 on 31Dec2020, the patient had already taken 3 doses of diphenhydramine (BENADRYL) which was not effective. Then, later on 31Dec2020, shortness of breath started with numbness in the hands/feet/chest area. Her daughter took her to the emergency room. She was started on intravenous diphenhydramine, dexamethasone, and famotidine (PEPCID). The medications took time to work but they did resolve her shortness of breath and the hives subsided to mild redness. She was sent home and given the following medications to take: diphenhydramine 50 mg every 4 hours, methylprednisolone (MEDROL DOSE PAK), cetirizine (ZYRTEC) daily, and famotidine (PEPCID) daily. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the red rash, rash was hot to touch, shortness of breath, and numbness, were reported as recovered with lasting effects; while that of the hives was recovering as they still flared up if she did not take the medications every 4 hours. The reporter assessed all the events as non-serious.; Sender's Comments: The reported shortness of breath together with red rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE together with rash was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), due to temporal relationship and clinical course. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees and Investigators, as appropriate.
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| 53 | 2021-01-10 | malaise, shortness of breath |
Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tyleno...
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Woke at 3 am with severe myalgias, tachycardia, nausea and shortness of breath. Went to get tylenol/ zofran but felt like I was going to vomit. Went into the bathroom and sat down. Woke up on the floor shaking. Not sure how long I was down. According to my watch my HR was around 110+ for a hour and a half (3-4:30 am)
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| 53 | 2021-01-10 | headache, chills, cough, dizziness, fatigue |
chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had n...
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chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital. Medical history included asthma and gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough. The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
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| 53 | 2021-01-11 | body temperature increased | 100.6 temp body ached |
| 53 | 2021-01-11 | fever, headache, chills |
4/5 hours bad headache, flu symptoms , nausea, Later that night I had chills, fever and was flush...
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4/5 hours bad headache, flu symptoms , nausea, Later that night I had chills, fever and was flushed which all lasted two days
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| 53 | 2021-01-11 | influenza like illness |
A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 ...
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A vasovagal response occurred after shot, after sitting for 25 min, I ate lunch. I left facility 1 hour later. After 2 hours of the shot, the left arm began to be noticeably sore. 12 hrs post vaccine, I had flu-like symptoms. 24 hrs post vac, flu-like symptoms continued and the injection site had a visibly 2" swollen, red warm circle and raised area; also, I experienced considerable lymph node soreness in left underarm and under jaw (neck area) and itchiness at injection area. 36 hrs post vaccine, the flu-like symptoms subsided, but the injection site continued to grow to 3" red, warm and swollen area. Also I continued to have the itchiness, sore lymph nodes in the left arm (injection arm). Today is 48 hours post vac and I continue to have the red, raised, warm and itchy swollen circle at the injection site with soreness in the lymph node glands on left arm.
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| 53 | 2021-01-11 | dizziness, headache, fatigue |
Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 wa...
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Approximately 5 min after administration are is tingling, then got light headed. Next AM at 0700 was extremely tired. When getting out of bed in AM blacked out and fell to the floor. Was able to get up but head was cloudy all day long. She felt very sore and head hurt all day. The next am had headache.
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| 53 | 2021-01-11 | somnolence, fatigue | Fatigue, sleepiness, pain on left arm |
| 53 | 2021-01-11 | fever, headache, chills | Fever, chills, muscle aches and headache. |
| 53 | 2021-01-11 | runny nose, malaise, fatigue |
I felt some fatigue just little tired; I have allergies too and I battle with allergies all the time...
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I felt some fatigue just little tired; I have allergies too and I battle with allergies all the time; Feeling a little under the weather; runny nose; Feeling a little under the weather; runny nose; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (Pfizer/BioNTech Covid-19 vaccine, lot/ batch number EL1284) on 30Dec2020 at a single dose for Covid-19 immunization. The patient had no medical history and had no concomitant medications. The patient got her vaccine on 30Dec2020 in the morning and she had not experienced any type of severe side effects from the Covid vaccine and only felt some fatigue just little tired. But she started feeling a little under the weather and runny nose on 03Jan2021. The patient also reported that she had allergies too and battled with allergies all the time (clarification required). The patient had no treatment received for the events. The patient had no fever. The events little under the weather and runny nose resolved on 03Jan2021 and outcome of other events was unknown. The patient would like to ask whether the events were related to the vaccine as it was happening a few days later.
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| 53 | 2021-01-11 | skin warm | I have a red silver dollar sized hard lump that is red and warm |
| 53 | 2021-01-11 | headache, dizziness |
Nausea, lightheaded, dizziness and headache starting 10 mins after. Felt like she was going to faint...
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Nausea, lightheaded, dizziness and headache starting 10 mins after. Felt like she was going to faint. Also felt like she was developing a migraine. Improved after about 20 minutes.
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| 53 | 2021-01-11 | chills, fever | Patient describes chills, later a fever of 101.2 and body aches. |
| 53 | 2021-01-11 | shortness of breath |
Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (histor...
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Patient developed Tinnitus for 20 minutes immediately after COVID vaccine. Severe joint pain (history Rheumatoid Arthritis) began 4 hours later, and she could barely move hands. She had a severe asthma attack (history asthma) 1 hour later. Breathing has been poor since then with many asthma attacks and oxygen level as low as 79%. Still cannot sleep lying down without oxygen level dropping. Seen at Lung Center 12/31/2020 began tapering prednisone dose beginning at 60mg. Didn't tolerate 40mg so was at 60mg through 1/9/2021. Now decreased to 40 mg and is having increased shortness of breath and more breakthrough nebulizers. 1/4/2021 feeling no better. Given dexamethasone and kept on steroids. Returned to working just at home on 1/11/2021. No history of asthma reaction this severe in past other than post- ablation, but duration then was shorter.
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| 53 | 2021-01-11 | dizziness |
Patient reported symptoms of itching at injection site, denied any other symptoms. Patient stayed f...
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Patient reported symptoms of itching at injection site, denied any other symptoms. Patient stayed for 30 minute observation, at observation completion patient reports she was also feeling slightly dizzy and lightheaded, reports those symptoms were occurring intermittently throughout 30 minute wait. Patient offered oral fluids (water/juice), and to stay a little longer, patient refused, reports she is fine to go home. Patient left observation on her own.
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| 53 | 2021-01-11 | migraine |
Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photo...
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Rapid onset (less than 5 minutes) of acute migraine (knife-like stabbing pain in both temples, photophobic), nausea & diarrhea. This occured 4 days after my second COVID-19 vaccine. I had no symptoms prior to this.
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| 53 | 2021-01-11 | dizziness, headache, malaise |
Second dose: A few minutes after getting vaccine. I was sitting in the observation area and I start...
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Second dose: A few minutes after getting vaccine. I was sitting in the observation area and I started feeling a pinch in my arm, then I started feeling warm and light headedness. Then they checked my bp and it was 149/93 . Then I had to stay for 30 mins, then I left to go home. I had body ache and a mild temperature. It was 98.2 .My arm is sore, and my joints and body hurts. I have a headache too , and I just took an ibprophen. I am still not feeling well. I did not go to the ER, hospital or doctors office about this ae.
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| 53 | 2021-01-11 | headache |
nausea; Headache; insomnia; This is a spontaneous report from a contactable healthcare professional....
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nausea; Headache; insomnia; This is a spontaneous report from a contactable healthcare professional. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history was none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. There were no allergies to medications, food, or other products. Concomitant medications included vitamin b complex (VITAMIN B), colecalciferol (VITAMIN D [COLECALCIFEROL]), and zinc. On 31Dec2020, the patient experienced nausea, headache and insomnia. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering Information about batch/lot number has been requested.
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| 53 | 2021-01-12 | dizziness, headache, malaise |
12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND ...
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12/23/2020-RECEIVED VACCINE AT 9:52 AM. REPORTS NOT FEELING WELL IN THE AFTERNOON, LIGHTHEADED AND DIZZY, THROBBING HEADACHE. CRAMPING/ACHING IN BACK OF CALVES. 12/24/2020 CONTINUED WITH DIZZINESS, THROBBING HEADACHE, BLOOD PRESSURE ELEVATED, CHEST PRESSURE 8:00 PM REPORTED FEELING THAT SHE WAS GOING TO DIE, WENT TO LAKE CITY MEDICAL CENTER- BLOOD PRESSURE ON ARRIVAL 184/101 HR. 117. GIVEN NITRO AND MEDICATIONS. ADMITTED, DISCHARGED 48 HOURS LATER ON 12/26/2020. DISCHARGED ON BLOOD PRESSURE MEDICATION 12/27/2020-LESS THAN 24 HOURS AFTER BEING DISCHARGED SHE WAS READMITTED TO MEDICAL CENTER WITH SAME SYMPTOMS. 36 HOURS AFTER ADMISSION, TRANSFERRED TO MEDICAL CENTER. FOR CARDIC WORKUP AND HIGHER LEVEL OF CARE.
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| 53 | 2021-01-12 | headache |
12/27/2020 night head ache, ear popping, off balance, 12/28/2020 period upset and blood pressur...
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12/27/2020 night head ache, ear popping, off balance, 12/28/2020 period upset and blood pressure was 180/117 and husband took her to the hospital.
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| 53 | 2021-01-12 | dizziness |
@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), ...
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@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), 95-96% RA, rr 22, hr 84, temp of 97.2, Reports feeling dizzy and light headed. Patient has a history of allergies, swelling. @1004 repeat vitals 123/81y, 98% RA, hr 77, RR 21, denies pain, remains anxious and light headed. About 15 minutes later, she reports feeling better, less anxious, no more light headedness.
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| 53 | 2021-01-12 | fatigue, headache |
After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea,...
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After patient received Covid 19 second dose experienced fever for 4 days, severe joint pain, nausea, significant abdominal pain and abdominal cramping with nausea for 3 days, headache, body aches, fatigue. Unable to work . Injection site pain was minimal lasting 1 day.
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| 53 | 2021-01-12 | chills | Chills and Body aches |
| 53 | 2021-01-12 | fever, chills | Chills fever body aches |
| 53 | 2021-01-12 | dizziness |
Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased bloo...
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Experienced intense nausea and dizziness within 25 minutes of injection; tachycardia, increased blood pressure; skin redness with blotches on face and neck; uncontrollable shaking; chills. These diminished to tolerable level within 30 minutes after onset. Evening of injection: nausea, vomiting, fatigue, muscle cramping. Next day: nausea, light headedness
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| 53 | 2021-01-12 | chills, fatigue | Fatigue, chills, nausea, throwing up, body aches - persisted 2 days after 2nd dose shot |
| 53 | 2021-01-12 | headache, fever, chills | PAIN INJECTION SITE,HEADACHE,CHILLED,FEVER, SWELLING INYECCION SITE AND INFLAMATION IN GANGLIOS. |
| 53 | 2021-01-12 | malaise, chills |
Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the j...
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Red rash on left hand (a little on the right hand) and leg, left side of face under ear across the jaw line to under the chin, malaise, large muscle spasms and cramps, chills and shaking, soreness and swelling at injections site, burning in face and lips, and severe unexplained drop in blood sugar (56) that was very slow to bring back up.
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| 53 | 2021-01-12 | fever, fatigue, headache, influenza like illness |
Two hours after second dose, 1/12/2021, nausea, mild headache. In evening fatigue, aching all over. ...
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Two hours after second dose, 1/12/2021, nausea, mild headache. In evening fatigue, aching all over. Next day 1/13/2021, flu like symtoms, felt feverish, sluggish, ache all over, felt better after 3PM in afternoon, but not 100% normal.
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| 53 | 2021-01-12 | fatigue, dizziness |
anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a co...
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anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, dizzy on 31Dec2020, arm was really sore on an unspecified date, tiredness on an unspecified date. Event details: She was dizzy that day especially with changing positions, she didn't need to go to the doctor or anything. It wasn't severe. She was just a little dizzy. It's probably just the vaccine and it did go away. Her arm was really sore and went away after a few days. the tiredness, it wasn't a big deal. She did feel better about. it wasn't a serious anaphylactic reaction. It didn't happen right away. She had arm soreness. it wasn't immediate. She usually didn't have. It was really weird. She thought she was well hydrated. The outcome of event was really sore was resolved, outcome of other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events due to temporal relationship. There is very limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-13 | chills |
1/11/2021 7pm whole body felt painful, chill, lower back pain, under armpit of injection side very p...
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1/11/2021 7pm whole body felt painful, chill, lower back pain, under armpit of injection side very painful. Not able to get up this morning. Took 1000mg Tylenol. Last time took Tylenol was 1 am this morning. Staff is worried. Please advise. exposed 1/1/2021 (daughter).
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| 53 | 2021-01-13 | migraine |
15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and...
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15 hours after the vaccine was received I started to experience a migraine-like headache, nausea and muscle aches.
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| 53 | 2021-01-13 | fever, fatigue, chills, body temperature increased |
Chills, Fatigue, Fever, injection site pain, redness and swelling starting 12.23.2020 I experience i...
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Chills, Fatigue, Fever, injection site pain, redness and swelling starting 12.23.2020 I experience increase of temperature and fatigue.
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| 53 | 2021-01-13 | fever, chills, fatigue, headache |
FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, ...
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FIRST DOSE- FEELING HOT, CHILLS, TIREDNESS, MILD HEADACHE AND GENERAL BODY PAIN SECOND DOSE-FEVER, CHILLS, SEVERE HEADACHE, ITCHY IN THE VACCINATION AREA AND PAIN IN THE VACCINE ARM AND RADIATES UNDER THE ARMPIT TO THE BREAST AND DIARRHEA
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| 53 | 2021-01-13 | chills, malaise, fatigue, fever |
Felt very tired the evening of my 2nd dose of Covid vaccine. Woke early the next morning (01/08/21)...
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Felt very tired the evening of my 2nd dose of Covid vaccine. Woke early the next morning (01/08/21) with a high fever, chills, body aches, fatigue. Fever broke around midnight that night and I felt back to normal around noon the next day. Overall, I felt unwell for about 48 hours, and very sick for about 18 hours. I did not medicate for sx as we were advised by the hospital against NSAIDS to maximize antibody production.
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| 53 | 2021-01-13 | fever, fatigue |
Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on ...
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Fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 1284) intramuscularly at right arm on 06Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included known allergies to opiate derivatives and penicillin. Concomitant medication included clopidogrel, sertraline, simvastatin. The patient previously received first dose of bnt162b2 (lot number: ELC5730) intramuscularly at right arm on 18Dec2020 13:00 at single dose for COVID-19 immunization. The patient experienced fever; wide-spread body pain; hot flashes; intense, unrelenting itching on underarm and down arm on side of injection with no rash; fatigue, all on 07Jan2021 01:30. No treatment received. This is a non-serious report. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
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| 53 | 2021-01-13 | fatigue, chills |
I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body ...
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I experienced soreness at the sight of injection, lymph nodes swollen and sore under left arm, body aches, chills, tiredness. I took 2 Aleve before injection and Benadryl 25mg at 9p after injection.
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| 53 | 2021-01-13 | fever |
Left arm soreness for 24 hours and low grade fever of 100 F; Left arm soreness for 24 hours and low ...
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Left arm soreness for 24 hours and low grade fever of 100 F; Left arm soreness for 24 hours and low grade fever of 100 F; This is a spontaneous report from a contactable nurse. A 53-year-old non-pregnant female received bnt162b2 (lot: EK9231), intramuscular in the left arm on 30Dec2020 14:30 at a single dose for covid-19 immunization. The patient's medical history included migraine, seizure (resolved x2years) from an unknown date and unknown if ongoing , and allergy to penicillin. There were no concomitant medications. On 30Dec2020 20:00, the patient experienced left arm soreness for 24 hours and low grade fever of 100 f. The outcome of the event was recovered on an unknown date. No treatment was given to the patient for the event. The vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have Covid prior to vaccination and has not been tested post vaccination.
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| 53 | 2021-01-13 | fatigue |
Lymphadenopathy and fatigue; Lymphadenopathy and fatigue; First dose of BNT162B2 administered on 17D...
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Lymphadenopathy and fatigue; Lymphadenopathy and fatigue; First dose of BNT162B2 administered on 17Dec2020 and second dose on 04Jan2021 (18 days apart); This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 04Jan2021 at 10:00 (second dose) on the right arm, and on 17Dec2020 at 15:00 (first dose) on the left arm; both via unspecified routes of administration at a single dose for immunization. Medical history included hypertension and liver disease. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ), ibuprofen, paracetamol (TYLENOL), propanol, and sennoside a+b (SENOKOT). The patient experienced lymphadenopathy and fatigue on 05Jan2021 at 05:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered.
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| 53 | 2021-01-13 | shortness of breath |
Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a...
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Patient experienced rash shortly after administration. Felt hot. Patient took zyrtec. Was having a little bit of difficulty breathing. Symptoms except rash resolved after 30 minutes of observation. Patient discharged home from the vaccination clinic.
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| 53 | 2021-01-13 | dizziness, head discomfort, headache |
Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lig...
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Patient received covid-19 vaccine @ 1217 per site. Came to EH approx. at 1230pm. States she was lightheaded 1st, then headache, feels like someone is pressing down on head and neck- temples and note- feels like a band around head. Pain is 2/10, progessed to 6/10. States muscles are starting to get sore around trapezius region. Stated she had feeling of euphoria initially, BP 128/76, HR 66, 98% RA. Nausea, but no emesis. Metallic taste to mouth- pins and needles when drinking water.
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| 53 | 2021-01-13 | fatigue |
Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest a...
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Severe myalgia; arthralgia; body stiffness; pain/pain under right axilla, extending to right chest and neck; fatigue; Nausea; food aversion; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck; first dose on 18Dec2020 15:30, second dose on 06Jan2021 12:15; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration on 06Jan2021 12:15 in right arm at single dose for COVID-19 immunization. Medical history included ADHD (attention deficit hyperactivity disorder), depression in remission, Known allergies: yes: Nitrofurantoin, cephalexin, penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included ashwagandha (ASHWAGANDHA), rhodiola rosea (RHODIOLA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 15:30 for COVID-19 immunization. Adverse event on 07Jan2021 01:00: Severe myalgia, arthralgia, body stiffness, pain and fatigue in early AM of 07Jan2021, continuing into 08Jan2021, though improving. Nausea and food aversion on 07Jan2021, Moderate/severe lymph node swelling and pain under right axilla, extending to right chest and neck still evolving as of this report. Treatment: Ibuprofen OTC, bed rest, warm showers, rest. The outcome of the events was recovering.
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| 53 | 2021-01-13 | shortness of breath | Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath |
| 53 | 2021-01-13 | fatigue, headache, chills |
The side effects started early morning the day after the vaccine with body aches chills and tirednes...
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The side effects started early morning the day after the vaccine with body aches chills and tiredness and also a light headache. Very similar symptoms to COVID 19.
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| 53 | 2021-01-13 | sweating, fatigue, chills, shortness of breath, dizziness, weakness, cold sweat |
Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm ch...
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Within 5 minutes of shot, diarrhea and severe stomach cramps, sensitive to light and sound 5:30pm chills, temp 97.8 7:00pm warm shower 7:15pm diarrhea, shortness of breath, sweat dripping down body, dizzy, nauseated 7:45pm cool compresses on head and neck, clams, shortness of breath, still dizzy, weakened began shacking. 7:55pm. Dressed by husband and put in bed. Temperature 90.0 8:00pm 3 blankets on me, gloves on, socks and slippers on and heating pads to ankles and feet, still dizzy and shacking. no circulation to hand or feet. no capillary refill. 8:30pm Called nurse on Call who stayed on the phone with me for 45 minutes, two Advil taken. Trying to eat crackers and hydrate. 8:45pm. feeling blood flowing to hands but not feet. 9:45pm gloves off hands and heavy blanket off, toes still ice cold.10:15pm Up to bathroom with husbands help, no strength. Urinated, no more diarrhea. Stomach still making a lot of noise. Still sensitive to light and sound, feeling to toes, still dizzy.11:30pm Feeling more like myself. Just exhausted. Slept off and on throughout the night and hydrated and up to urinate on my own without assistance. Jan. 14, 2021 , 10:00am- Sitting up in bed. Very tired. Drinking water. 12:00 noon able to eat an egg and avocado sandwich
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| 53 | 2021-01-13 | fatigue, dizziness | dizzy, nauseous, tired that lasted 24 hours- missed a day of work |
| 53 | 2021-01-13 | headache, chills | headache, chills, body ache |
| 53 | 2021-01-13 | influenza like illness |
plantar fasciitis pain disappeared; hit hard as if flu; teeth are particularly sensitive to cold; Th...
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plantar fasciitis pain disappeared; hit hard as if flu; teeth are particularly sensitive to cold; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via intramuscular route on her left arm on 06Jan2021 (lot number: EL1823) at 15:45, and first dose via an unspecified route of administration on an unspecified date; both at a single dose for COVID-19 immunization. Medical history included hypothyroidism and tooth recession. Concomitant medication included levothyroxine. The patient previously took amoxicillin and experienced allergies. The patient's plantar fasciitis pain disappeared so she thought that her body was too busy responding to vaccine. She was hit hard as if flu. One notable side effect was that teeth were particularly sensitive to cold. She used Sensodyne for periodontal recession and they were really, really uncomfortable to cold. All occurred on 07Jan2021 at 15:00. Outcome of the events was unknown.
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| 53 | 2021-01-13 | migraine, fatigue | stomach issues, migraines. body aches Fatigue |
| 53 | 2021-01-14 | chills |
3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on ch...
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3:00 PM injection site pain swelling resolved within 48 hours 7:00 PM Skin redness sensitivity on chest, abdomen right trunk resolved within 6 hrs. 9:00 PM chills, body aches, nausea resolved within 48 hrs 1:50 AM. Diarrhea resolved within 12 hours 2:00 AM. Vomiting multiple times resolved within 30 minutes
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| 53 | 2021-01-14 | fatigue |
At 1:16PM patient complaints of pruritus, but patient said feeling ok. At 1:35PM continue with pruri...
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At 1:16PM patient complaints of pruritus, but patient said feeling ok. At 1:35PM continue with pruritus Benadryl 50ml IM were administrated. Vital signs Oxygen saturation 95%, HR 85bpm, BP 155/91mmHg, Dxt 119 and RR 12 rpm. At 1:45pm patient complaint of fatigue, an Rapid Response (RR) code for anaphylactic reaction was activated. Patient received Epinephrine 0.3mg IM (1 dose), Solu-Cortef 200mg IM (1 dose) and was transferred to the ER per anaphylactic shock protocol. Vitals signs at ER were 132/76mmHg, RR 14rpm, Osat 99% and HR 83bpm.
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| 53 | 2021-01-14 | fever | Body aches, chills, fever 24 hours |
| 53 | 2021-01-14 | dizziness |
COVID Vaccine Clinic. Upon staff member receiving vaccination, collapsed after getting up from chai...
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COVID Vaccine Clinic. Upon staff member receiving vaccination, collapsed after getting up from chair. Rapid Response was called. Staff member was positioned supine with legs elevated. Blood pressure 147/88 HR 92.Po2 at 100% on room air. Complained of feeling faint and dizzy. Assessed by Rapid Response RM and MD. Escorted via cart to mid hallway for further evaluation. SM symptoms continued to be concerning, transported to ED with MD escort. Staff member was evaluated in ED. fluids given, Zofran for nausea and Benadryl. CTOH was completed and resulted as no abnormalities. Staff member was discharged to home in stable condition.
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| 53 | 2021-01-14 | fatigue, chills |
Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot a...
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Chills; Body ache; Fatigue; redness and hot about 1-3 inches below injection site; redness and hot about 1-3 inches below injection site; patient received the second dose in less than 21 days from the first dose; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ0142), intramuscular in the left arm on 05Jan2021 at 08:00 AM (at the age of 53-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received the first dose of BNT162B2 intramuscular on 19Dec2020 at 19:00 PM, lot number: EJ1685 at the age of 53-year-old for COVID-19 immunization in the left arm. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 05Jan2021 at 22:00 PM the patient experienced chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. The patient took Motrin for chills, body ache, fatigue, redness and hot about 1-3 inches below injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the chills, body ache, fatigue, redness and hot about 1-3 inches below injection site was not recovered.
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| 53 | 2021-01-14 | chills, headache |
Chills; body ache; headache; insomnia; This is a spontaneous report from a contactable healthcare pr...
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Chills; body ache; headache; insomnia; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on the right arm on 07Jan2021 16:00 at a single dose for COVID-19 immunization. Medical history included depression. Patient was not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA). The patient experienced chills, body ache, headache, insomnia on 08Jan2021 02:00. Outcome of the events was not recovered. No treatment was given for the adverse events. The reporter assessed the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Information of lot/batch number has been requested.
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| 53 | 2021-01-14 | headache, fatigue |
Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- ...
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Day 1- RUE injection site tender Day2- RUE Large knot at injection site, tenderness. Fatigue Day 3- Right Axillary lymph nodes swelling, grapefruit size, painful. Edema from injection site to fingertips with numbness to 3,4,5 digits. Fatigue and headache. Day 4- RIGHT sided lymph nodes swelling, palpable to neck, axillary and groin. Severe fatigue. Headache. Edema still complete to RUE- with numbness to fingers. Grapefruit sized axillary, slightly improved. NO FEVER, COUGH, DYSPNEA
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| 53 | 2021-01-14 | chills, fatigue, fever |
Fatigue; fever; Chills; body aches; This is a spontaneous report from a contactable consumer (patien...
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Fatigue; fever; Chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 07Jan2021 09:00 at a single dose for COVID-19 immunization. The patient had no medical history. The patient previously took 1st dose of BNT162B2 on an unknown date for COVID-19 immunization. There were no concomitant medications. The patient wanted to report a side effect of the Pfizer COVID vaccine. Stated that she had her second dose yesterday morning at 9am. Stated that she woke up this morning 08Jan2021 at 3am with fever, chills and body aches. The reporter is a nurse's aide in ICU COVID unit. Stated that she took acetaminophen (TYLENOL) and her fever resolved at 6am this morning. Stated that the chills resolved at 6am this morning. Stated that the fatigue started at 9am this morning. Outcome of the events fever and chills was recovered on 08Jan2021 at 06:00 while not recovered for the other events. Information on the Lot/Batch number has been requested.
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| 53 | 2021-01-14 | headache, chills, fatigue, fever |
Headache; muscle aches; fatigue; chills; 102.2 fever; This is a spontaneous report from a contactabl...
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Headache; muscle aches; fatigue; chills; 102.2 fever; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), intramuscular on the left arm on 08Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypertension (HBP). Concomitant medications included irbesartan (IRBESARTAN), ibuprofen (ADVIL 12 HOUR), and sumatriptan succinate (SUMATRIPTAN SUCCINATE). On 08Jan2021 12:00, the patient had headache, muscle aches, fatigue, chills, and 102.2 fever and was recovering from these events. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events.
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| 53 | 2021-01-14 | headache | Joint pain . Inflammation in knee Headache nausea vomiting |
| 53 | 2021-01-14 | fatigue, headache |
Light headache ( first day); nausea ( 3 days); severe fatigue (2 days); This is a spontaneous report...
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Light headache ( first day); nausea ( 3 days); severe fatigue (2 days); This is a spontaneous report from a contactable healthcare professional (patient). A 53-years-old female patient received first dose on bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number Bj1685, expiration date not reported), intramuscular, on the left arm, on 07Jan2021 at 15:00 at a single dose for Covid-19 immunization. Medical history included scleroderma, interstitial lung disease (ILD), and Raynauds. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant. On 06Jan2021, the patient had a nasal swab with negative result. On 07Jan2021, the patient experienced light headache (first day), nausea (3 days) and severe fatigue (2 days). The patient had a nasal swab with negative result on 06Jan2021. The patient did not receive treatment for the adverse events. The outcome of the events was recovering.
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| 53 | 2021-01-14 | fever, headache |
Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is ...
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Nausea; fast heart rate; low grade temp (99.4-100); headache; body aches; soreness at site; This is a spontaneous report from a contactable Nurse (patient herself). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 13:00 (Lot number: EK5730) at SINGLE DOSE (first dose, left arm); and via an unspecified route of administration on 07Jan2021 13:00 (Lot number: EK9231) at SINGLE DOSE (second dose, left arm) for COVID-19 immunization. Medical history included hypertension, high cholesterol, Graves disease, and Known allergies: Sulfa from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the vaccine at hospital. Concomitant medication included hydrochlorothiazide, atorvastatin, amlodipine from unspecified dates for unspecified indications. The patient experienced nausea, fast heart rate, low grade temp (99.4-100), headache, body aches, soreness at site on 08Jan2021 06:00. The patient underwent lab tests and procedures which included temp 99.4-100 and heart rate fast on 08Jan2021. Treatment was not received for adverse events. Event outcome was recovering. The reporter assessed the events as non-serious.
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| 53 | 2021-01-14 | fever |
aches; fever; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant f...
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aches; fever; This is a spontaneous report from a contactable consumer. A 53-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 07Jan2021 at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her most recent COVID-19 vaccine in a hospital. The patient experienced aches and fever on 07Jan2021 22:00. The outcome of the events was recovered in Jan2021. The reporter considered the events as non-serious. The patient received ibuprofen as treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Information on Lot/Batch number has been requested.
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| 53 | 2021-01-14 | malaise, chills, fever |
fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in...
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fever; chills; malaise; body aches; Metallic taste in mouth; cotton mouth; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after; This is a spontaneous report from a contactable Nurse, the patient. This 53-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (dose #1), via an unspecified route of administration in the right arm on 07Jan2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. Medical history included food allergy (shellfish) from an unknown date and unknown if ongoing, drug hypersensitivity (sulfa) from an unknown date and unknown if ongoing, migraine headaches from an unknown date and unknown if ongoing and contrast media allergy (lodine dye) from an unknown date and unknown if ongoing. Concomitant medication included propranolol (PROPRANOLOL), vitamin d3 (VITAMIN D3) and ascorbic acid, zinc (VITAMIN C + ZINC). The patient previously took avelox and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 07Jan2021 at 14:30, the patient experienced metallic taste in mouth, cotton mouth and flush/tingly sensation in extremities (like when receiving IV contrast dye) after receiving vaccine for about an hour after. She did not tell anyone, just tried to work through it. The patient thought it was strange. She has a shellfish allergy/sensitivity, not sure if it was related. On 08Jan2021 (reported as the following day after vaccination), the patient experienced low grade fever, chills, malaise and body aches. Therapeutic measures taken included Advil and Tylenol. The clinical outcome of metallic taste in mouth, cotton mouth, flush/tingly sensation in extremities, low grade fever, chills, malaise and body aches was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 53 | 2021-01-14 | chills |
shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontan...
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shivering; tachycardia; BP 139/89/BP 148/91; Left arm very sore; Left arm tingled; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 10:30 in left arm at single dose for COVID-19 immunization. Medical history included mild hypertension, chronic migraine and recent elevated liver tests - Alk Phos (alkaline phosphatase) & GGT (Gamma-glutamyltransferase) from an unknown date and unknown if ongoing. Concomitant medication included metoprolol succinate 25 mgs daily and colecalciferol (VITAMIN D). On 07Jan2021 21:30, following shot for a few minutes, the patient experienced left arm tingled, had a brief period lasting a few minutes of shivering that evening and tachycardia. Noted at 9:30 pm, patient's BP 139/89, pulse 88 (BP 115/88 and pulse 76 4 days prior). Then BP 148/91, pulse 69 at 10 am on 08Jan2021 after two doses of Metoprolol Succinate ER 25 mgs at 9:45 pm on 07Jan2021 and at 8:30 am on 08Jan2021. The patient experienced left arm very sore on 07Jan2021 after receiving vaccine. Seems to be improving on 08Jan2021. The outcome of the events was not recovered. no treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 53 | 2021-01-15 | somnolence, headache, chills, weakness |
Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very...
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Chill, terrible headache, noisy sound in ears, body aches, swollen lymph node at left armpit is very big, injection site is harder. Lower back at kidney sites are so painful. Weakness. No energy to lift up arms or legs. Have difficult to get up and get out of bed to get medicine or food. So sleepy, maybe because Tylenol 500mg q4h to help for pain but reduce just little from 10 down to 8 for a short time enough to get out of bed to get something. Ice pack at armpit, heat pat at lower back but just reduce the pain from 10 down to 9 only. No appetite. Eat lentil and rice porridge but indigestible and have to take Pepcid. All symptoms prolong until Friday 1/15/2021 around 1pm. I pushed myself hard to get up to drive to employee health for testing which I missed on Thursday due to unable to get up. After that the symptoms down to moderate that I able to report CDC. I wonder why 2 dose is so horrible to me.
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| 53 | 2021-01-15 | cough |
Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 min...
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Patient reported chest tightness (1-2 on 0-10 pain scale) and left arm tingling approximately 10 minutes after receiving the 2nd COVID vaccine dose. Patient reported symptoms felt similar to times when she had exposure to cats or after exercising. She denies any previous treatments for anaphylaxis or any previous severe reactions. Vital signs at time of initial assessment were BP 147/100, pulse 80, O2 Sat 99% on room air. Patient was observed for 50 minutes and chest tightness/arm tingling symptoms resolved. Patient did also develop a dry "tickly" cough about 60 minutes post vaccination. Patient was administered albuterol 2 puffs via MDI and reported improvement of cough. She again reported the cough to be similar to the type of cough she had gotten when exposed to cats. No further treatment needed. Patient stable and released to go home.
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| 53 | 2021-01-16 | malaise, headache, chills, fever | Chills, severe headache, muscle and joint pain, malaise, fever, diarrhea |
| 53 | 2021-01-16 | fever | Fever, chills, achey, underarm pain. |
| 53 | 2021-01-16 | sweating, fatigue, fever, headache, chills |
Hair and clothes wet with diaphoresis the night of injection, woke up with nausea, vomiting. Tempera...
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Hair and clothes wet with diaphoresis the night of injection, woke up with nausea, vomiting. Temperature ranged 99.5-101.3, l check my temp daily. Sweating, chills, headache, body aches and fatigue. The symptoms began to decline approximately 24H after vaccine but headache, mild nausea and extreme fatigue continued. I felt so bad that I missed 2 days of work and got a COVID test to be safe, as I am a nurse, results were negative and employer was made aware of reaction.
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| 53 | 2021-01-16 | throat swelling |
I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower...
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I Approx 3 hours after receiving the vaccine I began feeling tingling/numbness in my left foot lower leg. Tingling spread to both feet & hands arms lower legs. Slight swelling of tongue/ throat but I could swallow and breathe. It is now 16 hours since I received the vaccine and I?m still experiencing tingling / numbness and slight tongue/ throat swelling. I have decided to take Benadryl to see if it helps.
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| 53 | 2021-01-16 | headache, body temperature increased, fatigue |
Late evening/night of 1/16/21, noted soreness of L arm pit. Morning of 1/17/21, felt mild headache a...
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Late evening/night of 1/16/21, noted soreness of L arm pit. Morning of 1/17/21, felt mild headache and fatigue. Left arm pit pain continues but seemed to be less as the day went on on 1/17/21. Took temperature earlier in day and was 99.1. Took temperature at around 4pm and temperature was 101.1 and took acetaminophen 500 mg. At time of this report, left arm pit pain more mild. Called primary care provider for advice and will continue to monitor self at home.
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| 53 | 2021-01-16 | chills, dizziness, fatigue, fever, headache, malaise |
Pfizer-BioNTech COVID-19 Vaccine EUA: dizziness, headache, muscle aches, nausea, chills, fever, tir...
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Pfizer-BioNTech COVID-19 Vaccine EUA: dizziness, headache, muscle aches, nausea, chills, fever, tiredness, feeling sick
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| 53 | 2021-01-16 | fever, respiratory tract congestion, chills, cough |
Was coughing , had chills back pain, fever, Stayed home wed, Thursday. Went back to wk Friday. Sa...
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Was coughing , had chills back pain, fever, Stayed home wed, Thursday. Went back to wk Friday. Sat at work she couldn't taste or smelled food. Took covid test, +for covid on 1/2/21. On 1/13/21 had another covid test it was negative. Congestion, h/a cough. Feels better and report back to work 1/18/21.
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| 53 | 2021-01-17 | shortness of breath, throat irritation |
Hx Covid infection Had Covid vaccine #1 - no problems Within 1 hr after Covid vaccine #2 progressed ...
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Hx Covid infection Had Covid vaccine #1 - no problems Within 1 hr after Covid vaccine #2 progressed to SOB, pruritis throat tickle TxT-ed self with Benadrl but symptoms persisted Went to ED txt with Bendryl, prednisone, zyrtec.
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| 53 | 2021-01-18 | headache, fever |
Low-grade fever; severe joint/muscle aches; severe joint/muscle aches; headache; loss of taste; This...
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Low-grade fever; severe joint/muscle aches; severe joint/muscle aches; headache; loss of taste; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 18Dec2020 at single dose in right arm for covid-19 immunization. Medical history included hypertension and anxiety. No other vaccine was received in for weeks. Concomitant medications in two weeks included losartan, famotidine, aspirin (acetylsalicylic acid), prazosin, escitalopram. The patient did not have COVID prior vaccination and patient did not underwent COVID tested post vaccination. The patient experienced low-grade fever, severe joint/muscle aches, headache, loss of taste on 19Dec2020 01:00. The patient did not receive any treatments of the events. The outcome of the events was recovered on an unspecified date. Information on Lot/Batch has been requested.
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| 53 | 2021-01-18 | runny nose, fatigue |
She had sniffles and post nasal drip; Got first dose then went to (Entertainment complex name) and c...
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She had sniffles and post nasal drip; Got first dose then went to (Entertainment complex name) and contracted COVID/tested positive after getting the 1st dose; Tested positive after getting the 1st dose; She returned home with sniffles, fatigue, and no taste/She had sniffles and post nasal drip; This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program: IBCC (Inbound Call Center for HCPs). A 53-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, exp date not reported), via an unspecified route of administration on 19Dec2020 for given since patient works with COVID patients (COVID-19 immunisation). The patient had no relevant medical history. There were no concomitant medications. Nurse called asking if she can get the 2nd dose of the vaccine 6 days after the 21st day. She tested positive on 05Jan2021 after getting the 1st dose and was still in quarantine. The nurse works at a hospital. She received her first dose of the COVID-19 Vaccine on 19Dec2020, and afterwards donated blood on the same day. She got the vaccine through her place of work. She said when she donated blood on 19Dec2020, her blood was tested for the COVID-19 Virus antibodies, and her blood was negative for the virus antibodies. She lives about 30 mins from work, so she thought she would get both done in the same day. She gave blood right before she got the vaccine. She gave the blood then went and got the Vaccine. She said on 26Dec2020 she went to Entertainment complex as it was her vacation. Her and her family went for 4 days. On 30Dec2020 she returned home with sniffles, fatigue, and no taste. She said she tested positive for the COVID-19 Virus on 05Jan2021. On 30Dec2020 they got back, and on 02Jan2021 she had sniffles and post nasal drip. On 03Jan2021 she did not wanna get out of bed. She was profoundly fatigued. She also lost her smell. She had to go back to work on 07Jan2021, but did not want to go back in unless she was sure she was okay because she works with babies. She had no other symptoms after 03Jan2021, except no smell and no taste. She got tested for COVID and was positive on 05Jan2021 (also reported as 06Jan2021 [pending clarification]). Her and her husband were both positive, but her kids were not. The weird thing was she also on 06Jan2021 got her results back from giving blood and she was negative for COVID on 19Dec2020 prior to getting the vaccine. Caller clarifies that her COVID test was a nasal swab. Patient thought her age may have contributed to her feelings of fatigue. She had indicated she worked in either a hospital NICU or nursery, and that is why she had to quarantine for 14 days. She probably would not have even gotten tested for COVID if she was not a nurse and did not know that losing taste and smell were a sign. She feels fine. She said she was scheduled for her second dose of the COVID-19 Vaccine on 12Jan2021. She said she was now in quarantine for 14 days due to testing positive for the COVID-19 Virus, and her quarantine period ends on 14Jan2021. Since now she is in quarantine, she will miss her second dose which was supposed to be on 12Jan2021. She said she rescheduled her second dose of the COVID-19 Vaccine to 18Jan2021, which was 6 days later than when she was supposed to receive the 2nd COVID-19 Vaccine dose. She asked if getting the dose 6 days late was okay. The events were considered as non-serious by the reporter. The outcome of the events was unknown.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-01-19 | throat swelling, weakness, chills, headache, dizziness |
? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swellin...
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? headache ? muscle pain ? chills ? joint pain nausea swollen lymph nodes (lymphadenopathy) Swelling of your face and throat ? A fast heartbeat ? A bad rash all over your body ? Dizziness and weakness
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| 53 | 2021-01-19 | headache | Body aches, headache. Treated with IBU 600mg and Tylenol 1g. Symptoms lasted 48 hours. |
| 53 | 2021-01-19 | chills | EPIGASTRIC AREA PAIN NAUSEA CHILLS |
| 53 | 2021-01-19 | fatigue, headache, fever | Headache, body aches, low grade fever (100.6), fatigue, injection site tenderness |
| 53 | 2021-01-19 | headache, fatigue |
Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection si...
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Initial headache within approximately 10 hours of injection, then body aches, insomnia, injection site soreness, fatigue, slight mental fog.
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| 53 | 2021-01-19 | chills | ON 1/20/21 DEVELOPED EYE/MOUTH DROOPING, VOMITING, NAUEA, CHILLS AND BODY ACHES. HAS CALL OUT TO PCP |
| 53 | 2021-01-19 | dizziness, headache, fever | Shakes, fever of 102.8, sever body aches, diarrhea, headache, dizziness Lasted 24 hours. |
| 53 | 2021-01-19 | chills, body temperature increased |
Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The...
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Started having some blurry vision on the night of 01/17/2021 which lasted for 45 mins to 1 hour. The next day on 01/18/2021 at about 1445 started having some itchiness on the face[ cheeks, forehead and around lips] with chills on and off. My face became little puffy and swollen with redness. By the evening, I also ended up with high temperature 100 degree and started having body pain , mainly on the lower back . Took 600 mg Ibuprofen along with Vitamin C 1000 mg and Zinc 1 tablet at night. All my symptoms resolved by 01/19/2021 noon.
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| 53 | 2021-01-19 | weakness, fever, headache, chills |
chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a sp...
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chills; Headache; muscle spasms; extreme weakness; body aches; fever; sinus congestion; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 09:45 at single dose for covid-19 immunisation. Medical history included hypertension (HTN), high cholesterol. Concomitant medication included lisinopril, levocetirizine dihydrochloride (EURO ZYSOL), ezetimibe (ZETIA) and stool softner. No other vaccines within 4 weeks prior to the COVID vaccine. No diagnosed with COVID-19 prior to vaccination. The patient experienced woke up with chills, headache, muscle spasms, extreme weakness, for 24 hours continued with body aches, fever, sinus congestion. Still have sinus congestion, all other symptoms ended in 24 hours from onset. Events onset date reported as 09Jan2021 01:00. No treatment received for the events. Outcome of events was recovered with sequelae. Since the vaccination the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 53 | 2021-01-21 | chills, fever, headache |
1/11 woke at 0400 with extreme shivering, vomiting, fever 101.8, headache. Previously COVID + 11/17/...
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1/11 woke at 0400 with extreme shivering, vomiting, fever 101.8, headache. Previously COVID + 11/17/2020.
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| 53 | 2021-01-21 | fever, headache, chills | Approximately 11 hours after receiving vaccine developed chills,fever,headache,bodyaches,arm pain |
| 53 | 2021-01-21 | weakness, throat pain, nasal congestion, chills, fatigue, headache |
First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chill...
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First dose was given 12/23- Xuan states from 12/24-12/26 she had no energy, throat felt weird, chills, and her arm was very sore for a day. Second dose was given 1/15- On 1/19 she had body aches, chills, severe headache, fatigue, abdominal pain, stuffy nose and sore throat. Her arm was very sore for several days, she could not raise her arm. Treatment: took tylenol every 6 hours for 24 hours. on 1/19 and 1/20 she took Dayquil.
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| 53 | 2021-01-21 | fatigue, headache, chills |
Headache that last two days. Severe chills that started day three and have continued for nine days....
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Headache that last two days. Severe chills that started day three and have continued for nine days. Nausea, diarrhea, abdominal pain, body aches, increased joint pain, increased inflammation, and increased fatigue that started day two and has continued for nine days.
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| 53 | 2021-01-21 | headache, fatigue |
On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening e...
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On 1/6 developed tenderness at left axilla and headache. That night began having muscle stiffening especially in back of neck, worsening headache. 1/7 awoke with nausea/vomiting lasting throughout the day and diarrhea also started. 1/8 continued vomiting but diarrhea stopped and also noted confusion and brain fog. 1/11 mostly recovered and back to work with slight headache and body soreness from exhaustion.
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| 53 | 2021-01-21 | fever, headache, fatigue, chills |
Received dose on 1/20/2021 at 0818 by 1400 had a horrible headache. At 2100 started having body ache...
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Received dose on 1/20/2021 at 0818 by 1400 had a horrible headache. At 2100 started having body aches all over body. Injection site pain as well. On 1/21/2021 at 0500 began having chills and running a fever of 102.4. The head ache subsided around 1800. The body aches and fever were gone by 0700 on 1/22/2021. At this point (1/22/2021 1450) just exhausted, but no other aches or pains. During the time of the head ache initially took Tylenol which did nothing. Then took a low dose of Ibuprofen which took an edge off.
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| 53 | 2021-01-21 | fever, chills, shortness of breath, productive cough, headache |
Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, ...
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Started with shaking chills at 11:45 pm 1/10/21 and fever spikes up to 103 degrees with body aches, nausea, vomiting and diarrhea, continuous headache for 4 days. Then started with productive cough and dyspnea on exertion. Took Tylenol initially and then Proair inhaler starting 1/15
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| 53 | 2021-01-21 | fever, shortness of breath, chills |
shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grad...
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shortness of breath insomnia, high blood pressure, feeling of something logged in my throat,low-grade fever and chills, digestive issues weight loss body aches.
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| 53 | 2021-01-24 | dizziness, headache |
20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a...
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20 mins after the injection, my BP increased to 193/113 ( no h/o HTN), pulse was 134, flushing and a rash across my chest, headache, nausea, numbness/tingling in both hands and lightheaded.
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| 53 | 2021-01-24 | chills, headache | Severe diarrhea, severe vomiting , severe headaches and chills |
| 53 | 2021-01-24 | headache, body temperature increased, chills, fatigue | T(max) 100.7 body aches chills headache and fatigue |
| 53 | 2021-01-24 | fatigue | pain at injection site- 24 hours warmth at injection site- 24 hours fatigue- 24 hours |
| 53 | 2021-01-25 | sweating, fever, chills, headache |
Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; Thi...
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Chills/shivering; fever at 102°F; Headache; sweating; Arm is sore and red; Arm is sore and red; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL0142, expiry date not reported), via an unspecified route of administration on 11Jan2021 11:30 at a single dose in the left arm for Covid-19 immunization (as patient works in a nursing home and wanted to get it). Medical history included ongoing asthma and had COVID back in Apr2020 to an unknown date. There were no concomitant medications. The patient previously had flu shot and had arm red and sore. Patient had a reaction after receiving her Covid shot yesterday at 11:30 AM. Patient mentioned that she woke up this morning (12Jan2021) at around 3 AM with chills, a headache and fever at 102-degree Fahrenheit and felt that she has to move her legs every time to feel better. She has asthma but stated that her breathing was fine. Patient wanted to know if this was normal and when this will go away. She called her doctor and left a message to let them know. She had COVID back in Apr2020, but got the vaccine yesterday, which she wanted. She was unsure what was going on. She was also shivering and cannot settle down, like her legs. She just has a massive headache with chills, shivering, and some sweating (12Jan2021). Her arm was also red and sore (12Jan2021). It was like she gets with the Flu shot, but she never has had any other symptoms with the flu shot. The events were reported as non-serious. Therapeutic measures were taken as a result of chills/shivering, fever at 102-degree Fahrenheit, headache, and arm was sore and red. Patient took Tylenol this morning when she woke up at 3 AM. She did not fall asleep until 5 AM. Then she got up at 7 AM and took some more. She will take more at 11 AM. The outcome of the events chills/shivering, fever at 102-degree Fahrenheit, headache, sweating, and arm was sore and red was not recovered.
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| 53 | 2021-01-25 | dizziness, headache, throat pain |
Dizziness, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, dizziness w...
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Dizziness, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, dizziness worse when standing, facial flushing
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| 53 | 2021-01-25 | dizziness, throat pain, headache |
Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone ache...
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Dizziness, lightheadedness worse upon standing, HA, sore throat, body aches, muscle aches, bone aches, cold hands, cold toes, facial flushing. Missed work for 2 days and went to urgent care. Treated with APAP, Motrin, and meclizine
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| 53 | 2021-01-25 | fever, fatigue, headache |
within 2 hours extreme fatigue; more muscle soreness than the first/soreness went across the back an...
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within 2 hours extreme fatigue; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back; headache; fever; This is a spontaneous report from a contactable healthcare professional (patient herself). A 53-year-old female patient received the second dose of bnt162b2 (BNT162B2, Pfizer, lot number was not reported), via an unspecified route of administration on the left arm on 11Jan2021 15:00 at a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient is not pregnant. Concomitant medication included metformin, atorvastatin calcium (ATORVASTIN), vortioxetine hydrobromide (TRINTELLIX) and insulin glargine, lixisenatide (SOLIQUA). The patient previously took the first dose of BNT162B2 (Pfizer, lot number was not reported) on 23Dec2020 on the left arm and experienced tingly lips; and previously took codeine and experienced allergies. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. On 11Jan2021 18:00, the patient experienced within 2 hours extreme fatigue, lots more muscle soreness than the first. This soreness went across the back and to the other shoulder then down the back. The patient slept from 6 pm to 8 am and would wake to take ibuprofen and TYLENOL. Ran some fever. Had a headache since 6 pm. She had extreme fatigue and stayed in bed all day. The patient did not receive treatment for "within 2 hours extreme fatigue" and "more muscle soreness than the first/soreness went across the back and to the other shoulder then down the back". The patient has not recovered from the events. Information about lot/batch number has been requested.
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| 53 | 2021-01-26 | fever, fatigue |
Low grade fever of 101.4, achy muscles, tiredness, and cannot lift left arm above my head without fe...
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Low grade fever of 101.4, achy muscles, tiredness, and cannot lift left arm above my head without feeling extreme pain.
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| 53 | 2021-01-26 | nasal congestion, dizziness |
On 01/25/21, 53 yo F received the Pfizer BTN162b COVID-19 vaccine. ~2-3 hours after the injection, p...
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On 01/25/21, 53 yo F received the Pfizer BTN162b COVID-19 vaccine. ~2-3 hours after the injection, pt developed swelling of eyelids, lightheadedness and nasal congestion. Pt reported similar symptoms related to seasonal allergies which she also experiences at this time of year. Pt self-medicated with fexofenadine (Allegra). Pt notified primary care provider. Pt denied any shortness of breath, difficulty swallowing or rash. Pt was advised to take diphenhydramine 50 mg. In no improvement in swelling, pt was advised to go to urgent care.
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| 53 | 2021-01-26 | headache, dizziness |
dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side ...
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dizziness nausea and vomit Pounding Heachache crushing pain in my left leg numbness on my left side numbness on my face limping leaning to the left side when walking tingling on my gums and teeth
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| 53 | 2021-01-26 | headache |
elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbn...
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elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy. The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-01-26 | headache, fatigue | fatigue, body aches, HA |
| 53 | 2021-01-28 | throat irritation |
1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a s...
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1-2 hives on face near mouth (outside) scratchy, dry throat ER doctor had the nurse administer a steriod shot (methylPREDISolone (Medrol (pak)) and I was given famotidine (Pepcid pill). A prescription was called into my pharmacy (famotidine and methylPREDNISolone)
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| 53 | 2021-01-28 | migraine |
Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed bl...
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Associate was started developing side effects on 1/20/21 -developed a migraine; 1/22/21-developed blurry vison; 1/25/21 - had an e-visit ; 1/26/21 - evaluated by her PCP referred to ophthalmologist; 1/27/21 - evaluated by ophthalmologist and referred to retina specialist as she had pressure behind her eye; 1/29/21 - retina specialist used laser to decrease pressure behind her eye.
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| 53 | 2021-01-28 | headache, migraine |
Bad headache about 45 minutes after shot. Had headaches for a few days after. Then after 3 weeks, ...
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Bad headache about 45 minutes after shot. Had headaches for a few days after. Then after 3 weeks, had a migraine - felt like the one I had the same day of the vaccine, but way more intense. I now wake up with headaches almost every morning.
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| 53 | 2021-01-28 | fever | FEVER, "THICK TONGUE", LOWER BODY ACHES |
| 53 | 2021-01-28 | fever |
Fever; body ache; This is a spontaneous report from a contactable healthcare professional (patient)....
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Fever; body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL0142, unknown expiration), intramuscular in right arm on 13Jan2021 at 07:15 AM at a single dose for COVID-19 immunization in a hospital. Medical history included diabetes and high cholesterol. The patient's concomitant medication included unspecified vitamins. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, unknown expiration) via intramuscular in left arm on 23Dec2020 at 07:15 AM in a hospital. The patient also had known allergies to codeine. The patient experienced fever and body aches on 13Jan2021 at 13:00. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the events. The patient had not yet recovered from the events.
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| 53 | 2021-01-28 | headache, fever |
Fever; joint pain left side; Rash on legs; headache; This is a spontaneous report from a contactable...
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Fever; joint pain left side; Rash on legs; headache; This is a spontaneous report from a contactable other healthcare professional (hcp; patient for herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration in the left arm on 13Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, HTN (hypertension), migraines, and blepharitis. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), metoprolol tartrate, lisinopril, colecalciferol (VIT D3), fish oil, and "mul" as reported. The first dose of BNT162B2 (brand Pfizer, lot EL1284) for COVID-19 immunization was administered on 22Dec2020 at 05:30 pm in the left arm. The patient had no other vaccines in four weeks. On 13Jan2021 08:45 pm, the patient experienced fever, joint pain left side, rash on legs and headache. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The events fever, joint pain left side, rash on legs and headache were recovered on an unknown date in Jan2021.
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| 53 | 2021-01-28 | headache |
Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). A 53-year-old ...
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Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3302, expiry date: unknown), via an unspecified route of administration in the left upper arm, on 12Jan2021 at a single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included other medications but declined to provide those medications. The patient previously took azithromycin and amoxicillin, clavulanic acid (AUGMENTIN) and experienced allergies. The patient had no history of previous immunization and no additional vaccines administered on same date of the suspect drug. The patient had no prior vaccination within four weeks. On 13Jan2021, the patient experienced severe nausea and headache. The patient reported she just stayed at home and drinking ginger ale and crackers. The events did not require visit to emergency room or physician office. Therapeutic measures were taken as a result of the events nausea and headache. Outcome of the events nausea and headache was not recovered.
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| 53 | 2021-01-28 | fatigue |
Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle ...
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Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle that is still present.
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| 53 | 2021-01-28 | chills, sweating |
lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is ...
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lost eyesight, everything went black; sweating really bad; cold chills; feels kind of achy; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) received from a contactable consumer. A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3249), intramuscular in left arm on 14Jan2021 12:00 at a single dose to prevent COVID-19. Medical history included shingles recently and was not given any medicine for that and breast cancer when she was 29 so she can't have shots on her right side. There were no concomitant medications. On 15Jan2021 05:00, she went to the bathroom and everything went black. When her eyesight did come back after a while, she was sweating badly and had the chills. As soon as her husband helped her get back to bed, she started sweating really bed. Her nightclothes were soaked, it wasn't like a normal sweat. She also got the cold chills. She got the cold chills right after she had the experience with her eyesight. She was just kind of achy. However, the sweating, chills, and achiness are all listed on the form she has. She isn't really worried about that. The patient was more concerned about the fact she couldn't see anything. Caller wanted to know if losing her eyesight is a side effect of the vaccine. She confirmed her eyesight came back. The outcome of the event losing her eyesight was recovered while the outcome of the remaining events was unknown. No follow-up attempts are possible. No further information is expected.
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| 53 | 2021-01-28 | chills, fever, headache |
mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pai...
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mild fever; chills; anorexia; headache; discomfort in her chest; myalgia/severe muscle pain; leg pain; Looked pale; was so hungry; This is a spontaneous report from a contactable physician (patient herself). A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. The patient medical history included that the patient has a severe allergy cold and humidity and therefore before getting the vaccine she took an Advil and loratadine. There were no concomitant medications. The first dose of BNT162B2 for COVID-19 immunization was given on 23Dec2020 (Lot: EL0140) at the age of 53 years old and reported sore arm (added that she cannot move it from the pain) for 24 hours. In regards to the first dose, she only had a severe sore arm and couldn't elevate the arm but this only lasted for 24 hours and then she didn't have any soreness. She received the second dose on 13Jan2021 and experienced mild fever, chills, anorexia, headache, and myalgia. Her supervisor asked her to test positive for covid however she is wondering if she could get a false positive since it is still within 72 hours after vaccination. Patient asked if after vaccination do they not check for antibodies to make sure the vaccine is working. The patient reporting on COVID and who stated she got her second dose on Wednesday (13Jan2021) and who stated she has some questions about side effects and getting tested after vaccination. It was explained that she has had fevers, chills, headache, and discomfort in her chest (Jan2021). She was told to get a test by her job but wondered if she will test positive since it has been less than 72 hours since getting the vaccine. She got the second shot around 7:50pm or 8pm. At midnight she woke up with chills, mild fever, and severe muscle pain. Then she woke up in the morning early with a headache, severe muscle pain, it was very hard to make it. She had severe anorexia, she was so hungry she ate a little and went back to bed. Then she only woke up for lunch and ate something. At that time her fever was gone. She went back to bed but at 8pm she woke up and still had muscle pain. She had a very difficult time yesterday. In the night she woke up with leg pain, muscle pain. The patient explained she felt better today so she went to work and spoke to her supervisor who told her it was better to take a test for COVID. It was mentioned she looked pale and it was better for her to have a test just in case. The patient reported that she knows a bit about vaccines and the proteins and RNA. Since it has been less than 72 hours since she had the second dose, would she test positive if she had a COVID test. No treatment after the doses. Patient states she has no had any testing done at this point. Therapeutic measures were taken as a result of event so hungry. The event fever recovered on an unspecified date in Jan2021. The outcome of the events chills, anorexia, headache, discomfort in her chest and myalgia/muscle pain, leg pain, looked pale, and was so hungry was unknown.
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| 53 | 2021-01-28 | respiratory tract congestion |
she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tigh...
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she was 235 pounds, but since getting COVID, she is now 224 pounds; sore arm; feeling her chest tighten, and congestion; back was hurting; she had lost her taste and smell; she had lost her taste and smell; feeling her chest tighten, and congestion; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; allergy symptoms; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer (patient) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on left arm for COVID-19 immunization as COVID-19 prevention. Medical history included ongoing asthma diagnosed more than three years ago. The patient's concomitant medications were not reported. She had no other vaccines on the same day as her COVID vaccine. The patient had the first dose of the Pfizer COVID vaccine on 29Dec2020, and since then she has contracted COVID, and tested positive for it on 07Jan2021 with symptoms. She asked if she still can get the second shot on the 21st day following her first dose. When she got the vaccine, she was fine, just had a sore arm. A couple days before 07Jan2021, she developed allergy symptoms, and so on the 7th (07Jan2021), she went to get tested, and it was positive. She was 235 pounds, but since getting COVID on Jan2021, she is now 224 pounds. She reported that she started to have allergy like symptoms on maybe 05Jan2021, and on the 7th she went to get tested for COVID, because she had started feeling her chest tighten, and congestion, and her back was hurting, and she has a history of asthma, so she wanted to be seen. She confirmed that on 07Jan2021, she had a Rapid test for COVID, and the results came back the same day, as Positive. She was told that she should also have a 48-hour test, so she had that performed as well, and that one also came back positive, but she knew it would, because by then she had lost her taste and smell. The patient is scheduled for her 2nd dose 19Jan2021. She was wanting to know if she can still get the 2nd dose. She was told she needed to wait 30 days from her positive diagnosis before she could get the 2nd dose. She added that she will still be in isolation when her 2nd dose is due. Outcome of the events was unknown.
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| 53 | 2021-01-31 | discomfort, headache, head discomfort, fever |
tested positive later in the day; tested positive later in the day; exposed to someone with covid vi...
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tested positive later in the day; tested positive later in the day; exposed to someone with covid virus; headaches in the back of head and ears; heaviness, it seems like pressure; Fever/101.6; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration, administered to the left deltoid, on 14Jan2021 between 2:30-2:45pm (14:30-14:45) at single dose for COVID-19 immunisation. It was offered at her worksite. The patient's medical history included ongoing Baker's cyst right knee. The patient had no family history. Concomitant medication included celecoxib (CELEBREX) from May2020 for Baker's cyst. The patient had no additional vaccines administered on the same date of the BNT162B2. The patient previously took flu shot and she got sick (in the 1980's or 1990's). The patient had no prior vaccinations that were within 4 weeks prior to the first administration date of BNT162B2. The patient, a Senior facility HCP, took a covid test on Monday and was negative. Yesterday (14Jan2021), she received the first dose and then tested positive later in the day. She wanted to know if she can get the next dose at the appropriate time or if she has to wait 90 days. On 14Jan2021, the patient experienced headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus. It was reported that the patient was debating on getting the Pfizer BioNTech Covid vaccine and so she finally decided to get it yesterday (14Jan2021). Two hours after getting it and getting home, her head started to hurt and fever, which she thought that was typical. That night the fever broke and it started again this morning (15Jan2021). She works at a senior facility and had to ask for an extended medical leave. She was tested yesterday for Covid that morning and had the vaccine in the afternoon. She was exposed to someone with the virus. She knows there are 2 shots and now she has had the one. She wanted to know if it's safe to get the second one since someone said she may need to wait 90 days since being exposed. She still has the headaches in the back of head and ears, heaviness, it seems like pressure. The fever has been under 100, it's been about 99 and the highest it got was yesterday at 101.6 degrees. By the time she went to bed last night it got down to 98.2 degrees. She has alternated Advil and Tylenol. She took temperature at 6am today (15Jan2021) and it was 99.8 and so she took a couple of Advil to help and by 7am it was down to 99.2. So, it's staying in the 99.2-99.3 range. The patient did not receive any other vaccines the same day or 4 weeks prior. The patient mentioned when getting the her very first flu shot, which she was hesitant about getting, she did get sick, but it wasn't immediately after. Since then she has been fine. She thinks this was in the 1980's or 1990's. She mentioned that this is a new vaccine and there is not a lot of information out there. She wanted to know if she will get immunity right away. She mentioned she was tested on Monday for Covid and told if she didn't get a call she was fine and she didn't hear anything. Then was told yesterday she was exposed to someone with Covid and so she had testing again yesterday. She is awaiting results (pending clarification). No further details provided. She was diagnosed around Memorial Day last year for right knee baker's cyst and given celecoxib. She went through physical therapy and has full range of motion, but cyst still there and tender. She may see a rheumatologist. She just finished her 30 days of celecoxib and didn't see any difference. It was reported that the events did not require a visit to emergency room nor physician office. The outcome of the event " tested positive later in the day" was unknown while the outcome of the events headaches in the back of head and ears, heaviness, it seems like pressure, fever, and exposed to someone with covid virus was not recovered.; Sender's Comments: The reported tested positive on the same day that the patient received first dose of COVID 19 vaccine, BNT162B2, is considered unlikely related to the suspect. Of note, the patient exposed to someone with the virus.
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| 53 | 2021-02-01 | fatigue |
after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like ...
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after vaccine experienced very sore arm couldn't hold anything, body aches and joint pain felt like I had a fever but did not, extreme fatique
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| 53 | 2021-02-02 | throat swelling |
Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spont...
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Chest tightness; wheezing; wheezing; throat swelling; tongue tingling; lip numbness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration in the left arm on 18Jan2021 17:15 at a single dose for COVID-19 immunization. Medical history included hypertension (HTN) and asthma, both from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of PFIZER BIONTECH COVID 19 VACCINE on 28Dec2020 at 01:15 PM (lot number: EL1284) in the left arm for COVID-19 immunization given when the patient was 53 years old. The patient did not receive any other vaccine in four weeks prior to covid vaccine. She had known allergies which were not specified. She was not pregnant. The patient experienced chest tightness, wheezing, throat swelling, tongue tingling and lip numbness, all on 18Jan2021 at 05:45 PM with outcome of recovering. The events resulted to Emergency room/department or urgent care. Treatment received for all events included DECADRON and Benadryl script for Epipen. The patient had no covid prior vaccination. She was tested for covid post vaccination through nasal swab on 20Jan2021 with pending result.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of chest tightness, wheezing, throat swelling, tongue tingling and lip numbness due to temporal relationship. However, the chest tightness, wheezing may possibly be associated with the patient's history of asthma. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray and pulmonary function tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 53 | 2021-02-04 | chills, sweating, headache, weakness, dizziness |
She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrena...
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She thinks she had a delayed anaphylactic shock she was definitely in shock; hypothermic; her adrenal glands are over compensating, working over load; she was having diarrhea; throwing up; she went from cold to profusely sweating back to having chills; she went from cold to profusely sweating back to having chills; she had no blood to her extremities; severe abdominal cramps; headache; her body is just weak; she was feeling dizzy; Her legs were cramping; her heart was racing fast; her lactic acid was really high; This is a spontaneous report from a contactable Nurse. A 53-years-old female patient receive the first dose of bnt162b2 (BNT162B2; Lot # EL3249) vaccine , via an unspecified route of administration in the right deltoid on 13Jan2021 15:55 at single dose for Covid-19 immunisation . Medical history included hypertonic bladder from an unknown date., drug hypersensitivity from an unknown date , migraine from an unknown date. She had migraines. Concomitant medication included solifenacin succinate (VESICARE), buspirone hydrochloride (BUSPAR), spironolactone (SPIRONOLACTONE). The patient previously took flu vaccine VII, bactrim and experienced drug hypersensitivity. The patient stated she thinks she had a delayed anaphylactic shock she was definitely in shock on an unknown date with outcome of unknown , hypothermic on an unspecified date with outcome of unknown , her adrenal glands are over compensating, working over load on an unspecified date with outcome of unknown , she was having diarrhea on an unspecified date with outcome of not recovered , throwing up on an unspecified date with outcome of unknown , she went from cold to profusely sweating back to having chills on an unspecified date with outcome of unknown , she had no blood to her extremities on an unspecified date with outcome of unknown , severe abdominal cramps on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of not recovered , her lactic acid was really high on 18Jan2021 with outcome of unknown , her body is just weak on an unspecified date with outcome of not recovered , her heart was racing fast on 18Jan2021 with outcome of unknown , she was feeling dizzy on 22Jan2021 with outcome of unknown , her legs were cramping on 19Jan2021 with outcome of unknown. The patient was hospitalized because of the events from 16Jan2021 to 17Jan2021. The patient underwent lab tests and procedures which included blood lactic acid: high on unknown date, chest x-ray: unknown results on unknown date, computerised tomogram: unknown results on 18Jan2021 , electrocardiogram: unknown results on unknown date. The patient was given fluids, Toradol and Xanax to treat the events. Further information has been requested.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
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| 53 | 2021-02-08 | fatigue, malaise |
her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that fel...
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her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported. The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
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| 53 | 2021-02-21 | headache, chills |
About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hour...
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About 12 hours later I had a mild headache, body aches, chills that lasted another 18 hours. 36 hours after the shot I felt a lump under my left armpit and there was visible swelling about the length of my fist. The lump was sore and pain could be felt with touch and with squeezing my arms across my breasts. 4 days after the shot, the lump under my arm isn't very painful but there is still some swelling.
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| 53 | 2021-02-21 | dizziness, headache |
Patient reported, feeling "like I have to cough," dizziness, lightheadedness, headache. Patient eval...
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Patient reported, feeling "like I have to cough," dizziness, lightheadedness, headache. Patient evaluated by EMS staff. BP 167/95, P 116, O2 100%. Upon further questioning, patient reports h/o POTS syndrome, autonomic dysfunction, dual chamber pacemaker and low BPs on occasion. Re-evaluated by EMS done 15 minutes later, BP 170/95, P 100, O2 100% patient refused to go to ER. Patient monitored in clinic for an additional 30 minutes. Stated symptoms had resolved.
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| 53 | 2021-02-21 | influenza like illness, chills, fatigue, headache, malaise, fever |
Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with fl...
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Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contactable nurse(patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 02Feb2021 11:45 AM at a single dose for COVID-19 immunization. Medical history included Crohns disease which is in remission (No immunosuppressants in 5 years) and shellfish sensitivity. The patient received the first dose of BNT162B2 on 15Jan2021 for covid-19 immunization and experienced syncope. The patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Concomitant medication included duloxetine hydrochloride (CYMBALTA), trazodone, buspirone hydrochloride (BUSPAR), lisdexamfetamine mesilate (VYVANSE) methylfolate and Ma. The patient experienced syncope after injection in Feb2021. A few episodes in 18 hrs, the patient experienced headache, body aches, intermittent fevers with flushing/chills, nausea night of 2nd injection and next day in Feb2021. The patient experienced severe fatigue, joint pain, felt very ill, akin to the flu in Feb2021.No treatment received for the adverse events. The patient underwent lab test included body temperature: intermittent fevers in Feb2021.The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to the event syncope is possible based on available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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| 53 | 2021-02-21 | shortness of breath |
Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, sympto...
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Tachycardia, palpitations, SOB, anxiety before, during and after injection. She did go to ER, symptoms resolved quickly.
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| 53 | 2021-02-22 | malaise |
1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spot...
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1st vaccine: Patient reports hives 4-6 hrs later, took Benadryl, itching stopped within 24 hrs, spots remained (upper calf to her knee) 2nd vaccine: talked with her doctor who agreed it was a good idea to preload with Benadryl, she stated that she took several doses for 24 hours after vaccine and thought she was still in the clear. Wed 2/17 hives started at work, itching arms and legs, noticed hives/spots left elbow, several both hips, a few more on legs near previous spots from 1st dose, both fingers swollen and red with some bumps, felt "unwell" and achy "grumpy" for 24-48 hours- took Benadryl, could not take Benadryl 2/19/21 because she had to work, itching is better 2/19 and she feels okay, spots remain.
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| 53 | 2021-02-22 | fatigue, malaise |
2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and fre...
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2/19/21 – 6:30 pm start feeling fatigue. Right arm carpel tunnel started twitching randomly and frequently. This continued all evening and all the next day. 2/20/21 – Woke with fatigue, upper arm pain round injection site, muscle pain randomly over body, joint pain in previous arthritic sites. Continued all day randomly. General feeling of tiredness or unwell. Evening the pain worsed, muscles contracting around spine creating spinal pains and severe headaches. 2/21/21 – Woke feeling tired but better. 2/22/21 – In the evening started feeling pain in spine and muscles in middle to upper back and cervical region. Lymph nodes under jaws and side of neck are painful and inflamed. 2/23/21 – woke up feeling better.
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| 53 | 2021-02-22 | malaise, chills |
Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent ...
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Aside from the usual chills arm pain aches and general malaise for 5 days , I?ve had more frequent and looser stools and stomach cramping since the day of the vaccine .
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| 53 | 2021-02-22 | discomfort, dizziness, fatigue, head discomfort |
Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure w...
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Heart enzymes were elevated; Anaphylactic reaction; Blood pressure was 220/116/ her blood pressure was out of control; dizziness does not allow her to go to work; lingering dizziness; Get a tightening in her chest; Fatigue; Left side of temple toward the crown of head she has pressure on the left side of the body; Left side of temple toward the crown of head she has pressure on the left side of the body; lightheadedness; troponin kept increasing; Inflammation around heart; This is a spontaneous report from two contactable consumers or other non health professional (including patient self, a healthcare worker works with patients with lymphomas, a licensed massage/lymphatic therapist). This 53-years-old female received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expiry Date: 30Apr2021) at 0.3 ml single dose intramuscular injection in left arm on 22Jan2021 10:28 (also reported as 10:38) for Covid-19 vaccination. Medical history was none (also reported as no patient history). Concomitant drug was none (reported as no other products). Family Medical History Relevant to AE(s) was none. Historical vaccine included flu shot in Nov2020 for immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No other vaccines given the same day or 4 weeks prior. AE(s) following prior vaccinations was none. Patient never had a reaction to any vaccine or shot before. Patent experienced anaphylactic reaction on 22Jan2021, heart enzymes elevated on 22Jan2021, blood pressure was out of control on 22Jan2021, get a tightening in her chest on an unknown date, lingering dizziness on an unknown date, dizziness did not allow her to go to work on an unknown date, inflammation around heart on 22Jan2021, troponin kept increasing on 22Jan2021, fatigue on an unknown date, lightheadedness on an unknown date, left side of temple toward the crown of head she has pressure on the left side of the body on an unknown date. Seriousness for heart enzymes elevated and anaphylactic reaction was hospitalization from 22Jan2021 to 23Jan2021. The events anaphylactic reaction required a visit to Emergency Room, but not Physician Office. The event clinical course was as follows: patient received her 1st dose of the Pfizer vaccine she had an anaphylactic reaction. She was given 3-4 Epis on site (on 22Jan2021) before being transferred to the ER. In the ambulance, she was administered a 4th EpiPen (on 22Jan2021) before getting to the ER, and then admitted to the cardiac unit on 22Jan2021 for observation. Patient also reported Given 3-4 EpiPens on 22Jan2021 and EpiPen auto-injector was Lack of Effect. No Return Sample Received. When she first started having symptoms, her blood pressure was 128/73. When the symptoms got worse her blood pressure started increasing. Her blood pressure was 220/116, they had to admit her to the cardiac unit because her heart enzymes were elevated and her blood pressure was out of control. Her troponin kept increasing and had inflammation around her heart. Her symptoms of anaphylactic reaction went away that same day, 22Jan2021, at the vaccination from her anaphylactic reaction. Patient was discharged and released from the cardiac unit on that Saturday (23Jan2021 ) around 7:30pm. No one could tell her anything about this since she was still having lingering effects and was getting ready to locate a cardiologist and still has tightness in the chest. She mentioned the dizziness did not allow her to go to work. She experiences it on and off, not consistent but less severe than initially. She still had lingering dizziness and she had to drive for a majority of her day and that was concerning. She said that on the left side she will get a tightening in her chest. She said that no one knows what this means moving forward. Patient was concerned about the severity of the reaction and was still not back to normal. She had never had a reaction to any vaccine or shot before and has been in the military. She needed help, direction since she was still not at the full potential to work. She was still fatigued and has tightness of her chest and those are concerns for her. Patient mentioned a part of the symptoms she also had were lightheadedness and dizziness and that started after the vaccine and it's not as severe, but she still had it. On left side of her temple toward the crown of her head she had pressure on the left side of the body and that was the same side where she received the injection, on that left side. Outcome of anaphylactic reaction was resolved with sequel on 22Jan2021. Outcome of heart enzymes elevated was resolved on 23Jan2021. Outcome of blood pressure was out of control was resolved with sequel on 23Jan2021. Outcome of lingering dizziness was resolving. Outcome of left side of temple toward the crown of head she had pressure on the left side of the body, lightheadedness was not resolved. Outcome of tightness in the chest and fatigue was not resolved. Outcome of inflammation around heart and troponin kept increasing was resolved with sequel on an unknown date. Outcome of the other event was unknown.
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| 53 | 2021-02-22 | shortness of breath, headache |
Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler...
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Shortly after the vaccine I developed chest tightness and SOB causing me to use my Albuterol Inhaler. Later that evening I took my reg asthma meds. Sat morning still experiencing the SOB but a bad headache appeared and had some stomach aches as well. 1/9 I spoke with my Allergist who advised to take an additional Singulair and Xyzal meds on top of what I was originally taking already. 1/10 was advised to take and Allergra for the SOB along with my reg meds that evening and by the Tuesday of the next week I was finally able to get my back Asthma balanced out.
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| 53 | 2021-02-23 | influenza like illness, weakness | having flue symptoms, no energy began on 2/14/2021 consistant |
| 53 | 2021-02-24 | chills, thirst, headache, fever, somnolence |
Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, ch...
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Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.
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| 53 | 2021-02-25 | headache, fever |
Fever of 101; body aches like the flu; headache; like the flu; This is a spontaneous report from a c...
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Fever of 101; body aches like the flu; headache; like the flu; This is a spontaneous report from a contactable health care professional, the patient. A 53-years-old female non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK 9231), via an unspecified route of administration in the right arm on 25Jan2021 at 14:30 (at the age of 53-years-old) as a single dose, for COVID-19 vaccination. Facility where the most COVID-19 vaccine was administered was a Nursing Home/Senior Living Facility. Medical history included breast cancer on an unspecified date (Breast cancer survivor) and Covid-19 on an unspecified date (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication included escitalopram oxalate (LEXAPRO), tamoxifen (TAMOXIFEN). The patient had no known allergies. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. On 26Jan2021, The patient experienced fever of 101, body aches, like the flu, headache. The events were considered non serious. The patient underwent lab tests and procedures which included body temperature:101 fahrenheit (fever 101) on 26Jan2021. No treatment was given for the events. The clinical outcome of the events Fever of 101, body aches like the flu, headache was recovering.
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| 53 | 2021-02-25 | weakness, headache, fatigue |
Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; head...
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Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 53 | 2021-02-25 | headache, chills |
suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from a...
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suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP); Headache; Chills; Nausea; swollen lymph node; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1686), via an unspecified route of administration on the arm/deltoid, on 07Jan2021, at single dose, for covid-19 immunization. Medical history included suffering from an auto immune disorder - idiopathic thrombocytopenic purpura (ITP). The patient had questions about some side effects from the COVID vaccine. She stated she received the first dose on 07Jan2021. About a week after that or maybe 7 to 9 days after the first shot, she started having side effects and was given a handout of a different side effects and risk of the vaccine and; she had like 4 or 5 of the side effects on Jan2021 such as headache, chills, nausea and swollen lymph node. She started with the headache initially then the chills, and nausea, and then lymph node. Her lymph nodes were still swollen. She informed was due to get the "booster" vaccine this Thursday (28Jan2021) and she just wanted to call and see if she should still go and get the booster vaccine with the swollen lymph nodes. She added she did get a test for the COVID this past Thursday (21Jan2021), because of the symptoms, and it was negative. She had the test because she didn't know if it was the vaccine side effect because the side effect also fell in line with actual COVID symptoms. She wanted to make sure that she didn't have the virus. At the time of the report she had not recovered from the adverse events headache, chills, nausea and swollen lymph node and she did not receive any treatment for these. The outcome of the other remaining events was unknown.
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| 53 | 2021-02-28 | dizziness, headache |
First muscle soreness at site of injection, then severe redness at site, cherry electric red and pin...
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First muscle soreness at site of injection, then severe redness at site, cherry electric red and pink, severe muscle aches, severe joint aches, severe headache, diarreah, dizzyness, the extreme rapid heart rate of 205 BPM. SEVERE SVT, SUPREVENTRICULAR TACHYCARDIA lasting from 9 p.m. Friday evening through the a.m. until I was transported from Urgent Care via Paramedics to Emergency Hospital. I was given an IV of a Medicine to restart my heart twice. I felt like I was dying.
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| 53 | 2021-02-28 | dizziness |
Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer ...
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Nausea; Dizzy; left arm soreness; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: May2021), intramuscular on the left arm, on 08Jan2021 16:29, at single dose, for Prevention/COVID-19 immunization, at a public health department. There were no medical history and concomitant medications. The patient did not receive other vaccinations within 4 weeks. On 09Jan2021 at 08:00, the patient experienced left arm soreness. On 27Jan2021 at 07:00, the patient felt dizzy. Shortly after, at 07:15, the nausea started. The patient wanted to know if these could be side effects and would it still be okay to get the scheduled second dose on 29Jan2021. The patient also asked if she can get the second dose if she has a fever on the day she is supposed to get the second dose. The events did not require emergency room or physician's office visits. The patient was recovering from the events. The reporter assessed the events as non-serious.
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| 53 | 2021-03-02 | fever, fatigue |
Joint aches (hips); tiredness; fever 102; patient is taking anastrazole for breast cancer; patient i...
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Joint aches (hips); tiredness; fever 102; patient is taking anastrazole for breast cancer; patient is taking anastrazole for breast cancer; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient, who was also 53-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EL3247, via an unspecified route of administration on left leg on 29Jan2021 14:45 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer, stroke, migraines is situ melanoma, penicillin allergy, and COVID-19 prior vaccination. Concomitant medication included atorvastatin (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), anastrozole, and colecalciferol (VITAMIN D). On 30Jan2021 04:30, the patient experienced Joint aches (hips), tiredness, and fever 102 (unknown unit). The outcome of the events was recovering. No treatment given for the events. The patient has COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination.
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| 53 | 2021-03-08 | shortness of breath, throat irritation |
Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively wors...
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Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively worse, trouble clearing throat, had epi and IM benadryl and sent by EMS to hospital, SOB, wheezing, EC- epi, Decadron, admitted and then intubated and had epi infusion.
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| 53 | 2021-03-14 | nasal congestion, runny nose |
also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days...
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also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently); mild pain/soreness at the site of injection evening and following day post vaccination; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (at the age of 53-years-old) on 27Jan2021 11:30 at a single dose in left arm for COVID-19 immunization. Medical history type 2 diabetes. Concomitant medication included metformin (METFORMIN), colecalciferol (VITAMIN D), omega-3 fatty acids (OMEGA-3 FATTY ACIDS), multivitamins with minerals [umbrella term] (CENTRUM) and ''tumeric". The patient previously took azithromycin and experienced drug allergies. The patient experienced mild pain/soreness at the site of injection evening and following day post vaccination, on 27Jan2021 23:00, also developed a minor runny nose/occasional nasal congestion that has persisted for at least 3 days (this might also be due to extreme cold weather in my area currently) on 28Jan2021. No treatment received for the adverse events. The outcome of the events was recovered. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 53 | 2021-03-15 | fever, night sweats |
Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous...
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Severe night sweats; body aches; low grade temps continuing growth off and in; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231), via an unspecified route of administration (left deltoid) on 09Jan2021 at single dose, for COVID-19 immunization. Medical history included celiacs, hypertension (HTN), thyroid disease, gastrooesophageal reflux disease (GERD), migraines, allergies: celiacs (gluten), and allergies: culturelle. Concomitant medications included levothyroxine and prednisone which was stopped 4 days prior. The patient previously took dilaudid and experienced allergies and received first dose of bnt162b2 for COVID-19 immunization on 18Dec2020, 13:15, left arm (lot ELO140). On 11Jan2021, the patient experienced severe night sweats, body aches and low grade temps continuing growth off and in since second vaccine. Patient reported to have missed work. This has been going on for 3.5 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab: negative on 27Jan2021. Outcome of events was not recovered.
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| 53 | 2021-03-16 | fatigue, headache |
Immediate onset Rapid heartbeat, headache, nausea, extreme immediate fatigue onset Treatment: Atara...
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Immediate onset Rapid heartbeat, headache, nausea, extreme immediate fatigue onset Treatment: Atarax, benadryl, extra strength Tylenol, Hydrochloathiazide
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| 53 | 2021-03-17 | dizziness, discomfort, chills, fatigue |
Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chil...
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Hallucinating; I feel like my body is having a Allergic reaction; lot of pain all over my body; chills; funny taste; dizziness; itchy feelings; tired; discomfort; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202, expiry date not reported), via an unspecified route of administration administered in arm right on 26Feb2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and known allergies: arrhythmia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced hallucinating, lot of pain all over her body, chills, funny taste, discomfort, dizziness and feel like her body is having a allergic reaction and itchy feelings and tired on 27Feb2021 01:00. The patient did not recover from the events.
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| 53 | 2021-03-17 | headache |
neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM...
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neuropathy in left foot; HEADACHES/INTERMITTENT HEADACHES; NAUSEA; MUSCLE ACHES; BILATERAL LOWER ARM PAIN AND JOINTS/PAIN PROGRESSING TO CONSTANT SEVERE PAIN AND HAS MOVED INTO UPPER ARMS WITH PAIN WORSENING DAILY; BILATERAL LOWER ARM PAIN AND JOINTS; SWOLLEN LYMPH NODES IN ELBOWS; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284, expiration date: not reported) intramuscular in the arm left on 01Feb2021 08:00 at single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and lamotrigine (LAMICTAL). The patient previously took codeine and experienced allergic reaction to drug; naproxen and sulfur and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was at the hospital. On 02Feb2021 06:00, the patient experienced neuropathy in left foot, headaches/intermittent headaches, nausea, muscle aches, bilateral lower arm pain and joints, swollen lymph nodes in elbows, pain progressing to constant severe pain and has moved into upper arms with pain worsening daily. No treatment received for the adverse event. Outcome of the events was not recovered.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event neuropathy peripheral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 53 | 2021-03-21 | dizziness | c/o dizziness, chest pressure and palpitations after vaccine administration. |
| 53 | 2021-03-22 | shortness of breath |
FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREAT...
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FACE BEGAN TO TINGLE THEN TONGUE BEGAN TO SWELL. I WAS FINDING IT TO BE AN EFFORT TO TAKE IN A BREATHE. OVER THE NEXT 48 HOURS MY OTHER AREAS WHERE I HAD BEEN BITTEN BY FIRE ANTS AND A HORNET STING BEGAN TO SWELL AGAIN AND MORE BENADRYL AND PEPCID
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| 54 | 2020-12-31 | thirst, fever, fatigue | Fevers, muscle, joint aches, fatigue, "crawling skin"extreme thirst X6 days as of this form |
| 54 | 2020-12-31 | dizziness |
Hypotension noticed 24 hours post injection. Effect lasted for 48-72 hours while improving. Lowest...
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Hypotension noticed 24 hours post injection. Effect lasted for 48-72 hours while improving. Lowest BP 85/60, with symptoms: lightheaded at rest.
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| 54 | 2021-01-01 | fatigue | Body aches, fatigue, arm pain(first couple of days), diarrhea and nausea |
| 54 | 2021-01-01 | fatigue, weakness, chills, fever, dizziness, headache |
Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe head...
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Within 24 hours of receiving vaccine, I became very dizzy , had severe weakness, nausea, severe headache, muscle and joint pain, chills, fever (temperature-102.8),and exhaustion. Redness, pain, and swelling at injection site that has continued to worsen even after 48 hours. Could not perform regular activities of daily living. I could not drive home from work the day after the injection because the adverse reactions were getting more severe, especially after the 24 hour mark. Treatment: treated my symptoms at home with medications (I am a nurse), after researching possible adverse reactions. I figured there was not anything someone else would to treat me besides treat my symptoms.
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| 54 | 2021-01-02 | headache, dehydration, dizziness, fatigue |
5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31-...
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5pm 12-29-2020 slight headache, that lasted through Wednesday evening, 12-30-2020. Thursday, 12-31- 2020, no adverse reaction. Friday, 1-1-2021 , entire body, including internal organs were trembling. Saturday, 12-31-2020, extremley dizzy, unable to stand, function. Nauseated, extremely dehydrated, extreme exhaustion. This lasted 24 hours. Sunday, 1-3-2020, still exhausted, but not to extreme. All other symptoms have subsided.
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| 54 | 2021-01-03 | chills, fever, cough, malaise, weakness |
12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with lo...
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12/31/20 - cough, sneezing, weakness. Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95
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| 54 | 2021-01-03 | fever, headache, chills | Chills, low grade fever, severe body aches, head aches, (for 2 days) injection site hematoma |
| 54 | 2021-01-03 | shortness of breath |
Difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 54-year-old fema...
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Difficulty breathing; This is a spontaneous report from a contactable pharmacist. A 54-year-old female patient received her first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at 04:15 PM at single dose in left arm for COVID-19 immunisation at the age of 54-year-old. Lot number was ELO140. Medical history was unknown, concomitant medications were unspecified. Patient was not pregnant at the time of vaccination. On 22Dec2020 at 04:30 PM, the patient experienced difficulty in breathing, and she was hospitalized for one day. The patient was treated with EPI for the event. The patient was recovering from the event.; Sender's Comments: Based on the compatible temporal association, the Company considers the event difficulty in breathing is possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-03 | runny nose |
I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of ...
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I got Pfizer vaccine on 12/29. Had muscle soreness at site, Stomach cramp same day after 35 mins of shot. Mild lower back pain that evening (vaccine on left arm and pain on same side). On 12/30 soreness was only to palpation. Rhinorrhea all day long, took NyQuil, moderate back pain, took naproxen and did some back stretches. On 12/31 no sore arm but little tender. Increased back pain , used back brace , took naproxen not that much help though. used heat pack finally fall asleep around 3 am. on 01/01/2121 around 6 am woke up with excruciating left lower back pain, could not move, get off the bed. took a while to get off the bed. Have to drag my legs very slowly to walk. Went to ER. X-ray did not show anything. In ER took Narco 5 and Baclofen. MD thinks that it might not be side effects of vaccine. But I wonder, I never had left lower back pain before. Taking Baclofen and Advil TID since 0101/2021. 01/04 still in pain. increase pain after 6-7 hours after meds. Sitting or standing more than 30 mins Increases pain. Going to see PMD today
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| 54 | 2021-01-03 | body temperature increased, headache, malaise |
got localized pain for a few days on my left arm from injection site, I developed malaise, headache...
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got localized pain for a few days on my left arm from injection site, I developed malaise, headache, a fever 101.8 the day after the injection, fever subsided that night. Headache went away the 2nd day of vaccination.
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| 54 | 2021-01-04 | throat irritation |
About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, ...
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About 49 hours after receiving the Pfizer mRNA COVID-19 vaccine, patient developed chest tightness, itchy throat, upper and lower eyelid swelling, lip swelling, difficult swallowing. Selt-treated with prednisone 40mg, fexofenadine 1 tablet, famotidine 40mg, albuterol breathing treatment. Felt better, but then 6-8 hours later, felt chest tightness again that did not resolve with breathing treatment. Went to the Hospital Emergency Department. No epinephrine was administered. But received IV corticosteroids, diphenhydramine and famotidine, and was discharged with 6 days of oral corticosteroids
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| 54 | 2021-01-04 | headache, chills, skin warm, fever, fatigue |
Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided...
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Fever began on 24th around 10 with chills. Took Tylenol for low grade fever about 12:30 pm. Subsided for 6 hours and then 6:30 that evening it returned at 100.7. Again 6 hours later, fever was 100.4. Christmas day, still had fever around 100. Then again that afternoon. Lymph node swelling underneath the arm. The site of the injection I had a large knot. Very swollen, small bruise, hot, and red. No streaking or red lines. Lymph node underneath the arm was about the size of a ping pong. I did not want to go to the ER. I called the nurse line and was triaged over the phone. I was instructed to take BP and pulse and gave numbers over the phone. BP was a little elevated, but nothing to extreme. I pretty much stayed laying down. It sucked the life out of me. I used hot compress and cold compress on site of the injection. It was late Saturday evening when I decided to see a change in the size of the lymph node. By Sunday, the 27th, there was no fever. Not even on Saturday. By Sunday, the lymph node had subsided as well. I did get a headache, but it was like a nagging headache. My left shoulder in the muscle area towards the neck area, I had soreness.
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| 54 | 2021-01-04 | dizziness |
Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (p...
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Left arm pain - mild; Mild lightheadedness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EK9231, expiration date unknown), via an unspecified route of administration on the left arm on 28Dec2020 at 11:15 at a single dose for COVID-19 immunization administered at the hospital. Relevant medical history included hypertension (HTN), obesity, hypothyroid, allergies to penicillin (PCN), and was diagnosed (Dx) with an unknown virus in Feb2020. Concomitant medications included chlorthalidone (CHLORTHALIDONE), levothyroxine sodium (SYNTHROID), olmesartan medoxomil (BENICAR), atenolol, and minoxidil (PANT). The patient previously took levofloxacin (LEVAQUIN), gatifloxacin (TEQUIN), and morphine and experienced allergies from all these medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced left arm pain - mild and mild lightheadedness. The reporter assessed the events as non-serious. The patient did not receive any treatment for the events. The outcome of both the events was unknown.
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| 54 | 2021-01-04 | productive cough, malaise, fatigue, lethargy |
Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sp...
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Since 4pm Tuesday 29th, extremely lethargic, sleeping heavily and wet productive cough with clear sputum. No fever, has had body aches, lethargy, malaise, fatigue, bloodshot eyes and diarrhea, loss of appetite.
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| 54 | 2021-01-04 | headache, dizziness |
Started to feel dizzy about 9 hours after the injection. Went to bed. Woke up 8 hours later with a...
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Started to feel dizzy about 9 hours after the injection. Went to bed. Woke up 8 hours later with an extreme headache 9/10 and nausea. Took 325 Tylenol and brought the pain down to a 7/10. Slept for a couple of hours and woke up with a headache at a 7/10 - took 650 mg Tyleno, drank some Focus Aid and ate some veggie straws. After about 1/2 hour the headache was down to a 4/10,
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| 54 | 2021-01-04 | dizziness, headache |
Started to feel dizzy about9 hours after the vaccine. Went to bed. Woke up at 6:20 AM with nausea ...
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Started to feel dizzy about9 hours after the vaccine. Went to bed. Woke up at 6:20 AM with nausea and a tremendous headache - 8 out of 10. Took 325 mg Tylenol and helped a little - 7 out of 10. Slept a couple of hours and the headache was still 7 out of 10. Took 650 mg Tylenol, ate some veggie straws, and drank some Focus Aid. After about 1/2 hour the headache was a 4/10. 2 hours later and headache remains, currently 5/10.
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| 54 | 2021-01-04 | headache |
Within 72 hrs. of receiving the first dose of her Pfizer vaccine she developed sharp headache unlike...
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Within 72 hrs. of receiving the first dose of her Pfizer vaccine she developed sharp headache unlike any headaches that she has had in the past, located bilateral frontal and on top of her head. Not associated with photophobia, phonophobia, nausea, vomiting, or vision changes, but can be severe enough that she has to sit down
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| 54 | 2021-01-04 | dizziness, fever, weakness, fatigue, chills, headache |
chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fa...
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chills fever muscles pain joint pain headache arm pain difficulty of breathing weakness dizziness fatigue tiredness
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| 54 | 2021-01-04 | fever, lethargy, headache, fatigue, chills |
chills; chills and fever/ 99.2 degrees Fahrenheit; body aches; tired and lethargic/ feels very fatig...
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chills; chills and fever/ 99.2 degrees Fahrenheit; body aches; tired and lethargic/ feels very fatigue; tired and lethargic; severe headache; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 28Dec2020 09:15 at single dose on left deltoid for COVID-19 immunization in hospital. Medical history included allergies; COVID-19 and received her positive result on 22Oct2020, the reporter didn't know if that was pertinent, she was out of work for 15 days. Concomitant medication included lisinopril, clarithromycin (CLARITIN) for allergies, mometasone furoate (FLONASE) for allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her flu vaccine was in Oct2020. The patient received the vaccine on 28Dec2020 and was having side effects. No shortness of breath, but she did have some side effects. She felt fine most of the day. In the afternoon around 2PM (28Dec2020 14:00), she developed a severe headache and took 600mg ibuprofen and it didn't touch it. She took another 600mg of ibuprofen in the evening. She felt tired and lethargic on 28Dec2020 20:00 so she went to bed. This morning (29Dec2020) she had body aches and feels very fatigue. She still has a headache. She has chills and fever on 29Dec2020 08:00. Her temperature was 99.2 degrees Fahrenheit about 2 hours before (29Dec2020). The severe Headache was compared to last night it was better, but she still had slight headache. About tired and lethargic, driving to work she wanted to go to sleep. she was at work at her desk and she was not as tired as before. The lot number was on the card she was given. She was not sure if it was ELO140 or EL0140. No emergency room or physician office was required for any adverse event. The outcome of headache, tired and lethargic was recovering, of chills and fever was not recovered, of body aches was unknown. For events severe headache, tired and lethargic, chills and fever, the seriousness was reported as non-serious, the relatedness was related with COVID vaccine.
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| 54 | 2021-01-04 | fever, chills | fever ,chill and achiness |
| 54 | 2021-01-04 | headache, chills, malaise, fever |
she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/Sh...
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she could not stop shaking; Resting heart rate went to 130; Chills; Headache; Running Temperature/She just took it now and it is 100.4 degrees Fahrenheit; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer reporting for herself. A 54-y ears-old female patient received bnt162b2 (BNT162B2) vaccine, intramuscular in the right arm on 23Dec2020 07:00 at single dose for covid-19 immunisation . Medical history included covid-19 from Jul2020 to an unknown date. There were no concomitant medications. The patient experienced chills on 24Dec2020 with outcome of recovering , nausea on 23Dec2020 23:00 with outcome of recovering , headache on 24Dec2020 with outcome of recovering , running temperature at 100.4 degrees Fahrenheit on 24Dec2020 with outcome of not recovered , feeling unwell on 23Dec2020 with outcome of not recovered , resting heart rate went to 130 on 24Dec2020 with outcome of recovering , she could not stop shaking on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 99.8 Fahrenheit; 99.2 Fahrenheit, 100.4 Fahrenheit, heart rate: 130 (66-72. Normally) , sars-cov-2 test: negative on 21Dec2020 , sars-cov-2 test: negative on 24Dec2020 . Information on the lot/batch number has been requested.
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| 54 | 2021-01-05 | fatigue, respiratory tract congestion, runny nose | CONGESTION, RUNNY NOSE, VATIGUE, ACHY MUSCLES |
| 54 | 2021-01-05 | headache | I had off and on body aches and a pretty severe headache for three days but no fever but nausea. |
| 54 | 2021-01-05 | shortness of breath | LEFT SIDED CHEST PAIN, SHORTNESS OF BREATH, FELT WARM AND FLUSHED |
| 54 | 2021-01-05 | head discomfort, dizziness, headache |
One week after the vaccine I was find until....I got out of my car after driving and started stagger...
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One week after the vaccine I was find until....I got out of my car after driving and started staggering and could not function. Severe dizziness, heavy headedness , nausea and vomiting and a horrible headache. My husband had to physically muscle me back to my car. He wanted to take me to the ER and I would not let him because of the waiting room is full of COVID positive patients. I threw up along the way home and multiple times to the point I had drive heaves. I am a Registered Nurse and felt the symptoms I were experiencing were Vertigo. I had one bout with Vertigo in 2015 and it was extreme. I had Meclizine on hand and and took one tablet and slept. The severity of this was so bad I could not walk unassisted or sit up without falling over. After 6 hours of sleeping I got up, dizziness continued, and vision a little off. I still do not feel 100% I have had a headache since. It never dawned on me this could be from the vaccine I had taken a week before.
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| 54 | 2021-01-05 | headache |
PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THA...
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PATIENT RECEIVED VACCINE ON DEC 18TH. ON DEC 30, PATIENT BEGAN EXPERIENCING HAND AND JOINT PAIN THAT SPREAD TO ENTIRE UPPER BODY. SHOOTING PAINS UP HER NECK AND DOWN HER ARMS. DEVELOPED ITCHY RASH ALL OVER UPPER BODY AS WELL AS HEADACHE AND SWOLLEN LYMPH NODES. CRP WAS 3.6 AND SED RATE 25. COVID TEST WAS NEGATIVE. PATIENT PUT ON MEDROL DOSE PACK AND SYMPTOMS RESOLVED IN 5 DAYS
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| 54 | 2021-01-05 | body temperature increased, headache | Temp 101.9, body aches, headache for 36 hours |
| 54 | 2021-01-05 | shortness of breath, dizziness |
c/o lightheadedness, sob for short period. resolved. stated, "feeling weird, maybe I'm anxious." Vit...
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c/o lightheadedness, sob for short period. resolved. stated, "feeling weird, maybe I'm anxious." Vitals stable, Given Juice PO. 145/89, 74, 20, 100% O2sat. D/C'd after 30 minutes in stable condition 117/67, 65, 20, 100% O2 sat..
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| 54 | 2021-01-05 | headache |
patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joi...
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patient received vaccine on dec 18th. on dec 30th patient started experiencing extreme hand and joint pain and had to take analgesics. Pain radiated through her upper body and at times was shooting. she was unable to perform ADLs. She then developed an itchy rash all over her upper body as well as a headache and swollen lymph nodes. Covid test was negative, CRP was 3.6 and sed rate was 25. all other labsl WNL, symptoms resolved after 5 days
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| 54 | 2021-01-05 | sweating, respiratory tract congestion, fever, cough, fatigue, night sweats, runny nose, weakness |
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); ...
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positive COVID-19 test with symptoms; positive COVID-19 test with symptoms, tested for COVID (PCR); night sweats; Soreness at injection site; slight temp 99.5 degrees/her temperature was 101 degrees Fahrenheit/it was 102.5 degrees Fahrenheit/99 degrees Fahrenheit and then 98 degrees Fahrenheit; Tiredness she related to giving blood; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via intramuscular on 19Dec2020 15:45 on left deltoid at a single dose for prevention as frontline health worker at hospital (COVID-19 immunisation). The patient donated blood on 18th and no antibodies were present then. The patient was a former smoker and quit 2 or 3 years ago. Patient diagnosed Osteoporosis in 2015, benign heart arrhythmia in 2005. The patient took 70 mg alendronate sodium (FOSAMAX) once weekly and just a regular OTC daily multivitamin. Caller reported she was having the covid vaccine on 19Dec2020 and began having fever, night sweats, loss of taste and smell and then tested positive for covid. The patient received the Pfizer COVID 19 vaccine through work on 19Dec2020. She received it at 3:45 pm and should have taken temperature before, but she was afebrile the day before because she donated blood. At 7pm, she had slight temp 99.5 degrees Fahrenheit and by 10:30, her temperature was 101 degrees Fahrenheit and she still felt fine. She was surprised that it was that. She woke up at 2:30 am on 20Dec2020 and took her temperature and it was 102.5 degrees Fahrenheit. She took 2 Tylenol and went back to bed and felt fine. By morning it was 99 degrees Fahrenheit and then 98 degrees Fahrenheit a little later. She has been afebrile since then. She was a little tired because she gave blood and though it was related. She does not know if it was a side effect or not. It was not significant tiredness and was just not having energy in the evening of 19Dec2020. She also had soreness at injection site that night after 22:00 and the next day. It did not bother her until she woke up in the middle of night, and she noticed her left arm was sore. She received the vaccine at 3:45pm and started with low grade fever at 6:30 pm, earlier stated at 7:00 pm. There was no prescriber. She tested for COVID (PCR) on Saturday, 26Dec2020 at 14:50and it came back positive 28Dec2020 18:45. At 10pm on 19Dec2020, her temperature was 101 degrees Fahrenheit. If she had not been monitoring her temperature, she would not have known. She has been Afebrile since morning of 20Dec2020. Tiredness she related to giving blood and the holidays. She was a little stressed about the holidays and running around. It was very mild. Soreness at injection site was during the night after 10pm when she went to bed. On Wednesday, 23Dec2020, she woke up congested, sniffly, sneezy, with a runny nose. This persisted through Wednesday night. Her sense of taste was off. She had no problem with that on Tuesday. She had some horrible smell at work she recalled, so she knew her sense of smell was fine. On Thursday, 24Dec2020, she had no sense of taste or smell. She could not smell a pine candle. She was congested on Thursday and called employee health on 24Dec2020. This both improved and persisted. She is still congested but it has improved. She has never had a complete loss of sense of taste or smell before. Mild cough started yesterday morning. On the night of 20Dec2020, and 21Dec2020, she developed night sweats. She had not had any night sweats before this since menopause and she woke up really wet. The patient was not hospitalized and not admitted to an Intensive Care Unit. NO ER or physician's office required. She did not know if she was exposed on the day of the vaccine or if a couple of days later if the fever is from the vaccine. She stated what are the chances she goes 10 months and is super careful and then gets the vaccine and test positive. The patient did not display clinical signs at rest indicative of sever systemic illness. The patient did not require supplemental oxygen nor receive mechanical ventilation. No Multiorgan failure. The patient did not receive any additional therapies for COVID- 19. No initiation of new medication or other treatment or procedure. Not any preexisting diseases worsen during the SARS-CoV2 infection. She would like to know if there is a chance of false positive for this. It would just be her luck to be 10 months and not getting it. She has not gone anywhere without her N95 and then gets the vaccine and gets COVD. She wears mask and face shield at work always. She also wanted to know if she should get the second dose. The outcome of the event slight temperature was recovered on 20Dec2020 and the other event was recovering.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.
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| 54 | 2021-01-06 | cough, headache, chills, fever | Fever, chills, headache, dry cough, left calf pain, tremor in left thumb |
| 54 | 2021-01-06 | headache, runny nose, fatigue |
Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th ar...
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Headache, Myalgia, Diarrhea, NauseaVomiting, injection site soreness initially, then on the 30th arm was very sore, runny nose, shoulder/neck aches, severe N/V/D, severe fatigue Narrative: Did not need to seek medical care. Stayed at home.
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| 54 | 2021-01-06 | fatigue, fever | Low Grade fever temp 100.0, Body aches and joint aches, fatigue, |
| 54 | 2021-01-06 | dizziness | NauseaVomiting dizziness |
| 54 | 2021-01-06 | fever, fatigue | Patient reported feeling, tired achy fatigued and a fever of 100 degrees |
| 54 | 2021-01-06 | dizziness |
Pt stated she felt dizzy and lightheaded. She laid down and VS were taken. BP 120/85, HR 67. Pt reco...
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Pt stated she felt dizzy and lightheaded. She laid down and VS were taken. BP 120/85, HR 67. Pt recovered and left.
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| 54 | 2021-01-06 | nasal congestion | Significant nasal congestion for several days. No nasal discharge. |
| 54 | 2021-01-06 | shortness of breath, cough |
Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took ...
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Subject received vaccine at 0845 in 1/6. Felt chest tightness, cough wheezing 15-20 min later. Took personal albuterol inhaler and waited in car 50 minutes Reported to employee health office Sent to ED for SOB, wheezy, tingling in tongue per MD note. (arrived 0958) Nebulizer administered. Chext X-ray negative for acute disease. ED MD states: Asthma exacerbation Left 1143
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| 54 | 2021-01-06 | shortness of breath |
Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia. Presented to ED. CXR/EKG normal, l...
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Sxs 90 minutes post vax. SOB, palpatations, nausea, tachycardia. Presented to ED. CXR/EKG normal, labs normal, given Zofran inj.
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| 54 | 2021-01-06 | dizziness |
her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her le...
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her face started to go numb/felt like a dental block you would get with Lidocaine; She got on her left side, a cold spike feeling up her shoulder and neck and up to her face; upper esophageal sphincter got tight and felt funny like she was going to throw up; her whole body was shaking- her head, hands, and legs; feeling giddy; blood pressure was up; being stressed; was going to throw up/transient nausea; felt a little funny; This is a spontaneous report from a contactable Nurse(patient). A 54-year-old female patient received BNT162B2 (lot number EL0140), via an unspecified route of administration at left deltoid on 30Dec2020 14:28 at the 54 years old at 0.3 mL single for where she works she was exposed to patients who need rehab that were exposed and getting COVID. The patient medical history included Primary Essential Tremors and ongoing (had these for about 10-11 years. Her mother and grandmother also had them. Normally they were very fine, small tremors that people didn't notice. She can hold and turn her head and hide it) and Sulfa drug allergy (would get shortness of breath). The concomitant product was none. The patient previously took flu vaccine and experienced preservative made neck twitch and joint sores. Yesterday the patient got the COVID Vaccine and had a pretty significant adverse event. She was calling to report it and to see if she should get the second dose of the vaccine. The patient was also a licensed speech pathologist. She received the vaccine yesterday at 2:28 PM. She was allergic to Sulfa drugs and would get shortness of breath, so they wanted her to wait 30 minutes for monitoring. She was feeling giddy on 30Dec2020, but she ran into a friend that she had not seen before quarantine, so they were talking. It was exciting. After her 30 minutes she went to her car and felt a little funny. She thought she was hungry so she ate half a banana and had some water. She had an appointment to get to so she started to drive off, and by the time she got to the interstate she was feeling funny. She got on her left side, a cold spike feeling up her shoulder and neck and up to her face on 30Dec2020. This was like the precursor. Then on 30Dec2020 her face started to go numb. It felt like a dental block you would get with Lidocaine. It went from her temple area, below her eye all the way to her lips. It was midline on the left side. She was breathing fine. She was trying to figure out if she should pull over or call(Number), but her airway did not close up. Her upper esophageal sphincter got tight and felt funny like she was going to throw up. She drove to the hospital close to her house which is affiliated with where she got the vaccine. She normally had primary tremors, small to where people do not notice. But her whole body was shaking- her head, hands, and legs on 30Dec2020. She looked like a bobble head. But she could still breath. They took her right in and they did an EKG to make sure it was not her heart. Her blood pressure was up on 30Dec2020, she assumes for being stressed. They monitored her. They gave her Pepcid and Benadryl. She did not want any nausea medications. She stayed for about 2 hours and slept some from the Benadryl. Her face slowly became less numb. The numbness went away started from her lips and outward to her check and temple area. Then it just felt funny. When she touched it, which she never lost sensation, it was like, whose face is this? It was strange. She is not numb anymore. It took a while for it to go away, and it still felt weird. When she woke up this morning it was completely gone. She had recovered completely from all of these things. The only thing she has now was some transient nausea. It was very mild. It comes and goes. It had improved. She had not taken anything for it. The events Feeling funny, her face started to go numb, upper esophageal sphincter got tight, a cold spike feeling up her shoulder and neck and up to her face, Her whole body was shaking- her head, hands, and legs, were all assessed as Medically significant. The outcome of the event Nausea was recovering, the events Felt giddy, blood pressure was up, Stress was recovered on 31Dec2020, the other events were recovered on 30Dec2020. The reporter considered there was a reasonable possibility that the events Feeling funny, a cold spike feeling up her shoulder and neck and up to her face, Face started to go numb from her temple area, below her eye all the way to her lips, upper esophageal sphincter got tight , whole body was shaking- her head, hands, and legs, Nausea, were related to the product BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-07 | dizziness |
About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. ...
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About 25 minutes after receiving the shot patient became dizzy, jittery and had some palpitations. She was in the parking garage and called 911. She was taken to ED and treated with IV fluids. Her potassium was low and was replaced. Felt better after fluids and was discharged
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| 54 | 2021-01-07 | fatigue |
At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fati...
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At night I felt fatigue and palpitations and could not sleep. Next morning the palpitations and fatigue went away but I start with a rash and very itchy and noticed my face swelling up. I took some prednisone I had home and Benadryl and went to the ER. They monitored me and medicated me and told me to keep with the Benadryl. On the 24th I started with the rash and on the 26th no more rash. My second dose is scheduled on the 13th and I will see my PCP on the 12th to decide if I should have the second dose. I am not allergic to anything and thought I would die on 12/24. I was swelling up in less than a minute after I woke up it was awful. I also have a consultation with an allergist on Tuesday before the vaccine.
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| 54 | 2021-01-07 | fever, headache, chills, fatigue |
Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous repo...
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Chills; fever; fatigue/tiredness; headache; body aches; diarrhea; nausea; This is a spontaneous report from a contactable pharmacist (patient). A 54-year-old female patient received her first dose of BNT162B2 Lot # EJ1685, via an unspecified route of administration at Arm Left on 30Dec2020 11:00 at single dose for COVID -19 immunization. Medical history included Hypothyroid. She was not pregnant. There were no known allergies. Concomitant medication in two weeks included levothyroxine, mometasone furoate (FLONASE), ibuprofen, iron, biotin, and unspecified "B". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Started 03Jan2021 10:00 AM, the patient experienced chills, fever, fatigue, tiredness, headache, body aches, nausea, diarrhea resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment was received for all events. The patient did not have Covid prior vaccination and Covid was not tested post vaccination.The outcome of all the events was not resolved. The pharmacist considered all the events as non-serious.
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| 54 | 2021-01-07 | fatigue | Extreme fatigue, swollen lymph node near collarbone, nausea on day two post second vaccination |
| 54 | 2021-01-07 | chills, headache, fatigue, dizziness | Fatigue ,chills,headache, nausea,lightheaded |
| 54 | 2021-01-07 | fatigue, headache | Fatigue, headache, nausea, and body aches |
| 54 | 2021-01-07 | fatigue |
Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ p...
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Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ pain in her arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Right Upper Arm on 03Jan2021 (around 9:15 to 9:30AM) at single dose for COVID-19 immunization. Medical history included ongoing lupus (diagnosed about 2-1/2 years before 04Jan2021) and fatigue with lupus. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient said later in the evening of 03Jan2021, she got pain in her arm she got the COVID-19 Vaccine. She received her first check-in call after receiving the COVID-19 Vaccine, and at that time she had no pain in her arm. She clarified the pain in her arm at the injection site started in the evening of 03Jan2021. On 04Jan2021 she had fatigue. She stated she got fatigue sometimes with her lupus. No treatment received for the adverse events. No emergency room or physician office involved. The patient reported she saw her rheumatologist and had blood work done. The outcome of pain in arm at the injection site was recovering, of fatigue was not recovered. The information on the batch number has been requested.
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| 54 | 2021-01-07 | headache, fever |
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-1...
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Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-19-20. Symptom onset several hours later, needed to miss work on Monday 12-21-20 on account of symptoms. No immediate medical intervention required. Self-managed with tylenol.
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| 54 | 2021-01-07 | headache | Headache, nausea |
| 54 | 2021-01-07 | fever, malaise, fatigue, chills |
Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a sponta...
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Injection site pain; Tiredness; Muscle pain; Chills; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable nurse, the patient. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EJ1685, Expiration 31Mar2021) solution for injection in the left arm on 02Jan2021 (at the age of 54-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 03Jan2021 at 02:00, the patient experienced injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell. Treatment was provided for the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell included ibuprofen. The outcome of the events injection site pain, tiredness, muscle pain, chills, fever, nausea and a feeling of unwell was unknown. There was no physician office/ emergency room visit.
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| 54 | 2021-01-07 | fever, throat pain |
ON 1/1/21, DEVELOPED SORE THROAT LASTING 2 DAYS. LOW GRADE FEVER (99.3 ON 12/31 AND 1/1. MUSCLES ACH...
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ON 1/1/21, DEVELOPED SORE THROAT LASTING 2 DAYS. LOW GRADE FEVER (99.3 ON 12/31 AND 1/1. MUSCLES ACHES 1/1/21-1/3/21.
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| 54 | 2021-01-07 | fatigue, headache | Patient developed fatigue, headache, and body aches after receiving vaccine. |
| 54 | 2021-01-07 | cough, throat irritation |
Patient reported red injection site, itchy throat and cough while being monitored. Patient was taken...
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Patient reported red injection site, itchy throat and cough while being monitored. Patient was taken to emergency department for evaluation.
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| 54 | 2021-01-07 | headache, chills |
Severe bilateral headache and chills with nausea and unlike any headache I have ever had. Treaty wit...
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Severe bilateral headache and chills with nausea and unlike any headache I have ever had. Treaty with Goody headache powder, 2 vicodin and 16 hours of sleep. Outcome, it went away though I missed a day of work.
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| 54 | 2021-01-07 | throat swelling |
Shortly after receiving the vaccine, the patient felt like her throat was swollen and her heart was ...
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Shortly after receiving the vaccine, the patient felt like her throat was swollen and her heart was racing. Her blood pressure was taken in the observation area, and it was elevated. She was monitored in the observation area, and then she was escorted to the Emergency Department for continued observation. Reaction resolved with no treatment while she was in the Emergency Department and she was discharged. She was instructed to follow up with her allergist.
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| 54 | 2021-01-07 | malaise, fever |
Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling;...
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Starting to get really achy; Temperature is 101.7/ fever; Not feeling well; Injection site swelling; Injection site pain; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at a single for COVID-19 immunization. Medical history were reported as none. The patient's concomitant medications were not reported. On 31Dec2020, the night patient's arm didn't get sore till the night and it started swell at the injection site. Patient knew that the site pain was to be expected. On an unknown date, as the day progressed, patient started to get really achy and had a temperature of 101.7 when checked, she was just not feeling well. Outcome of the events was unknown Information on batch number has been requested.
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| 54 | 2021-01-07 | influenza like illness, headache, runny nose, fever, nasal congestion |
Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approxi...
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Symptoms - ? EE reports she received her vaccine during work yesterday and then worked until approximately 8:00 PM. EE reports arm soreness and pain at injection site. EE reports she woke up around 04:00 with flu like symptoms, body aches (reporting so bad she is barely able to get out of bed), fever (Tmax 101.4). + runny nose, congestion and headache. EE reports + exposure to pt with only wearing surgical mask approx. 3 weeks, and was contacted by EH and was considered low-risk and not scheduled for testing. Last day of work and shift - ? yesterday left work at approx. 8:00 PM Home remedies? - Tylenol at 0700, 600 mg ibuprofen at 11:30 Any improvement? - none Recommendation? After completely algorithm, EE meets criteria to be COVID tested and removed from work at this time. EE provided with EH command center and instructions to notify them need for COVID-19 testing. EE educated to notify his manager. EE verbalized back understanding and denied further questions at this time.
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| 54 | 2021-01-07 | fever, headache, cough |
Symptoms started 1/5/2021 around 6:00pm lasted about 36 hours. headache mild fever fatigue Lt calf p...
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Symptoms started 1/5/2021 around 6:00pm lasted about 36 hours. headache mild fever fatigue Lt calf pain tremors on Lt thumb - until today still with mild tremors episodes of dry cough
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| 54 | 2021-01-07 | headache | body chills aches and headace |
| 54 | 2021-01-07 | chills, fever, headache, fatigue, shortness of breath, dizziness, weakness |
chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; diz...
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chills; fever; headache; muscles pain; joint pain; difficulty of breathing; arm pain; tiredness; dizziness; weakness; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient (not pregnant at the time of report) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EL 3246) on 04Jan2021 12:00, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number PFR EK 5730) on 18Dec2020 11:00, both intramuscularly on left arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Hospital. Medical history included migraine, known allergies: kiwi. Concomitant medications were not reported. The patient experienced chills, fever, headache, muscles pain, joint pain, difficulty of breathing, arm pain, tiredness, dizziness and weakness, all on 04Jan2021 19:00. Treatment received for all events included Ibuprofen, Alive. The outcome of all events were not resolved.
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| 54 | 2021-01-07 | dizziness, chills, weakness, fever, fatigue, headache, cold sweat |
dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; c...
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dizziness; severe weakness; fevers of 102.8; muscle and body aches; muscle and body aches; chills; cold-clammy skin; headache; exhaustion; nausea; Redness and swelling at injection site that is still getting more severe after 48 hours; Redness and swelling at injection site that is still getting more severe after 48 hours; This is a spontaneous report from a contactable nurse reporting for self. A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899, intramuscularly from 30Dec2020 13:00 (age at vaccination: 54 years old) at single dose in left arm (dose 1) for COVID-19 immunization. There was no other vaccine administered in the 4 weeks prior to COVID vaccination. The patient was not pregnant. Medical history included hypertension, arthritis, degenerative disc, CRPS/RSD, thyroid cancer, thyroidectomy during 2007, and Crohn's disease. Known allergiesincluded insect stings and environmental allergies. The patient had COVID prior to vaccination. Concomitant medication included thyroid (THYROID); ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN); hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ); meloxicam (MOBIC); vitamin D; alpha lipoic acid (ALPHA LIPOIC ACID); duloxetine hydrochloride (CYMBALTA); and pantoprazole sodium sesquihydrate (PROTONIX). Within 24 hours of receiving COVID vaccine, the patient experienced dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, and nausea, from 31Dec2020 at 08:00. These continued to worsen over the next 24 hours. Redness and swelling at injection site that was still getting more severe after 48 hours. The patient was unable to drive home from work the day after injection due to adverse reactions getting worse throughout the day. The patient self-treated at home with medications (not further specified). The outcome of the events dizziness, severe weakness, fevers of 102.8, muscle and body aches, chills, cold-clammy skin, headache, exhaustion, nausea, and redness and swelling at injection site were not recovered. The events were reported as non-serious. The patient was not COVID-tested post-vaccination.
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| 54 | 2021-01-07 | headache, fever, malaise | fever, body aches, Heache, does not feel well, nausea |
| 54 | 2021-01-07 | fatigue, runny nose |
first day of vaccine, developed a runny nose (Wednesday, Jan 6) second day, felt fatigued third day,...
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first day of vaccine, developed a runny nose (Wednesday, Jan 6) second day, felt fatigued third day, felt lungs were burning and chest heaviness, tachycardia ~ 90's (today) went to an urgent care at work place tonight, lungs clear
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| 54 | 2021-01-07 | fever, malaise, fatigue |
throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contract...
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throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contracted COVID-19; thought she had contracted COVID-19; tired; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration on left arm on 17Dec2020 at 19:15, at a single dose for vaccination. Medical history included ongoing ulcerative colitis, onset date was unknown, but when she was about 25 years of age. Concomitant medication included ongoing azathioprine for ulcerative colitis, started probably 5-10 years ago and taken daily since. In the past, she took different products for ulcerative colitis off and on when she had an episode. This patient reported she was administered her first Pfizer COVID-19 Vaccine injection on 17Dec2020 and was just kind of tired on 17Dec2020; but she had onset of serious reactions to the COVID-19 Vaccine starting 18Dec2020 for 2 days straight and then as suddenly as the events started they suddenly stopped after 2 days with no lasting effects. She called to ask if there is any data about if the second dose of the COVID-19 Vaccine will be just like the first shot or if the events are just hit or miss; she is really hoping not to be that sick again with the second dose. Serious reactions to the COVID-19 Vaccine further described as sick for like 2 days straight. Afternoon of 18Dec2020 she was throwing up; had fever; body aches; thought she had contracted COVID-19 in between injection and onset of symptoms; she had no lung issues; her whole body hurt; she could not stop throwing up; her whole intestines hurt; it was horrible; she could not hold anything down for like 2 straight days and then just left on 20Dec2020. Scheduled date for second dose was on 06Jan2021, she has no plan to change dose schedule. The outcome of the event of tired recovered in Dec2020, while other events recovered on 20Dec2020.
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| 54 | 2021-01-08 | dizziness |
"Lightheaded", "woozy", "stressed that may play a role" @ 1524 BP 168/100 HR 68 SPO2 97% RA, @1527 B...
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"Lightheaded", "woozy", "stressed that may play a role" @ 1524 BP 168/100 HR 68 SPO2 97% RA, @1527 BP 161/87, @1532 BP 158/84, @1538 BP 151/97 Narrative: Report provided to this RN by staff, monitor post Covid vaccination: @1524 (Post 15 min monitoring after receiving vaccination) Employee reported to staff, monitor, a mild feeling of being lightheaded or "woozy" and stated " have been a bit stressed regarding news and uncertain if that is playing a role, vitals were taken. Employee agreed to stay for another 15 mins, @1538 last BP taken and Employee stated she felt better. Symptoms resolved and employee was able to go.
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| 54 | 2021-01-08 | headache, fatigue, migraine, fever, chills |
12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning ...
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12/31--slight headache that morning, by that evening migraine level headache 01/01/21-early morning fever 101.9, severe chills, severe aches of lower back, hips, joints, loss of appetite these symptoms continued thru 01/02/21 01/03/21 fevere abated, still body aches but much less severe, fatigue 01/04/21 fatigue only slowly resolving
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| 54 | 2021-01-08 | fever, chills | Chills, fever, body aches |
| 54 | 2021-01-08 | fever, fatigue, headache |
Dose 1 - headache mild 12 hours Dose 2 - foggy brain, sore eyes within 6 hours, severe headache, tem...
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Dose 1 - headache mild 12 hours Dose 2 - foggy brain, sore eyes within 6 hours, severe headache, temp 101.2, myalgias within 10 hours lasting for 18 hours and fatigue lasting 48 hours
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| 54 | 2021-01-08 | headache, fatigue | Headache, Sedation, fatige |
| 54 | 2021-01-08 | chills, fever, cough, shortness of breath, fatigue, headache | Myalgia, Fever, fatigue, Chills, HA, Sinus congestion, Difficulty breathing, Dry cough improving |
| 54 | 2021-01-09 | headache, fever |
Day. 6: fever, headache , intense body aches more on the right side. Vomited once but tensioned na...
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Day. 6: fever, headache , intense body aches more on the right side. Vomited once but tensioned nauseous. Day 7: symptoms worsened . I had a fever throughout the night but fever broke my morning Day 8 post vaccine, feeling much better, no fever. I recognize these symptoms aren?t life threatening and I could have been exposed to covid after the vaccine, I don?t know. I?m just trying to help get the data out there for the pharmaceutical companies and the public to have
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| 54 | 2021-01-09 | dizziness, fever, fatigue |
I woke up the next morning with fever, fatigue, aches and feeling faint. I didn't take my temperatur...
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I woke up the next morning with fever, fatigue, aches and feeling faint. I didn't take my temperature, I went back to bed after taking Advil until I woke up at 2pm, then took Tylenol. By 4 pm I felt much better. My injection site was much more sore than the first dose.
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| 54 | 2021-01-09 | chills, influenza like illness |
Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-l...
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Patient received 2nd dose of covid vaccine 1/9/2020 around 1100. Report having mild reaction (flu-like sx) with first dose. She began experiencing feeling like she was outside of her body about 10 min after receiving her booster. BP was taken and was slightly elevated 140s/90s. Ice packs were provided for hot flashes. Warm blankets provided for chills. BP was trending up to SBP 160s then started to decline to normal. Patient was accompanied to restroom by clinic staff and was able to walk without incident. Patient was observed in covid clinic for total of 2 hours and reassured that she was not likely to have worsening of sx at this point. Patient was walked to mother's car by clinic staff and left feeling better. 1/10 - patient presented to ED with low grade fever (100.4), chest pain, severe joint and muscle pain, nausea and "fog brain." She reports BP being 187/101 in ED. Given 1L of normal saline, zofran, toradol, and dilaudid. Observed until BP drcreased to SBP 140s. Nausea improved enough to allow her to eat. Labs were WNL, CK normal. Discharged home with diagnosis of "adverse effect of COVID-19 vaccine"
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| 54 | 2021-01-09 | headache |
Pfizer-BioNTech COVID-19 Vaccine EUA Beginning the day of vaccine, very sore upper left arm for 2 d...
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Pfizer-BioNTech COVID-19 Vaccine EUA Beginning the day of vaccine, very sore upper left arm for 2 days. Moderate headache beginning on day after vaccine, lasting for one day.
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| 54 | 2021-01-09 | headache, fatigue, chills | Pfizer-BioNTech COVID-19 Vaccine. Chills, headache, body aches, nausea, fatigue |
| 54 | 2021-01-10 | dizziness |
30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and...
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30 min after vaccine she became hot, flush, dizzy, heart pounding, hands face and feet were numb and tingly, she passed out at her desk and was taking to the ER for evaluation. Benadryl & Solumedrol Admin with hydration with NS. Pt discharged from ER. Pt in ~10am discharged from ER ~2hrs later.
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| 54 | 2021-01-10 | headache |
Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, pa...
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Apart from normal reactions like pain in injection site, headache, myalgias, on about fourth day, patient starts seeing a cloud-like blurry vision, intermittently, during the day.
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| 54 | 2021-01-10 | chills, fatigue |
Developed chills and rigors lasting approximately 15 minutes. Followed by fatigue also had arm pai...
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Developed chills and rigors lasting approximately 15 minutes. Followed by fatigue also had arm pain at injection site which subsided after episode of rigors.
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| 54 | 2021-01-10 | fever, headache, fatigue, chills |
Extreme Exhaustion-day of shot (01/06/2021 - 01/09/2021, Body aches - day after shot (01/07/2021),...
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Extreme Exhaustion-day of shot (01/06/2021 - 01/09/2021, Body aches - day after shot (01/07/2021), fever - day after shot (01/07/2021 - 01/08/2021, Chills - day after shot (01/07/2021), Headache - day after shot (01/07/2021-01/09/2021)
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| 54 | 2021-01-10 | headache |
Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours. Sat...
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Extreme headache and nausea. Headache started on 1/8/21 about 6pm and lasted a couple of hours. Saturday 1/9, just had tenderness to injection site until 1030pm when the headache returned. Hurt to move my head. Woke up on 1/10, extreme headache and nausea. Hurt to move head and was nauseated whenever I bent over.
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| 54 | 2021-01-10 | headache, fever | Fever and headache next day; sore arm next day; headache and sore arm lasted through 1/11/21 |
| 54 | 2021-01-10 | fever, throat pain, respiratory tract congestion |
ON 12/31/20 IN THE MORNING, DEVELOPED CONGESTION AND MILD SORE THROAT. ALSO, JOINT PAIN IN THE HANDS...
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ON 12/31/20 IN THE MORNING, DEVELOPED CONGESTION AND MILD SORE THROAT. ALSO, JOINT PAIN IN THE HANDS. LOW GRADE FEVER WITH ONSET ON 1/2/21 WHICH RESOLVED 1/3/21. STATES JOINT PAIN CONTINUES
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| 54 | 2021-01-10 | chills |
Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps ...
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Pain and swelling with numbness into left arm and into neck. Also body aches and chills with cramps in arms and legs. Feelings of restless, stomach upset. Knee charley horses.
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| 54 | 2021-01-10 | dizziness |
Patient complained of dizziness and feeling of something in her throat. She felt the need to clear h...
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Patient complained of dizziness and feeling of something in her throat. She felt the need to clear her throat.
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| 54 | 2021-01-10 | chills, body temperature increased | Rigors, hands and feet felt frozen Temp spikes up to 103.7 lasted 2 days |
| 54 | 2021-01-10 | dizziness, headache, fatigue, shortness of breath | Shortness of breath, Fatigue, muscle aches, chest pain, dizzy and light headed, headache |
| 54 | 2021-01-10 | shortness of breath |
Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe. 911 ...
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Staff member checked on her at 3am and patient stated that she felt like she couldn't breathe. 911 was called and taken to the hospital. While in the ambulance, patient coded. Patient was given CPR and "brought back". Once at the hospital, patient was placed on a ventilator and efforts were made to contact the guardian for end of life decisions. Two EEGs were given to determine that patient had no brain activity. Guardian, made the decision to end all life saving measures. Patient was taken off the ventilator on 1/9/2021 and passed away at 1:30am on 1/10/2021. The initial indication from the ICU doctor was the patient had a mucus plug that she couldn't clear.
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| 54 | 2021-01-11 | sweating |
9 min post injection pt felt her heart rate increase, was pale and diaphoretic. Vitals signs were t...
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9 min post injection pt felt her heart rate increase, was pale and diaphoretic. Vitals signs were taken with BP being 183/113, HR 103 and respirations 22. Pt was sat down, given cool water and apple juice. She reported having not eaten much for the day. Her symptoms began to subside within 10 min and she required no further intervention. She was observed for a total of about 1 hr post injection . Her BP was 136/ 98, HR 83 and respirations 17 when she left for home with her husband.
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| 54 | 2021-01-11 | fatigue |
Extreme fatigue; This is a spontaneous report from a non-contactable other healthcare professional. ...
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Extreme fatigue; This is a spontaneous report from a non-contactable other healthcare professional. A 54-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH19899, expiry date not reported), intramuscular on 04Jan2021 11:00 at a single dose on right arm for COVID-19 immunization. Medical history included Prior type 2 diabetic, high cholesterol, and an OTC allergy. Concomitant medication included semaglutide (OZEMPIC), sertraline (SERTRALINE), fish oil (OMEGA 3 ELITE), biotin (BIOTIN), ergocalciferol (VIT D), l-lysine [lysine] (L-LYSINE [LYSINE]), chromium (CHROMIUM). The patient previously took l-lysine [lysine] and experienced allergies. The patient experienced extreme fatigue on 05Jan2021 07:30. No treatment received for the adverse event. The outcome of the event was recovering. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The event was assessed as non-serious. No follow-up attempts are possible. No further information is expected.
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| 54 | 2021-01-11 | chills, fatigue, fever | Fever, body aches, extreme chills, nausea, fatigue. >16 hrs |
| 54 | 2021-01-11 | headache, chills |
HA resolved with Tylenol. Achy, chills and arm soreness resolved with Ibuprofen. All symptoms comple...
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HA resolved with Tylenol. Achy, chills and arm soreness resolved with Ibuprofen. All symptoms completed resolved.
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| 54 | 2021-01-11 | fever, chills |
I am running my temperature 100.1; Chills; Body is still painful; my body achy, my back hurts; every...
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I am running my temperature 100.1; Chills; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; This is a spontaneous report from a contactable consumer (patient) and a contactable other health professional. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. On Jan2021, the patient reported that: "I am running my temperature 100.1, chills in my body and my body is still painful. I don't have shortness of breath, but I am very painful. I took 2 TYLENOL. I woke with chills, I have my body achy, my back hurts. I am in pain, every joint hurt in me. I took my temperature and I realized it was 100.1". The patient outcome of fever and chills was unknown, the outcome of the other events was not recovered. Information on Lot/Batch has been requested.
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| 54 | 2021-01-11 | fever, headache, migraine |
I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that ...
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I had four visual migraines followed by a migraine headache and my PCP prescribed me some meds that helped. A little soreness at the injection site nothing extraordinary. I had the vax on a Monday and the last migraine I had was maybe on Friday the same week. I received the second dose yesterday and now I have a headache, low grade fever (99.9F about 8AM this morning) and body aches. Just treating myself at home. The headaches I have now are different, in a difference place in my head, they are lighter, it feels more like the headache you have when you have fhe flu.
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| 54 | 2021-01-11 | headache, chills |
I had soreness in my left arm for 2 days. Muscle aches for 1 day. I had a headache on 12-24-2020. I ...
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I had soreness in my left arm for 2 days. Muscle aches for 1 day. I had a headache on 12-24-2020. I also had chills on 12-25-2020 with muscle aches. The muscle aches got worse on 12-26-2020 and that's when I visited an urgent care center. At the ER they did a nasal swab test, covid test.
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| 54 | 2021-01-11 | fever, headache, chills |
Overnight early am 7th woke up to shaking chills fever >101, muscles, joints aches, headache, nause...
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Overnight early am 7th woke up to shaking chills fever >101, muscles, joints aches, headache, nausea sinus congestion Treated fevers for 3 days. Felt horrible missed 3 days wrk and call due to symptoms. Tested for COVID-19 was negative on01- 11-21 FLU test done also NEG..01-11-21
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| 54 | 2021-01-11 | headache, fatigue |
Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right...
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Severe splitting headache for 3 days Flushing for 2 days Burning feeling at the injection site right after injection for 2 days Moderate Pain at the injection site for 5 days Muscle weakness and aches, mild for 2 days Difficulty with concentration Feeling tired for a few weeks
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| 54 | 2021-01-11 | night sweats, malaise, headache, dizziness |
Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizzi...
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Stomach cramps, bowel cramps, malaise, bloating, loose stools, night sweats, nausea, headache, dizziness, joint pain
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| 54 | 2021-01-11 | fever, chills, headache |
Symptoms: severe (high fever (101.6F), body ache, headache, shivering, lymphadenopathy) Treatment:...
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Symptoms: severe (high fever (101.6F), body ache, headache, shivering, lymphadenopathy) Treatment: Tylenol 325mg (650mg Q4hrs) followed by Naproxen 250mg (Q12hrs), lots of fluids and rest Time Course: 2 days
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| 54 | 2021-01-11 | fatigue, headache, dizziness |
Within 12 hrs of first dose of Pfizer Covid vaccine, patient experienced tiredness. Within 36hrs pat...
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Within 12 hrs of first dose of Pfizer Covid vaccine, patient experienced tiredness. Within 36hrs patient experienced nausea, severe headache, and dizziness. Patient reports after these symptoms she had to stay in bed for the next day but by day 4 she was significantly improved and just tiredness occurred over the weekend. 6 days total.
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| 54 | 2021-01-11 | headache, chills, fever |
chills; fever, up to 100.9; muscle aches; headache; nausea; diarrhea; This is a spontaneous report f...
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chills; fever, up to 100.9; muscle aches; headache; nausea; diarrhea; This is a spontaneous report from a contactable other HCP (patient). This 54-year-old female reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were not reported) on 03Jan2021 11:00 (at the age of 54-years) as single dose, Intramuscular left arm for COVID-19 immunisation. Medical history included no allergies to medications, food, or other products and asthma. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications include DOXYCYCLINE (DOXYCYCLINE), METRONIDAZOLE (METRONIDAZOLE), minerals nos, vitamins nos (ONE A DAY) and CALCIUM CARBONATE (CALTRATE). Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 03Jan2021 at 03:30 AM the patient experienced fever, up to 100.9, muscle aches, headache, nausea, diarrhea, chills. Events lasted about 24 hours. The patient did not received treatment as a result of the events. Lab data included body temperature up to 100.9 on 03Jan2021. The outcome of event chills was recovered, fever, up to 100.9 was recovered, muscle aches was recovered, headache was recovered, nausea was recovered and diarrhea was recovered all on Jan2021. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
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| 54 | 2021-01-11 | influenza like illness, weakness, fatigue |
crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; havi...
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crystals in her urine; muscle pain; joint pain; flu like symptoms/feeling like she has the flu; having no energy; feeling tired/Tiredness; kidney stone; pain in her back; did not feel good; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140) intramuscular on 31Dec2020 16:00 at a single dose on left arm for Covid-19 prophylaxis. Medical history included rheumatoid arthritis. There were no concomitant medications. The patient wanted to know if she could receive the second dose of the COVID-19 vaccine if she presented the following side effects with the first shot: feeling tired/tiredness on 02Jan2021; having no energy on 03Jan2021; muscle pain, joint pain, and flu like symptoms/feeling like she has the flu, on 04Jan2021. She went to work on Monday and has taken the last couple of days off because she did not feel good on Jan2021. She did have rheumatoid arthritis, but it was different and has not been like this. She went to the doctor on Monday after she got off of work and thought at first maybe she had a UTI; treated herself with AZO, but had a urinalysis that was negative on an unspecified date. She was told some of the pain in her back might have been a kidney stone on Jan2021 because they found crystals in her urine on 04Jan2021, but she did not know about that. She noticed having no energy on Sunday. She wanted to know if it was recommended that she get the second vaccine since she was having side effects. The events required a visit to physician office and did not require a visit to Emergency Room. Prior vaccinations within 4 weeks was noted as none. Family medical history relevant to the events (AE) was noted as none.The outcome of the events of feeling tired/tiredness was not recovered; of having no energy, muscle pain, joint pain, flu like symptoms/feeling like she has the flu was recovering; of the rest of events was unknown.
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| 54 | 2021-01-11 | fatigue |
developed muscle aches post vaccine. 48 hours post vaccine had to leave shift early and was unable ...
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developed muscle aches post vaccine. 48 hours post vaccine had to leave shift early and was unable to work shift 72 hours post vaccine due to aches and fatigue
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| 54 | 2021-01-11 | chills, fever, cough |
fever of 103.7; Cough; body aches; Joint pain; chills; This is a spontaneous report from a contactab...
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fever of 103.7; Cough; body aches; Joint pain; chills; This is a spontaneous report from a contactable Nurse reporting for herself. A 54-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose in left deltoid for COVID-19 immunisation at the age of 54-year-old. Lot number was EL1284. Medical history included Asthma since 1991 and ongoing, high blood pressure since 2020 (6 months before the report) and ongoing. Concomitant medications were unknown. On 07Jan2021, the patient experienced fever of 103.7 at 1:30PM, chills at 9:00AM, body aches at 11:00AM, Joint pain at 09:00AM, cough at 1:00PM; the events were considered medically significant. The patient was not treated for the events. On 13Nov2020, test showed she had COVID-19. On 07Jan2021, body temperature was 103.7 Fahrenheit. The patient did not recover from the events. The nurse considered the events were related to suspect vaccine.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 54 | 2021-01-11 | chills, headache, fatigue |
headache within 4 hours (not severe) arm pain (site of injection within 4 hours) lasted through 12/3...
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headache within 4 hours (not severe) arm pain (site of injection within 4 hours) lasted through 12/30 next morning - chills, muscle pains (sharp/fast) entire day 12/30 fatigue entire day 12/30 skin hurt (especially in shower, felt like water was burning my skin) entire day 12/30
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| 54 | 2021-01-11 | shortness of breath |
pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma an...
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pt had periorbital swelling within 20 minutes of vaccination to urticaria, no new sob, has asthma and had some mild sob day before vaccine
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| 54 | 2021-01-11 | headache, dizziness |
severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report fr...
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severe dizziness; nausea; vomiting; headache; Vertigo type symptoms; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELU140), via an unspecified route of administration on 21Dec2020 11:00 in right arm at single dose for COVID-19 immunization. Medical history included vertigo from 2015 to an unknown date. There were no concomitant medications. On 29Dec2020 19:00, one week after vaccination, the patient experienced severe dizziness, nausea, vomiting and headache that continues and seemed to be severe vertigo type symptoms. No treatment was given to the patient for the events. The facility where the most recent COVID-19 vaccine was administered was in a Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 54 | 2021-01-11 | headache, runny nose | woke up next morning body aches headache sneezing and running nose |
| 54 | 2021-01-12 | chills |
14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of ...
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14 hours after vaccination, woke up to slight body aches so went to take Tylenol and sudden wave of nausea hit and passed out falling on floor. Had slight stomach upset and significant chills. Took Tylenol and was recovered by 8 a.m.
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| 54 | 2021-01-12 | headache, chills |
Chills and headache. Took extra strength Tylenol for the headache shortly after going to bed (around...
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Chills and headache. Took extra strength Tylenol for the headache shortly after going to bed (around 10pm). Still felt a slight headache the next morning (5:30am) and took two more tablets. Felt fine after that. I felt kind of cold during the evening, but by the time I went to bed around 10pm, that was when the chills had hit full force. I could not get warm enough. I continued to increase the temperature of my electric blanket and was not comfortable until I was at a 6 out of 10. When I woke up the next morning the chills were gone. Also experienced soreness in the left arm.
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| 54 | 2021-01-12 | cough |
I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was ...
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I woke up the next morning with no voice, chest tightness and a mild cough, The 24th, my throat was worse, the chest tightness was worse and definately had a cough. I self isolated over christmas. My ribs were sore from the coughing. I was screened for FLU & COVID on the 28th before I could return to work. I was treated for bronchitis. I was given cough syrup and an antibiotic.
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| 54 | 2021-01-12 | dizziness, weakness, fatigue | NAUSEA AND VOMITING, WEAKNESS AND DIZZINESS, FATIGUE, SORE MUSCLES |
| 54 | 2021-01-12 | head discomfort, cold sweat, headache, chills |
Vaccine was given 1/12/21 at 10am, 3pm having chills and slight sore on L arm, 6pm chills continues...
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Vaccine was given 1/12/21 at 10am, 3pm having chills and slight sore on L arm, 6pm chills continues and head pressure ( took Tylenol ) 8pm body aches, stiffness back of my neck, soreness on L arm worsen. Next morning 1/13/21 L side arm, back and neck stiff, soreness and backaches, and also chills, hands are clammy and headache.
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| 54 | 2021-01-12 | throat swelling |
Woke up on the 24th with a puffiness in the face, patient looked at the back of her throat and noti...
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Woke up on the 24th with a puffiness in the face, patient looked at the back of her throat and noticed some swelling, pt was able to maintain the airway. Pt was able to stay monitor sx which resolved the next day.
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| 54 | 2021-01-12 | headache, fever, fatigue, chills |
headache; muscle pain; chills; fever; injection site redness and swelling; injection site redness an...
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headache; muscle pain; chills; fever; injection site redness and swelling; injection site redness and swelling; Injections site pain; tiredness; This is a spontaneous report from a contactable nurse (patient herself). A 54-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via intramuscular on 05Jan2021 10:30 in left arm at single dose for covid-19 immunization. Medical history included hypothyroidism, arthritis, hypertension, eczema. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was known allergies: daptomycin and cefdinir (OMNICEF). The most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included clonidine, levothyroxine sodium (SYNTHYROID), ibuprofen. The patient experienced injections site pain, tiredness, headache, muscle pain, chills, fever, injection site redness and swelling on 06Jan2021 11:00 with outcome of recovering. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the adverse event. Events were reported as non-serious.
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| 54 | 2021-01-13 | throat irritation, headache, throat pain, fatigue, cough |
1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this...
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1/13/20:05:30 awoke with rt arm tenderness/pain at site of injection - has continued to time of this document 1/14/21 08:00 07:30 increased dry cough, scratchy throat 08:30 sore throat 09:30 mild headache and muscle aches, sore throat, cough when talking 10:30 increasing muscle aches and headache, laryngitis, cough resolving, mild intestinal discomfort 11:00 left work 11:30 all symptoms at 10:30 continuing, increasing fatigue; took 1000mg acetominophen slept most of the time noon - 4 pm 4pm cough resolved, muscle aches continued, headache improved, laryngitis continued. mild fatigue 6:00 pm noted loss of smell (could not smell cooked garlic - my husband could) Laryngitis & muscle aches continued throughout evening 7:30 pm 2nd dose 1000mg acetaminophen 1/14/20 - 06:00 am laryngitis resolved Ongoing scratchy throat, mild muscle aches, mild nausea/intestinal discomfort. Laryngitis and cough mostly resolved - but i am not talking much; speech is an irritating factor for both symptoms. Fatigue improved. Headache mostly resolved. Took 1000 mg acetaminophen.
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| 54 | 2021-01-13 | headache, fever, fatigue |
48 hours of fever up to 102 degrees. Severe headache, fatigue and bodyaches. Nausea and severe arm...
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48 hours of fever up to 102 degrees. Severe headache, fatigue and bodyaches. Nausea and severe arm pain radiating to neck. Took tylenol and tramadol for 36 hours and then symptoms began to subside. By the third day post vaccine, all symptoms except for fatigue resolved.
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| 54 | 2021-01-13 | shortness of breath |
About 15-20 minutes after vaccination, the patient began to feel chest heaviness and chest tightness...
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About 15-20 minutes after vaccination, the patient began to feel chest heaviness and chest tightness. She then felt like she had postnasal drip and her throat began to feel like it was closing. She was short of breath until Epi pen was administered. She did not notice any swelling.
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| 54 | 2021-01-13 | dizziness |
Approximately 20 hours after the vaccine I woke up very confused. I was dizzy. I had a very poor s...
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Approximately 20 hours after the vaccine I woke up very confused. I was dizzy. I had a very poor sense of balance and could only walk by holding onto walls. This resolved after approximately 10 hours
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| 54 | 2021-01-13 | fever, malaise, headache, chills |
Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing,...
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Arm soreness; Huge headache; Low grade fever (99.5); Felt cold, couldn't get warm; chills; Stabbing, shooting pain in right parotid glands; General feeling of unwellness; This is a spontaneous report from a contactable nurse. A 54-years-old female patient started to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL0142, on 06Jan2021 (at the age of 54-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included chronic granulomatous disease. Concomitant medication were unspecified. The patient previously received the first dose of BNT162B2, Lot number: EK5730, on 17Dec2020, administration time: 08:00 AM, in the left arm for covid-19 immunization. The patient previously took Oxacillin and Levaquin and experienced allergies. The most recent COVID-19 vaccine was administered in the workplace clinic. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 07Jan2021 09:30, the patient experienced arm soreness, huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellnessThe events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events arm soreness, Huge headache, Low grade fever (99.5), Felt cold, couldn't get warm, chills, Stabbing, shooting pain in right parotid glands and General feeling of unwellness was recovered. Since the vaccination, the patient has not been tested for COVID-19.
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| 54 | 2021-01-13 | fatigue, chills | Chills , body aches, fatigue, swollen lymph nodes in right axilla, throat, and under right clavicle |
| 54 | 2021-01-13 | chills, headache | Chills 2 hours Headache 36hours Body aches 36 hours |
| 54 | 2021-01-13 | chills, fatigue, headache | Chills, Headache, Fatigue, Injection Site Soreness (Shot 2 Only) |
| 54 | 2021-01-13 | sweating, headache, chills |
Developed sweating and chills with headache around 3:00 am. Got up at my usual time 5:30 am to use t...
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Developed sweating and chills with headache around 3:00 am. Got up at my usual time 5:30 am to use the bathroom and get dressed but felt nauseous with headache. Went to wash my hands and then walked back to bedroom but had syncopal episode along the way lacerating my lower lip and injuring my knees. Still unable to extend knee due to injury with pain and swelling
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| 54 | 2021-01-13 | fever, chills, headache | Dever, chills, muscle and bone pain, headache |
| 54 | 2021-01-13 | fatigue, fever, headache, chills |
Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm ...
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Fever of 101 degrees, severe headache, fatigue and bodyaches. Chills and nausea. Severe right arm pain. Took tylenol and tramadol for pain and fever.
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| 54 | 2021-01-13 | headache, chills | Headache; Chills |
| 54 | 2021-01-13 | fatigue, headache, cough, chills, fever |
I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within...
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I just wanted to inform you of my reaction that I had with my Covid Vaccine #2: (all resolved within 24-48 hours ~ except the Right Axillary Lymph Node Swelling and Pain ~ This is still currently present, please let me know if you want me to let you know when this last symptom/reaction resolves?) Fatigue Sore Right Arm (injection) Chills Fever Headache Cough Right Axillary Lymph Node Swelling and Pain
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| 54 | 2021-01-13 | fever, chills | Rash and redness around injection site Arm soreness Chills Fever |
| 54 | 2021-01-13 | fatigue, fever, headache |
She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; s...
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She was wiped out the next day with aches and pains still.; tired; brain fog; started to get cold; shake/her hands were shaking so hard; they took her temperature and it was 100/her fever went to 101/temperature had gone to 102.6; heart rate was elevated at 100/heart rate was 110/heart rate went to the high 120s; headache; backache; nauseated; chest was hurting; The initial case was missing the following minimum criteria: Invalid for unspecified adverse event. Upon receipt of follow-up information on 08Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration in deltoid left on 29Dec2020 07:30 at single dose for COVID-19 immunisation. Medical history included ongoing sleep apnoea (diagnosed about 3-4 years ago, wear her CPAP religiously), Hashimoto's hypothyroid, and chronic low vitamin d (lack of sunlight). Concomitant medication included levothyroxine sodium (SYNTHROID) from 2016 and ongoing for Hashimoto's hypothyroid, ergocalciferol (VIT D) from 2018 for chronic low vitamin d; lack of sunlight (She did not take it religiously, but was supposed to take it everyday). At 10:30 AM (29Dec2020), she started to get cold and shake. She thought that this was insane and it was in her head. It became so severe she could not use her computer her hands were shaking so hard. She went back up to where they were giving vaccines, they took her temperature and it was 100. It had been normal the morning before she got the vaccine. Her heart rate was elevated at 100. They put a blanket on her and said they wanted to watch her for 15 minutes. In that time her fever went to 101 and her heart rate was 110. They took her to the ER. She was there for 5 hours. Her heart rate went to the high 120s. They did a 12 lead EKG. Her temperature had gone to 102.6, which was the highest. They gave her a liter of Normal Saline. She also had a headache, backache, and felt nauseated. The liter of fluid helped, no doubt. She was not admitted. She was wiped out the next day (30Dec2020) with aches and pains still. Their concern was they said they did not give her epinephrine because her heart was too high. She had no breathing issues. Just extreme cold. At one point she had woke up in the ER (29 or 30Dec2020) and her chest was hurting, she knows from her heart rate being too fast. She was so cold. She had on 6 blankets. The next day (30Dec2020) she still had the aches and pains, she was tired, and had brain fog. It all went away on 30Dec2020. She had nothing after that. What scared her was the heart rhythm. The ER doctor says its not great, but felt that getting the second dose was better than her having COVID. The Electrophysiologist she saw, said she was unsure if she should get the second dose. The hospital said that for this next dose, they would give her the injection, wait 15 minutes, then send her home, expecting that she would have the same thing happen. When after the first dose, she was in the ER on a 12 lead EKG with an intravenous (IV). She had no arm pain the whole time. The reporter assessed all events related. She felt fine prior, walking in to get the vaccine. But she was much better the next day and recovered completely. She was just worried about the second dose. The outcome of events was recovered on 30Dec2020.; Sender's Comments: Based on the compatible temporal association and the drug's known safety profile, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-13 | body temperature increased, dizziness |
Started getting dizzy on my way home from work around 6pm, when I got home I was feeling nauseous. W...
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Started getting dizzy on my way home from work around 6pm, when I got home I was feeling nauseous. Went to the bathroom and had diarrhea and then began to vomit. My temp spikes to 102.6. Had a restless night but by the next evening I was fine, no issues or fever.
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| 54 | 2021-01-13 | dizziness, headache, fatigue | TEMP LOSS SENSE OF TASTE BODY ACHES, MUSCLE CRAMPS, FATIGUE SEVERE HEADACHE DIZZINESS LIGHT HEADED |
| 54 | 2021-01-13 | headache, fever |
The first day I had a weird headache . Three days later I felt like I could go into chills and had l...
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The first day I had a weird headache . Three days later I felt like I could go into chills and had low grade fever of 99.6/99.7, feeling like I didn't feel right. I had terrible cramping in my abdomen and had diarrhea twice . My employer sent me to the ER to test for Covid, Flu, RSV. By the 22nd I was feeling fine about 5-6 days later.
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| 54 | 2021-01-13 | shortness of breath, dizziness | c/o dizziness, SOB, hives, "flushed" |
| 54 | 2021-01-13 | headache, malaise, fatigue |
sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling we...
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sore arm, headache,fuzzy head, neck pain, body aches, insomnia, tiredness, and just not feeling well
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| 54 | 2021-01-14 | fatigue |
12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet...
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12/3 flu shot; employer made me get the shot. I started with burning nerve pain, neuropathy, in feet to legs. I called office and put on prednisone for 3 days. Then another 7 days prescribed; 12/23rd 1st vaccine; The same day, I was having the tingling and pain came back after the shot. But I still had had from flu shot, it just came on stronger. It wasn't as bas as after the flu shot. Took another 10 days of prednisone. 1/13/2021 2nd vaccine; sore arm, little tired. But could be as I had to wake up early.
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| 54 | 2021-01-14 | shortness of breath, headache |
1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SV...
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1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SVT with first dose of some new medications. Pt reports intermittent SVT and PVCs post ablasion. HR 136, regular rhythm. 1828: 176/101 (119), HR 108, Resp 22, 99% on room air Pt reports feeling like her HR is returning back to normal, hand tremors continue. Reports mild shortness of breath, which is typical with her SVT episodes. 1831: 151/82 (98), HR 81, regular rhythm, Resp 12, 98% on room air. Denies any worsening or any additional symptoms. Hand tremor no longer present. 1839: 151/104 (113), HR 76, regular rhythm, Resp 10, 98% on room air. Pt reports headache and mild nausea that is typical with her SVT episodes. Pt appears relaxed sitting in chair. 1845: HR 78, regular rhythm. Pt remaining in monitoring area for 15 additional minutes. No s/s further distress. Pt calling husband to take her home. 1905: BP 157/91 (107), HR 87, regular rhythm, 98% on room air, Resp 14 Pt c/o numbness to L arm with some L chest tightness. Reports this sometimes happens with her SVT episodes. 1907: No further chest tightness or L arm numbness. Pt reports feeling anxious. Does not want to go to the ED for further monitoring. Continues to report that her symptoms feel typical after her SVT episodes with some additional nausea. 1910: 132/112 (117), HR 78, regular rhythm. Pt reports improvement of symptoms. Pt relaxed in chair. Instructed pt to stop and call 911 if she has any concerning symptoms after leaving clinic including difficulty breathing or HR abnormalities.
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| 54 | 2021-01-14 | headache, chills |
1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen,...
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1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen, headache and chills by afternoon mouth and right eye was drooping. Was prescribed RX prednisone on 1/15/2021. Current symptom (1/15/2021) is mouth drooping, other swelling and eye drooping resolved. Reports has occurred twice before. About 7 years ago with unknown etiology, lasted for about 6 months, Occurred again about 5 years ago with unknown etiology and lasted about one month.
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| 54 | 2021-01-14 | weakness, dizziness |
Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She ...
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Around 1330, approx 11 minutes after receiving her vaccine the EE was in the observation area. She felt a sudden weakness from head to toe and felt an impending sense of doom. She began to feel dizzy and panicked. EE moved to evaluation area at 1333. HR78 BP 174/96 O@ 97%RA. Pt was anxious and noted BP was high for her. FNP continued chatting to EE. EE declined the ED at this time. A&O x4. 1350 HR 75 BP 151/94 O@97%. EE reports feeling much beter. EE opted to wait in the observation area an additional 30 minutes, declining again to go to ED for further evaluation. EE will call if her condition changes.
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| 54 | 2021-01-14 | fever, headache | Fever 100.4, headache, nausea, body aches, right arm soreness |
| 54 | 2021-01-14 | fatigue, fever, headache |
Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea....
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Fever 101.5. Body aches, chills, severe headache and eye pain, foggy head and forgetfulness, nausea. This started 8 hours after injection and lasted for 24 hours. Extreme exhaustion followed the next 24 hours. Severely blood shot eyes developed during first 24 hours and remains still after 78 hours. Still having brain fog after 78 hours.
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| 54 | 2021-01-14 | fever, headache | Fever 101f Diarrhea Aches and pains Headache |
| 54 | 2021-01-14 | headache |
Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakn...
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Headache neck pain Dec 28 , 29, then extreme muscle weakness in right leg and right hand . The weakness in my right hand had become progressively worse since dec 30 or 31 st . Had the second shot on Jan 11 . In last 2 data I am having trouble holding a mug or iPhone in right hand . It feels very numb From Jan 12 to today my right hand is having trouble gripping pen , hair brush , difficult to open doors .
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| 54 | 2021-01-14 | malaise |
I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate...
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I waited for 30 minutes; I walked to my car and didn't feel well; I thought maybe I was hungry I ate 1/2 banana and drank some water. I started to drive home. It felt like a huge cold railroad spike was being driven up the top of my shoulder to my neck, it was a cold sensation anteriorly and posteriorly on my neck. Then my face (left side) started to go numb, it started just about the top of my left ear and went all the way to my lips. It stopped midline. It felt like a dental block. I could still swallow and breathe. I started shaking, felt nausea, my upper esophageal sphincter started to spasm. I kept checking my tongue and airway to see if I should pull over and call 911. I drove to the ER. My left side of face was numb, I was trembling, tremoring. They gave me small dose of IV Bendadryl (12.5 mg) and Pepcid, I slowly started to feel better and the feeling came back to my face moving from midline lip to cheek. It still felt "funny" but much better. I was in the ER for around 2 hours. I have had more tremoring since my vaccine in my neck and hand (I do have primary essential tremors but it is tremoring much more now) and more neck pain (could be due to the increased tremors)
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| 54 | 2021-01-14 | chills, somnolence, fever |
Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose...
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Left arm sore, instantly nauseous for 2 hours, metallic taste in mouth for 2 hours. Fasting glucose was 89 in the morning. by 1400 hours my glucose was 250. By bed time it was 300. I did not eat dinner and adjusted my insulin and took an extra 500mg metformin. I had chills and fever through the night and all the next day. Fever 99 to 101. Tylenol and showers used to control fever. I was very sleepy all that day. I was sleepy with the first shot also. I woke up on Jan. 6, 2021 with a hemorrhage in my right eye. I called the retinol specialist and was given a shot of Eylea in my right eye Jan. 7, 2021., He asked that I report this advers reaction.
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| 54 | 2021-01-14 | headache |
Lymphadenopathy under left clavicle 2 days post injection. Also had minor headache 1 day post vacci...
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Lymphadenopathy under left clavicle 2 days post injection. Also had minor headache 1 day post vaccination which resolved by day 2. No medical treatment needed at this time.
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| 54 | 2021-01-14 | chills, fatigue, headache |
Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, head...
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Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Nauseous with injection.; This is a spontaneous report from a contactable nurse (patient). A 54-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), intramuscular at left arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included migraine and No known allergies. Concomitant medication included sumatriptan succinate (IMITREX), fluoxetine hydrochloride (PROZAC). The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization at right arm on an unknown date. The patient experienced nauseous with injection on 08Jan2021. Next day (09Jan2021), she had sore arm, neck, body, headache, tired chills, afebrile. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information about lot and batch number was requested.
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| 54 | 2021-01-14 | fever, chills, somnolence |
Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hour...
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Pain in left arm. Joint pain, I immediately had nausea and a metallic taste in my mouth for 2 hours. Mysugar climbed to 250 by dinner time. By bed tme my sugar was 300. I did not eat dinner. I had no appectite. I increased my insulin and metformin dose. I had chills and fevery thru the night and the next day. High fever 101. I treated this with tylenol and showers. I was really sleepy all day. I had little to eat and still my sugar was 300 most of the day. on Jan 6. I woke up and had a hemmorrhage in my right eye. I called my retinol specialist and and received an injection of Eylea on Jan 7, 2021
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| 54 | 2021-01-14 | cold sweat |
Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccin...
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Patient's heart felt racing, started to get clammy and flushed 10 minutes after receiving the vaccine.
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| 54 | 2021-01-14 | chills |
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (oth...
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Increase in BP to 184/91; symptoms lasted 1 day
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| 54 | 2021-01-14 | headache |
Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as...
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Soreness at the injection site x2 days Headache x1day Right eye upper lid (spasms/weakness, feels as if my upper lid gets stuck, lasting only a few seconds, not painful and doesn't affect my vision). It occurs intermittently throughout the day and began approx. 2 hours after receiving the injection.
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| 54 | 2021-01-14 | chills, fever, fatigue |
convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints wer...
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convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation. Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.
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| 54 | 2021-01-15 | fatigue, fever, chills | Body aches Chills Fever Exhaustion |
| 54 | 2021-01-15 | dizziness | Dizziness and Palpitations within 15 minutes of vaccine administration |
| 54 | 2021-01-15 | headache, fever | Fever Body aches Headache Nausea |
| 54 | 2021-01-15 | fever, skin warm, headache |
Low grade fever, severe joint pain and headache 16 hours post injection. Headache for over 72 hours....
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Low grade fever, severe joint pain and headache 16 hours post injection. Headache for over 72 hours. Large swollen right supraclavicular lymph node noticed at 72 hours post injection. Painful and warm to touch approx size golf ball. Entire right clavicle swollen and painful.
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| 54 | 2021-01-15 | fatigue, fever |
No treatment from medical professional. I took Tylenol and drank water. I had the vaccine at 10 am....
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No treatment from medical professional. I took Tylenol and drank water. I had the vaccine at 10 am. I felt perfect as I did with the first vaccine until I woke at midnight with a high fever , diarrhea, severe fatigue and muscle aches. Hard for me to move or walk. Needed assistance from husband to get to the bathroom. The symptoms lasted until approximately 9 am. Then I felt tired but fine. Today I feel tired but no symptoms. Back to normal.
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| 54 | 2021-01-15 | fatigue | awoke with fatigue and arthralgia |
| 54 | 2021-01-16 | fever |
Sudden onset of extreme vertigo with associated near syncope (felt like vagal). No vomiting and no r...
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Sudden onset of extreme vertigo with associated near syncope (felt like vagal). No vomiting and no real nausea. Vertigo still present but now minimal. That same night I had a mild fever, but I am not concerned by this. Had some mild vertigo after the first vaccination (lot EH9899) but it only lasted 48 hrs.
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| 54 | 2021-01-17 | shortness of breath |
Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulati...
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Dose #1 ER5730 12/30/2020. From day 1 post injection 2 - repeat symptoms of extreme SOB on ambulation - worse than with #1. RR 36+ O2 sat stayed at 93 or above with ambulation. HR in supine position 70 w/in 10-15 seconds of ambulation greater than 105. On day 6 post injection, with bagging up a bag of garbage (bending over and picking things up with a spilt can) I had to sit down I was that SOB. HR 130 on pulse ox - O2 sat. 94-95. Day 7 post injection - ER work up for PE - negative, chf evaluation - negative. no pneumonia or cardiomegaly on CTA. CBC all w/in normal limits except on diff - lymph 0.5 above normal range only. CMP ok as well. BMP and trops normal. Day 9 diffuse itchy rash has developed, even worse now on day 10. Raised, blanching, papules - no pustules/vesicles noted. Trunk presentation spreading to extremities. leg signifiant more populated than arms. Rash now on tops and bottoms of feet. Minimal spots on dorsal hands and none on palms. Extremely itchy. + Celiac patient (Dx- genetically 7-8 years ago, symptoms for over 10) and + Hashimotos patient (29 years). No recent gluten exposure resulting in GI response. (I can get bowel incontinence with cross contamination. ) I'm taking Synthroid as prescribed. Since I'm in the CD8 peak days (9-11)- can this just be some type of autoimmune storm since it was a viral vaccine? No history of any problems with my yearly influenza vaccine.
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| 54 | 2021-01-17 | headache, weakness |
I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed...
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I woke up and had a horrible headache. I went to the bathroom to take a Maxalt then went back to bed. I woke up again at 6:30 with the same horrible headache not relieved at all by Maxalt so I took another dose. I had vertigo so I went back to bed. I woke up at 8:00 still with the horrible headache and vertigo but had horribe nausea. I never vomited. I felt weak all day, had no appetite and my neck felt very stiff all day. In the evening my knees were aching. The next day I continued to have a mild headache and neck stiffness.
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| 54 | 2021-01-19 | fever |
2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat any...
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2 days after infusion, severe arm pain and fever, body aches, and extreme nausea (unable to eat anything). Started on 1/6 in morning and gone by night of 1/6.
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| 54 | 2021-01-19 | fever |
Fever, 100.6 F TO 100.9 F; This is a spontaneous report from a contactable pharmacist reportin for h...
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Fever, 100.6 F TO 100.9 F; This is a spontaneous report from a contactable pharmacist reportin for herself. A 54-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL1283) vaccine , in the right arm on 08Jan2021 18:15 at single dose for covid-19 immunisation . Medical history included rhinitis allergic , seasonal allergy , drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (CETIRIZINE [CETIRIZINE HYDROCHLORIDE]), estrogens conjugated (PREMARIN). The patient previously took tramadol and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity. The patient received the first dose of BNT162b2 on 18Dec2020. The patient experienced fever, between 100.6 °F and 100.9 °F on 09Jan2021 10:30 with outcome of recovering.
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| 54 | 2021-01-19 | fever, chills | Fever, muscle aches, chills occurring approximately 17 hours after injection. |
| 54 | 2021-01-19 | headache, malaise | HEADACHE,FEELING SICK,PAIN ON SHOULDER,PAIN ALL OVER THE BODY AND TWO EPISODE OF VOMITING. |
| 54 | 2021-01-19 | headache, fatigue, fever | LOW GRADE FEVER, BODY ACHES, HEADACHE, RESTLESSNESS, TIREDNESS. TOOK TYLENOL EVERY 6 HRS AND REST. |
| 54 | 2021-01-19 | dizziness, lethargy |
On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and...
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On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and shoulders. Along with aching all over. Over the course of the day, I started to feel bad. Then on Monday January 18, 2021, in addition, to the joint pain, I started feeling disoriented, dizzy like spells of vertigo. I went to my PCP who did lab work and all was normal. He said it muse be delayed reaction to the vaccine. Later in the day, I was having difficulty putting words together and more dizzy and very lethargic. I laid down and slept until the next morning. (Tuesday 1/19/21) On Tuesday 1/19/21, they symptoms were improved but still had some dizziness. On Wednesday 1/20/21, the symptoms have improved except for an occasional dizzy spell.
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| 54 | 2021-01-19 | fever, chills, dizziness, shortness of breath, headache |
Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest ...
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Rash, SOB, Flushing, fever, severe Chills, HA, Dizziness, Tachycardia , Muscle pain/weakness, chest pain, palpitations--Treated with EpiPen onsite, Ambulance--Epi/O2/Monitoring---ER IV benadryl/ IV Solumedrol/ IV dexamethasone--Sent home 5 hrs later with oral benadryl and predinsone
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| 54 | 2021-01-19 | chills, shortness of breath |
Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of b...
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Recipient reported waking with chest tightness, chills, heart racing, pulse- 124-126, shortness of breath chocking sensation and dry throat. Worried about her breathing, she went to the emergency department, blood pressure taken- 183/103. She was given IV fluids and recommended follow up with PCP.
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| 54 | 2021-01-19 | fever | Swelling to armpit on side of injection, low grade fever persisting |
| 54 | 2021-01-19 | cough, headache | body ache, headache, cough. called in sick to work. |
| 54 | 2021-01-19 | sweating, headache, chills, fatigue |
emesis; sweats; horrible headache; Extremely tired; chills; This is a spontaneous report from a cont...
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emesis; sweats; horrible headache; Extremely tired; chills; This is a spontaneous report from a contactable other health professional. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL0142) via an unspecified route of administration at left arm on 10Jan2021 at a single dose (dose number: 2) for COVID-19 immunization. Medical history included allergies to cefaclor (CECLOR), azithromycin (ZITHROMAX Z-PACK, reported as z pack), pinapple, coconut. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included warfarin sodium (JANTOVEN), sertiline, metformin (reported as metforman, to be clarified). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) intramuscularly at left arm on 20Dec2020 at 09:30 AM at a single dose (dose number: 1) for COVID-19 immunization and reported events included emesis within 40 minutes, upset stomach for 3 hours approx, sweating and headache, lasting about 4 hours. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient was not pregnant at the time of vaccination. After the 2nd shot, it was reported emesis within 40 minutes and lasting all day, extremely tired, horrible headache, sweats and chills. This lasted 36 hours. Start date of adverse event was reported as 10Jan2021 at 10:30 AM. No treatment received for the adverse events. The outcome of events was resolved in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 54 | 2021-01-19 | dizziness, fever, fatigue |
fever; aches; feeling faint; fatigue; This is a spontaneous report from a contactable Nurse (Patient...
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fever; aches; feeling faint; fatigue; This is a spontaneous report from a contactable Nurse (Patient). This 54-year-old female patient (No pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Left arm on 08Jan2021 15:00 at single dose (Lot EK9231) for covid-19 immunisation. No other vaccine in four weeks. Medical history included allergies: Sulfa, Augmentin. Concomitant medications included ciclosporin (RESTASIS, eye drops), mometasone furoate (FLONASE), boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN), ipratropium and xylometazoline hydrochloride (NASAL SPRAY II). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on Left arm on 17Dec2020 04:30 PM (Lot: VK5730) for covid-19 immunisation. The patient woke up 09Jan2021 at 7:00 am with fever (did not use thermometer) Aches, feeling faint, fatigue, took Advil and slept until 2pm, then took Tylenol and Felt better by 4pm. Outcome of the events was recovered.
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| 54 | 2021-01-21 | headache, fatigue, chills, fever, respiratory tract congestion, runny nose |
Extreme arm soreness, body aches, joint pain, headache, chills , congestion, runny nose, and fever u...
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Extreme arm soreness, body aches, joint pain, headache, chills , congestion, runny nose, and fever up to 100.9 even on Tylenol. Symptoms were more than moderate. Had to alternate Tylenol and Advil every 3 hours for fever. Arm soreness started just hours after shot and hurt even when arm was stationary. Other symptoms started overnight and lasted through the next night. Received shot We?d at 4:30 and took until Friday for major symptoms to subside. Still with some congestion, runny nose and tiredness as of today (Friday).
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| 54 | 2021-01-21 | headache, fever, fatigue, chills | HEADACHE, LOW GRADE FEVER, CHILLS, ACHES, FATIGUE DEVELOPED 1/19/21 @1300, ENDED 1/21/21 @0630 |
| 54 | 2021-01-21 | headache, fever |
Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection s...
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Low grade fever; Headache; Stomach ache; body ache; metallic taste in mouth; sore arm at injection site; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EKQ231), via an unspecified route of administration at the left arm on 11Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 11Jan2021, patient experienced metallic taste in mouth, which was reported as worsened and sore arm at injection site. On 12Jan2021within about an hour after vaccination, the patient experienced lowgrade fever that was slowly going up, headache, stomach ache, & body ache. The patient has not recovered from the events.; Sender's Comments: Based on the time association, the reported events are possibly related to suspect BNT162B2 administration in this patient. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-01-21 | weakness | SORENESS AT SIGHT, NO ENERGY/ SWOLLEN LYMPH NODES |
| 54 | 2021-01-21 | shortness of breath, cough |
Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezin...
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Shortly after receiving vaccine developed flushing, numbness, tingling, coughing, horseness, wheezing, difficulty breathing. Transported to ER
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| 54 | 2021-01-21 | fever, headache, malaise | Tightness in throat and chest. Approx 8 hours after vaccine malaise, muscle aches, fever, headache |
| 54 | 2021-01-21 | chills, body temperature increased | temp 100.2-100.6/fever/chills, body aches, injection site L.arm very sore/heavy/painful |
| 54 | 2021-01-21 | headache, fatigue, somnolence |
was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with s...
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was extremely tired and could not stay awake fell asleep at 10 am for 5 hours to wake at 3 pm with slight low blood sugar , known by slight tremor in hands and body and also resolving 30 min after eating proteins and drinking orange juice. A few hours later around 5pm began getting headache, ate dinner and did not resolve so I took 100mg of Tylenol . could not sleep and was awake until 1am woke at 930 am with low sugar again resolved after eating and drinking orange juice. Had a headache less severe only took 500 mg of Tylenol it resolved. Stayed awake all day was fatigued. no other remarkable symptoms the rest of the day. the next day was about the same only less severe and by the fourth day I only noticed being tired during the day. I think it resolved completely by the 7th or 8th day I lost track due to my step mother coming out of rehab after having had COVID in December. as I write this I am fine and it is 1/22/21
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| 54 | 2021-01-24 | sweating, fatigue, chills, shortness of breath, fever | Body aches, chills, fatigue ,fever, SOB. sweats, joint pain. |
| 54 | 2021-01-24 | headache, fever | Fever, body aches, lump on arm, nausea, headache less than 24 hours, treated with meds |
| 54 | 2021-01-24 | chills, fatigue, headache | Headache, Injection site pain, Tiredness, Joint pain, Chills |
| 54 | 2021-01-24 | throat irritation |
scratchy throat at 45 mins post injection. Patient was placed in a 30 min post vaccine observation w...
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scratchy throat at 45 mins post injection. Patient was placed in a 30 min post vaccine observation window. No issues at the site. Patient went home. Approximately 45 mins after vaccine administration, called with symptoms. Advised to take Benadryl . Patient with no improvement. I was contacted by patient at 1803 she went to the hospital and was treated for an allergic reaction. Discharged at 1844 with rx for Epi-Pen.
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| 54 | 2021-01-25 | headache |
1/13/21 woke at 4am with neck pain 1/14 Pain worse, could not move neck, radiated on both sides of n...
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1/13/21 woke at 4am with neck pain 1/14 Pain worse, could not move neck, radiated on both sides of neck to back of head, saw doctor, was given a muscle relaxant, pain worsened, went to ER was given valium and sent home 1/15 called doctor, was given hydrocodone, increased pain, went to ER due to pain, was hospitalized 1/19 discharged from hospital, off work till 2/3/2021 per PCP
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| 54 | 2021-01-25 | shortness of breath, dizziness, chills |
After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your abo...
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After about between 10 to 15 minutes of the shots, started feeling hot and cold symptoms of your about to pass out. Then tightness of chess where its hard to breath. EMS were around to give me 2 shots of Epi one at a time with the interval of about 5 to 15 minutes. the first Epi was OK but still having hard time breathing and the second one feels a lot better but cant stop shivering's. then I was transferred to emergency room and treated also with some allergy med. (Benadryl administer through IV)
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| 54 | 2021-01-25 | headache, fever, chills | Fever, chills, terrible body aches, unrelenting headache, nausea for 14 hours |
| 54 | 2021-01-25 | headache, fatigue, discomfort |
I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid...
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I felt good all day till about 130am then I started feeling very uncomfortable. I had positive Covid-19 and I was having some of those symptoms- very painful headache, terrible lower back pain , very tired, upset stomach and sore at injection site. I couldn't get comfortable . I started taking 3 Tylenol ES, Ibuprofen 800mg, and Pepto Bismol at same time every 4 hours. After about 18 hours I started feeling normal. The testing site told me some people are having reactions.
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| 54 | 2021-01-25 | headache, dizziness |
Non-dose-related adverse reaction to medication, initial encounter Diagnosis management comments: Pa...
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Non-dose-related adverse reaction to medication, initial encounter Diagnosis management comments: Patient is a 54-year-old female with a history of hyperlipidemia presenting to the ED with complaints of dizziness and headache after receiving the second dose of the COVID-19 vaccine. Upon presentation to the ED and exam, patient reports that she is feeling a lot better at this time. She denies any chest pain, shortness of breath, hives or any feelings of her throat closing. On exam the patient's heart rate is regular lung sounds are clear. No evidence of rash noted. No angioedema noted on exam. She was given p.o. Tylenol here in the emergency department. She was monitored here in the emergency department with no further adverse reactions noted.
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| 54 | 2021-01-25 | fever, headache | Reported tightness in throat, headache, fever,body aches, and blurry vision. |
| 54 | 2021-01-25 | fatigue, headache |
fatigue; headache; muscle ache; injection pain site; This is a spontaneous report from a contactab...
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fatigue; headache; muscle ache; injection pain site; This is a spontaneous report from a contactable consumer (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: El1283; expiration date: unknown), via an unspecified route of administration right arm on 12Jan2021 17:15 at SINGLE DOSE for covid-19 immunization. Medical history included diabetic, high blood pressure, high cholesterol, ADHD (attention deficit hyperactivity disorder), anxiety, depression and IBS (irritable bowel syndrome). The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lovastatin (LOVASTAT), bupropion hydrochloride (BUPROPION HCL XL) and networking 750mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the Pfizer Covid 19 vaccine in a hospital. The patient experienced fatigue, headache and muscle ache and injection pain site on 13Jan2021 06:00 PM (18:00). The patient did not received treatment for the adverse events. The events were reported as non-serious. The patient has not been tested for COVID-19 since vaccination. The outcome of the events was recovering.
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| 54 | 2021-01-25 | sweating |
heart rate increased; pale; diaphoretic; This is a spontaneous report from a contactable nurse. A 54...
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heart rate increased; pale; diaphoretic; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284 and expiry date unknown) intramuscular in the left arm on 12Jan2021 15:30 at single dose for Covid-19 immunization in a workplace clinic. Medical history included hypertension, asthma, hysterectomy and tumor debulking (reported as on 21Dec2021). The patient was not pregnant. Concomitant medications included hydrochlorothiazide, asthma medication and antibiotic; all from unspecified date for unspecified indication. The patient previously took erythromycin and experienced allergies. On 12Jan2021 15:45 (also reported as approximately 9 minutes post injection), the patient reported feeling her heart rate increased, was pale and diaphoretic. The patient was not COVID tested post vaccination. The patient did not receive treatment due to the events. The outcome of the events heart rate increased, pale and diaphoretic was recovered on Jan2021.
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| 54 | 2021-01-25 | fever, headache | mild fever, body-aches, headaches |
| 54 | 2021-01-26 | dizziness |
1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. ...
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1638: Lightheadedness - Reports happening with 1st shot as well. BP 136/60. HR 53. Given water. 1651: no symptoms BP 111/86, HR 54 1705: Hands colder than normal 1708: observed for 30 minutes; BP 127/68; HR 53; still cold hands. off balance, neck pain. 1717: continues to report feeling off and didn't wan tto leave. moved to chair for more observation and given crackers. 1726: Warming up, felt normal, felt okay to leave. Release home.
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| 54 | 2021-01-26 | fever, runny nose, chills |
I received the vaccine last Jan. 5, 2021 @ 240pm. I had fever and chills, running nose, itchy lower ...
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I received the vaccine last Jan. 5, 2021 @ 240pm. I had fever and chills, running nose, itchy lower part of my body. I took Tylenol every 6hrs. and zyrtec. It took 3 days, feeling better.
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| 54 | 2021-01-26 | fever |
I received the vaccine on 1/25/2021 at 11:00 A.M. and felt fine all day and evening. I began feeling...
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I received the vaccine on 1/25/2021 at 11:00 A.M. and felt fine all day and evening. I began feeling body aches and ran a low grade fever of 100 around 5:00 P.M. on 1/26/2021. The injection site has a lump about the size of a quarter, red and warm to the touch. I took two Tylenol at 9:30 P.M. on 1/26/2021 and went to bed. I awoke at 7:30 A.M. on 1/27/2021 feeling fine, but he injection site is still swollen, red and warm to the touch.
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| 54 | 2021-01-26 | headache | NAUSEA, DIARRHEA, HA |
| 54 | 2021-01-26 | dizziness, shortness of breath |
Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vac...
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Patient complained of feeling light headed and dizzy 3-5 minutes after receiving Pfizer COVID-19 vaccine. (per son accompany by patient for vaccine). Pt then became SOB and complained of chest pain. Patient appeared disoriented. EMS already station on the scene was notified by staff. Patient evaluated by EMS.( Patient's son reported patient had mild reaction after 1st vaccine but recovered quickly). Patient was taking to ER by EMS for further evaluation.
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| 54 | 2021-01-26 | weakness, dizziness |
Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little we...
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Started feeling kind of off almost immediately after getting the vaccine. Felt flush and a little weak. Thought I was imagining things. Walked outside took elevator to the car felt increasingly more dizzy and weak. Got to car and started it, drove a few feet then knew it was dangerous to drive. parked and called My husband. He alerted people he knew . I then called 911. Symptoms progressively worsened. Thought I was going to code. Went to Er by ambulance. Trembling, dizziness, fast heart rate continued. Felt like i was going to die and my heart was going to jump out of my chest. In emergency room, they did an ekg and chest X-ray which were normal. They did some blood work. My potassium was very low ? 3.3. My TSH was 0.05; glucose 108;auto absol basos 0.1. Other results were normal. They told me the reaction was due to my low potassium and TSH levels. ER doctor recommended to change my levothyroxine dose with my pcp. Was in ER from approximately 1 pm - 6 pm on 1/7/21. They had me drink potassium and sent me home. Some symptoms subsided but still felt weak and dizzy when I left.
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| 54 | 2021-01-26 | dizziness |
Vertigo the morning after the shot. Very slight dizziness the rest of the day. Vertigo was back the ...
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Vertigo the morning after the shot. Very slight dizziness the rest of the day. Vertigo was back the next day in the morning just after waking up.
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| 54 | 2021-01-26 | fever |
fever 101.4; This is a spontaneous report from a contactable other healthcare professional (patient)...
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fever 101.4; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient started to receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), intramuscular on 12Jan2021 12:00 PM at single dose on the left arm for COVID-19 immunization. The patient is not pregnant. The patient has no known drug allergies (NKDA). There were no medical history and concomitant medications. No other vaccines in four weeks and no other medications in two weeks. No COVID prior vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685) intramuscular on 22Dec2020 12:00 PM on the left arm. Facility type vaccine was hospital. On 13Jan2021 12:00 PM, the patient experienced fever 101.4. No treatment for the event. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID post vaccination.
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| 54 | 2021-01-28 | throat pain, headache, fever | FEVER, SORE THROAT, BODY ACHES, HEADACHE |
| 54 | 2021-01-28 | headache |
Headache; Vomiting; Lower abdominal cramping; she scanned the bar code it said it was her first one ...
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Headache; Vomiting; Lower abdominal cramping; she scanned the bar code it said it was her first one but it really was her second one; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL1284), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. Medical history included systemic lupus, autoimmune disorder. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunization and experienced headache. The patient stated that she had her second vaccine on Monday (11Jan2021) and when she scanned the bar code it said it was her first one but it really was her second one. She was not given the paper too for monitoring what she got at first one but ever since she got her first one she had a constant headache and that continued today and then at the middle of the night for whatever reason she had some vomiting and lower abdominal cramping and so to call out sick to work. She did have autoimmune disease, systemic lupus. She was not currently on any kind of suppressants or anything like that. She was advised to have a Covid test. The only criteria that she need according to her work was having the headache. Was it possible that this was just side effect from the immunization? The patient received Tylenol as treatment for the headache. The outcome of events was unknown.
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| 54 | 2021-01-28 | headache, malaise | Whole body hot, then general malaise, cephalgia and insomnia. |
| 54 | 2021-01-28 | discomfort, headache |
her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle sor...
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her body felt uncomfortable; had pain at injection site for a little bit; muscle soreness/muscle soreness in left arm at injection area after receiving the second dose; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse (patient) reported that a 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302, expiration date: May2021), intramuscular on 12Jan2021 09:00 at 0.3 mL, single on left arm for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient received her first dose of BNT162B2 on 22Dec2020 around 08:15am to 08:30 am, intramuscular injection in left arm. The dose she received was 0.1ml (lot number: EH9899). The patient received flu shot on Nov (no year reported). The patient experienced headache on 12Jan2021 and muscle soreness on 13Jan2021 in left arm at injection area after receiving the second dose. Her headache was not very strong. It was mild headache since she took Tylenol. She clarified it recovered completely as of yesterday (14Jan2021). When querying seriousness, she states it was a normal side effect so she did not think it is serious. She reported her body felt uncomfortable, and she cannot explain what it was happening, she did not have shortness of breath or diarrhea or anything. States it was like she got flu vaccine and had pain at injection site for a little bit. She received the flu vaccine in Nov (no year reported) and she does not know the name of the flu vaccine. The patient recovered from headache and muscle soreness/muscle soreness in left arm at injection area after receiving the second dose on 14Jan2021. Outcome of the rest of the events was unknown.
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| 54 | 2021-01-31 | fever, headache, fatigue, dizziness, weakness |
Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalanc...
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Dizziness and weakness; Numbness and tingling; Other ADVERSE REACTION Reported: Electrolyte imbalance requiring hospitalization for More than 48 hours with repeated hematology follow up. Patient is a 54-year-old woman with history of Roux-en-Y gastric bypass surgery and some alcohol abuse who presented to the hospital with fatigue, headache, muscle cramps and weakness. She also had a slight fever that followed her 2nd dose of COVID-19 vaccine. She had basic lab work which revealed pancytopenia along with multiple electrolyte disturbances including hypokalemia, hypomagnesemia, hypocalcemia and hyponatremia. She admits that she had heavy alcohol use over the weekend with binge drinking of liquor. She otherwise does drink a couple of mixed drinks a night. She has also been trying to lose a lot of weight. She says that she lost about 60 lb in the last 6 months on purpose. She is doing this so that she can have a panniculectomy and tummy tuck. She recently had a breast reduction in November. She has not been following with a dietitian or having her vitamin levels checked. Despite having pancytopenia, her levels remained pretty stable during her stay. She had a peripheral smear sent which was pending at the time of discharge. She was also checked for vitamin deficiencies. She is given a dose of IM B12, IV iron, IV calcium and started on oral calcium vitamin-D supplements. She does take a daily multivitamin. Due to her reported history of heavy alcohol use she is also given thiamine and folate. After speaking with Hematology, recommendations were for her to have a follow-up appointment which is scheduled on February 10th. I also put in a referral for a dietitian to evaluate her for further recommend deficiencies in the setting of Roux-en-Y gastric bypass surgery with heavy weight loss. I prescribed her calcium vitamin-D along with folic acid. I recommended she continue her multivitamin. I also recommended that she abstain from alcohol use.
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| 54 | 2021-01-31 | cough, headache |
body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; ...
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body aches; bad arm and armpit pain.; bad arm and armpit pain/leg pain; cough; neck pain; headache; a little swelling; throat dry at night; joint pain/ankle pain; This is a spontaneous report from a contactable nurse. A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 08Jan2021 14:00 at a single dose for COVID-19 immunization. The patient medical history was none. Patient's concomitant medications were not reported. The patient previously took cortisone. It was reported that the patient got the vaccine on 08Jan2021 and started having the headaches right after. Still has some pain in the forehead and temples area. Has had neck pain, overall body aches, joint pain, pain in ankles and legs that still happens with getting up and down from sitting position. Overall pain is improved but still there, still has pain in ankles and legs. Got the shot in the left upper arm and having real bad armpit pain and a little swelling there. It has gotten a little better, but mostly hurts when moving and laying down. Has had a cough since she got the vaccine, it's mostly a dry cough and not really wet and mostly in the morning. She drinks a lot of fluids throughout the day and still has a little cough off and on. During the night her throat is really dry and which causes more coughing which she did not have before the vaccine. They are mostly concerned with the cough and the stuff when read online about the side effects that last about 2-3 days, but these have been since she got the vaccine. They know this is also know and not much known about it or what is normal yet, but they want to know if she could get the second vaccine, would it be okay. It was stated that the seriousness of the events is in the middle of not serious and medically significant. She is worried about the cough since it is ongoing, when reads online the side effects are listed as 2 or 3 days and her side effects have been going on since she got the vaccine which is worrisome. The outcome of the events cough and throat dry was not recovered, event pain was recovering, while the outcome of the rest of the events was unknown. Information on the Lot/batch number has been requested.
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| 54 | 2021-02-01 | throat irritation, chills, fever |
heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irrita...
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heart rate 160 (elevated); she had an allergic reaction to the vaccine; fever of 102; chills; irritation in throat; Diarrhea; felt funny; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (BNT162B2 reported as Pfizer COVID 19 vaccine; lot number: EL3302; expiration date: unknown), via an unspecified route of administration left arm on 15Jan2021 09:30 at a single dose (reported as unknown dosage with a needle to left arm one time) to prevent Covid 19 and build up antibodies to Covid 19 (COVID-19 immunization). The patient has no medical history and concomitant medications. The patient reported that last Friday (15Jan2021) at 9:30 she took the first dose of vaccine and felt funny, so she waited for 15 minutes. She mentioned that she had not eaten before so they gave her glucose tablets. She then mentioned that later on that night (15Jan2021) that she had a fever of 102 [unit unspecified], elevated heart rate of 160 [unit unspecified], had chills and felt like she had Covid. She further stated that she had irritation in her throat that started after the vaccine. She stated that her doctor mentioned that she may be positive for Covid 19 and did not know it before she had the vaccine. The patient mentioned that she had the nasal swab for Covid and they drew her blood on an unspecified date, but all came back negative. She was told that she had an allergic reaction to the vaccine. She added that she had no symptoms prior to the vaccine. The patient reported that she has to go back for the second Pfizer Covid 19 vaccine on 05Feb2021. The patient received treatment included prednisone, diphenhydramine (BENADRYL) and was given an epinephrine injection (EPIPEN) to bring home. She also was given acetaminophen (TYLENOL) for fever. She was given fluids to try to bring everything down. She added that she was given famotidine (PEPCID) for her stomach due to diarrhea on 15Jan2021 that she is still taking. The outcome of the events allergic reaction and felt funny were unknown, as for diarrhea was not recovered, for the event irritation in throat was recovered on 15Jan2021 while the outcome of the other events was recovered on 17Jan2021.
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| 54 | 2021-02-01 | weakness, fatigue, headache, chills, dizziness |
kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Hea...
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kind of fainted; Body feels tender and skin feels tender to touch; dizziness; Weakness; Fatigue; Headache; Chills; Left arm hurting really bad; A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Jan2021 07:15 at single dose in left arm for covid-19 immunisation. Medical history included menopause from May2020 and ongoing (She is going through menopause, which started 7 months ago). There were no concomitant medications. Received call from consumer regarding the Pfizer BioNtech COVID vaccine. She had first vaccine yesterday morning and is experiencing some side effects. It looks like it was prescribed by a pharmacist, but she is not able to see the name and does not have any contact details to provide. She signed up at the online thing for reporting. Her arm is much better this morning. She woke up at 03:00 with the headache and still has it. Dizziness and weakness started 06:30 this morning. She kind of fainted. She was walking from one room to the next and she just gave out. It has improved and she is not really dizzy any more. She is having a little fatigue though. Chills began at 06:30 and they come and go. She is going through menopause and it could have something to do with it. She was unable to answer outcome for this. She just wants the headache to stop. She has not been able to do anything today. She is going through menopause, which started 7 months ago. She would like to know if there is something she can take for the headache. AE Details and time of onset: Left arm hurting really bad 18:00. When she first got it, she did not feel it. As the day progressed, she could feel the pain. Headache 03:00. Dizziness and weakness 06:30. Fatigue 06:30. Chills 07:00-07:30. She layed down at that point. Body feels tender and skin feels tender to touch 09:00. NO ER or physician's office required. No prior Vaccinations (within 4 weeks). The outcome of the event dizziness was resolved, Chills was unknown, Headache was not resolved, while the outcome of the other events was resolving. Information on the lot/batch number has been requested.
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| 54 | 2021-02-02 | headache |
swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrre...
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swelling lips; numbness; rashes in the face and legs; high blood pressure; itching; nauseas; diahrrea; palpitation; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 14Jan2021 13:15 at single dose at left arm for covid-19 immunization. Medical history included known allergies: sulfas, codeine, latex. Concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. After 22 minutes received the vaccine on 14Jan2021: started swelling lips, numbness, rashes in the face and legs, high blood pressure, itching and headache, nauseas and diarrhea, until now still felling palpitation and headache. The adverse events resulted in emergency room/department or urgent care. Patient received treatment famotidine 20 mg, epinephrine for events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Outcome of events palpitation and headache was not recovered, and outcome of other events was recovered with lasting effects in Jan2021. Information of lot/batch number has been requested.; Sender's Comments: The reported events swelling lips, numbness, rashes in the face and legs, high blood pressure, itching, nauseas and diarrhea, palpitation and headache, were causally related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
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| 54 | 2021-02-07 | fever |
next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE...
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next day fever and palpitations. Coming and going for days. on 2/4/2021 started having LLE and RLE numbness and tingling. Went to ED given hx of CVA. Testing all normal. Started to resolve 2 hours later. Continues to have pain at injection site (today is 2/8/2021)
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| 54 | 2021-02-09 | shortness of breath, dizziness | SHORTNESS OF BREATH, DIZZYNESS |
| 54 | 2021-02-17 | fatigue |
Big echo on right ear; Very tired; Discomfort on right arm injection site; This is a spontaneous rep...
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Big echo on right ear; Very tired; Discomfort on right arm injection site; This is a spontaneous report from a contactable nurse report for self. This 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, Expiry Date: Apr2021) Intramuscular injected in right deltoid on 24Jan2021 12:00 at single dose for COVID-19 immunization. Patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Diabetes surgically induced in 2013. None prior vaccinations within 4 weeks. She takes flu vaccine each year and never has any problems. None vaccines administered on the same date with BNT162B2. There were no concomitant medications. Patient got the first vaccine on 24Jan2021 and was fine. The next day on 25Jan2021 patient experienced discomfort on right arm injection site, and at 18:00, she was very tired, she wanted to just go to bed and not get up. On 26Jan2021 18:00, she started having a big echo in her right ear, the nurse considered "Big echo on right ear" was medically significant. She could hear herself talking to herself. Since then, she has a difference in her ears. She heard people from a distance if she closes right ear. Right now, it echo's so bad. She did not have a problem with her ear before the vaccine. The ear has improved but persisted. Some noises are intolerable and some are ok. She is going for second dose in 3 weeks. Workplace clinic visit on 28Jan2021. They looked at her ear and had no medical intervention. Events outcome was recovering. Relatedness of vaccine to all events reported "related".; Sender's Comments: By close temporal relationship and absence of factors which may provide an alternative cause the events reported as tinnitus, vaccination site discomfort and fatigue, may be attributed to suspect product BNT162b2; the event vaccination site discomfort is consistent with the known toxicity profile of the suspect product. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-02-21 | headache, body temperature increased, fatigue |
Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the he...
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Almost immediately got a very bad headache and nausea. About 30 minutes later I got foggy in the head. Within an hour, I felt exhausted. I went to sleep until about 7pm and when I woke up I felt really nauseous and still very tired. I had a little broth and went back to sleep. on 02/19/2021 at 1am I woke up feeling really hot and had horrible body aches. Even my joints hurt. I took my temperature and it was only 99.2 but my temperature usually runs 97.4 or 97.6. I woke up on 02/20/2021 and my left eye was crusted over just like the first vaccine. My body aches and nausea lasted until 02/20/2021. In the evening of 02/20/2021 I noticed about 10 little red bumps in various places on my body. (2 on left arm, one on back neck in hairline, two on upper back, one on chest, two on left leg, one on lower back and one on left buttock. Today is 02/22/2021 and I am still feeling fatigued. It's not as bad as it was over the weekend but I am still tired. My arm was much sorer with this injection.
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| 54 | 2021-02-21 | dizziness |
Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one epi...
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Approximately 15 minutes post-vaccination (0830), pt started feeling dizzy, nauseous and had one episode of emesis. Vital signs at 0830 were bp:184/108, p:112, SpO2:99%. At this time pt was flushed, skin was hot and dry. Vitals at 0835 were bp:179/124, p: 92. Pt began feeling chest pain. Vitals at 0840 were bp: 182-108, p:86. Emergency services were called and pt was transferred to local ED.
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| 54 | 2021-02-21 | cold sweat, dizziness |
At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108...
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At 1333 I was called to lobby. Upon arrival, pt states she is feeling light headed and dizzy. VS 108/68, 97.6, RR 16, o2 98% on RA, and HR 45. Pt AOx4. Pulses thready. Patient?s skin is moist and clammy. Called for a WC and took pt to exam room where she sat in a reclining chair. VS taken every 5 minutes. She kept mentation through her stay. She states she felt slightly nauseated but was able to hold down water. VS started to improve once she was reclined in exam room. Education provided about f/u with PCP as HR fluctuated between 57-85. Educated about monitoring for symptoms the rest of the day and when to go in for evaluation is symptoms reappear. Pt verbalizes understanding. At 1400, pt states she is feeling better and feels well enough to leave facility. She has no one in town to come get her. VS= 02 98% HR 60, T97.8, BP 120/74, RR 16. Time of leaving, pulses were strong and equal, cap refill WNL. Will call at 1700 for F/U call.
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| 54 | 2021-02-21 | skin warm |
Hot red rash first appeared behind knees, then on elbows, the on knees and shins, then by sitting bo...
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Hot red rash first appeared behind knees, then on elbows, the on knees and shins, then by sitting bones and then ankles over the course of a week. Prednisone was prescribed and helped.
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| 54 | 2021-02-21 | headache, chills, fatigue |
This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I s...
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This was my first vaccine... almost immediately I had a headache and my blood pressure went up. I stayed for 45 minutes after my vaccine due to my blood pressure was high. I also felt a little fuzzy. About an hour later I got nauseous, had chills and felt very fatigued. The next morning when I woke up, my left eye was crusted over. I did not think anything of it until I got the second vaccine and it crusted over with it as well. I was very fatigued for 2 1/2 days. Arm was a little sore.
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| 54 | 2021-02-21 | head discomfort |
inability to multitask, difficultly with problem solving, significant reduction task completion; Slo...
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inability to multitask, difficultly with problem solving, significant reduction task completion; Slow mental processing; reduced concentration; significant reduction in memory; dense Brain fog set in; This combined with an increasing pressure at the center of my head pushing out.; This is a spontaneous report from a contactable nurse (patient). A 54-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date: unknown), via an unspecified route of administration left arm on 26Jan2021 14:00 at a single dose for covid-19 immunization. Medical history included low back pain, and allergy to peanuts, gluten and nickel. Concomitant medication included vitamin b complex (VITAMIN B COMPLEX), egcg (EGCG), colecalciferol (VITAMIN D) and vitamin c [ascorbic acid] (VITAMIN C). The patient did not receive other vaccine in four weeks. The patient previously took ketorolac tromethamine (TORADOL) but had allergies. The patient recieved her most recent COVID-19 vaccine in her workplace clinic. On 26Jan2021 05:30 PM (reported as 3.5 hours after the vaccination), the patient had a dense brain fog set in, slow mental processing, reduced concentration, inability to multitask, difficultly with problem solving, significant reduction in memory and task completion. This has remained unchanged for 8 days. This combined with an increasing pressure at the center of her head pushing out. The patient reported that she received treatment for the adverse events and the events resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included covid-19 test with negative results on an unspecified date. The outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of mental impairment / mental disorders cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-02-22 | shortness of breath |
Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with dimin...
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Around 0840 on 2/16/2021 Heart Palpitations, swelling of tongue, left sided neck swelling with diminish flow, tingling of the lips and tongue, pressure, tightness and pain in the chest. shortness of breath, right sided weakness and tingling of limbs and face. 50 ml of Benadryl, and 2 shots of epinephrine was given before transported to the Emergency Room via Ambulance On 2/22/2021 was sent to Urgent Care with the same symptoms. Urgent care sent me back to the Emergency room with heart arrythmias, chest tightness, tingling of lips and tongue.
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| 54 | 2021-02-22 | shortness of breath, cough |
Cough, shortness of breath, tachycardia. Transported to ER. Tryptase drawn - 4.6. Symptoms resolved ...
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Cough, shortness of breath, tachycardia. Transported to ER. Tryptase drawn - 4.6. Symptoms resolved with benadryl
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| 54 | 2021-02-22 | dizziness, shortness of breath |
Patient became mildly short of breath with some chest tightness and light headedness approximately 2...
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Patient became mildly short of breath with some chest tightness and light headedness approximately 23 minutes after receipt of the vaccine. She notified the nursing counter who notified me. Patient was A&Ox3 upon my arrival and able to speak in full sentences. Heart rate was noted to be 105 bpm. 50mg oral Benadryl was administered and patient was monitored for 25 minutes. Heart rate improved as did patient's work of breathing, chest tightness, and her dizziness subsided completely. Her final heart rate at time of discharge was 93 bpm and patient was able to ambulate under own power to depart the site. She was escorted to her husband's vehicle and he received instructions to take her to the hospital to fill her epi-pen prescription which was placed at the time of the incident as well as reasons to use the epi-pen and report to ED if needed.
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| 54 | 2021-02-22 | fever, malaise |
ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense mala...
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ill-effects started 16 hours after injection; sore arm; brief low-grade fever; vomited; intense malaise for 24 hours followed by 2.5 days of fatigue
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| 54 | 2021-02-24 | fever |
14 days after first dose, high fevers (104.5-103), low platelet count, have had 4 weeks of multiple ...
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14 days after first dose, high fevers (104.5-103), low platelet count, have had 4 weeks of multiple tests, including CT scans, Lumbar puncture, abnormal lab work with no known cause. High lymphocytes count (abnormal lymphocytes), abnormal red blood cells, high D Dimer, etc.. Most recent labs show Monoclonal paraproteinemia, Im currently waiting to see a hematologist. Have seen internal medicine, infectious disease, rheumatology, . No one can determine the cause of the ongoing symptoms.
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| 54 | 2021-02-25 | discomfort, dizziness |
After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressu...
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After 2nd dose on 2/3/21, I waited 10 minutes and felt tingling and cold, heaviness and blood pressure dropped significantly. They put me onto a gurney and monitored my BP and waited, gave me some juice and crackers, but I continued to have the sensation of fainting (syncope). They transferred me to the ER for further monitoring. After a while, it stabilized more, but still continued to happen throughout the day.
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| 54 | 2021-02-28 | fatigue |
Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigu...
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Soreness in arm, inability to lift above head; Soreness in arm, inability to lift above head; fatigue; minor nausea; This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318 and expiration date unknown), via an unspecified route of administration on the right arm on 27Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included COVID-19; prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included Vitamin D NOS and Multi-Vitamin. The patient previously took injectable Iodine and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced soreness in arm - inability to lift above head, fatigue and minor nausea on 27Jan2021 at 13:00 (01:00 PM). No treatment was administered for the events. Since the vaccination, the patient has not been tested for COVID-19. The events were resolving.
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| 54 | 2021-03-01 | headache |
I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very...
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I had my 2nd does of the Pfizer vaccine on February 27, 2021. The next morning I awoke with a very bad headache. I took and Advil. My husband was making breakfast. I came downstairs, ate, had a cup of coffee, then got a glass of water and an ice pack and sat on a recliner in the living room. I don't remember much of the rest. It was like a dream. My husband said I let out a yell, my arms flailed and my eyes were very strange. I lost muscle strength in my lift side mimicking a stroke. He called 911. I was taken to Emergency facility where I gained consciousness. I was then transferred to Hospital. So far every test has come back negative. I have an EEG scheduled for this Thursday.
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| 54 | 2021-03-02 | chills, headache, fatigue |
Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells...
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Uncontrollable chills; stabbing pain all over; headaches; body shakes; nausea; sensitivity to smells; motion; tired; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: T23248), intramuscular in the left arm on 29Jan2021 at 10:00 AM as a single dose for COVID-19 immunization. Medical history included known allergies to sulfa. The patient did not have COVID prior to vaccination, had no other vaccine in four weeks and was not pregnant at the time of vaccination. Concomitant medications included multivitamins, ibuprofen, and paracetamol (TYLENOL). The patient received the first dose of BNT162B2 on 10Jan2021. On 29Jan2021 at 07:00 PM, the patient experienced uncontrollable chills, stabbing pain all over, headaches, body shakes, nausea, sensitivity to smells, "motion", and tired. The patient was not COVID tested after vaccination. The patient received no treatment for the events. Outcome of the events was recovering.
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| 54 | 2021-03-02 | fatigue, headache |
exhausted; body aches; headache; This is a spontaneous report from a contactable consumer (patient)....
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exhausted; body aches; headache; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient (non-pregnant) received second dose of (BNT162B2, Solution for injection, Batch/lot: EL3248), via an unspecified route of administration on 03Feb2021 14:30 at single dose in left arm for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Historical vaccine of BNT162B2 for covid-19 immunisation, (administration date: 15Jan2021, time=02:30 PM, vaccine location: Left arm, dose number: 1, lot number: EL3248). Concomitant medication included desvenlafaxine succinate (PRISTIQ), levofloxacin (LEVOXAL), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc, calcium. The patient was exhausted, body aches and had headache on 04Feb2021 and it started 04:30 AM. The treatment was not received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. The outcome of the events was recovered on an unspecified date of Feb2021.
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| 54 | 2021-03-07 | fever |
Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A...
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Nausea; sore arm; fever; This is a spontaneous report from a contactable healthcare professional. A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3246), via an unspecified route of administration on the right arm on 02Feb2021 08:15 at single dose for COVID-19 immunisation. Medical history allergies: pcn, latex, wheat/gluten, dairy, soy, corn. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (lot number: EL 3246) on 11Jan2021 06:30 PM on the right arm for covid-19 immunisation; epinephrine and experienced allergies. At 6:00 PM on 02Feb2021, patient developed fever 99.4 and steadily rose to 101.5 by 9:30 PM; sore arm all day and night, following day much less sore and easier to move. Fever stayed overnight, down to 100.5 morning on 03Feb2021. Nausea accompanied fever and still have slight nausea. The patient received no treatment. The outcome of the events was recovering.
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| 54 | 2021-03-09 | shortness of breath, cough |
difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This...
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difficulty inhaling; cough; hives; tongue and lips tingling; tongue and lips tingling; itching; This is a spontaneous report from a contactable nurse reporting for herself. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL 3246/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 at 08:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284/expiration date: not provided), via an unspecified route of administration, on 26Dec2020 at 10:00 (at the age of 54 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included exercised induced asthma, and psoriatic eczema. The patient had known allergies to penicillin, fentanyl, and levofloxacin (LEVAQUIN). Concomitant medication included levothyroxine sodium (SYNTHROID) and atorvastatin (LIPITOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 15Jan2021 at 08:15, the patient experienced difficulty inhaling, cough, hives, itching, tongue and lips tingling. The events resulted in an emergency room visit. The patient received treatment for these events which included treatment epi: IV fluids, IV benadryl, Pepcid, Solumedrol then IM. The outcome of the events difficulty inhaling, cough, hives, itching, tongue and lips tingling was recovered with lasting effects (sequel) on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
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| 54 | 2021-03-09 | chills |
sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days l...
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sore arm; slept for 17 straight hours; chills; upset stomach; upper body flushing for up to 4 days later; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Jan2021 08:00 at single dose for COVID-19 immunization. Medical history included Known allergies to Possible latex, Diabetes, sleep apnea, PTSD (Post-traumatic stress disorder)/anxiety, herpes, vitamin d deficiency, environmental allergies, asthma. Concomitant medication was unspecified medication in two weeks. On 16Jan2021 08:00, The patient experienced sore arm, slept for 17 straight hours, chills, upset stomach, upper body flushing for up to 4 days later. Treatment received for the events included OTC medications. The patient was not pregnant. She had no COVID tested post vaccination. There was no other vaccine received in four weeks. The outcome of the events was recovered in 2021. information on the lot/batch number has been requested.
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| 54 | 2021-03-13 | sweating |
pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose ...
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pt was anxious about getting the shot, stated she's diabetic with heart condition pre vaccine. dose approx 1:20, at 1:28 said her arm was going numb and declined water and food. 1:33 continued tingling numbness of left arm and jawline, she again declined food and water. 1:43 hot, sweaty, ache in chest and rapid pulse feeling. called ems, gave water and crackers, 1:48 bp between 103/80 Pulse 94 to 127/79 pulse 86. 1:55 bp 156/113 pulse 88. said her arm was tingly and face going numb, feeling her heart flutter. when EMS arrived she said her blood glucose was 286 this am and she took Humalog then. normal bp 130s/80s pulse in 90s. Tx to hospital, FU 3/12&3/14 said she had throat closing and vax site numb and swollen
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| 54 | 2021-03-14 | fatigue |
Exhaustion; muscle soreness; lack of sleep; This is a spontaneous report from a contactable consumer...
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Exhaustion; muscle soreness; lack of sleep; This is a spontaneous report from a contactable consumer (patient). This 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 08Feb2021 09:15 for COVID-19 immunisation. Medical history included allergy to Sulphur derived antibiotics. There were no concomitant medications. Previously the patient received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On 08Feb2021 19:00, the patient experienced exhaustion, muscle soreness, lack of sleep with outcome of recovered on an unspecified date in Feb2021. No treatment required. The vaccine was administered at Workplace clinic. Information on lot number/batch number has been requested.
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| 54 | 2021-03-14 | headache |
increased AFib episodes; joint ache esp to left knee with pain; Headache; This is a spontaneous repo...
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increased AFib episodes; joint ache esp to left knee with pain; Headache; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration at arm left on 28Jan2021 at 11:00 (at the age of 54-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included atrial fibrillation (AFib), depression, aortic stenosis and allergy to sulfa, all from an unknown date and unknown if ongoing. Concomitant medication included losartan, HCTZ, sertraline hydrochloride (ZOLOFT), vitamin D3, magnesium and cyanocobalamin (VITAMIN B12). The patient previously took LEVOQUIN and prednisone and experienced allergies. On 02Feb2021 at 08:00, the patient experienced increased AFib episodes, joint ache esp. to left knee with pain and headache. The patient underwent lab tests and procedures which included SARS-COV-2 (nasal swab) test: negative on 22Feb2021. Therapeutic measures were taken as a result of the events and included acupuncture and the events required physician office visit. The patient outcome of the event was not recovered.; Sender's Comments: There is not a reasonable possibility that event atrial fibrillation is related to BNT162B2. The event only occurred 4 days after vaccination. And the patient had underlying atrial fibrillation, which is considered the most likely cause of the reported event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 54 | 2021-03-15 | fever |
Low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient herself). A ...
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Low grade fever 99.5; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration in right arm on 24Jan2021 10:30 AM (at the age of 54-year-old) at single dose for COVID-19 immunisation in Public Health Clinic/Veterans Administration facility. The patient's medical history included high blood pressure, anxiety, bipolar. Concomitant medications included escitalopram oxalate (LEXAPRO), lamotrigine (LAMICTAL), quetiapine fumarate (SEROQUEL); the patient received all the drugs within 2 weeks of vaccination. The patient previously took phenytoin sodium (DILANTIN), levofloxacin (LEVAQUIN), hydrocodone bitartrate, paracetamol (VICODIN) and experienced drug allergy for all the drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 24Jan2021 16:00, the patient experienced low grade fever 99.5. The patient underwent lab tests and procedures which included body temperature: 99.5 (low grade fever 99.5) on 24Jan2021. The event was considered as non-serious by the consumer. The patient was treated with Tylenol for the adverse event. The outcome of the event was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.
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| 54 | 2021-03-16 | dizziness |
On March 16, I was sitting in a chair next to my kitchen counter when I felt like my body was being ...
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On March 16, I was sitting in a chair next to my kitchen counter when I felt like my body was being thrown. My head was thrown forward and I hit the counter hard and sustained a large contusion above my left eye. The room was spinning and I was dizzy for the next few hours. I never lost consciousness but had no control of my body for the few seconds of the episode. The episode was sudden and violent and I was just sitting when it happened. I spoke with my physician who diagnosed me with having experienced a Tumarkin otolithic crisis. He has instructed me to wear a helmet and not to leave my home. He is also recommending that I have a labyrinthectomy to treat the symptoms. While I have a history of vertigo, I have not had any dizziness for more than a year. I now feel dizzy on and off most of the day.
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| 54 | 2021-03-20 | cold sweat, shortness of breath, headache |
I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; ...
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I had the vaccine on Wednesday and Friday morning i woke up with a headache; feeling hot and clamy; feeling hot and clamy; nausios; i could not breathe; It was like a really bad asthma attack; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EN6208), via an unspecified route of administration i as single dose in arm left on 10Mar2021 for COVID-19 immunisation. Medical history included known allergy to penicillin. The patient's concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 04:30 morning the patient experienced woke up with a headache, feeling hot and clamy, nausios. She took Iboprofin and was fine. On 12Mar2021 night she went to bed about 10 pm and woke up from a sound sleep about 12:30 am she could not breathe. It was like a really bad asthma attack which she have never had like that. It took a while to try to breath thru her nose but finally she was able to and took a nebulizer treatment with Abutero. She was very scary. She was wondering if she should take the 2nd dose. The events were considered life threatening. Therapeutic measures were taken as a result of events. Covid was not tested post vaccination. The outcome of events was not recovered.
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| 54 | 2021-03-22 | migraine, fatigue, headache |
Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued na...
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Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued nausea & migraine. Tuesday 3/9 went to ER with same symptoms. Was admitted to hospital on 3/9 with acute kidney injury, nausea & Migraine. Was discharged from hospital on 3/14. Followe up with primary doctor on 3/17. Primary DR requested more bloodwork. Had low potassium. Ended up back in ER 3/17 with nausea and vomiting. They pushed more fluids and sent me home. Will have follow up blood work on 3/26 and next Dr appointment on 4/19. Returned to work for 1/2 day on 3/22. Absent 3/23 for extreme fatigue.
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| 55 | 2021-01-01 | dizziness |
Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved ...
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Employee states pain in left shoulder down into chest and lightheadedness but the symptoms resolved within 15 minutes.
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| 55 | 2021-01-03 | dizziness |
5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling s...
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5 days after 1st vaccine, experienced sync opal event at home. .Arrived at work 12/28/2020 feeling slightly lightheaded and tachy. went home.
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| 55 | 2021-01-03 | fever, chills |
Received the shot 1710 on 12/21/20. Restless sleep. Awoke with body aches, took 1000mg Acetaminop...
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Received the shot 1710 on 12/21/20. Restless sleep. Awoke with body aches, took 1000mg Acetaminophen. Felt fine until 1500, started with fever/chills, temp 100.8. Went to sleep then, awoke at 1845 with oral temp at 103.4. Took 2nd dose 1000 mg Acetaminophen. Temp decreased to 102. 5 within 45 mins, dropped to 101 by 2030.
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| 55 | 2021-01-03 | fever, headache, chills |
Severe chills, fever, headache, diarrhea Starting approx. 8:30 PM on 12/30/2020 until approx. 12:30...
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Severe chills, fever, headache, diarrhea Starting approx. 8:30 PM on 12/30/2020 until approx. 12:30 am 01/01/2021.
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| 55 | 2021-01-03 | dizziness |
Stated she felt "light-headed" @ 1805. Denies being "light-headed" before vaccination. States that...
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Stated she felt "light-headed" @ 1805. Denies being "light-headed" before vaccination. States that she felt the same way after she received her influenza vaccine this year. This nurse assisted Ee on bed in clinic for 15 mins. State she felt better @ 1830. Left observation @ 1830. V/S BP-122/76, P-56, O2-98.
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| 55 | 2021-01-04 | dizziness |
During her 15 minute waiting period after the injection, the patient began to experience dizziness, ...
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During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; During her 15 minute waiting period after the injection, the patient began to experience dizziness, anxiety.; This is a spontaneous report from a non-contactable other health professional. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) dose number 1, intramuscularly on an unspecified date at single dose on left arm (left deltoid muscle) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She had no history of previous hypersensitivity reactions to immunizations. During her 15 minutes waiting period after the injection, the patient began to experience dizziness, anxiety. She denied rash, hives, difficulty breathing, difficulty swallowing, throat tightness, hoarseness, itching, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea and increased work of breathing, vomiting and abdominal pain. Planned action included: observation, serial examination. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was unknown. Assessment by reporter: transient anxiety associated with COVID vaccine administration. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-04 | headache |
Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-conta...
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Her arm was very sore; Intermittent stabbing headache; This is a spontaneous report from a non-contactable consumer (patient's Sister). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. On 27Dec2020 patient experienced an "intermittent stabbing headache" and her arm was very sore but much better the day of the report. Patient would not take paracetamol (TYLENOL) because she was still very functional. Outcome of the events was unknown. Information about lot/Batch number cannot be obtained. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-04 | headache |
Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer (patient). A 5...
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Nausea; Vomiting; Headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 at single dose in right upper arm for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On 29Dec2020 the patient experienced nausea, vomiting and headache: patient worked at the hospital; 30-45 minutes after she received the vaccine, she got really nauseated. She was also vomiting and had a headache. She has stopped vomiting on 29Dec2020 (30 min before the report). Events were all non-serious. Patient recovered from vomiting on 29Dec2020; outcome of nausea and headache was not recovered. Information on the lot/batch number has been requested.
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| 55 | 2021-01-04 | throat pain, dizziness, shortness of breath, headache, fatigue |
PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ...
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PATIENT VACCINATED AROUND 9AM. SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS. SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM: FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING. AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED. SYMPTOMS REPORTED IMPROVED FOLLOWING EPI. EMS ARRIVED 10:05AM. PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL. WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.
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| 55 | 2021-01-04 | dizziness |
Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed fee...
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Rapid heart beat- 2 brief instances within 15-20 minutes of vaccine administration; Light headed feeling; This is a spontaneous report from a non-contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm on 23Dec2020 07:30 at single dose for COVID-19 immunization. Medical history included high blood pressure (HBP), supraventricular tachycardia (h/o SVT), h/o breast cancer, and sulfa drugs allergies. The patient was not pregnant. Concomitant medication included famotidine, metoprolol succinate, and tamoxifen. The patient experienced lightheaded feeling and rapid heartbeat- 2 brief instances within 15-20 minutes of vaccine administration on 23Dec2020. No treatment was received for the events. Facility where the most recent COVID-19 vaccine was administered was at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination via nasal swab on 24Dec2020, results was pending. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-04 | fatigue, somnolence, malaise, headache |
Tiredness; sleepy; headache; malaise; This is a spontaneous report from a contactable Other HCP (pat...
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Tiredness; sleepy; headache; malaise; This is a spontaneous report from a contactable Other HCP (patient). A 55-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in arm Left on 16Dec2020 12:45 at single dose for COVID-19 immunisation. Medical history included none. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced tiredness, sleepy, headache, malaise on 16Dec2020 16:00. The patient underwent lab tests and procedures which included Nasal Swab: negative on unknown date in Dec2020. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. No treatment received for the adverse event. Case was non-serious. The outcome of events was recovered in Dec2020. Information on the Batch/Lot number has been requested.
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| 55 | 2021-01-04 | dizziness |
Vertigo/it is now full blown vertigo; Stuffy head; She does not feel safe walking in her home; Nause...
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Vertigo/it is now full blown vertigo; Stuffy head; She does not feel safe walking in her home; Nausea/ Acute nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK3730, expiration date: 20Mar2021), via an unspecified route of administration on 17Dec2020 at left deltoid, at single dose for covid-19 immunization. Medical history included patent foramen ovale in patient's heart from 2013 and ongoing, and the patient used to be 5'4" and noticed the shrinkage before the Covid 19 vaccine and baby aspirin. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) from 2013 and ongoing for patent foramen ovale. The patient got the Pfizer vaccine on 17Dec2020 and on 25Dec2020 had experienced acute nausea and dizziness that persisted during weekend. Stated that it is now full blown vertigo. Stated that her doctor and pharmacist stated that people reported symptoms but did not know if these were symptoms of the vaccine because it is not listed. The patient experienced stuff head on 28Dec2020. Stated that the nausea comes and goes. Stated that she got physical therapy treatment Epley for vertigo on 28Dec2020 and it did some good but she woke it with it again this morning on 29Dec2020. Stated that the therapy lessened her nausea as well. Stated vertigo was manageable 25-26 and then did not feel safe walking in her home on 26Dec2020. Stated that she had no symptoms after she received it up until 25Dec2020. Stated that she will get the second dose 07Jan2021. The outcome of the events was not recovered.
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| 55 | 2021-01-04 | fever, fatigue |
fatigue; Fever/Woke up on 27Dec2020 with 100.5F; some soreness at injection site; This is a spontane...
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fatigue; Fever/Woke up on 27Dec2020 with 100.5F; some soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), intramuscular on the right arm on 26Dec2020 10:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included hypertension. Concomitant medications included lisinopril (LISINOPRIL), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), citalopram (CITALOPRAM), ascorbic acid (VITAMIN C), calcium (CALCIUM), loratadine (LORATADINE) and Sudaphrene pene (as reported). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 06:00 (as reported), the patient had fatigue, and some soreness at injection site. It was reported that the patient woke up on 27Dec2020 with 100.5 F that lasted most of day until 5 pm. It was mentioned that the patient did not receive any treatment for the events. The patient recovered from fever on 27Dec2020 17:00 while recovering for the remaining events.
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| 55 | 2021-01-05 | fever, chills |
1/5 Chill-fever 101.6 @6:45A Reaction 9pm 116 Resolved. Went to ED, covid rapid (-) prior covid (-) ...
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1/5 Chill-fever 101.6 @6:45A Reaction 9pm 116 Resolved. Went to ED, covid rapid (-) prior covid (-) Antibodies result (-) 2nd dose
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| 55 | 2021-01-05 | dizziness |
5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lig...
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5 minutes after receiving Covid-19 vaccination patient reacted with chest tightness and was very lightheaded. Patient has a history of anaphylaxis and had Epi Pens with her. 1600 Vitals: BP: 184/72 P: 117 SaO2: 100% Epi Pen self-administered. 1605 Vitals: BP: 125/74 P:103 SaO2: 100% Nurse transferred patient to ER in wheelchair for further treatment and evaluation.
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| 55 | 2021-01-05 | chills, headache |
Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; ...
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Excruciating pain from left deltoid radiating downward to wrist; Left hip pain/Bilateral knee pain; Shivering; Headache; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), intramuscular in the left arm, on 28Dec2020 at 16:30 (at the age of 55-years-old) at a single dose for COVID-19 immunization. Medical history included insomnia, gastrooesophageal reflux disease (GERD), anxiety, mitral valve replacement (MVR) on an unspecified date, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. Concomitant medications, taken within two weeks prior to vaccination, included atenolol (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC), sertraline hydrochloride (ZOLOFT), eszopiclone (LUNESTA), krill oil (MANUFACTURER UNKNOWN), linum usitatissimum oil (FLAXSEED OIL; MANUFACTURER UNKNOWN); ascorbic acid (VITAMIN C; MANUFACTURER UNKNOWN), and calcium (MANUFACTURER UNKNOWN). The patient previously took erythromycin (MANUFACTURER UNKNOWN) and experienced allergy, nitrofurantoin (MACRODANTIN) and experienced allergy, and loracarbef (LORABED) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache on 29Dec2020 at 07:00. The events were reported as non-serious. The excruciating pain from left deltoid radiating downward to wrist woke the patient up from her sleep. Therapeutic measures were taken as a result of the events, which included treatment with hydrocodone bitartrate, paracetamol (VICODIN) and heat application. The clinical outcome of excruciating pain from left deltoid radiating downward to wrist, left hip pain/bilateral knee pain, shivering, and headache was recovered with sequel in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 55 | 2021-01-05 | headache, chills, fatigue |
Nausea; Fatigued; chilled; Massive headache; Muscle and joint pain; Muscle and joint pain; This is a...
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Nausea; Fatigued; chilled; Massive headache; Muscle and joint pain; Muscle and joint pain; This is a spontaneous report from a contactable other HCP (patient). A 55-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in left arm on 29Dec2020 10:30 at first single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medication received within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient started with muscle and joint pain, within an hour had a massive headache (took ibuprofen). The next day patient began to feel fatigued, chilled, still massive headache, muscle and joint pain and nausea set in the second evening. On 31Dec2020 still had a massive headache but all other symptoms began to fade as the day went on. Currently the evening of the 31Dec2020 still a massive headache. Adverse event start date reported as 29Dec2020 01:15 AM. Events were considered as non-serious. No other treatment received for the adverse events (except ibuprofen). Since the vaccination, the patient had not been tested for COVID-19. Outcome of event headache was not recovered, of other events was recovering. Information about lot/batch number requested
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| 55 | 2021-01-05 | weakness |
On 12/24/20 through Wed 12/30 daily while exercising; either back country skiing, resort/alpine ski...
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On 12/24/20 through Wed 12/30 daily while exercising; either back country skiing, resort/alpine skiing, Nordic/skate skiing or hiking uphill, I developed rapid onset, severe, debilitating, crippling 8/10 pain in my right fectus femoris thigh muscle. Duration of spasms 1-2 seconds, frequency every 10-15 minutes while exercising up to 6 hours/day. Self treatment included taking Ibuprofen 400 mg tabs po daily, OTC electrolytes po daily, application of topical diclofenac (Voltaren) gel, increase in hydration of non caffeinated/non alcoholic beverages; without any improvement.
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| 55 | 2021-01-05 | headache | Queasy No taste headache tight neck- stiff |
| 55 | 2021-01-05 | fatigue, fever, cough | Temperature, cough, chest pressure, fatigue, redness and bump at immunization site |
| 55 | 2021-01-05 | dizziness |
Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure wa...
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Wave of coolness reported. Lightheadedness that resolved 10 minutes post vaccine. Blood pressure was high on taking 183/91. Patient reports History of "White Coat Hypertension". Symptoms resolved. MOnitored for at least 15 minutes and released to home. Recommended patient follow-up with PCP regarding potential underlying hypertension..
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| 55 | 2021-01-05 | skin warm |
Within five minutes of the vaccine my face broke out with a rash and was warm to the touch. Doctor ...
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Within five minutes of the vaccine my face broke out with a rash and was warm to the touch. Doctor took my blood pressure and it was fine, recommended Benadryl when I got home.
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| 55 | 2021-01-06 | fever, body temperature increased, headache, chills |
12 hours after injection I had chills, body aches, fever, headache, nausea, vomited, diarrhea. Tempe...
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12 hours after injection I had chills, body aches, fever, headache, nausea, vomited, diarrhea. Temperature was in the 101.5 range for more than 24 hours, About 30 hours with a fever.
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| 55 | 2021-01-06 | fever, headache |
First dose of vaccine administered on 1/6/2021 at 1:33pm. Headache and fever started 1/7/2021 around...
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First dose of vaccine administered on 1/6/2021 at 1:33pm. Headache and fever started 1/7/2021 around noon. Reports taking Tylenol to help alleviate symptoms.
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| 55 | 2021-01-06 | chills, fever, dizziness, headache |
Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observatio...
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Headache, Fever, Tachycardia, rigor, lightheaded, back ache, BP 80/50, admitted to ER for observation from 11 am to 5 pm
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| 55 | 2021-01-06 | headache, cough, weakness, chills |
Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall ...
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Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.
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| 55 | 2021-01-06 | headache, fatigue | Headache, Myalgia, tireness Narrative: |
| 55 | 2021-01-06 | fatigue, headache | Headache, NauseaVomiting, Fatigue |
| 55 | 2021-01-06 | migraine | Migraine sore arm nausea body aches stiff elbows |
| 55 | 2021-01-06 | headache |
Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patien...
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Patient initially experienced headache, body aches, arm pain, and swelling under the armpits. Patient managed symptoms with ice packs. Symptoms have resolved as of 1/6/2021
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| 55 | 2021-01-06 | headache |
Pharmacist noticed the patient trying to clear her throat and she said she thinks she just needed a ...
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Pharmacist noticed the patient trying to clear her throat and she said she thinks she just needed a drink. When the drink did not help she was given 12.5mg of diphenhydramine at 4:57pm. It was recommended and offered for her to take 25mg of diphenhydramine but patient stated it made her too drowsy. After a few minutes, the patient stated it felt like her throat was tightening so she was given the other 12.5mg of diphenhydramine given at 5:03pm. She stated her heart was racing and her head was pounding. Her blood pressure was 164/72 and pulse 117. She stated her chest was feeling tight and at 5:11 an EpiPen was administered and call to 911.
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| 55 | 2021-01-06 | headache |
Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also ...
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Same evening body aches and injection site was painful. In 24 hrs my lymph nodes were swollen, also neck and arm pit. I also had headaches and body aches across my shoulder, neck and back.
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| 55 | 2021-01-06 | sweating, throat irritation, shortness of breath, skin warm |
Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot ...
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Vaccine administered at 11:15 AM. At 12:00 pm the top of my head became very hot, my face felt hot and red with raised rash, my scalp became very itchy, my heart felt like it was beating out of my chest and I had pounding in both ears. My bilateral forearms began to itch and then developed hives. I notified my Supervisor that I was having a reaction. I was checked in to ER (where I am an RN). My blood pressure was elevated 180's systolic and my heart rate was 180BPM and short of breath. An IV was started and I was given Normal Saline Bolus, Solu-medrol 125MG and Benadryl 25MG IV. Prior to medications, my throat felt itchy and "tight" but resolved once medication given. The itching and hives continued to spread to my upper back, neck, bilateral feet and behind my bilateral knees. After approximately 1 1/2 hrs itching and hives continued then I was given Pepcid IV and Benadryl 25mg PO which after 40 minutes my itching and hives resolved. I was later discharged home with a prescription of Methylprednisolone 4MG dose pack. Symptoms resolved until approximately 1:30 am on 5/7/2021 when I awoke to pounding in my ears and the feeling once again my heart was beating out of my chest. My heart rate was 132BPM, I became hot and diaphoretic, short of breath. My scalp felt it was on fire and then I broke out in hives. I immediately took Prednisone, benadryl and pepcid. I took a cool shower, got dressed and drove to the hospital down the road and sat in the parking lot just in case my throat became itchy and tight (which it did not). The hives and itching began to resolve after an hour. My heart rate went back to 67BPM and shortness of breath resolved as well. I called Employee Health at hospital and made a report of symptoms.
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| 55 | 2021-01-06 | shortness of breath | edema of eyelids, SOB |
| 55 | 2021-01-06 | fatigue, fever, malaise | fever feeling of unwell fatigue |
| 55 | 2021-01-07 | headache, chills, fever |
1/7/2021: 1200 PM H/A 1700 - 1100 PM Chills with continued shaking 1100 PM Febrile 102.5 1100 PM ...
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1/7/2021: 1200 PM H/A 1700 - 1100 PM Chills with continued shaking 1100 PM Febrile 102.5 1100 PM Swollen/Painful lymph nodes -left axilla
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| 55 | 2021-01-07 | fever, chills, headache |
At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around ...
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At 330 am I got the chills and could not go back to sleep, after an hour went back to sleep around 530 am started running a fever of 100.3 and had a severe headache and body aches. Fever went down with tylenol, but had headache all day. Fever did come back later in the day resolved with Tylenol. Next day fine but did have cold sores inside mouth . Head ache on 1/8 no fever or anything.
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| 55 | 2021-01-07 | headache, fatigue, fever, chills |
Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit o...
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Body ache / pain; Tiredness; Headache; my head is still throbbing; Muscle pain; Chills; Little bit of nausea; Ear ringing; Left eye was twitching a lot; At 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) solution for injection, intramuscular on her arm on 30Dec2020 at a single dose for COVID-19 immunization. Medical history included neuropathy in feet and thyroid condition. The patient's concomitant medications were not reported. Patient reported she was having some of the symptoms like the body ache and just the normal and not the really difficult symptoms or whatever just the tiredness, headache, muscle pain and chills, and pain and a little bit of nausea but last night her ears were ringing and her left eye was twitching a lot and she hadn't taken her temperature because she really didn't think she had a temperature. Then she decided to go ahead and take it and at 5 o'clock it (temperature) was 99.2 and at 6:20 it was 98.8 at 9 o'clock it a 99.5 and at 3 AM it was 101 and the information in the packet doesn't say like if she can take Tylenol or Motrin trying to get this headache to go away. The patient did not receive any treatment for the events. Outcome of the event headache was not recovered, ear ringing was recovering, left eye was twitching a lot was recovered, while the other events was unknown. No follow-up activities are needed. No further information is expected.
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| 55 | 2021-01-07 | dizziness, headache | By the evening pounding headache not relieved by Tylenol. Body hurts nausea still dizziness restless |
| 55 | 2021-01-07 | chills, headache | Chil,bodyache, headache upset stomach |
| 55 | 2021-01-07 | night sweats, fever, fatigue, chills |
Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymph...
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Dose 1 site soreness Dose 2 severe muscle and bone pain, chills, night sweats, fever, axillary lymphadenopathy, fatigue, nausea-evaluation for symptoms- no prescribed treatment
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| 55 | 2021-01-07 | fatigue, migraine, headache |
Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain...
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Fatigue; Migraine; Body aching everywhere including joint and muscle everything; General aches, pain; Headache; Severe muscle pain around the injection site; Severe muscle pain around the injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231), via an unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date, covid-19 from an unknown date. Concomitant medication included metformin. The patient stated the side effects were initially day one (30Dec2020) was this general aches, pains and headache. It almost started as if it was a Covid itself starting all over again because she had this disease already earlier this year and the headache and general ache and pains and pretty severe muscle pain around the injection site and also the general aches and pain. The second day (31Dec2020) was extreme fatigue, migraine that the never went away, body aching everywhere including joints and muscle everything. It almost felt like the Covid itself all over again. Patient took Motrin essentially around the clock something 6 (intent: 600mg) to 800 mg every 6 hours or so. The outcome of event migraine was not recovered, the other events was unknown.
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| 55 | 2021-01-07 | sweating, throat irritation, throat swelling |
Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling,...
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Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes.; hives on neck; This is a spontaneous report from a contactable health care professional nurse, the patient. A 55-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9844), intramuscular in the left arm on 20Dec2020 13:45 as a single dose, Lot number EK5730 for COVID-19 vaccination. Medical history included ongoing complex regional pain syndrome. The patient previously took Ceftiaxone, tizanidine, vancomycin, triamcinone, duloxetine and experienced drug hypersensitivity. Concomitant medication were taken within two weeks but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 20Dec2020 14:00 the patient experienced flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating. Started after 5 minutes. No treatment was given for the events. The clinical outcome Flushing, increased heart rate, tingling and swelling of lips, scratchy throat with slight swelling, eyes felt like pinpoints, hives on neck, sweating was recovered.
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| 55 | 2021-01-07 | headache |
HA starting for 1 hour after injection, lasted for 24-26 hours despite Advil, Excedrine and Fiorocet...
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HA starting for 1 hour after injection, lasted for 24-26 hours despite Advil, Excedrine and Fiorocet Abdominal cramps with diarrhea starting 4 hours later, lasted another 4 hours (I get diarrhea very rarely)
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| 55 | 2021-01-07 | headache |
Headache Narrative: 12/22 1300 vaccinated. 12/22 1430 onset of headache. 12/23 headache persists. No...
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Headache Narrative: 12/22 1300 vaccinated. 12/22 1430 onset of headache. 12/23 headache persists. No medication necessary to treat he headache. She denies all other symptoms.
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| 55 | 2021-01-07 | headache |
Headache; Body aches; This is a spontaneous report from a contactable nurse (patient). A 55-year-ol...
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Headache; Body aches; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscular (hope it was IM, but did not know for sure because she was not watching) at right arm deltoid on 29Dec2020 08:40 at single dose for COVID-19 immunization, at the hospital where she works. The vaccine was not administered at military facility. The patient's second dose was scheduled to be 19Jan2021. The patient's medical history included potassium low, hypertension, pericarditis, asthma, herniated disc in back, pain, gastrointestinal infection (GI), Vitamin D low, wheezing, exposed to someone who was positive with COVID at a wedding on 28Dec2020, "diuretic", "cardiac/heart" and "Cholesterol". Concomitant medication included ranolazine (RANEXA) for heart, isosorbide for cardiac, potassium chloride for potassium Low, furosemide for diuretic, atorvastatin (LIPITOR) for cholesterol, acetylsalicylic acid (ASPIRIN) for cardiac, montelukast sodium (SINGULAIR) for asthma, pregabalin (LYRICA) for herniated disc in back take for pain, nebivolol hydrochloride (BYSTOLIC) for blood pressure, pantoprazole sodium sesquihydrate (PROTONIX) for GI, celecoxib (CELEBREX) for pain, spironolactone for diuretic, vitamin D for Vitamin D low, nitroglycerin for angina, salbutamol (ALBUTEROL) for wheezing, and oxycodone for pain; all ongoing. History of all previous immunizations with the Pfizer vaccine considered as suspect was reported as none. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. The patient reported events on the Pfizer COVID Vaccine. She reported after getting the vaccine she had body ache and headaches. On 30Dec2020 16:00, the patient experienced headache and body aches. The event headache was reported as serious medically significant. She received the COVID vaccine on 29Dec2020 and had significant body aches, but she still had a headache that had not gone away since she got the vaccine. The patient explained the body aches were mild to non-existent/resolved, later confirmed as still ongoing, but better. Her main issue was the headaches that had not gone away. The events headache and body aches started around 16:00. She worked nightshift and she woke up with it. The events did not require a visit to the emergency room or physician office. The day after she received the COVID Vaccine she was tested for COVID. She found out she was exposed the day before she received the COVID vaccine, 28Dec2020 to someone who was positive with COVID at a wedding. She later found out her COVID test on 30Dec2020 was negative. The reporter assessed both events headache and body aches as related to the suspect vaccine. She believed the body ache and headache were related to the COVID Vaccine itself. She added, she felt it's related because these events are not part of her typical health problems. She added they're not going away even with medications (oxycodone, Celebrex, and ibuprofen). Oxycodone was located in an orange pharmacy filled bottle and she was unable to provide a lot/exp/NDC. Celebrex was located in an orange pharmacy filled bottle and unable to provide a lot/exp/NDC. She saw a use by date of 10Mar2021. Ibuprofen (Lot number: OCE2824A and expiration date: Dec2021). The outcome of the event headache was not recovered, for the event body aches was recovering.; Sender's Comments: There is a reasonable possibility that the event headache was related to BNT162b2 based on known drug safety profile and close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-01-07 | fever, headache |
High fever 101degF for 36 hrs, headache, muscle pain, joints pain, stomach discomfort. Took Tylenol...
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High fever 101degF for 36 hrs, headache, muscle pain, joints pain, stomach discomfort. Took Tylenol every 6 hrs.
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| 55 | 2021-01-07 | chills |
Recipient reported having chills overnight and reported to work today with left arm to left flank so...
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Recipient reported having chills overnight and reported to work today with left arm to left flank soreness. She took Motrin
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| 55 | 2021-01-07 | throat swelling |
Tingly lips, felt like throat was swelling. I was able to breath fine. Given Prednisone and Prevac...
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Tingly lips, felt like throat was swelling. I was able to breath fine. Given Prednisone and Prevacid and symptoms went away.
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| 55 | 2021-01-07 | migraine, fatigue |
VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea...
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VERY sore joint (couldn?t walk using my knees). Very exhausted, migraine headache and slight nausea.
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| 55 | 2021-01-07 | headache, fever, chills |
at 10:10pm, started with chills and shivers for over an hour. Muscle aching as a result of the shive...
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at 10:10pm, started with chills and shivers for over an hour. Muscle aching as a result of the shivers that last over an hour. Fever of 101.5 at 1am in the morning. Head ache that was first in the temples and then went behind the eyes. Water had a metal taste to it. Did not take a tylenol or anything to relieve the fever or ache. I prefer to allow my body to fight it naturally. Used an ice pack at the nap of my neck to help with fever and also headache. Also took 2 showers to help with body ache. 1/8/21 12:20pm fever is still 100.4. Body is still achy with slight headache.
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| 55 | 2021-01-07 | fever, chills |
felt the need to have a COVID test, which turned out positive; felt the need to have a COVID test, w...
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felt the need to have a COVID test, which turned out positive; felt the need to have a COVID test, which turned out positive; felt the need to have a COVID test, which turned out positive; Chills; Fever; This is a spontaneous report from a contactable Other HCP. A 55-year-old female patient received frist dose of BNT162B2 (Batch/lot number: EK5730) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient explained receiving the COVID-19 vaccine on the 21Dec2020 and experienced fever and some chills. She pursed explaining that she was fine afterwards but felt the need to have a COVID test, which turned out positive of the 31Dec2020. The patient stated that she only had chills and fever the evening of 29Dec2020 and had been fine every since. Her fever that night did not hit 100 degrees. She thought that it would be better if she did not go to work on that Wednesday since she had had a fever the night before. She called her doctor who told her to come into the office on 31Dec2020 to have a rapid COVID test done and it came back positive. She only had fever and chills that one night and has not had any other symptoms. She received no treatment and did not take anything for the fever. This all happened during the night. She felt fine when she got up the next morning. Because she had received the first dose of the COVID vaccine, she thinks that this helped her. She thinks if she had not had the vaccine, then the virus would have been a lot worse. She stated that her second dose of the vaccine is scheduled on the 11Jan2021, and asked if it is safe to get the second dose of the COVID-19 vaccine. The outcome of events chills and fever was recovered; of other events was unknown.; Sender's Comments: The association between lack of effect (suspected COVID-19, SARS CoV2 test positive) with BNT162b2 can not be completely excluded.
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| 55 | 2021-01-07 | lethargy, night sweats, weakness, chills, dizziness, headache, fever |
left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection si...
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left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.
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| 55 | 2021-01-07 | throat irritation |
pt reported "throat feels itchy and is tightening", epinephrine im given, vitals monitored Pulse ox ...
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pt reported "throat feels itchy and is tightening", epinephrine im given, vitals monitored Pulse ox 99-100%, Pt reported within 1 min of epinephrine administration, that she no longer felt that her throat was "itchy and tightening" response team arrived within 5 min, and pt was transported to ER
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| 55 | 2021-01-07 | nasopharyngitis |
sick; Cold; This is a spontaneous report from a contactable consumer (patient). A 55-year-old femal...
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sick; Cold; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 via an unspecified route of administration on 30Dec2020 at a single dose as Covid vaccine. Medical history included did have Covid on unspecified date. There were no concomitant medications. It was reported that the patient got her vaccine Covid shot on the Wednesday (30Dec2020) and now she's sick again on 02Jan2021; she could still smell everything (still smell it again) and could still taste everything, so none of that has gone away. She thought she came up with the cold on 02Jan2021. She was not sure if it was just cold. She had already been and had that her full shot. She had not been tested for Covid again. She asked if she should go tested again. The reason for no lot number was because she didn't know that. That's from work, they could provide the lot. No treatment was received for the events. Lab data included tested for Covid: did have Covid on unspecified date. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
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| 55 | 2021-01-07 | weakness |
usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type ...
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usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type feeling in wrist
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| 55 | 2021-01-07 | dizziness |
within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl ...
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within 5 minutes became lightheaded, flushed, tachycardia , itching in both hands Given Benadryl 25 mg , Pepcid , solu-medrol
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| 55 | 2021-01-08 | fever, fatigue |
2 inch area red and swollen around injection site, headache, fatigue, fever Tylenol and ibuprofen ta...
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2 inch area red and swollen around injection site, headache, fatigue, fever Tylenol and ibuprofen taken
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| 55 | 2021-01-08 | fever, fatigue, headache | 2 inch red area around injection, fever, aches, fatigue, headache Taking tylenol and ibuprofen |
| 55 | 2021-01-08 | headache | Headache & Myalgia |
| 55 | 2021-01-08 | headache | Headache Narrative: |
| 55 | 2021-01-08 | headache, throat pain, fatigue | Headache fatigue, sore throat Narrative: |
| 55 | 2021-01-08 | dizziness, headache |
Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. ...
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Headache started 12/30/2020. Nauseous and dizzy off and on. Arm pain at injection site for 3 days. Headache unresolved even after taking headache med, ibuprofen, oxycodone. Nausea and dizziness is intermittent.
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| 55 | 2021-01-08 | chills, headache, fatigue, body temperature increased | Severe muscle aches, headache, 100.3 temp, chills, tirid |
| 55 | 2021-01-08 | dizziness, chills, fatigue |
Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills ...
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Severe right arm pain initially, about 8 hours post infection. Body aches, profound fatigue, chills and dizziness starting 10 hours post injection and persist entire next day.
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| 55 | 2021-01-08 | headache |
SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest an...
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SkinRash Vaccinated with 2nd dose @ 0942 w/o issue. After she returned to work, c/o rash to chest and arms. At 1500 returned to the immunization clinic. Take to ED for evaluation BP 224/108, 88, 18, 97% O2sat. Narrative: Vaccinated with 2nd dose @0942 w/o issue. 5 hours later at 1500 returned to the immunization clinic with c/o rash to chest and arms and c/o slight H/A. BP elevated. Taken to ED for evaluation BP 224/108, 88, 18, 97% O2sat.
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| 55 | 2021-01-08 | chills, headache, cough, fever |
fever, chills, body aches, nausea, headache, cough-over the counter meds symptoms lasted about 2-3 d...
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fever, chills, body aches, nausea, headache, cough-over the counter meds symptoms lasted about 2-3 days
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| 55 | 2021-01-09 | chills, fever |
Chills/Fever (103 at the highest) This started around 10:00pm, so I took 600 mg of ibuprofen and the...
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Chills/Fever (103 at the highest) This started around 10:00pm, so I took 600 mg of ibuprofen and the chills continued for 3 hours. Muscle aches and right arm stiffness occurred and remained for a couple days. The second day, my fever was hovering around 101 most of the day. I took ibuprofen and the fever let up, but returned in the night and persist today (day 3). My fever is right at 100 today.
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| 55 | 2021-01-09 | cough, headache | Cough, body aches, headache |
| 55 | 2021-01-09 | chills |
Pfizer-BioNTech COVID-19 Vaccine EUA~ 8 hrs after receiving second vaccine, developed severe nausea...
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Pfizer-BioNTech COVID-19 Vaccine EUA~ 8 hrs after receiving second vaccine, developed severe nausea & intense vomiting for several hours associated with severe chills and severe myalgia and severe arm pain (though no redness) at vaccine injection site. Vomiting/nausea continued despite Zofran x 2 and lasted ~ 8 hrs. The intense chills and myalgia lasted ~ 48 hrs- symptoms severe enough to keep me in bed for that time. Other than soreness at injection site and mild headache the next day, I had no adverse reaction after first vaccine dosage that was given on 12/21/20
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| 55 | 2021-01-10 | nasopharyngitis, shortness of breath, fever, cough, throat irritation |
1/5/21 at 1512, employee was having cold like symptoms prior to getting vaccine. REcieved vaccine a...
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1/5/21 at 1512, employee was having cold like symptoms prior to getting vaccine. REcieved vaccine and next day was feeling SOB on 1/6/21 and progressively SOB worsened. 1/7/21 called in due to severity of symptoms and went to Urgent Care that day. TEsted + for STrep but negative for Covid. Other symptoms are cough, scratchy throat and low grade fever off and on (high was 100.4). On 1/8/21 employee went to ER for increased SOB. Tested negative again for Covid but had an elevated D-dimer. No diagnosis was given. Employee was discharged home. As of 1/11/21 still continues with SOB due to unknown etiology.
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| 55 | 2021-01-10 | fatigue, influenza like illness |
1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2...
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1/8/21 tingling/ sensitive/extra warm lips - from 5 mins after injection till 8pm that night 01/08/2021 (thought due to wearing mask?) 1/9/21 soreness & heat to injection site - joint pain esp. hands, elbows and wrists; and flu-like symptoms - tired 1/10/21 little redness to site-swollen/soreness & heat still ; joint pain in fingers still not so much in main joints 1/11/21 finger joint pain - lot of redness/soreness/heat/swollen to site of injection ** new symptom sharp pinching pain around site
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| 55 | 2021-01-10 | chills, fatigue, somnolence, headache |
Date of onset: 01/08/2021 - headache, chills and fatigue. Intense headache and chills lasted most o...
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Date of onset: 01/08/2021 - headache, chills and fatigue. Intense headache and chills lasted most of the day on the 8th. The fatigue was most of the weekend. I slept 12 hours on Saturday night the 9th, and preceded to nap in the afternoon on the 10th. Both of these sleep times are very much out of the ordinary for me. I also took 3 doses of Ibuprophen for the headache on the 8th.
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| 55 | 2021-01-10 | chills, fever, headache | Fever, chills, headache, body aches, nausea |
| 55 | 2021-01-10 | fatigue, headache, chills, fever |
Fever, chills, nausea, achiness, fatigue started at 1:00am in 1/11. Now at 6:08 pm on 1/11, headache...
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Fever, chills, nausea, achiness, fatigue started at 1:00am in 1/11. Now at 6:08 pm on 1/11, headache and fatigue are persisting.
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| 55 | 2021-01-10 | headache |
Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased B...
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Numbness lips,mouth; Was feeling bad; leg numbness/numbness in head, face; pain in head; increased BP; blood pressure was up and down; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) via an unspecified route of administration in left arm on 29Dec2020 6 am at single dose for covid-19 immunisation. Co-suspected drug amoxicillin;clavulanic acid (AUGMENTIN, Batch/lot number: KN4291, Expiry Date: Mar2022) by mouth from Dec2020 to 28Dec2020 at 875mg, 1 tablet twice daily for pain or infection; MOXIFLOXACIN HYDROCHLORIDE (AVELOX, strength:400mg) by mouth from 29Dec2020 and ongoing at 400mg, 1 tablet once daily for infection; fluconazole (DIFLUCAN, strength:200mg) orally (by mouth) from unknown date and ongoing at 200mg, 1 tablet once daily for Infection.The patient's medical history was reported as ongoing high blood pressure, ongoing pains in her fingers and toes and they thought she had an infection from 02Dec2020, white count went down on 09Dec2020, ongoing pain was up and down. No other vaccines given at that time and none given 4 weeks prior. Had a Flu shot back in Oct2020, but no problems. None diagnosed allergies and family medical history relevant to adverse event. The concomitant medications included unspecified blood pressure medication by mouth daily for high blood pressure. She had also started 2 antibiotics around the same time that she received the vaccine. No further details provided Was on antibiotics at the time she was given the Pfizer COVID-19 vaccine. Patient experienced increased BP/ high blood pressure, pain in head, and leg numbness; all started 2 days (on 31Dec2020) after receiving the vaccine and persisted for 48 hours. First her blood pressure was up and they had to get it stable and had numbness in her head, face, and mouth for 48 hours. Her blood pressure was up and down and she has history of blood pressure and takes medicine. Was taken off work for a few hours and went to the emergency department on Fri night about 2am. Her blood pressure was 170/92 on 01Jan2021. Not sure if this was related to the vaccine, but the numbness in her head started from her upper neck to face to the right side of her check and she also had leg numbness. Wanting to know if this was related because she was worried about getting the second dose. Had a hard time for 48 hours. Weight was between 150-155 pounds. Stated everything improved after 48 hours. Her lip was also just a little bit numb, but it is feeling better. Patient was feeling bad from 01Jan2021, all Fri and Sat and much better by Sun. Events of increased BP/ blood pressure up and down, leg numbness, numbness in lips, head, face, mouth with emergency room visiting. Wanted to know if she should have the second dose. The action taken in response to Augmentin was permanently discontinued on 28Dec2020, for Avelox and Diflucan was dose not changed. The outcome of events was recovering.
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| 55 | 2021-01-10 | dizziness |
Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not sub...
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Patient experienced throat tightness, chest tightness, anxiety, and lightheadedness that did not subside after 30 minute observation. She was transferred to the ED for further evaluation.
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| 55 | 2021-01-10 | dizziness |
Patient experienced throat tightness, chest tightness, lightheadedness, and anxiety which did not su...
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Patient experienced throat tightness, chest tightness, lightheadedness, and anxiety which did not subside after 30 minutes of observation. She was transferred to the ED for further evaluation.
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| 55 | 2021-01-10 | headache, fatigue, malaise, chills |
The morning after the shot I woke up with chills, total body aches, headache and extreme fatigue. I ...
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The morning after the shot I woke up with chills, total body aches, headache and extreme fatigue. I broke my wrist last year and the ache in that wrist was awful. Motrin helped but this persisted throughout the day. General feeling of being unwell for the whole day and evening. The second day after the shot I woke up feeling better but in my armpit on the arm I received the shot it felt like I had a lump in my arm pit and it is sore. This is still there today, the third day after the shot.
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| 55 | 2021-01-10 | lethargy, headache, fatigue, weakness | Tiredness, queasy stomach, low energy, lethargic, headache, swelling and pain at injection site |
| 55 | 2021-01-10 | fever | fever, vomiting, diarrhea. called in sick to work. |
| 55 | 2021-01-10 | fatigue, influenza like illness, headache |
lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure du...
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lips sensitive- tingling/felt warm - right after injection/vaccination till about 8pm ( not sure due to mask or injection) started with soreness/heat to site, joint pain, flu-like symptoms- body aches, tired and headaches. - January 9th. most joint pain gone except to fingers gone. soreness and heat to site of injection. - January 10th finger joints hurt still hurts, site of injection - redness swollen/ heat still - around site a "pinching" pain, which is a new today - Jan11th
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| 55 | 2021-01-10 | sweating | pt reported bilateral arm numbness and was diaphoretic at 0904 |
| 55 | 2021-01-10 | headache, fever, chills, chills, headache, fever | significant rigors, severe headache, felt feverish, but no fever for about 12 hours |
| 55 | 2021-01-11 | fever, chills, headache |
HEADACHE STARTED 17 HOURS POST VACCINATION TOOK TYLENOL,IBUPROFEN AND FIORCET (IT WENT AWAY 24 HRS L...
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HEADACHE STARTED 17 HOURS POST VACCINATION TOOK TYLENOL,IBUPROFEN AND FIORCET (IT WENT AWAY 24 HRS LATER). BODY ACHES STARTED 29 HOURS POST VACCINATION (WENT AWAY 48 HOURS POST VACCINATION) FEVER 100.4 AND CHILLS STARTED 52 HRS POST VACCINATION AND WERE GONE BY 36 HOURS.
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| 55 | 2021-01-11 | chills, headache, fatigue | Headache, Body Aches, Chills, Fatigue |
| 55 | 2021-01-11 | chills, headache | Headache, nausea, chills, Body aches |
| 55 | 2021-01-11 | cough |
Itching; neck rash; cough; This is a spontaneous report from a contactable nurse. A 55-year-old fema...
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Itching; neck rash; cough; This is a spontaneous report from a contactable nurse. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 27Dec2020 08:15 at a single dose for COVID-19 immunisation. Medical history included hypertension and allergies from IVP dye, sulfa, and iodine. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril, and calcium carbonate (CALTRATE). On 27Dec2020 08:30, the patient experienced itching, neck rash and cough. The patient underwent lab tests and procedures which included investigation: unknown results (Pending) on 02Jan2021. Therapeutic measure was taken as a result of the events that included Benadryl. Clinical outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.
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| 55 | 2021-01-11 | dizziness |
PATIENT BECAME DIZZY AND ELEVATED HEART RATE (120) PATIENT OBSERVED AN EXTRA 15 MINS PATIENT SYMTOM...
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PATIENT BECAME DIZZY AND ELEVATED HEART RATE (120) PATIENT OBSERVED AN EXTRA 15 MINS PATIENT SYMTOMS RESOLVED
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| 55 | 2021-01-11 | shortness of breath, cough |
Sharp stabbing pains in right rib then left.; Shortness of breathe; cough; eyes swelled shut; This i...
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Sharp stabbing pains in right rib then left.; Shortness of breathe; cough; eyes swelled shut; This is a spontaneous report from a contactable nurse. This 55-year-old female nurse reported for herself and received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3246; Expiration date was not reported) on 30Dec2020 08:45 (at the age of 55-years) as single dose, Intramuscular in left arm for COVID-19 immunisation. Medical history included allergy to hydroxychloroquine sulfate (PLAQUENIL), patient experienced sleep disorder, migraine, and lupus. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications include pregabalin (PREGABALIN), amitriptyline (AMITRIPTYLINE) for sleep, solifenacin succinate (SOLIFENACIN SUCCINATE), leflunomide (LEFLUNOMIDE), omeprazole (PROTONIX), ondansetron (ZOFRAN), mirabegron (MYRBETRIQ), azathioprine (AZATHIOPRINE), and sumatriptan succinate (SUMATRIPTAN SUCCINATE) for migraine. Since the vaccination, the patient has not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 31Dec2020 at 17:15, the patient experienced sharp stabbing pains in right rib then left. Shortness of breathe, cough, and eyes swelled shut. The patient did received treatment as a result of the event with benadryl, aderol inhaler. The outcome of event eyes swelled shut was recovering, Shortness of breathe was recovering, cough was recovering, and sharp stabbing pains in right rib then left was recovering.
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| 55 | 2021-01-11 | malaise, fatigue |
Stomach issues. Cramping in lower stomach. Tired. My GERD started to bother me and still not feeling...
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Stomach issues. Cramping in lower stomach. Tired. My GERD started to bother me and still not feeling well.
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| 55 | 2021-01-11 | headache, malaise, chills |
headache; chills; nauseous; did not feel very well at all; diarrhea; hemorrhoid; This is a spontaneo...
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headache; chills; nauseous; did not feel very well at all; diarrhea; hemorrhoid; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (medical assistant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 02Jan2021 15:00 (3:00pm) at a single dose on the left deltoid as vaccination. The patient had no medical history. There were no concomitant medications. The patient reported having side effects from her first dose of Pfizer Coronavirus Vaccine administered on 02Jan2021. She tried reporting this information online but has been unsuccessful. Starting the evening of 04Jan2021, she had a headache, chills, felt nauseous, did not feel very well at all, diarrhea, and got a hemorrhoid. She still has a slight headache today; and when she woke up this morning, she felt a little nauseous but that went away; other side effects have improved at this time. Her doctor made her go get a Coronavirus test today in order to go back to work; because he said that the diarrhea and something else of the side effects, she did not remember were not a symptom of the Pfizer Coronavirus Vaccine. She had the Coronavirus test this morning on 06Jan2021 (unknown result); but would not get the results of that test until 48-72 hours after being tested. They would email her those results. Second dose was scheduled for 23Jan2021 at 3:45pm; she still plans to get the second dose. The outcome of the event nauseous was recovered on 06Jan2021 as it already went away while of the remaining events was recovering.
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| 55 | 2021-01-11 | fatigue, dizziness, headache |
headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report fr...
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headache; dizziness; fatigue; couldn't sleep; severe abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient herself). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration on the left arm on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history included Addison's disease, papaya allergy, and gluten intolerance. Concomitant medications included hydrocortisone and fludrocortisone acetate (FLORINEF ACETATE). The patient verbalized, "At first, on 29Dec2020, I experienced only mild side effects such as headache, dizziness and fatigue. Later, I woke up in the middle of the night with severe abdominal pain and couldn't sleep the pain was so bad. I had to take the following day off due to abdominal pain and fatigue." No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovered on an unspecified date.
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| 55 | 2021-01-11 | respiratory tract congestion, headache |
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a cont...
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tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse (patient) from a Pfizer-sponsored program Pfizer First Connect. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration in the right arm on 18Dec2020 at single dose for covid 19 immunisation as healthcare professional and husband was high risk. Medical history included hypertension from 2019 and ongoing. Concomitant medication included amlodipine besilate (NORVASC, 5 mg) from 2019 and ongoing for high blood pressure. The patient experienced tested positive for covid-19 on 03Jan2021 with outcome of not recovered, congestion and headache in Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID test on 03Jan2021 and the results came back positive on 04Jan2021. The patient was scheduled to receive her second injection on 08Jan2021. Since her first injection she had tested positive for COVID-19. The second dose had to be given a certain amount of days after the first. She would be outside that window. She would like to know if there is any guidance regarding the if/when she should get the second dose. The reporter would like to know if she waits longer than the recommended 21 days to receive her second dose of the COVID-19 vaccine would she need to restart the vaccination series. The reporter said this was not serious as she only had congestion and headache with treatment: using over the counter stuff. Event relatedness with COVID vaccine was unknown.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 vaccine cannot be completely excluded for reported "tested positive for COVID-19".
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| 55 | 2021-01-12 | shortness of breath, runny nose, headache, fatigue, cough, chills |
12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck....
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12/23/20 @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2. Headache, runny nose, fatigue, general achiness---became worse as the day progress to include both hips and knees becoming painful. Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
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| 55 | 2021-01-12 | weakness |
After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weake...
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After getting out of the bathtub as I was reaching for my towel, A VERY SUDDEN ONSET of severe weakeness hit me and I had to sit on toilet. I was unable to move my arms or legs for 20 minutes, then was able to get up but walked VERY WOBBLY AND WEAK to my bed just a few feet away. I collapsed on my bed and turned my fan blowing on me directly. {Im NEVER hot, usually cold ALL the time}. I layed there so weak I could barely move for another 20 to 30 minutes. I thought I was having a stroke honestly and my thoughts were about my doors being locked so nobody could get in to help me and my phone was in the living room and for that time period I WAS TOTALLY UNABLE to go get it. THANKFULLY, after about 45 minutes total, all symptons went away and I returned to my baseline mobility. Im very grateful that this was not a stroke as I thought. but I do believe it may have been a reaction to the vaccine. I did not notify any physicians yet, and as of this writing Im perfectly fine, Thank the Lord.
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| 55 | 2021-01-12 | chills | Body aches, chills |
| 55 | 2021-01-12 | chills | Chills Very sore arm |
| 55 | 2021-01-12 | fatigue, chills | Chills, fatigue,full body aches, abdominal pains |
| 55 | 2021-01-12 | fever | Fever, body aches. |
| 55 | 2021-01-12 | chills, headache |
Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth...
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Headache ongoing Chills with no fever ongoing Pain at injection site ongoing Metallic taste in mouth right after injection lasted 1 hour or so
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| 55 | 2021-01-12 | lethargy | Lethargic Muscle fatigue |
| 55 | 2021-01-12 | headache, fatigue |
On 1/7/21, seven days after receiving the first vaccine, I noticed a swollen and painful lymph node ...
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On 1/7/21, seven days after receiving the first vaccine, I noticed a swollen and painful lymph node in my neck on the right side. The lymph node was about the size of a large gumball. The next day I started having pain in the lymph nodes of my arm pit on the right side. The symptoms are still present six days later and I now have some swollen and tender lymph nodes in the antecubital area of the same arm. I am scheduled to get my second dose on 1/21/21. I have not had any other side affects that I know of other than feeling a little tired and mild headache on and off but that didn't seem unusual for me. The lymph node in my neck seems to be getting a little smaller as of today 1/13/21.
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| 55 | 2021-01-12 | cough |
Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed...
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Patient began to complain of itching all over body, numbness & tingling of lips. Patient was placed on guerney, O2@ 4L via mask placed, vital signs taken (pulse 81, BP 140/80), O2 sat on 4L via face mask 98%. Patient given epi pen injection @1422 and transported to ED. Upon arrival to ED, patient began to cough.
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| 55 | 2021-01-12 | sweating | Systemic: Sweating |
| 55 | 2021-01-12 | headache |
Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Loca...
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Tuesday, 1/12/21 around 8:00 am I noticed a Numbness, similar to when novocaine is wearing off. Location of numbness is in the area of the Right temple upper cheek bone easing toward ear. By 2:00 pm that day was experiencing a dull headache centering on my temple. I went home from work to lie down. The headache and numbness lasted into the next day. At the time of this report 8:57 pm on 1/13/21 the numbness is still there.
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| 55 | 2021-01-12 | shortness of breath | chest tightness with shortness of breath; nausea for 10 minutes. Pain radiating to jaw |
| 55 | 2021-01-12 | fever, headache |
headaches; tachycardia/fast heart beat; fever; body aches; joint pain/ joint ache; This is a spontan...
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headaches; tachycardia/fast heart beat; fever; body aches; joint pain/ joint ache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for work. The patient's medical history and concomitant medications were reported as none. The patient reported events of fever, headaches, body aches, joint pain, tachycardia, on 07Jan2021. Patient developed fever in the night, 100.5 at 1-3 am. Then, developed body ache and especially joint ache. She had a bad headache from 2-3 am. She also experienced a fast heart beat that started around 2-3 am. She received the vaccine at work. She started taking the paracetamol (TYLENOL) which did pushed down her fever. She thought it helped her headache as well and it helped her heart rate. Her headache was controlled with paracetamol. So she could not tell if it was improving, persisting, or worsening. Her heart rate at around 2-3 am was 115bpm, after paracetamol it got down to 105 bpm. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL). The outcome of the events fever and tachycardia was recovering, outcome of event headaches was unknown, outcome of the other evets was not recovered. The report was reported as non-serious.
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| 55 | 2021-01-12 | migraine | migraine with mild vomiting resolved by morning with medications |
| 55 | 2021-01-12 | fatigue, headache |
vomiting; tiredness; severe headache; nausea; This is a spontaneous report from a contactable other ...
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vomiting; tiredness; severe headache; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm from at 00:00 on 06Jan2021 at single dose for COVID-19 immunization. Medical history included depression and anxiety. Concomitant medication included bupropion, vortioxetine hydrobromide (TRINTELLIX). The patient experienced tiredness, severe headache, nausea, vomiting at 08:00 AM on 06Jan2021. It lasted about 36 hours total. The events were reported as non-serious. The patient did not receive any treatment from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on 07Jan2021. Information on the Lot/batch number has been requested.
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| 55 | 2021-01-13 | chills, fatigue, shortness of breath | Awakened severe shortness of breath, chills, muscle shakiness and pain, nausea, vomiting |
| 55 | 2021-01-13 | fatigue, fever |
Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, requi...
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Bilateral lower arm urticaria-(below elbow to and including writs.)red, welts, severe itching, required 10mg prednisone for 3 days to stop itching. Lasted 4 days. Also Left arm pain, 4 days. Fatigue and subjective fever.
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| 55 | 2021-01-13 | fever, headache, chills, fatigue |
During the early morning following my second Covid vaccination, I started having fever and chills, m...
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During the early morning following my second Covid vaccination, I started having fever and chills, muscle aches, and a headache. I woke up about 230 am and my stomach was hurting. I thought I would have to have a bm in a little while but was able to go back to sleep. About an hour and a half later, I again woke up with stomach pain, maybe some bloating. I decided to go into the bathroom and I sat on the floor beside the toilet and began vomiting. I vomited 5 times and had one dry heave. The vomitus was clear in color, thin with some small pieces of food. I had felt very hot before vomiting, but was unable to check my temperature due tp nausea and vomiting. I checked my temperature a little while later and it was 100.2 F. I was able to go back to sleep for a while and kept checking temperature during the day. It was between 99.1 and 99.8 for most of the day.
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| 55 | 2021-01-13 | headache, fatigue | Fatigue, Headache, Body aches |
| 55 | 2021-01-13 | headache, fever, chills, fatigue, nasopharyngitis |
Got her vaccine yesterday 01/12/2021. Took 2 Tylenol yesterday. Last night at 10pm, Started feeling...
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Got her vaccine yesterday 01/12/2021. Took 2 Tylenol yesterday. Last night at 10pm, Started feeling very cold/chills, and had fever of 102, also have headache, very tired. When she had fever her ear hurt.
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| 55 | 2021-01-13 | throat irritation |
I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a d...
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I began to experience a dry throat about 10 minutes after injection - I attributed it to needing a drink. My throat then felt a bit warm and I thought this was due to thirst as well. I left the monitoring area. I was walking to my vehicle and began to feel more of a warm sensation in my throat and not into my upper chest. About 5 minutes after this took place my face became flush and began tingling and feeling sunburned and tight - I looked in the mirror and my cheeks and nose and chin were red and felt extremely warm - I did not have facial swelling that i noticed buy my face felt tingly and like it was sunburned - my eye felt puffy but did not look puffy enough to notice in the mirror. Approximately 30-35 minutes after the immunization, I took 50mg of Benadryl and 1300mg of Tylenol. I felt my symptoms begin to improve about 25-30 minutes after taking the medication - my throat and chest were not as warm. the facial flushing lasted about an hour or hour and a half. The morning after my immunization I did have a scratchy throat - I did not take any further medication - by the afternoon - this is almost gone - still just a little scratchy.
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| 55 | 2021-01-13 | headache, chills, fatigue |
Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Mediu...
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Systemic: Rash (other than injection site)-Medium, Systemic: Chills-Mild, Systemic: Exhaustion-Medium, Systemic: Headache-Mild, Systemic: upper body test rash, itchiness around eyes and mouth, she discribed a tingling sension in the back of her throat, verbilized her tongue was swelling; symptoms lasted 1 day
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| 55 | 2021-01-13 | chills, headache, fatigue |
chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a conta...
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chills; body aches; headache; nausea; dry heaves; fatigue; This is a spontaneous report from a contactable Nurse. This Nurse reported for self that the 55-year-old female patient received second dose of bnt162b2 (BNT162B2, brand:ELI,, Batch/lot number: 283), via Intramuscular on Left arm on 06Jan2021 03:30 PM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known allergies to medications, food, or other products: Penicillin, sulfa drugs and Hypothyroid, genital herpes. Concomitant medications included the patient received within 2 weeks of vaccination: levothyroxine, Valacyclovir. The patient previously took first dose of bnt162b2 (BNT162B2, brand: EK, Batch/lot number: 5730), by injection via Intramuscular on Arm Right on 16Dec2020 03:30 PM at single dose for covid-19 immunisation. Facility type vaccine was Hospital. No other vaccine in fourweeks. At approximately 12 hours post injection chills, body aches, headache, nausea, dry heaves, fatigue from 07Jan2021 03:30 AM. No covid prior vaccination. No covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-13 | fatigue | fatigue, nausea, generalized feeling "junk" |
| 55 | 2021-01-13 | headache |
states she developed back pain unable to move, pain mid back shoulder blades and small headache inte...
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states she developed back pain unable to move, pain mid back shoulder blades and small headache intermittently; unable to sleep; feeling better at time of notification
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| 55 | 2021-01-14 | dizziness, headache |
About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by fee...
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About 20 minutes after vaccination, felt tingling throughout body. Slight headache, followed by feeling dizzy and wobbly. Must hold onto something to walk. Has some trouble focusing, "like a fog".
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| 55 | 2021-01-14 | headache, fatigue |
Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a histor...
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Developed shingles on left side of spine on mid/lower back area. 1.5 inch x .5 inch. I have a history of shingles in 2011. I received the 2 dose shingles vaccine in 2019. I received my second Pfizer dose on 1/11. Developed fatigue and muscle aches on 1/12, then slight headache, muscle weakness, myalgia's and arthralgia on 11/13. Morning of 11/14, woke up and noticed a sore spot/blister on my lower/mid back area. Slowly became more painful (burning sensation). No injury to area or any other reason for blister and pain. 11/15, realized it was shingles.
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| 55 | 2021-01-14 | fever | Fever, myalgia |
| 55 | 2021-01-14 | chills, headache, fever |
Headache with sharp shooting pains in temples, chills, low grade fever 100.6, body aches especially ...
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Headache with sharp shooting pains in temples, chills, low grade fever 100.6, body aches especially knees
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| 55 | 2021-01-14 | influenza like illness |
Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am ...
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Injection appx 12noon 1/13. Mild flu-like sympotoms started 8pm 1/13. Severe flu symptoms began 7am 1/14, lasted until appx 12noon. On 1/15, appx 8am I awoke with nausea. Began to vomit and all my extremities began to tingle. At that point, my hands and feet became rigid. This spread throughout entire body, including my head. I was unable to move my hands or feet. My fingers were frozen so hard that my husband could not even close my hand for me. My tongue felt thick and I was having difficulty speaking. Husband picked me up off the floor and carried me to our bed. We were getting ready to call 911 when my feet began to wake up and the rigidity subsided for all areas. Epidsode lasted appx 15 mins.
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| 55 | 2021-01-14 | headache | Joint aches, and headache |
| 55 | 2021-01-14 | chills, fatigue, headache |
Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report...
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Pain at shot location; swelling; chills; headache; body aches; fatigue; This is a spontaneous report from a contactable other healthcare professional (hcp). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) first dose on 18Dec2020 13:00 (lot 121820, expiry date not reported), then second dose on 08Jan2021 15:30 (lot EK9231, expiry date not reported); both intramuscular in the left arm at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient was not pregnant at the time of the vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The vaccines were administered in a hospital. On 09Jan2021 06:30, the patient experienced pain at shot location, swelling, chills, headache, body aches and fatigue. Post vaccination, patient had COVID test nasal swab (PCR) on 05Jan2021 and the results was negative. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient did not receive any treatments in response to the events reported. The patient was recovering from the events pain at shot location, swelling, chills, headache, body aches and fatigue.
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| 55 | 2021-01-14 | dizziness |
Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of t...
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Patient became lightheaded at approximately 11:10 a.m. which was 9 minutes after administration of the vaccine. The patient had expressed some anxiety about receiving the vaccine but wanted to receive it. The patient complained of lightheadedness and we lowered her to the floor with feet elevated. Her blood pressure had lowered significantly (60/40 approximately). Patient began to feel better and sat back in her chair. She again began to complain of lightheadedness and was lowered to the floor with feet elevated once more. Patients stayed in this position for several minutes. When her blood pressure was rechecked, it had risen back to 118/78. Patient felt much better and also ate some crackers and drank some water. Patient's blood pressure was checked a final time in a seated position after approximately 20 minutes and her blood pressure was 118/82. Patient reported having an event like this 36 years ago after her first visit to an OB/GYN and was similarly nervous that day. Patient was counseled extensively on preventing future lightheadedness and signs of any vaccine related adverse event. After approximately 45 minutes of observation from the event, patient was driven home by her husband.
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| 55 | 2021-01-14 | chills, body temperature increased, fever, headache, cough |
Pt received second dose Pfizer COVID vaccine 1/7/21. On 1/8/21 t 8 PM developed fever and chills, T-...
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Pt received second dose Pfizer COVID vaccine 1/7/21. On 1/8/21 t 8 PM developed fever and chills, T-max 100.4, as well as a dry cough and headache. No shortness of breath or chest pain or wheezing. No sore throat. Virtual Urgent Care visit 1/9/21. COVID test negative. No treatment performed, no escalation of care.
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| 55 | 2021-01-14 | headache |
Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, r...
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Reaction delayed - self-care: Day 1 body aches, bad headache, Day 2 sore feet and heel especially, rash on right arm. Lymph nodes sore on neck on Day 2.
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| 55 | 2021-01-14 | malaise, fever, fatigue, chills |
Started to have horrible body aches and chills about 10 hours after shot. Felt very febrile with fro...
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Started to have horrible body aches and chills about 10 hours after shot. Felt very febrile with frozen finger tips. Could not warm them up. Continued fatigue and febrile and malaise.
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| 55 | 2021-01-14 | headache, cold sweat |
Within 1 and 1/2 hours headache, nausea, diarrhea, cold sweats. Lasted for about another hour and 1...
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Within 1 and 1/2 hours headache, nausea, diarrhea, cold sweats. Lasted for about another hour and 1/2. Now feel weak. All other symptoms are gone.
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| 55 | 2021-01-14 | fatigue, chills |
fatigue the next day; sudden onset of chills/shaking; severe abdominal cramping and vomiting; severe...
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fatigue the next day; sudden onset of chills/shaking; severe abdominal cramping and vomiting; severe abdominal cramping and vomiting; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EL3246), via an unspecified route of administration on the left arm on 07Jan2021 13:30 at SINGLE DOSE for COVID-19 immunization at the hospital. The patient had allergies with penicillin and sulfa drugs. The patient's concomitant medications were not reported. On 07Jan2021 22:30 (9 hours after vaccine), the patient had sudden onset of chills/shaking , severe abdominal cramping and vomiting which lasted about 1 hr 15 min and then resolved on 07Jan2021 23:45. It was reported that the patient had no other effects than fatigue the next day (08Jan2021). Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the event of fatigue was unknown while remaining events recovered on 07Jan2021 23:45.
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| 55 | 2021-01-14 | influenza like illness, dizziness |
flu-like symptoms; dizziness; heavy feet; This is a spontaneous report from a contactable pharmacist...
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flu-like symptoms; dizziness; heavy feet; This is a spontaneous report from a contactable pharmacist reporting for herself. A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek9231), via an unspecified route of administration on 07Jan2021 13:45 in left arm at single dose for COVID-19 immunization. Medical history included allergies to cherries and hazelnuts amd Hashimoto's thyroiditis from an unknown date and unknown if ongoing; h/o possible GBS (Guillain-Barre syndrome) from an unknown date and unknown if ongoing post influenza vaccine in 2016. Concomitant medication included fish oil, minerals nos, quercetin, thioctic acid, vitamins (EMERGEN-C) and multivitamins. On 08Jan2021, the patient experienced flu-like symptoms and bouts of dizziness, and a feeling of "heavy feet" 24 hours post administration of BNT162B2. No treatment was given to the patient for the events. The outcome of the events was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 55 | 2021-01-14 | throat pain | left side sore throat, symptoms started 2 days after vaccine received. |
| 55 | 2021-01-14 | headache, chills |
nausea; vomiting; chills; headache; This is a spontaneous report from a non-contactable nurse (patie...
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nausea; vomiting; chills; headache; This is a spontaneous report from a non-contactable nurse (patient). A 55-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EL1283), via an unspecified route of administration on 07Jan2021 at 10:30 AM on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to sulfa. The patient's concomitant medications were not reported. The patient previously received the first dose of (Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EJ1685) on 21Dec2020 at 10:00 AM on the left arm for COVID-19 immunization. The vaccine was administered in the hospital. The patient was not administered any other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient experienced nausea, vomiting, chills and headache on 07Jan2021 at 11:45 PM. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported to be non-serious. No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-01-14 | headache |
sudden onset of headache, neck pain and back pain. the head and neck pain subsided over the course o...
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sudden onset of headache, neck pain and back pain. the head and neck pain subsided over the course of 24 hours with no pain relieving medication needed. the lower back pain has been constant since then and today it reached it's highest level of discomfort. I cannot climb stairs, bend over and have limited walking. I have taken 800 mg ibuprofen with in the last 30 minutes with no relief.
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| 55 | 2021-01-15 | fever, malaise, headache, chills |
Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol fo...
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Fever up to 102 degrees pain at site headache chills muscle pain nausea felt unwell Took Tylenol for fever and aches
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| 55 | 2021-01-15 | fever |
I cannot be entirely sure if this is due to the vaccine. However, I have never had this symptom befo...
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I cannot be entirely sure if this is due to the vaccine. However, I have never had this symptom before. And it occurred within the 24 hrs post vaccine and continues to persist. I felt feverish and had myagia for a day which settled with Ibuprofen. However I also developed right middle metatarsal inflammation and joint swelling with pain which is ongoing. thought it will settle down., but still persisting for 6 days currently.
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| 55 | 2021-01-15 | headache, fever, fatigue |
Low grade fever , tired ness , headache and swelling and pain at injection site lasting more than 7...
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Low grade fever , tired ness , headache and swelling and pain at injection site lasting more than 72 hours
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| 55 | 2021-01-15 | sweating, weakness, body temperature increased, chills, malaise |
Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At ...
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Per husband, was in usual state of health on the AM of 1/10/20, AOx3 able to perform all I/ADLs. At around 2:30pm that day was complaining of chills and generalized malaise. Then at ~9:30pm when husband returned home from work found patient diaphoretic, confused (stating things like "not now, I want to go to lake"), and complaining of chills and weakness. Unable to provide any additional hx regarding other sx. Initially presented to ED, where mental status had deteriorated to AOx0, unable to respond to verbal commands. Initial vitals notable for T102.6F (unclear other vitals). Patient is now AOx0 most concerning for encephalopathy.
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| 55 | 2021-01-15 | fatigue, head discomfort |
Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when...
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Rash on chest and abdomen appeared morning following injection. Appearance of sunburn, blanched when touched, second day it was itchy, resolved totally day 4. Other symptoms included pressure headache which lasted one week. Fatigue and muscle achelasted 2-3 days.
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| 55 | 2021-01-15 | fatigue, migraine, fever, chills |
Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatig...
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Sever body aches, chills, migraine headache, fever of 100,8, nausea, loss of appetite, extreme fatigue, pain a swelling a injection site.
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| 55 | 2021-01-15 | fatigue, dizziness, shortness of breath, fever, headache |
The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feelin...
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The adverse events are side effect perhaps but extremely strong. Lightheadedness x 1.5 days, feeling shaky and short of breath- afternoon of injection Significant headache x 48 hours (note: still having intermittent HA associated with 1st dose.) Significant arm pain (injection site)- 2 days Feeling shaky in legs- evening of injection Low grade fever x 48 hours, ongoing intermittently Waking at night several times- this does not happen to me. Waking overnight last night (AM of 1/16/21) with right hand numbness that lasted for some time. Extreme, extreme fatigue- the worst lasted 48 hours post vaccination. Still continuing but not as severe as the first 48 hours. Body aches, particularly (but not only) right hip and knee that have arthritis- worst sx ~ 36 hours post vaccination. Ongoing intermittently. Heart palpitations but unable to determine if related to vaccination. Chest pain, mid-left sternal, intermittent, ongoing. More of a muscular pain/discomfort. Note: for 1st injection had some similar "side effects" but also some that were different.
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| 55 | 2021-01-15 | fatigue, headache |
fatigue, headache, body aches. sx severe in am (day after vaccine) , improved by the evening. none ...
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fatigue, headache, body aches. sx severe in am (day after vaccine) , improved by the evening. none by the next day.
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| 55 | 2021-01-16 | fatigue, headache, dizziness |
I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such a...
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I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awake with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take the day off work due to fatigue and pan. I have a couple of autoimmune diseases and I surmised this is why the vaccine affected me in this way
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| 55 | 2021-01-16 | dizziness |
I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for se...
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I received the vaccine about 8:55 AM, about 9:05 AM my heart started pounding and I got dizzy for several minutes. My lips, tongue, lower jaw and teeth started to feel tingly and strange. This started to get better in about 30 minutes but didn't completely resolve for about 3 hours.
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| 55 | 2021-01-17 | dizziness, headache |
12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle ac...
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12 hours after injection: Heart racing, pounding in chest, chills, significant body aches, muscle aches, dizziness, headache, disorientation. 20 hours after injection: swelling of lips. Continued body aches, headache, 32 hours after injection: chest pain, continued body aches, headache, swelling of lips.
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| 55 | 2021-01-17 | headache | SYMPTOMS: HEADACHE. TOOK TYLENOL. |
| 55 | 2021-01-19 | influenza like illness, chills | Aches and chills for 24 hours. Flu like symptoms. |
| 55 | 2021-01-19 | sweating, headache, fever, chills |
Chills and headache beginning approximately 2 hours after injection. Proceeding to full body aches,...
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Chills and headache beginning approximately 2 hours after injection. Proceeding to full body aches, fever to 103, sweats and mild nausea over next 24 hours. Symptoms mitigated by use of Ibuprofen. 48 hours post vaccine, symptoms are resolving - minor headache and sweats remain. Afebrile.
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| 55 | 2021-01-19 | chills, body temperature increased, headache | Chills, headache 1/19/2021 Motrin Chills, temp 100.3 1/20/2021 Tylenol |
| 55 | 2021-01-19 | dizziness |
Covid vaccine, felt dizzy with palpitations 5 minutes after. Elevated bp 150s systolic. No past m...
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Covid vaccine, felt dizzy with palpitations 5 minutes after. Elevated bp 150s systolic. No past medical history no surgical history.
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| 55 | 2021-01-19 | headache | Developed severe headache post vaccination |
| 55 | 2021-01-19 | throat swelling | Patient reported sensation of throat tightness/swelling post vaccine |
| 55 | 2021-01-19 | shortness of breath |
Per patient she began experiencing shortness of breath and tightness in her chest a few minutes aft...
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Per patient she began experiencing shortness of breath and tightness in her chest a few minutes after vaccine administration. Pt reports using her inhaler and nebulizer treatments with relief in symptoms. Symptoms have persisted for 24 hours.
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| 55 | 2021-01-19 | chills, headache | STINGING HEADACHE FROM 1/8 TO 1/10. CHILLS ALL DAY ON 1/9. TOOK TYLENOL EVERY 4 HRS |
| 55 | 2021-01-19 | chills |
on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and i...
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on 1/12 started body aches and chills, took Tylenol and felt better, Wednesday felt short beat and irregular and heart beat not regular. checked pulse and it was irregular, that night 9-9:30 I went to ER close to house and pulse and heart rate abnormal after 2 hours went home and advised to contact cardiologist, he said to come in Thursday and the irregular beats were off and on atrial flutter, on Friday I came home and went back to hospital and got the shot cardio version or ablation to revert the rhythm and because the rhythm was back and forth I was observed until released on 1/19/21. Surgery was in 2017 and never had problems and they stated heart was compromised and maybe this is your reaction to the vaccine.
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| 55 | 2021-01-20 | headache, fatigue, fever |
Fever of 101.1; headache; extreme fatigue; muscle pain; This is a spontaneous report from a contacta...
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Fever of 101.1; headache; extreme fatigue; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscular on 07Jan2021 14:00 at single dose at left arm for covid-19 immunization. Medical history was none, no known allergies. Concomitant medications in two weeks included venlafaxine, levothyroxine sodium (SYNTHROID). Patient didn't receive any other vaccines in 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The patient experienced fever of 101.1, headache, extreme fatigue, muscle pain on 08Jan2021 with outcome of recovered on 10Jan2021. These symptoms subsided after 2 days. Patient didn't receive treatment for events. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.
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| 55 | 2021-01-20 | headache, shortness of breath |
Shortness of breath; Headache; Tinnitus; This is a spontaneous report from a contactable Physician. ...
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Shortness of breath; Headache; Tinnitus; This is a spontaneous report from a contactable Physician. A 55-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, gastroesophageal reflux disease and asthma, all from an unknown date and unknown if ongoing. Known allergies reported: drug intolerances with nausea/vomiting to Opiates, TRULICITY, sulfa antibiotics. The patient's concomitant medications were not reported. The vaccine was administered at Hospital Facility. It was unknown If other vaccine were administered in four weeks. The patient did not experience COVID prior vaccination. The patient was tested for COVID post vaccination on 01Jan2021 and was negative. On 31Dec2020 within minutes of vaccination the patient experienced shortness of breath, headache and tinnitus. The events required visit to Physician Office and Emergency Room. The patient was admitted to hospital for 7 days. Therapeutic measures taken as a result of the events included epinephrine without benefit, prednisone course but tinnitus remained about 12 days since vaccination, corticosteroids, and H1 and H2 antagonists. The patient underwent lab tests and procedures which included COVID test post vaccination (Nasal Swab) on 01Jan2021 with negative result. The outcome of the events was recovered with sequelae. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea, headache and tinnitus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-01-20 | chills, fever |
several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chi...
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several fainting spells because of everything going on; elevated HR in the 130's; Uncontrollable chills; fever of 102.8; pain all over my body; intractable vomiting; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EL0140, via an unspecified route of administration in left arm on 07Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included covid-19 on an unknown date prior vaccination. There were not known allergies. Covid was not tested post vaccination. Concomitant medication included vitamin D; vitamin E. On 08Jan2021 at 02:00 the patient experienced several fainting spells because of everything going on, uncontrollable chills, fever of 102.8, pain all over the body, elevated heart rate in the 130's, and intractable vomiting. The patient was not treated for the events. The outcome of the events was resolved in Jan2021.; Sender's Comments: Based on the time association, all events are reasonably related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-01-21 | nasopharyngitis, headache, fatigue |
1/19/2021 2nd vaccine Pfizer. background headache post vaccine, still present 1/22/2021. 1/21/202...
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1/19/2021 2nd vaccine Pfizer. background headache post vaccine, still present 1/22/2021. 1/21/2021 cold, low temp 93F, then registering "Low" on hand help Temp unit. Temp unit did register normal temp for other people so not a issue with unit. naseaous, very tired. resolved by 1/22/2021
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| 55 | 2021-01-21 | chills, fever, headache |
1/19/2021 7PM UNTIL 1PM 1/20: HEADACHE, CHILLS, LOW GRADE FEVER (100.9), BODY ACHES, SIGNIFICANT SO...
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1/19/2021 7PM UNTIL 1PM 1/20: HEADACHE, CHILLS, LOW GRADE FEVER (100.9), BODY ACHES, SIGNIFICANT SORENESS AT INJECTION SITE. TOOK TYLENOL 7AM 1/20.
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| 55 | 2021-01-21 | fatigue, chills, body temperature increased, weakness |
Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspot...
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Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspots: @ 12hrs temp 102.6 F: @ 15hrs Oxygen desaturation 89-90%, weakness, extreme fatigue Seen at ED aprox 6PM on 1/9/21: CBC, chem panel, CT abd, CXR Continued to have low sats and was admitted to hospital on 1/10/21 adverse reaction to vaccine, Reactive airway, asthma excerbation discharged on 1/12/21
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| 55 | 2021-01-21 | chills, headache | Body aches, headache, chills |
| 55 | 2021-01-21 | nasopharyngitis, chills, shortness of breath | Extreme cold chills, body aches and trouble breathing |
| 55 | 2021-01-21 | fever | FEVER 101 FOR 24 HRS/ BODY ACHES/ VOMITING/ TOOK ACETAMINOPHEN. |
| 55 | 2021-01-21 | fever, fatigue |
High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shakin...
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High fever 102 started at 2:30AM on the 7th . I had riggers, my whole body was out of control shaking like a seizure. I was extremely confused I had a 8/10 headache. I had serve fatigue. This last about 24 hours then went away I finally got out of bed the next day about 4:30PM.
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| 55 | 2021-01-21 | headache, nasal congestion | Muscle pain, tachycardia, headache, insomnia, nasal congestion |
| 55 | 2021-01-21 | body temperature increased, respiratory tract congestion, throat pain | SORE THROAT, CONGESTION, FUNNY FEELING IN CHEST (UNSURE HOW TO DESCRIBE), TEMP 99-100, MILD ACHINESS |
| 55 | 2021-01-21 | fever, chills |
Severely swollen lymph nodes in armpit and chest on side of injection for 48 hours (unresolved at th...
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Severely swollen lymph nodes in armpit and chest on side of injection for 48 hours (unresolved at this time) Fever 100.5-100.9 x 30 hours Severe muscle and bone aching x 36 hours Chills x 18 hours
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| 55 | 2021-01-24 | weakness, body temperature increased | Extremely week, extreme muscle pain, temp over 100 degrees farenheit |
| 55 | 2021-01-24 | fatigue, dizziness, chills, influenza like illness, headache |
I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt lik...
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I had serve tenderness and redness at the site I had dizziness, headache, feeling, tired, I felt like I had flu, chills, nausea, stomach cramps, muscle pain, joint pain. I had some insomnia. I had this for about 3-4 days after. I started feeling better on Saturday and got the vaccine on a Tuesday. I spoke to my Dr. about it and we decided to take Tylenol and a lot of baths.
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| 55 | 2021-01-24 | fever, dizziness, fatigue, sweating |
I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and d...
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I had vaccine at 8:30 and 11 i started having palpitations and chest pressure and light headed and diaphoretic while i was at work. i continued to work and didn't go home until close to 4pm, i thought it would go away like the first time but it didn't, i went home and laid down and took a zanax and it didn't go away. the next morning i went to the ER and they put me on a telemetry monitor and i was having bigeminy and palpitations and i thought my heart was going to come out of my chest and was hurting they gave me 4mg of morphine, 2 hrs they gave me more morphine, i was nauseated they gave me Zofran then it finally subsided later but till had bigeminy and chest pressure, they admitted me and i stayed overnight. i had the PVC and bigeminy slowed down i had an echo and it was normal the potassium was low and they gave me kedar, i was still ight headed and nauseated they gave me Zofran prn it was 4-5 doses they gave me IV fluid, my fever with up to 100.4, i was not really eating that 24 hrs because i was afraid to throw up. the doctor gave me meds to take home to manage light symptoms . i went home and felt tired and had more palpitations when i move around too much and I'm still having issues today. i have not gone back to work since the vaccination and have an appointment with cardiologist 2:pm tomorrow and today I will see my PCP at 1pm. I have not recovered and still having issues and very tired.
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| 55 | 2021-01-24 | lethargy, fever, chills |
On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. S...
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On 1/20/21 awaken at 1 am with excruciating pain right arm, shoulder, neck, head and right axilla. Sever shivers, sweating, whole body aches, lethargic, nausea, loss of appetite, low grade fever, developed golf tennis ball size lump right axilla.
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| 55 | 2021-01-24 | headache |
This was my 2nd. COVID-19 vaccine. First one on Dec 31 caused a headache and itching at injection si...
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This was my 2nd. COVID-19 vaccine. First one on Dec 31 caused a headache and itching at injection site. Today, 1/25, about 10 minutes after shot my eyes, face and neck began to itch. Developed small bumps. This continued to spread to armature torso and legs. Took Benadryl which seems to be helping. No difficulty breathing or swelling of any kind.
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| 55 | 2021-01-24 | cough |
Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the fac...
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Was sitting for observation, around 5 minutes later starting coughing and getting flushed in the face and saying it was getting hot. Then, continued to cough and was using her prescribed inhaler ( unknown what type of inhaler it was ). Administered epi-pen immediately, and called 9-1-1. Had to administer second epi-pen 5 minutes later, and patient also took two 25 mg benadryls. A nurse at the facility was the one to administer her epi-pens. They were the patient's prescribed epi-pens
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| 55 | 2021-01-24 | chills, fever |
viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (...
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viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (UTI); Chills; elevated temp 99 degrees,/elevated temp 101.4 degrees,; This is a spontaneous report from a contactable other health care professional (patient). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration at left arm on 08Jan2021 12:45 at single dose for covid-19 immunization. The vaccine was administered at hospital. Medical history included migraine headaches. The patient had no allergies to medications, food, or other products. Concomitant medication included vitamin d3 and sumatriptan. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration on 18Dec2020 12:45 PM at Left arm at single dose for covid-19 immunization. On 09Jan2021, the patient had chills and elevated temperature of 99 degrees; on 10Jan2021, the patient had chills and elevated temperature of 101.4 degrees, symptoms of urinary tract infection (UTI); on 11Jan2021, the patient was prescribed cephalexin for UTI; on 12Jan2021, the patient had cold sores covering lips and skin around mouth; on 13Jan2021, the patient was prescribed antiviral for cold sores, the patient was developed and diagnosed with viral pinkeye, prescribed steroid eye drops. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.
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| 55 | 2021-01-25 | chills, fatigue | Chills, joint pain, severe fatigue |
| 55 | 2021-01-25 | fatigue, headache | Muscle - body aches, bad headache, lower back pain, tired arm shot area pain |
| 55 | 2021-01-25 | dizziness, headache, nasopharyngitis, chills |
Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; ...
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Tender; Swollen glands, neck, face, and ear on left side/ glands on left side of neck were swollen; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Swollen glands, neck, face, and ear on left side; Cold, chills, and felt like freezing to death; Cold, chills, and felt like freezing to death; Felt like drunk driving; Cold, chills, and felt like freezing to death; Severe headache; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 07Jan2021 11:45 at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis (RA). The patient's concomitant medications were not reported. The patient experienced cold, chills, and felt like freezing to death, felt like drunk driving, severe headache and dizziness on 07Jan2021; swollen glands, neck, face, and ear on left side on 12Jan2021; tender on an unspecified date. The patient received COVID-19 Vaccine on 07Jan2021 at approximately 11:45. She felt like drunk driving: She waited the 15 minutes and was fine. Afterwards, she got into her truck and was literally weaving. Had to really concentrate to keep the truck in a straight line. She had severe headache: Did not go into work on Friday because headache was so bad. It was almost a migraine. She could still feel it, but it was not as severe. Patient known it's five days out, but yesterday (12Jan2021) she got up and glands on left side of neck were swollen. That side of her face and ear was swollen. It was very pronounced. She still swollen today (13Jan2021). Patient stated she worked with dementia and didn't know if she should go into work when she was still swollen and tender. The patient took Benadryl (Lot: P119936, Exp: Apr2023) as Equate Allergy Relief at 25mg, two capsules at night for the reaction. The patient had been taking it every night since she received the COVID-19 Vaccine. Headache was still there. This morning woke up with swollen glands, neck, ear, and face on the left side. The outcome of events "cold, chills, and felt like freezing to death" and dizziness was recovered on 10Jan2021; of event "Felt like drunk driving" was recovered on an unspecified date; of event severe headache was recovering; of event "Swollen glands, neck, face, and ear on left side" was not recovered; of event Tender was unknown. Information on Lot/Batch number has been requested.
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| 55 | 2021-01-25 | weakness, nasopharyngitis, malaise, fatigue, chills |
When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. aroun...
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When i first got the shot I didn't think it was bad at all I actually hardly felt the needle. around 5 o'clock I started feeling ill and then i started about quarter to 6 I started getting cold and shaking bad but it wasn't like a seizure. So really severe chills. When i got home i got under heated blanket then I started getting itchy and noticed hives all over body. then I started getting blisters on palms of my hands and they were like water blisters. I was uncontrollably itchy. I started looking up online what to do and asked friends and family and started taking Benadryl. I had to take it for 4-4.5 days so then the hives finally went away but I was still itchy. I've just been very very exhausted and been having to push myself to get up. I had anxiety about getting the vaccine but I decided to get it. I still don't feel like myself, I don't have much of an appetite but not losing weight because I've been forcing myself to eat. I'm taking vitamins and praying I feel better but I just don't feel like myself. I don't have as much energy and exhaustion is the big thing. My joints started hurting really bad.
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| 55 | 2021-01-25 | nasopharyngitis |
cold symptoms; This is a spontaneous report from a contactable consumer patient. This 55-year old fe...
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cold symptoms; This is a spontaneous report from a contactable consumer patient. This 55-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) shot at single dose on 11Jan2021 via an unknown route at left arm Covid-19 vaccination. Medical history and concomitant drug were reported as "none". Patient stated that she got a shot yesterday (11Jan2021) and had cold symptoms today (12Jan2021), and further stated that the cold symptoms come and go. No investigation assessment performed. No treatment performed. Outcome of the event was resolving.
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| 55 | 2021-01-25 | fever, chills | fever/chills, body aches |
| 55 | 2021-01-26 | fever, chills |
Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoul...
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Chills; Enlarged lymph nodes; Body aches in her back and shoulders; Body aches in her back and shoulders; fever of 99.6/low grade; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) from 06Jan2021 and ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), in the left upper arm with no issues. At first, she just had a sore arm on 08Jan2021. Then this morning, on 13Jan2021, she was having chills, enlarged lymph nodes, body aches in her back and shoulders, and a fever of 99.6. It is low grade but does not take much. She has been checking her temperature every 4 hours and it is not any different. She was taking paracetamol (TYLENOL) for a few days to ward anything off. Today (13Jan2021), she laid off the paracetamol to see if she really did have a fever. She did not want to mask it. So, she is taking paracetamol for that off and on. She talked to one person who said the symptoms should last 1-2 days. Then another person said they could last up to a week. She hopes that it is related to the vaccine. She will be mad if she gets COVID after doing all of this. Outcome of the sore arm was recovered on 09Jan2021 and of the remaining events was not recovered.
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| 55 | 2021-01-26 | fatigue, headache |
Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a sp...
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Soreness in neck; headache; nausea; joint ache; jaws hurting; rapid heartbeat; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3248), via an unspecified route of administration on 08Jan2021 14:30 (reported as 02:30 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history included Attack cardia, reflux and arthritis. Concomitant medications (other medications in two weeks) included amoxicillin, verapamil, omeprazole, estradiol (ESTROGEN) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No other vaccine in four weeks. The patient previously took morphine, Remeron, azithromycin and digoxin and experienced allergies. No COVID prior vaccination. The patient experienced soreness in neck, headache, nausea, joint ache, jaws hurting, rapid heartbeat and fatigue on 09Jan2021 8:00 AM. No treatment received for the events. Outcome of the events was recovering. Patient was not tested for COVID post vaccination.
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| 55 | 2021-01-26 | chills, dizziness, headache |
dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is ...
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dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: Apr2021) via an unspecified route of administration on left deltoid on 12Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient stated she had a shingles vaccine, got dizzy and nauseous, thought this was about 3 years prior to the report. The patient received the first dose of the vaccine after working a night shift. She went home, went to bed and then woke up very dizzy, nauseated, vomited and experienced cold chills on and off. She also stated that about 10 hours after she got the shot, she got dizzy, nauseous, threw up a couple of times, got chills, and had a little headache on 12Jan2021. She stated she was a little nervous about getting the second vaccine. She also worked nights and that she got off her night shift and got the vaccine on 12Jan2021, didn't know if maybe she was a little dehydrated possibly. The events are reported as serious due to medically significant. The outcome of the events nausea/nauseated/nauseous and vomiting/ vomited was recovered on 13Jan2021, for the events dizzy, cold chills/chills and a little headache were recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-01-26 | chills, fatigue, shortness of breath | fatigued, short of breath, chills, first dose had similar reactions for one to two weeks |
| 55 | 2021-01-26 | headache, fatigue |
frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back ...
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frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back of head and down back of neck; sore injection site; heavy metallic taste; no appetite; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 11Jan2021 08:30 at single dose in right arm for COVID-19 immunization. The patient medical history included obesity and known allergies to sulfa and penicillin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose in left arm for COVID-19 immunization and experienced mild metallic taste and arm soreness (including extreme burning for 10 min following vaccination, the patient believe this was poor administration tech), slight metallic taste 24 hrs post vaccination, lasted a few hours. Concomitant medications in two weeks included metoprolol, colecalciferol (VIT D3), Calcium, ascorbic acid (C) and probiotic. The patient had no covid prior vaccination. It was reported that after the second vaccination, the patient had no burning at site, on 11Jan2021 09:30 the patient had heavy metallic taste approximate 40 mins post vaccine and lasted approximate 12 hrs, at 12 hrs post vaccine (on 11Jan2021 20:30) sudden extreme fatigue, 15 hrs post vaccine (on 11Jan2021 23:30) frequent urination began and lasted approximate 18 hrs. The patient woke up with headache 6/10 that medication would not touch, no appetite but ate and drank anyway hoping would help with headache (it didn't) (reported on 11Jan2021 09:30), approximate 32 hrs post vax headache began receding from the front to back of head and down back of neck. Slept well and woke up 48 hrs post vax feeling normal but with sore injection site (reported as on 11Jan2021 09:30). The patient underwent lab tests and procedures related to covid included nasal swab and PCR with negative result on 04Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.
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| 55 | 2021-01-26 | headache |
had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...w...
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had a sudden headache come on about 1 hour after shot, but it went away within about 1 more hour...woke up at 5:00 this morning (day after shot) with horrible pain from shoulder all the way to finger tips....fell back asleep, woke again at 7:30 with the same symptoms got up and tried moving the arm (with pain) went ahead and used arm and read reactions and what to do...tried to use arm, after about 1 hour of trying to use arm the pain is just over the injection where there is a grapefruit size hard spot with intense pain. Will continue to try to move the arm and use cold compresses and drink water as the organization site suggested. Pain is not just in upper arm with majority of pain in that grapefruit size area.
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| 55 | 2021-01-26 | headache |
severe incapacitating headache starting several hours after vaccine and lasting at least through tod...
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severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. Steroids prescribed today; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 09Jan2021 11:30 at single dose for covid-19 immunisation. The patient's medical history included Asthma and hypertension. The patient's concomitant medication includes unspecified medication. On 09Jan2021 23:00, the patient experienced severe incapacitating headache starting several hours after vaccine and lasting at least through today 13Jan2021. The patient event resulted in doctor or other healthcare professional office/clinic visit and Steroids prescribed today. Treatment includes prednisone. The outcome of the event was unknown.; Sender's Comments: Based on the compatible time association and drug's safety profile, the event headache is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-01-28 | dizziness |
Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like ...
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Approximately 2 minutes after patient received vaccination, she reported dizziness and feeling like her skin was on fire. She also reported some tingling of her tongue and throat. She was administered Benadryl PO x 1 dose and monitored for approximately 60 minutes. Her symptoms improved and she left in improved condition.
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| 55 | 2021-01-28 | headache, fatigue |
Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Sat...
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Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days. By Saturday, her symptoms began to improve. On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR. Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H. Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions. Significant hematology workup with a clinical picture thought to be consistent with ITP. Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
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| 55 | 2021-01-28 | dizziness | had dizziness 15 minutes after vaccine. orthostatic BP taken and were negative |
| 55 | 2021-02-02 | influenza like illness |
Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for...
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Received 2nd vaccine on 1/14/21 on 1/15/21 was sick with flu like symptoms and pain in both legs for 5 days was seen by doctor who did covid test came back negative. After 5 days flu like symptoms some what resolved but leg pain continued. Hard to walk and painful. Seen doctors 2 more times when they finally did bloodwork and sent her for admission to hospital. They have done Bloodwork, MRI's and they are all coming back normal but still have leg pain, cant bend toes or touch leg. Been out of work since.
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| 55 | 2021-02-03 | skin warm, throat irritation, shortness of breath |
Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Pati...
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Patient felt she had warmth at site of injection,89 HR 81. Patient says normal BP 120's/80's. Patient states she is not anxious. She then started feeling like her throat and chest were getting itchy. Continued monitoring and she felt she needed to be evaluated in ER. Taken to ER. ED notes as follows: 55 y.o. female who arrived by to the emergency department for Throat and chest discomfort associated with voice change and pruritic rash. Past medical history of food and environmental allergies, Addison's disease, thyroid disease, primary immune deficiency disorder. Half an hour ago, the patient received her first injection the Covid vaccine. Seconds later, the patient started having a pruriti rash where the site of the injection was. She then noticed her chest getting red and warm. About 15 minutes later, the patient noticed her voice becoming hoarse her and associated with throat and chest discomfort. Reports that she is unable to take a deep breath. Denies any noisy breathing, nausea, vomiting, abdominal pain, shortness of breath, difficulty swallowing, drooling. She has never been hospitalized for anaphylaxis. She denies any past medical history of asthma or COPD Vital signs demonstrate hypertension with systolic blood pressures into the 180-190s. No oropharyngeal swelling. Hoarse voice. Scleral injection present bilaterally. Chest wall nontender. Mild, blanching, erythematous, pruritic rash on anterior chest. Shallow breathing when asked to take a deep breath. Injection site covered with bandaid with no other obvious rashes or swelling patient arrived to the ED in no acute distress and in stable condition. She was complaining of throat discomfort with voice changes. She has never had an anaphylaxis reaction before. She was given benadryl, famotidine, and methylprednisolone initially for her reaction. With her hypertension and reported chest discomfort, epinephrine was not given initially.  Her symptoms mildly improved with the initial treatment.  Patient complained of chest discomfort and EKG showing T wave inverted in leads V4-5. She was given aspirin. Initial troponin negative and repeat was ordered.  After four hours of observation, the patient reports her voice change has resolved but continued to have pruritis in different, migrating areas of the body such as ears, neck, and arms.  1330: patient complaining of increasing chest and abdominal pain. Described as a cramping chest pain that radiated to her abdominal. Denies nausea, vomiting or diaphoresis. Continues to deny shortness of breath. Given morphine for her pain and aspirin for her nonspecific EKG changes.  Internal Medicine consulted for admission due to allergic reaction. Patient is agreeable to this plan. Patient was transferred under stable condition to the IM service. Initial Vital Signs [02/03/21 1159] Blood Pressure 168/101 Heart Rate 73 Respiratory Rate 15 Temp 36.8 °C (98.3 °F) Temp src Oral SpO2 96 % Following one day admission she was discharged to home with Zio patch monitoring while on new beta-blocker therapy for symptomatic PVCs with plan for PCP follow-up. Regarding adverse drug reaction, she was advised to follow-up with PCP and immunologist for further discussion on benefits:risk of subsequent vaccine in series.
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| 55 | 2021-02-04 | fatigue, headache |
petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ...
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petechial rash around injection site and mouth; found to have platelet count of 2,000.; patient had ITP; extreme headaches; fatigue; This is a spontaneous report from a contactable pharmacist. A 55-year-old non-pregnant female patient of received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 21Jan2021 as first single dose for covid-19 immunization. Medical history included hypertension, diabetes, arthritis from unknown dates. Concomitant medication within two weeks included albuterol (salbutamol), dulaglutide (TRULICITY), escitalopram oxalate (LEXAPRO), glimepiride (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), insulin glargine (BASAGLAR), lisinopril (MANUFACTURER UNKNOWN), lorazepam (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN). The patient previously took ibuprofen (MOTRIN) and experienced allergies and drug intolerance. The patient experienced serious events, that involved hospitalization and were life threatening illness (immediate risk of death from the event) as follows: The patient experienced extreme headaches on 21Jan2021 with outcome of recovering; fatigue on 21Jan2021 with outcome of recovering; petechial rash around injection site and mouth on 25Jan2021 with outcome of recovering; patient had immune thrombocytopenia (ITP) on 21Jan2021 with outcome of recovering; found to have platelet count of 2,000 on 25Jan2021 with outcome of recovering. The patient was hospitalized for extreme headaches, fatigue, petechial rash around injection site and mouth, patient had ITP and found to have platelet count of 2,000 for five days. The events were also serious as they were considered life-threatening. The patient underwent lab tests and procedures which included platelet count 2,000 on 25Jan2021; platelet count 1,000 on 25Jan2021. Details were as follows: following the vaccine , which had been 21Jan2021 and had extreme headaches and fatigue for the next two days. On 25Jan2021, the patient developed petechial rash around injection site and mouth. Patient was seen at OSH emergency department and found to have platelet count of 2,000. Patient transferred to the reports facility on 25Jan2021 for hematology consult, and was found to have platelets of 1,000. Extensive hematology workup was completed and it was determined patient had ITP. Therapeutic measures were taken as a result of extreme headaches, fatigue, petechial rash around injection site and mouth (petechiae), patient had ITP and found to have platelet count of 2,000. Therapeutic measures included platelet transfusion, dexamethasone 40mg daily, 3 doses of IVIG. The patient was recovering from the events as aforementioned. The patient has not been COVID tested post vaccination. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association. However patient underlying medical conditions cannot be ruled out as contributing to the reported events
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| 55 | 2021-02-07 | chills, fever, headache, fatigue |
1st dose- 06Jan2021/ her 2nd dose received on 20Jan2021; wiped out/ tired; headache; had no energy; ...
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1st dose- 06Jan2021/ her 2nd dose received on 20Jan2021; wiped out/ tired; headache; had no energy; Rigors; fever of 102.6; This is a spontaneous report from a contactable nurse (patient). This 55-year-old female patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Jan2021 at 8:45AM via an unknown route at right arm for Covid-19 immunization. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Medica history and concomitant drug were reported as "none". Patient previously had 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 in right arm (Lot/NDC/Expiry unknown). No other vaccinations within four weeks prior to the first administration date of the suspect vaccine; no adverse events following prior vaccinations. No family medical history relevant to adverse event. The patient reported some side effects from her 2nd dose received on 20Jan2021 at 8:45AM. She had a fever of 102.6 which started at 8pm on 20Jan2021 and broke this morning at 6am. The patient stated that the fever was gone, but she wouldn't say she has recovered completely because she still feels wiped out; had headache and was tired; also stated that she was not able to eat, and had no energy while she had the fever. The rigors started at 9pm on Wednesday, 20Jan2021. She stated that she couldn't do anything for the few hours it lasted. No other relevant diagnostic and confirmatory test results for events. No investigation assessment performed. The event did not require a visit to Emergency room or Physician office. The reported considered seriousness for fever was medically significant, for rigors was disabling. Outcome of fever was resolving. Outcome of rigors was resolved on 21Jan2021. Outcome of the other events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia and chills cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-02-07 | malaise, weakness |
I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it wa...
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I felt numbness going up my neck while I waited in line after receiving the vaccine. I thought it was nerves. No one asked how I felt after the vaccine and was passed along ( I told my daughter - who drove me - about my neck while at the vaccine site.) I noticed that my face was also going numb a few minutes later. As soon as we arrived at our meeting place, I told my daughter that my face(vaccine side) was also numb: "like when you get an injection for dental work." It is now ten hours after I received the vaccine, and the numbness has not seized. It is still there and with a strong tingle sensation. I also feel generally unwell with body aches and weakness.
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| 55 | 2021-02-07 | headache, discomfort |
symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrib...
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symptoms of COVID/ believes it could be COVID; symptoms of COVID/ believes it could be COVID; terrible diarrhea; constant headache; Gas; Bloating; Her arm was sore for 24 hours; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL8982, unknown expiration), via injection once to right arm on 14Jan2021 at a single dose as she is eligible with first tier for vaccination. Medical history and concomitant medications reported as none. The patient reported that she received the first dose of COVID vaccine on 14Jan2021 (Thursday). The next day (15Jan2021), her arm was sore for 24 hours after the shot, and she didn't have any side effects over the weekend. On 19Jan2021, Tuesday, she started having constant headache, and was experiencing problems with gas and bloating, it is very rare for her to have this issue, and it was building the last of couple days, she was uncomfortable and was taking over the counter medication for relief. She was keeping the headaches at bay with generic ibuprofen (lot: S200378, expiry: Mar2023), but if she missed a dose or is feeling better and doesn't take, it is coming back, it is consistent. Gas and bloating are primarily after eating, on Wednesday, after 24 hours it was ridiculous. She got some generic Extra Strength Gas Relief one tablet after eating (lot: 75257, expiry: Jun2022), and it was giving her some relief until early this morning. Tuesday, Wednesday, and Thursday, the gas and bloating was worse. Last night, her entire chest, she wanted to burp so bad, but couldn't because it really hurt, and it took a while for the next tablet to kick in and give relief, she was like where is this coming from, she didn't know it could build up so much. On 22Jan2021, she had a terrible diarrhea. Diarrhea was painful and intense, she took generic Pepto Bismol 1-2 tablets, and she took 4, The first time she woke up at 04:30 AM and at 7 another wave hit her, so she took another two tablets. Right now, she is feeling okay, but the gas is building up, her chest is filling, she is uncomfortable. The patient asked if these are reported side effects. She works in a dental office, and the doctor is knowledgeable and sensitive to COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, and even though those symptoms are not listed as side effects on the information sheet, the doctor said they are symptoms of COVID, are these side effects or may she have COVID, though she doesn't know who she could have gotten COVID from. Out of protection for patients at dental clinic, the HCP at clinic wants her to get the COVID test as he believes it could be COVID and not side effect of the vaccine. She doesn't want to quarantine for nothing if it is just side effects of the vaccine. She will be getting rapid diagnostic for COVID and not the antibody test. She thinks she should get tested, but there is no testing appointment available until tomorrow, and she does not want to self-quarantine needlessly, she will live through it, she is happy to get the test, but she doesn't want to lose 2 weeks of pay if others are reporting the same side effects. She was happy to get the vaccine. The patient recovered from the event arm sore on 16Jan2021; not yet recovered from events constant headache, gas, and bloating; while unknown outcome for the remaining events.
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| 55 | 2021-02-21 | cold sweat, lethargy |
Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little...
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Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm. Lasting a little over 48 hours. Lymph nodes under left arm are still slightly swollen.
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| 55 | 2021-02-21 | chills, headache |
FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO H...
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FIRST ROUND ONLY A SORE ARM FOR A FEW DAYS. SECOND ROUND ON 2/20/21 AFTER A FEW HOURS I STARTED TO HAVE HOT FLASHES WITH FEELING THE CHILLS.. IN THE EVENING MY LEFT HAND WAS LIKE ICE BUT MY RIGHT SIDE WAS NORMAL AND WARM. CHILLS / NO FEVER . COLD HAND WAS GONE IN THE MORNING.. ABOUT 5 AM HORRIBLE HEADACHE WITH BLURRED VISION... TOOK TYLONAL AT 9AM.. FELT BETTER BY 11AM. CHILLS/AND SLEPT MOST THE DAY. I DO NOT BELIEVE I EVER HAD A FEVER. SUNDAY LEFT ARMPIT LYMPH NODES SWOLLEN AND SORE. MONDAY FEELING BETTER BUT LYMPH NODES STILL ACHE LIKE A BRUISE. I DO NOT BELIEVE I EVER HAD A FEVER.. JUST CHILLS. OH>>>. RIGHT SIDE OF MY NECK WAS STIFF FOR A BIT THE FIRST DAY.
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| 55 | 2021-02-21 | nasopharyngitis |
Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wr...
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Since the 1st shot, I have experienced a sudden onset and increasingly worsening pain in my left wrist. The immediate reaction at the time of the shot was strong tingling in my left arm. The next day, I felt sore all over my body, as well as cold/flu like symptoms for 2 days. But the wrist pain has been getting worse, and consistent. I broke that wrist 10 yrs ago, and may have some slight work related carpel tunnel. With that in mind, I can say that the current issues and pain I?m dealing with have been acute and severe since I received the first dose of the vaccine. I just received the second dose 3 days ago, and still my wrist is hurting. I am careful to make sure I don?t put too much weight on it, and often wear a wrist brace. I am currently waiting to see my primary care doctor to seek medical attention.
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| 55 | 2021-02-21 | dizziness | dizziness |
| 55 | 2021-02-22 | headache |
Patient phoned EHS on 2/22 and inquired about her side effects and how long they should be lasting? ...
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Patient phoned EHS on 2/22 and inquired about her side effects and how long they should be lasting? Patient experiencing ha, and pain at injection site. Patient states it is getting better, but still voiced her concerns. Education provided of side effects vs illness and side effects lasting 7 days, follow up with PCP Dr. for further advice, and if patient continues to have symptoms after 7 days, phone EHS back for further evaluation. Patient agrees to above plan of care. EHS filled out RL6 for pt.
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| 55 | 2021-02-22 | headache, fatigue, dizziness, fever | Sore arm, headache, dizzy, tired, chill. a little fever, from 6 hrs to 40 hrs after dose. |
| 55 | 2021-02-23 | headache |
3 days after vaccination I started to have intermittent localized "heat" sensation in right side o...
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3 days after vaccination I started to have intermittent localized "heat" sensation in right side of skull. It would only last for a short time, a minute or two, maybe a little longer and then disappear. It was an intense heat feeling but with no pain. I was sitting quietly doing a puzzle. Because of the weekend unable to contact Dr and on call Dr did not respond to my callback request. Monday 2/15/21 talked to Dr and he it's not a vaccine reaction and it'll go away. This continued occasionally for a few days until day 5 and 6 the heat sensation increased and duration of event was much longer, lasting most of the day with short time spans between episodes. Heat sensation moved from right side of skull to top of head and was very intense, having to use a icepack for some relief. Called Dr a second time and told me to wait it out and call him next week to report status. By day 7 there is a mild headache but intensity of the heat sensation in skull has decreased to milder and less frequent again. Day 13 symptoms were almost completely resolved but by 14/15 they have returned though milder than worst symptoms were. I called Dr's office on Friday 2/19 and they said to call back next week if symptoms do not get better will refer to nruology.
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| 55 | 2021-02-23 | sweating, fatigue, lethargy, fever |
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
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| 55 | 2021-02-23 | fever, fatigue |
achiness; low grade fever 100.6; fatigue; This is a spontaneous report from a contactable consumer. ...
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achiness; low grade fever 100.6; fatigue; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3248), via an unspecified route of administration on the left arm at the age of 55 years, on 09Feb2021 16:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), colecalciferol (VITAMIN D), vitamin c [ascorbic acid] (VITAMIN C) and Multi Vitamin. The patient had the first dose last 20Jan2021. The patient experienced achiness, low grade fever 100.6 and fatigue on 10Feb2021. The patient underwent lab tests and procedures which included body temperature: 100.6 on 10Feb2021. No treatment was received for the adverse events. The outcome of events was recovered on unspecified date.
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| 55 | 2021-02-24 | headache |
Headache; body aches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report f...
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Headache; body aches; neck and shoulder pain; neck and shoulder pain; This is a spontaneous report from a non-contactable consumer or other non hcp. A 55-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9264), via an unspecified route of administration left arm single dose on 10Feb2021 15:00 for covid-19 immunisation. The patient received the first dose on 20Jan2021 lot#lEL9263. The patient medical history was not reported. No other vaccine was received in four weeks. The patient's concomitant medications were not reported. The patient experienced headache on 11Feb2021 12:00, body aches on 11Feb2021 12:00, neck and shoulder pain on 11Feb2021 12:00. No treatment received. The events recovered in Feb2021 No follow-up attempts are possible. No further information is expected.
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| 55 | 2021-02-28 | headache |
sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour l...
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sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.
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| 55 | 2021-03-02 | chills, headache |
Headaches; Chills/shivering; Nauseated; Body aches; This is a spontaneous report from a contactable ...
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Headaches; Chills/shivering; Nauseated; Body aches; This is a spontaneous report from a contactable consumer (patient) reported that a 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 11:00 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After dinner of 30Jan2021, the patient started having symptoms listed as headaches, chills, nauseated, and body aches. She described her chills as being so bad that she woke up last night shivering. She said the nausea and body aches come and go. She asked how long will her symptoms last. The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 55 | 2021-03-07 | chills, throat pain |
white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore th...
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white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia; body ache; sore throat; chills; I've haven't had this shift before in lymphocyte; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunisation. Medical history included MS and saw neurologist in Nov2020, prior to getting the vaccine and at that time did not have the typical blood work drawn which would have been a CBC and CMP and white blood cell could usually runs in the 3.5-3.7. Concomitant medication included dimethyl fumarate (TECFIDERA). The patient previously took TYSABRI and had to be taken off of that in 2010 due to evidence by CBC of bone marrow suppression. The patient had IVIG and experienced myelosuppression. Patient participated in clinical trials with rituximab and took VIOXX before it was removed from the market. The patient really loved VIOXX and used to prescribe it to her patients; first dose of BNT162B2 on 17Dec2020 for COVID-19 immunisation. A week after the patient got the vaccine, she had a sore throat, chills and body aches. The patient just went to bed early and was fine. The patient reported those symptoms through the CDC VAERS site. The patient had blood work drawn on 29Jan2021 and was shocked that the white blood cell count was down to 2.3 and absolute neutrophils were low. The patient was referred to follow up with a hematologist for the neutropenia. The patient thinks this is not related to the Covid vaccine. The patient haven't had this shift before in lymphocyte and neutrophil count. On 29Jan2021, CBC and CMP and that is comprehensive metabolic panel, complete blood count and lipid panel. The patient received no treatment. The outcome of white blood cell count was down to 2.3/absolute neutrophils were low/neutropenia was not recovered and other events was unknown.; Sender's Comments: Based on the information available a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-03-08 | dizziness |
dizzy/Dizziness; nausea; This is a spontaneous report from a contactable Other Health Care Professio...
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dizzy/Dizziness; nausea; This is a spontaneous report from a contactable Other Health Care Professional, the patient. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), via an unspecified route of administration on 02Feb2021 at 07:00 (at the age of 55-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included COVID-19 infection on an unspecified date. The patient was not pregnant at the time of vaccination. Concomitant medications were reported as "No." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021 at 06:00, the patient experienced dizziness and nausea. The reporter commented that she did not think these were side effects from the vaccine because she got it on Tuesday but her husband pointed out that she normally does not have these side effects, so it has to be from the vaccine. The clinical outcomes of the events dizziness and nausea were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
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| 55 | 2021-03-10 | chills, headache, weakness |
extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chil...
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extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 55 | 2021-03-14 | fatigue, malaise |
diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COV...
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diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; diagnosed with COVID-19 disease/testing positive/sick/all the nightmares of COVID /felt very ill/COVID took the 3 pounds off/fevers my eyes/body temperature kept dropping; some fatigue/tired; stomach upset/stomach was really feeling weak; not feeling real well; nauseous; This is a spontaneous report from a contactable consumer reporting for self. This 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunisation. Medical history included menopause hormone replacement therapy. Concomitant medication included progesterone (PROGESTERONE), estradiol (MINIVELLE) for menopause hormone replacement therapy. The patient received her first injection of the Pfizer-BioNTech vaccine on 23Jan2021. She reported experiencing symptoms of COVID-19 on 09Feb2021 and was diagnosed with COVID-19 disease on 11Feb2021 after testing positive. After the first injection, and prior to getting COVID-19 disease, she did experience some fatigue, stomach upset, and not feeling real well. It was reported that when she had the first dose the only symptoms was stomach was really feeling weak, just felt extremely tired and nauseous so that was the first and then fine, by the third day she was feeling okay but then unfortunately, on 09Feb2021 and she began getting sick and went for a COVID test and tested positive on 11Feb2021. She had experienced multiple symptoms due to her COVID-19 disease and had to go to the ER for treatment after they appeared (she went to the emergency room so they didn't keep her there, she was there for maybe 6 hours). She felt very ill with this COVID, she had been in the hospital twice, she did not, she was not left in ICU that was good for her, but reported that "between the fevers my eyes, I don't know what happened to my eyes but ophthalmologist will be checking it seems to be same and it's been everything that you can ever think as 'hard' and I just want to know if tomorrow I can have the second boost." It was reported that when she was in the hospital because of the, body temperature kept dropping so the doctor send her to the hospital and they did blood test. Patient weight was 135 at that time, now she was 131. She thought COVID took the 3 pounds off. Her second dose of the Pfizer-BioNTech vaccine was cancelled due to her illness and now her second dose is scheduled for tomorrow (25Feb2021). The patient reported she is only now starting to feel a lot better, that she was really sick for 15 days. Today (24Feb2021) was the first day that she was feeling a little bit better from all the symptoms and all the nightmares of the COVID illness. The outcome of events was recovering.
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| 55 | 2021-03-16 | shortness of breath, influenza like illness |
4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post v...
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4 days psot vaccine patient developed eye angioedema and hives resulting in ED visit. 6 days post vaccine she devleoped flu like sxs with positive covid 19 test results on day 8 post vaccine as per pateint. 10 days post vaccine patient with dyspnea and hypoxemia-admitted to hospital.
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| 55 | 2021-03-17 | headache, night sweats |
pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain inte...
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pass out; 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe/lower lumbar pain; dull headaches; Some night sweats; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265) on left arm intramuscularly from 28Jan2021 15:00 (03:00 PM) at single dose for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), allergies to trees, pollen, grasses and latex. Concomitant medication included omeprazole (PRILOSEC), sucralfate (CARAFATE), sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , minerals nos/ vitamins nos (OPTISOURCE CHEWABLE VITAMIN & MINERAL SUPPLEMENT). There was no other vaccine in four weeks. The patient historical vaccine included bnt162b2 (lot number: EL1284) for first dose on 04Jan2021, 03:00 PM, Intramuscularly, left arm, for covid-19 immunisation. The patient previously took metoclopramide (REGLAN), pethidine hydrochloride (DEMEROL) and hydrochlorothiazide (HCTZ) and all had allergies. On 29Jan2021, 02:00 AM, 11 hours post injection developed severe lumber pain that radiated to front; the pain internally radiated up toward stomach so severe it caused me to pass out. In Jan 2021, 20 hours to 48 hours post injection continued to have dull headaches and lower lumbar pain achy at this point. Some night sweats. The vaccination facility type is hospital. There was no covid prior vaccination and covid tested post vaccination. There was no treatment for the events. The events were not result in emergency room visit or physician office visit. The outcome the events recovered in Jan2021.; Sender's Comments: Based on the compatible time association, the event back pain and loss of consciousness are possibly related to suspect vaccine BNT162B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 55 | 2021-03-22 | throat irritation |
- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors ...
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- Pt has history of anaphylaxis to flu shots, even requiring intubation at one point - Pt?s doctors and ID team discussed risks of COVID vaccine and determined low risk due to no similar components between flu vaccine and COVID vaccine - Pt received first dose of COVID vaccine today (3/22/21) around 1230 - Within 10 minutes of injection, pt felt nauseous and was flush. She was given a drink and snack, monitored for 30 minutes, and felt better ? went back to work upstairs - 4 hours post injection (~1630) pt came to ED - itchy throat, hoarseness, urge to clear her throat, chest heaviness - In ED, pt has received methylprednisolone 125 mg, famotidine 20 mg, diphenhydramine 25 mg, duonebs, epinephrine 0.3 mg IM, and fluids with improvement. - Pt is being admitted for further monitoring
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| 55 | 2021-04-07 | fever, chills |
Patient had shaking chills and fevers for the a few days after getting her 2nd shot. The patient co...
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Patient had shaking chills and fevers for the a few days after getting her 2nd shot. The patient complained uncomfortable numbness tingling in her arms and legs on 4/3. Was admitted to medical center on 4/5.
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| 55 | 2021-04-07 | chills, fever |
Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started a...
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Patient received vaccine on 3/29/21. Patient described rigors, fevers, and vommiting that started about 24 hours after receiving the vaccine. These symptoms resolved by day three. However, she started developing parasthesias in her feet and pain in left hip. Patient came to hospital on 4/5 after symptoms worsened. In hospital, patient received an LP and GBS was ruled out and was discharged with patient still complaining of burning of her feet and hands.
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| 55 | 2021-04-13 | sweating, headache |
The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her ri...
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The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her right eye that never went away. Then on Wednesday morning, March 31st (two weeks after receiving the first dose), she was found in bed by my mother, unable to walk or talk, her face was drooping, she was very sweaty, and had defecated on herself. My mother called the ambulance. She was transported to Hospital where it was determined she had suffered a massive hemorrhagic stroke. She was immediately transported by ambulance to another Hospital. She spent one day in ICU and then was put on palliative care. She died around 12/N on Friday, April 2nd, two days after the stroke.
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| 56 | 2020-12-31 | dizziness |
Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores o...
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Dizziness immediately after injection, anxiety, questionable tongue thickening. Then canker sores on tongue, lips swollen later in day and next day. No breathing issues.
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| 56 | 2020-12-31 | headache, dizziness |
Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then m...
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Heart racing few mins after shot lasted 10 mins then nausea, dizziness continues for 45 mins. Then mild headache for 24 hrs. No symptoms after 24 hrs except sore arm for 2 days.
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| 56 | 2020-12-31 | dizziness, headache |
patient had dizziness, headache and nausea. bp was 127/89 HR 87. Patient was evaluated by a doctor t...
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patient had dizziness, headache and nausea. bp was 127/89 HR 87. Patient was evaluated by a doctor that was working vaccination clinic. instructed to take tylenol. No further intervention required.
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| 56 | 2021-01-01 | throat irritation |
advised to wait 30 min post shot for monitoring d/t latex allergy. completed without s/s. returned a...
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advised to wait 30 min post shot for monitoring d/t latex allergy. completed without s/s. returned approx 20 min c/o itching to arm at injection site, stated, throat had been internally itchy for about 10 min after leaving vaccination area but that passed on its own. advised to use cold compress on arm and monitor self. let vaccination center without questions, concerns.
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| 56 | 2021-01-01 | headache |
headache, muscle pain, mostly in left calf area started few days after, hypertension (new onset), ch...
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headache, muscle pain, mostly in left calf area started few days after, hypertension (new onset), chest tightness
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| 56 | 2021-01-02 | chills |
BioNTech Covid-19 Vaccine I experienced sudden severe chills lasting 2-3 minutes. I also had extrem...
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BioNTech Covid-19 Vaccine I experienced sudden severe chills lasting 2-3 minutes. I also had extreme elevation of pain to my injured knee from a 5 to 10+ during this episode. The chills resolved spontaneously.
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| 56 | 2021-01-03 | headache |
After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was...
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After I got the vaccine around 30 minutes later I started to feel a headache and pain on my face was not to bad and I tought is a normal symptom but the pain and swelling an my face is increasing every day, even my teeth hurts and I'm taking Gabapentin 100MG 3 times a day. I am not sure if the vaccine components triggered my Trigeminal Neuralgia and if it's okay to get the second dose, I will see my Dr. tomorrow 01/05/21
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| 56 | 2021-01-03 | headache, fever |
Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appe...
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Extreme left arm pain. Site is redden and warm to touch. Low grade fever. Head ache. Loss of appetite I had a hard time sleeping. I just took Tylenol.
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| 56 | 2021-01-03 | headache, fever, chills | Headache Chills Temp (101.6) Body aches Skin hurts to touch Soreness in arm (injection site) |
| 56 | 2021-01-03 | chills, weakness, headache |
Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. ...
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Initial reaction day of vaccine: tenderness to injection site and swelling the size of half dollar. On day 2, patient experienced shills, diarrhea, headache, weakness that lasted 3.5 days. Reports follow-up with primary physician.
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| 56 | 2021-01-03 | fatigue |
They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd...
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They have my injection listed as Moderna which is a mistake. The Manufacturer is Pfizer. On the 23rd. I went into anaphalactic shock admitted to the ER, given an epinephrine drip, I was given iv bolises, chest xray, vitals were taken and blood was drawn. ABGs and chest xray and lactic acid tests were administered. I have to carry a epi pen and need to see a pulmonologist, I have triggers now where I need an emergency inhalor and was put on a course of steroids and my heartbeat is 20 beats higher than usual. I was really tired and having abdominal pain .
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| 56 | 2021-01-03 | fever, chills |
This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a ...
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This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a possible reaction to the COVID vaccine onset 2 days ago. The patient states that she has had a fever, chills, adenopathy, and body aches since her vaccination. Her highest recorded temperature was 101F, and she has been taking Tylenol. She states that her biggest concern is the adenopathy under her right armpit which is painful to touch. She denies any masses. She saw her PCP on 12/24 and had blood work done, which showed an elevated white count of 17.
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| 56 | 2021-01-03 | headache |
Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling ,...
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Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling , headache
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| 56 | 2021-01-03 | malaise, fever |
husband and daughter tested positive/after taking the shot, she was feeling sick and had a fever/won...
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husband and daughter tested positive/after taking the shot, she was feeling sick and had a fever/wondering if the vaccine can give the reaction, or maybe she has the virus; husband and daughter tested positive/after taking the shot, she was feeling sick and had a fever/wondering if the vaccine can give the reaction, or maybe she has the virus; having a lot IO symptoms; fever; has been feeling "sick"; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on the left arm on 22Dec2020 at single dose for COVID-19 immunisation. The patient's husband and daughter tested positive (COVID-19). There were no concomitant medications. The patient stated, "had the first vaccine shot, later clarified as Pfizer COVID vaccine, on 22Dec2020, and didn't have any symptoms before that, her husband and daughter tested positive, but she was staying away from that, had no symptoms, but after taking the shot, on 24Dec2020, she was feeling sick and had a fever, and has had a fever ever since, and she is taking Tylenol and Motrin every six hours, and even then she still gets the fever, it hasn't stopped, she is having a lot IO symptoms, and is wondering if the vaccine can give the reaction, or maybe she has the virus. On 24Dec2020 is when the fever started and she was feeling sick. States she filled out a report online, on (Website)". The outcome of the events was not recovered.
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| 56 | 2021-01-04 | fatigue, chills, throat pain |
About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I...
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About 15 minutes after vaccination I started itching all over, became flushed, my throat and sore. I was taken to the ED where I was given non drowsy antihistamine and observed. At home I experienced severe fatigue, muscle aches and chills. At about 30 hours the symptoms went away
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| 56 | 2021-01-04 | headache |
Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient...
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Aching all over; headaches; shingles; This is a spontaneous report from a contactable Nurse (Patient). A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) via an unspecified route of administration at right arm on 17Dec2020 13:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Relevant medical history and concurrent conditions was reported as "Structured information (Patient episode name): Fibromyalgia, tachycardia, shingles, breast cancer". Patient was diagnosed with COVID prior to vaccination. Patient known allergies included Codeine, morphine sulfate (Duramorph) and Sulfa. Concomitant medication included metoprolol succinate (TOPROL), alprazolam (XANAX) and desvenlafaxine succinate (PRISTIQ) received within 2 weeks of vaccination. No other vaccine in four weeks. Adverse events were reported as "Started day after shot. Aching all over headaches. Broke out in shingles 7 days later". Adverse event start date was reported on 24Dec2020. No treatment received for the events. since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
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| 56 | 2021-01-04 | chills, fatigue | DEVELOPED CHILLS, BODY ACHES, AND FATIGUE. LASTED APPROXIMATELY 24 HOURS BEFORE RESOLVING. |
| 56 | 2021-01-04 | throat irritation |
DEVELOPED SORES IN MOUTH AND FEELS LIKE DOWN HER THROAT. AS OF 1/5/21, CONDITION HAS IMPROVED, BUT N...
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DEVELOPED SORES IN MOUTH AND FEELS LIKE DOWN HER THROAT. AS OF 1/5/21, CONDITION HAS IMPROVED, BUT NOT RESOLVED.
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| 56 | 2021-01-04 | fever, fatigue |
Deep muscle soreness developed within 2 hours. Soreness restricted movement prevented normal activi...
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Deep muscle soreness developed within 2 hours. Soreness restricted movement prevented normal activities and work for 12 hours. Temperature 99 at 12 hours following injection. Insomnia 12/15. Fatigue x 2 days. No redness or swelling at injection site.
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| 56 | 2021-01-04 | fever | Fever 101.0 |
| 56 | 2021-01-04 | fatigue, chills, headache |
Headache; Chills; just really tired; achy; This is a spontaneous report from a contactable consumer....
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Headache; Chills; just really tired; achy; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (BNT162B2; reported as Covid Vaccine Pfizer; batch/lot number: EH9899; expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 vaccination. Medical history included AFib (atrial fibrillation), high blood pressure and has 25 percent of her colon. The patient's concomitant medications were not reported. The patient reported that she a Pfizer shot yesterday (28Dec2020) which was clarified as Covid Vaccine Pfizer and today (29Dec2020) she was having some reactions to it, but they are not serious. The patient mentioned that she has like a headache and some chills and something like that which she hoped would go away by tomorrow (30Dec2020) and hoping that it doesn't last long. The patient mentioned that this was her first dose. When inquired on treatment, the patient mentioned that she was just really tired and achy and was just going to try sleep. The patient underwent lab tests and procedures which included Covid Rapid testing every single week [unspecified date] but no results were provided and last time she was tested was on last Tuesday (22Dec2020) with negative results. The outcome of the event headache and chills were not recovered while the outcome of the other events was unknown.
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| 56 | 2021-01-04 | dizziness, fatigue, chills |
Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel righ...
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Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel right. It feels chilled.; soreness and pain at the vaccine site; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on left top upper arm where the muscles are below shoulder on 24Dec2020 at single dose for prevention because she works in hospital (COVID-19 immunisation). The patient medical history included high blood pressure. Concomitant medication included Hydrochlorothiazide started a year ago in 2019 at 12.5mg, once daily for High blood pressure. A later response of symptoms including nausea, dizziness, and vomited once. The patient got the COVID vaccine last Thursday, 24Dec2020. That day she had chills on 25Dec2020 06:00. (PENDING CLARIFICATION) She did not have any more problems with that. The second day, 25Dec2020 00:00 she had soreness and pain at the vaccine site. Then, it was ok but sore that day and then this morning. She is having dizziness, nausea and vomited one time at 07:30 on 29Dec2020. Started on 10:00 25Dec2020, her left hand, where she got the shot, it does not feel right. It feels chilled. On Monday, she was completely fine. She did not leave. At work on Sunday. No discomfort. Today morning, she has chills and started getting all the symptoms. Her left hand is not normal. She cannot say it is weak though. The left hand is chilled. She would like to know if Pfizer has reports of others with similar issues. She also would like to know if she should get the second dose and if she should see a physician about any of these. She works at the hospital and they were giving out to employees. There was no prescriber. It was not mandatory. Her daughter got it on 20Dec2020. She is a doctor and did not have any issues. Lots of people in her family got the vaccine. No further details provided. Regarding the first day she got chills, it was like an all over body chill. The chill described on her left hand went away on 25Dec2020, and today is feeling it again. Left hand is not bad cold, just chilly. She was still tired. She is not dizzy but didn't feel all that good. Outcome was provided as persisting but improved. She was tired the day she got the vaccine at night time on 24Dec2020, she went to bed early, slept all night and Friday morning she was also tired. By Friday afternoon, she felt better and was doing better until this morning and it started again. She did not feel this bad when she got the vaccine. Today, it is worse. She is nauseated, dizzy and tired. She never had a flu vaccine. This is the first time in her life getting a vaccine. The outcome of the events chills and left arm sore and painful was recovering and the outcome of the other events was unknown.
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| 56 | 2021-01-04 | dizziness |
Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had he...
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Patient stated after vaccination felt lightheaded and numbness on left side. She sat down and had her blood pressure taken. It was 171/105. Stated that she had not taken her morning blood pressure medications (lisinopril 10mg and atenolol 50mg). The nurse at the facility gave her a dose of lisinopril 10mg. Patient then stated prickly, numb feeling and foggy-headed. The facility then gave her 2 doses of diphenhydramine 25mg. At approximately 11am, patient was still not improving and felt like she was getting worse. The facility then called for an ambulance to take her to the ER for assessment.
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| 56 | 2021-01-04 | weakness, dizziness |
Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and abou...
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Pfizer-BioNTech COVID-19 Vaccine Patient received COVID-19 vaccine on 12/30/2020 at 7:21am and about 3 minutes later, experienced nausea, dizziness and weakness. Patient was brought to ED to be evaluated @ 07:35 am. Ondansetron 4mg inj was given at 8:29am and NS 1000 mL was given over 2 hrs at 8:30am. Patient felt better and tolerating oral at 09:19 am and discharged at 9:25am.
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| 56 | 2021-01-05 | headache, chills |
"Received vaccine around 9:30am without any initial reaction. Around 9:30pm developed rigors felt co...
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"Received vaccine around 9:30am without any initial reaction. Around 9:30pm developed rigors felt cold no fever went to bed and rigors subsided after 20 minutes. Body did ache overnight and headache developed. Took Tylenol with some relief. In am aches and rigors remained absent but still had dull headache. Took headache medicine and otherwise felt fine. I have a history of feeling like this in the past after receiving my flu shot."
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| 56 | 2021-01-05 | chills |
Chills, body aches began about 12 hours after injection. Side effects lasted approximately 24 hours....
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Chills, body aches began about 12 hours after injection. Side effects lasted approximately 24 hours. Tylenol resolved side effects for about 3 hours after taking it. Had to wait additional time to take more.
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| 56 | 2021-01-05 | headache, fatigue, chills |
Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from ...
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Headache, Myalgia, Tachycardia, Significant chills also reported. Required employee to be away from work, reported greater than 16 hours of sleep second to the overwhelming fatigue
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| 56 | 2021-01-05 | fatigue, dizziness, headache, chills |
Headache; Chills; Muscle ache; Dizziness; Fatigue; This is a spontaneous report from a contactable c...
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Headache; Chills; Muscle ache; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 29Dec2020 10:30 at single dose for preventive measure of COVID. Medical history included hypertension. Concomitant medication included atenolol at 50 mg for hypertension. Consumer stated, "It is Pfizer! I am having side effects, I started this morning. I am having the headache, chills and muscle ache, just feel like I have a flu but I don't. I have received the vaccine yesterday from my job, yesterday at 10:30. I think I got all the symptoms like the dizziness, fatigue, headache and muscle ache." Consumer stated, "I just took some Aleve" as treatment. The outcome of events was unknown. Information about lot/batch number has been requested.
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| 56 | 2021-01-05 | dizziness, fatigue |
Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left ...
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Lightheadedness was the first 2 days after the vaccine (arm discomfort). Felt numbness on the left upper lip 2-3 hours after vaccine, but noted facial droop 3 days later. Numbness is improving at this time. Some fatigue.
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| 56 | 2021-01-05 | chills, headache, fever |
Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade ...
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Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; Low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash.; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EKS730), intramuscularly on 20Dec2020 08:45AM at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. Patient was diagnosed with COVID-19 prior to vaccination. Known allergies included Penicillin. Concomitant medication included levothyroxine, pravastatin, buspirone, zinc, ascorbic acid (VITAMIN C), tocopherol (VITAMIN E), vitamin d3, vitamin b complex (B COMPLEX), calcium citrate, chondroitin sulfate, glucosamine sulfate, methylsulfonylmethane (GLUCOSAMINE CHONDROITIN & MSM). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low grade fever 99.8 at highest, chills, headache, body aches, joint pain, nausea, rash on 20Dec2020. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. The patient underwent Covid test type post vaccination - Nasal Swab: Negative on 23Dec2020.
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| 56 | 2021-01-06 | dizziness, headache, malaise |
2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; ...
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2 hours, after receiving injection, started feeling nausea, slight headache, very slight sore arm; 3-4 hours later took 3 ibuprofen due to the headache. Feeling light headedness. Next morning, sore arm was heavy, headache, body aches, temp 99, and nausea; felt unwell; took 3 ibuprofen. Time off from work to just lay flat and rest for the day.
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| 56 | 2021-01-06 | headache, fever | Arm hurts and woke up with headache fever and body aches 12 hrs after vaccine was administered. |
| 56 | 2021-01-06 | dizziness |
C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest tw...
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C/O left arm pain radiating down arm and up neck; pointed to mid-sternal area and reported "chest twinge". Radial pulse measured 88- pulse felt weak. Brought over to EMS for evaluation, monitor shows HR 87, BP 185/98 (160/88 manual), O2 99% on RA. HR came down to 79, BP 142/80. Around 0910 c/o nausea and dizziness. 0915 called daughter to drive her home, refused to transfer with EMT to hospital.
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| 56 | 2021-01-06 | fever | Fever, body aches, and body rash on Day 2 |
| 56 | 2021-01-06 | fever, chills, fatigue | Fever, chills, fatigue, itching |
| 56 | 2021-01-06 | chills, headache | Headache, chills, hot flashes, rash on face, feeling like "mosquito bites" all over the body |
| 56 | 2021-01-06 | shortness of breath, headache, chills |
Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites...
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Headache, feeling chills and hot flashes, shortness of breath, rash on face, feeling "mosquito bites" all over body
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| 56 | 2021-01-06 | cough, dizziness |
Patient complained of dizziness, wheezing, cough, and nausea. BP 180/110, P 72, O2 saturation 99% R...
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Patient complained of dizziness, wheezing, cough, and nausea. BP 180/110, P 72, O2 saturation 99% RA; 3:23PM BP 180-110, P 84, O2 sat 99% RA; 3:35PM BP 210/100 P88, O2 sat 98% -- > called emergency services; 4:25PM BP 140/92. Paramedics administered 1 dose 25mg diphenhydramine.
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| 56 | 2021-01-06 | fever | Patient reported fever and body aches for 8 hours |
| 56 | 2021-01-06 | dizziness, weakness |
Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/...
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Pfizer-BioNTech COVID- 19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
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| 56 | 2021-01-06 | weakness, dizziness |
Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2...
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Pfizer-BioNTech COVID-19 Vaccine EUA. Vaccine recipient received Pfizer-BioNTech vaccine on 12/19/2020. On 12/26/2020, the area on the left arm where the vaccine was administered started to get sore again, numb to the touch, and was throbbing sometimes. She reported that when she raises her arm up, it feels like something is tearing and sometimes feels weak. On 12/27/2020, she woke up with vertigo which subsided but has been lightheaded ever since and feeling off-balance. She also reported to have loud noises coming from her ears described as hissing sounds. This has been constant. She noted that years back, on two separate times she received chemotherapy treatment which really affected her ears. It felt like there was pressure and same kind of noises. She is pending occupational health follow-up.
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| 56 | 2021-01-06 | cough, chills, somnolence, headache, head discomfort |
Pt. states that she received vaccine and ten minutes after vaccination she started coughing, having ...
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Pt. states that she received vaccine and ten minutes after vaccination she started coughing, having tachycardia hr in the 110s, fullness feeling to head, chest irritation. Went to ER, discharged same day. On drive home she started having bilateral lower extremity weakness and felt super sleepy. 01/01/21 symptoms resolved. 01/02/21 woke up with chills at 2am, went back to sleep, woke back up at 5 am same day and symptoms resolved. 01/03/21-mild headache-took Tylenol sinus-headache resolved. Pt. states that she has felt fine ever since.
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| 56 | 2021-01-06 | throat irritation, shortness of breath |
Reports Itchy throat, difficulty breathing. Has a history of multiple allergies. Transferred to ED. ...
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Reports Itchy throat, difficulty breathing. Has a history of multiple allergies. Transferred to ED. Symptoms resolved.
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| 56 | 2021-01-06 | cough | SkinRash, CoughWheeze & Syncope |
| 56 | 2021-01-06 | headache |
Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red la...
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Started with muscle aches and weakness in the right arm on Jan 7th, this afternoon I have a red lacy rash all down my arm a little itchy. Headache and lips tingle .
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| 56 | 2021-01-06 | fatigue | arm soreness from 12/31/20 to 1/5/21. fatigue 12/31/20 to 1/4/21. |
| 56 | 2021-01-06 | chills, headache | headaches, hot flashes, chills, rash on face, feeling like "mosquito bites" all over body |
| 56 | 2021-01-06 | nasal congestion, throat pain, cough |
positive Covid results with symptoms; positive Covid results with symptoms; This is a spontaneous re...
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positive Covid results with symptoms; positive Covid results with symptoms; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension (diagnosed 3-4 years ago), hyperlipemia (diagnosed 3-4 years ago), supraventricular tachycardia since 2017, and asthma; all ongoing. Family history included hypertension. She has no history of adverse reactions or allergies to any vaccines received previously. The patient's concomitant medications were not reported. The patient explains that she got the COVID-19 vaccine on 20Dec2020. Afterward she had some coughing, so she went for a rapid test and found she tested positive after the vaccine. The patient was wondering if this has been reported previously, where someone tested positive after getting the vaccine. She has never tested positive before. She got the results on 28Dec2020 that she was positive. She was now in a hotel quarantining. She was looking trying to find information on this occurring. Since she was in the hotel, she would prefer to use email as communication for follow-up. The patient noticed the cough on 25Dec2020. She works nights so she stayed home on the 26Dec2020. Then on 27Dec2020 she had the test done and on 28Dec2020 the results were given to her and she was positive. Her second dose was due on 10Jan2020 and it was before the 14 days of quarantine will be up. She was checking to see is there anywhere else she can get the second dose. The patient explains that she has been researching and she wanted to get it because she was with elderly family members. She wanted to know how she was tested positive, what test was used as she had the rapid test. There were no treatments for the events. The caller patient was also experiencing a cough, sore throat, and nasal congestion. There was no shortness or anything else going on at this point. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded. The case will be reassessed if additional information becomes available.
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| 56 | 2021-01-07 | chills, head discomfort, cough |
48 hours after the vaccine , I awoke from a sleep with chills; Approximately 5-10 minutes after rece...
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48 hours after the vaccine , I awoke from a sleep with chills; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; Approximately 5-10 minutes after receiving the pfizer covid-19 vaccine . My heart rate became elevated 110-120 , my chest was irritated, my head felt full and a started to cough.; I still felt a little weak in my legs; This is a spontaneous report from a contactable nurses. A 56-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EK9231, expiration date unspecified), via an unspecified route of administration on 31Dec2020 at 13:00 at single dose at right arm for COVID-19 immunization. Medical history included hypertension, cholesterol (abnormal) and hypothyroid which were well managed. The patient was not pregnant at the time of vaccination and had no allergies to medications, food or other products. Concomitant medications were not reported. On 31Dec2020 at 13:30, approximately 5-10 minutes after receiving the Pfizer covid-19 vaccine, patient's heart rate became elevated at 110-120, chest was irritated, head felt full and started to cough. Patient was taken to the emergency room (ER) and was placed on a monitor/EKG was obtained. Patient was released to home that same day, however she still felt a little weak in her legs. It was reported that 48 hours after the vaccine, the patient awoke from a sleep with chills, all her vitals were within normal limits, but the dry cough had returned. The patient was treated with fluids, vitals, EKG closely monitored and rapid cov (as reported). The events resulted to a doctor or healthcare professional office/ clinic visit. The patient was vaccinated at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were other medications the patient received within 2 weeks of vaccination. The patient underwent lab tests and procedures which included a nasal swab was negative on 31Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was unknown.
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| 56 | 2021-01-07 | malaise |
After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I bec...
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After the shot the next evening my arm was so sore and couldn't move my arm. After 8 days when I became sick.
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| 56 | 2021-01-07 | chills, shortness of breath |
Came to ER on 12/20/20 with chills, heart palpitations, body aches and increased SOB. Had ST elevat...
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Came to ER on 12/20/20 with chills, heart palpitations, body aches and increased SOB. Had ST elevation on EKG in ER, taken to Cath Lab- no intervention done. D/C home 12/22/20. Previous Hx of COVID per patient
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| 56 | 2021-01-07 | chills, fever | Chills, fever, nausea, vomitting, diarrhea, and body aches |
| 56 | 2021-01-07 | fatigue | Fatigue, body aches, cellulitis at injection site |
| 56 | 2021-01-07 | chills, fever, cough | Fever 102.9, chills, body aches, pain at injection site, nausea, cough |
| 56 | 2021-01-07 | headache |
HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARG...
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HEAD ACHE, MUSCULAR ACHES, FEVER, CHEST PAIN AND IRREGULAR HEART RATE, EDEMA, ITCH, ERYTHEMA, ENLARGEMENT OF LYMPH NODE
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| 56 | 2021-01-07 | headache | Headache |
| 56 | 2021-01-07 | fatigue, headache | Headache Fatigue, sore arm |
| 56 | 2021-01-07 | headache, fatigue |
Headache TIREDNESS SAME DAY. NEXT DAY, BAD HEADACHE, BACK WAS HURTING. TODAY 01/05/21 JOINT PAIN WHE...
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Headache TIREDNESS SAME DAY. NEXT DAY, BAD HEADACHE, BACK WAS HURTING. TODAY 01/05/21 JOINT PAIN WHEN I WOKE UP. LEFT ARM JOINT PAIN AT ELBOW AND AT WRIST AND MY HAND AND FINGERS Narrative: 2 DAYS OF SAFETY LEAVE
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| 56 | 2021-01-07 | respiratory tract congestion, headache, fever |
I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not t...
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I became ache all over, fever of 100.7. Severe headache and nausea. That has past and now, can not taste and smell and congested.
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| 56 | 2021-01-07 | fever, chills |
ON 1/4/21, DEVELOPED FEVER, ARM SWELLING, CHILLS, AND BODY ACHES AROUND 8PM AND LASTED ABOUT 24 HOUR...
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ON 1/4/21, DEVELOPED FEVER, ARM SWELLING, CHILLS, AND BODY ACHES AROUND 8PM AND LASTED ABOUT 24 HOURS.
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| 56 | 2021-01-07 | dizziness |
Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/...
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Patient C/O palpations, hot, dizzy, slightly nauseated. No SOB Patient observed x 40 minutes B/P 126/86 HR 76 Sat 96% Patient did elect to call her husband to pick her up
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| 56 | 2021-01-07 | cough, shortness of breath, head discomfort, weakness |
Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27...
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Patient received first dose of Pfizer COVID-19 vaccine on December 26. On the next day, December 27, patient started having pressure in her head and sinuses, weakness. Then she developed nonproductive cough and progressive shortness of breath. She was seen at urgent care and tested positive for COVID-19 on December 29. She had low oxygen saturation on home oximeter and severe shortness of breath. Patient's husband is also ill with COVID-19 at home. Patient was sent to the ED and admitted to the hospital.
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| 56 | 2021-01-07 | dizziness |
Sxs started 3-5 minutes post vax. Dizziness, hypotension, throat fullness, CODE called, given IM Epi...
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Sxs started 3-5 minutes post vax. Dizziness, hypotension, throat fullness, CODE called, given IM Epi at vax site. Taken to ED from vax site. Started on epi drip. Admitted to SHC.
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| 56 | 2021-01-07 | headache |
The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went t...
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The next say I exp headache I was warranted cause on of my coworkers tested positive Covid. I went to ER high BP and got tested for Covid results negative. On that Saturday my BP was still high and left calf pain. Since I'm usually hypotensive I monitored my BP however it has continued to elevate.
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| 56 | 2021-01-07 | dizziness |
upon presentation for second dose, patient informed us that last time she was dizzy and we had her s...
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upon presentation for second dose, patient informed us that last time she was dizzy and we had her sit for 30 minutes . Upon further conversation she mentioned that she was dizzy when walking to her car the first time (12/17/2021) . She said the first time she felt dizzy walking to her car and vomited, then laid in her car for an hour before being able to drive home. Didn't eat much that night. Received second dose today 1/8/2021. She was feeling dizzy and nauseated less than 10 minutes from injection. at 11;05 a.m. blood pressure was 139/66; 11:15 a.m. 126/71 at approximately 11:35 a.m. 139/73. MOved her with wheelchair from vaccination room to patient room on a bed. Applied 92 per nasal canula. Physician in room (not privy to exam) Zofran 4mg Sublingual given and transported via wheel chair to other side side of hospital to ER
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| 56 | 2021-01-08 | dehydration, fever |
Body Muscle pains through out the body it started on 12/20/2020 The muscles were swollen One day I ...
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Body Muscle pains through out the body it started on 12/20/2020 The muscles were swollen One day I had a slight fever I also had dehydration. Virtual appointment with my doctor
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| 56 | 2021-01-08 | headache, fatigue, fever |
Fever 103.9 , headache, body aches, eye pain, fatigue Symptoms lasted for 48 hours. Fever responded ...
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Fever 103.9 , headache, body aches, eye pain, fatigue Symptoms lasted for 48 hours. Fever responded to Tylenol but returned as Tylenol wore off.
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| 56 | 2021-01-08 | headache, lethargy, fever | Fever, body aches, lethargy, headach |
| 56 | 2021-01-08 | dizziness, malaise |
Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, l...
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Had COVID vaccine and was being monitored. at 11:25a she developed dizziness, nausea, chest pain, left arm weakness/numbness, skin itching. BP checked and was 190/110, then 180/110. Hx HTN and BP meds taken today. Hx of allergies -- took loratadine and hydroxyzine this AM. Due to the dizziness and skin itching, feeling unwell/woozy with history of anaphylaxis, given epipen and called 911. EMS arrived and taken to ER.
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| 56 | 2021-01-08 | headache, fatigue | Headache, Myalgia, Arthralgia, fatigue, injection site pain Narrative: |
| 56 | 2021-01-08 | chills, fatigue, dizziness |
Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later ...
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Metallic taste, palpitations, nausea, dizziness, flush Subsided after 30 min headache 4 hours later Tylenol taken Next day painful injection site, body aches chills fatigue Tylenol Advil taken with some relief
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| 56 | 2021-01-08 | chills, throat pain, headache, fatigue | Next day felt extremely tired, chills, sore throat, headache, body ache |
| 56 | 2021-01-08 | headache | Patient reported headache shortly after admin, resolved at end of 15 min obs period. |
| 56 | 2021-01-08 | chills, fever | temp 100 F , chills body aches mainly lower back ache |
| 56 | 2021-01-09 | body temperature increased, headache, skin warm |
1.) immediate pain in injection site that lasted until the next day. Pain relieved after taking Tyle...
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1.) immediate pain in injection site that lasted until the next day. Pain relieved after taking Tylenol the morning after 2.) elevated skin temperature at night documented as 3 degrees above baseline by Fitbit Sense 3.) headache felt 26 hours after vaccine administration; 101.7 degree temperature documented 26 hours after vaccine administration since Tylenol 500 mg taken in the morning 4.) symptoms resolved the next day
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| 56 | 2021-01-09 | chills, fever, migraine, fatigue |
1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, ...
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1st vaccine: Approximately 24 hours after vaccine, I developed chills with fever of 100.2, fatigue, total body/muscle/joint aches, migraine headache, nausea, heart palpitations, as well as very sore, swollen arm. Had to spend the day in bed. Most symptoms relieved by the next 24 hours except arm pain and fatigue. 2nd vaccine: Similar, but worse symptoms developed approximately 12 hours after vaccine. All of the aforementioned symptoms, but fever of 101.4 and arm wasn't quite as sore. As above, had to spend a day in bed.
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| 56 | 2021-01-09 | weakness, headache |
Mild pain/soreness at injection site starting later the day of injection and next day. Approximately...
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Mild pain/soreness at injection site starting later the day of injection and next day. Approximately 2 pm the day after injection, began feeling overly hot and nauseated. That was followed by pressure type headache, muscle/bodyaches, and overall feeling of no energy progressing as the afternoon and evening continued. Spent that evening sleeping on/off. The following day spent in bed with continued headache, body/muscle aches, feeling overall drained/ no energy. Nausea improved some; was able to stomach some soup later in the day. So far today, feeling some improvement with bodyaches, but overall drained of energy. Headache has lightened some as well.
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| 56 | 2021-01-09 | chills, headache, fatigue | Very fatigues, headache, nausea, intermittent chills, vomited once. |
| 56 | 2021-01-10 | nasopharyngitis |
01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completel...
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01/05/2021 Warmth inside the body and cold outside the body. Rigid jaw I could not open it completely and in the vaccination area it turned red and with a protuberance. 01/06/2021 when ingest food the chewing made difficult the chewing process I bit my cheek on the inside throughout the day. Itching in the right arm throughout the day. 01/07/2021 the tongue felt enlarged and I had to keep my mouth half open so it did not stick to the palate. 01/08/2021. On this day the arm had already improved the body warmth had decrease I was not tired and the tongue had decreased in size and heaviness. At no time was medications ingest other than propranolol which I must take daily under doctor's order.
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| 56 | 2021-01-10 | chills, headache, fatigue |
3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, l...
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3 hours post vaccine- severe nausea. Lasted for 29 hours 3 hours post vaccine. Left arm pain-mild, less than flu shot pain. lasted 3 days. 6 hours post vaccine- bad headace-lasted 29 hours 8 hours post vaccine-mild chills. Lasted 5 minutes 10 hours post vaccine- another episode of chills-lasted 10 minutes 12 hours post vaccine-moderate tiredness. Lasted 24 hours 12 hours post vaccine-generalized achiness-lasted 24 hours
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| 56 | 2021-01-10 | fatigue |
After 7hrs of the vaccine I was feeling very tired I had muscle ache almost a week later I went to t...
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After 7hrs of the vaccine I was feeling very tired I had muscle ache almost a week later I went to the ER because I had a lot of pain on my legs mainly on my right one I thought I had a blood clot but in the ER they told me it was just a reaction the the vaccine.
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| 56 | 2021-01-10 | chills |
Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 a...
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Chills beginning Friday night into early Saturday morning. Low grade temperature on Saturday of 99 at 10 am. Took Advil with relief. Sunday afternoon low grade temperature of 99 at 3 pm. Reports arm soreness bilateral.
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| 56 | 2021-01-10 | fatigue | Extreme Fatigue and a few days after the shot, stomach pain (cramplike but not cramps) |
| 56 | 2021-01-10 | fatigue | Fatigue 1/9/2021 day of injection Body ache and joint pain 1/11/2021 |
| 56 | 2021-01-10 | fever, chills, throat pain, cough, fatigue | Fever, chills, arm ache, mouth ache, body aches, sore throat, dry cough, rash and exhaustion |
| 56 | 2021-01-10 | fever, chills | Fever, chills, body aches, injection area red and warm to touch started the next day |
| 56 | 2021-01-10 | fever, headache | Fever, headache, chest wall soreness, muscle and joint pains, and site of injection redness and pain |
| 56 | 2021-01-10 | chills, cough, body temperature increased, influenza like illness, throat pain |
I had sore throat starting on 12-24-2020 with chills, muscle aches, flu like symptoms. Next day I ha...
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I had sore throat starting on 12-24-2020 with chills, muscle aches, flu like symptoms. Next day I had temperature of 99.7 and my whole body was aching. The following day I started taking Tylenol and rested and took another rapid test 12-24-2020 and rested so more. I went for another test on 12-27-2020 for a rapid test and on 12-30-2020 I was let know i was positive for Covid. I still has some cough today that comes and goes.
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| 56 | 2021-01-10 | runny nose |
I noticed a runny nose for the entire first day and the next day I had an appointment. My right eye ...
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I noticed a runny nose for the entire first day and the next day I had an appointment. My right eye was puffy, swollen, red, itchy. I got a shot of dexamethazone and the next day I felt better. I also had a script for prednisone.
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| 56 | 2021-01-10 | fever | ON 12/31/20 AT 5PM, DEVELOPED FEVER THAT WENT TO 101.8. RESOLVED 1/1/21 AT 3PM. |
| 56 | 2021-01-10 | fever, chills, headache | Pfizer Bio NTech COVID 19 vaccine EUA- symptoms began 01/06/21 chills, fever, HA, body aches, N&V |
| 56 | 2021-01-10 | throat irritation |
Pt entered observation @ 0840. This nurse asked pt if she felt okay @ 0850. Pt stated that her thr...
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Pt entered observation @ 0840. This nurse asked pt if she felt okay @ 0850. Pt stated that her throat felt scratchy". Water was offered. Asked pt how did she feel @ 0900, stated that s/s were still the same. This nurse administered Benadryl 25mg @ 0904. @ 0912 pt stated to this nurse that s/s were somewhat better. Pt remains in observation @ present time, time 0923. Still remains to voice s/s of distress @ 0933. States Benadryl 25mg did not alleviate the s/s. States s/s were worsening. Epi 0.3mg given @0934. Administered in L thigh. Pt sent to ER after administration of Epi 0.3mg. Pt alive and breathing @ 0947, when going into Registration @ ER, still continues to voice s/s of distress to throat.
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| 56 | 2021-01-10 | chills, weakness, headache, fatigue |
Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the P...
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Pt to report to the RN on the morning of 01/11/2021 that since she received the second dose of the Pfizer vaccine (COVID-10) that she had had disturbing nightmares. Pt reports that she had two night-mares after the 1st dose, but said the second dose she started having nightmares this morning. Pt declined evaluation at the clinic after reporting of the events. Other S/S she had experienced are headache, nausea, chills, weakness, feeling tired but symptoms have improved.
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| 56 | 2021-01-10 | weakness, headache, fatigue, chills |
Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports...
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Pt with complaints of disturbing nightmares since administration of the COVID-19 vaccine. Pt reports on 01/11/2021 to this RN that she had a couple nightmares after the first injection. Pt reports that she had two nightmares after the first dose. Since her second dose was received on January 8, 2021 she reports having disturbing night mares and requested reporting of the events. Pt declined evaluation at the clinic after notification of the event. Pt voiced she will follow-up with her PCP if the nightmares continue. Other side effects she reported with the second dose is nausea, tiredness, fatigue, headache, chills and some weakness. Those symptoms have since improved.
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| 56 | 2021-01-10 | fatigue, fever |
SEVERE LEFT ARM PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, GENERALIZED JOINT PAIN, FEVER, MALAISE AN...
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SEVERE LEFT ARM PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, GENERALIZED JOINT PAIN, FEVER, MALAISE AND FATIGUE STATED ON 1/9/2021, TOOK PERCOGESIC ALTERNATED WITH ACETAMINOPHEN
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| 56 | 2021-01-10 | fatigue, fever |
STARTED WITH ACUTE LEFT ARM PAIN WITH DIFFULTY RAISING LIMB, PAIN EXTENDED TO LEFT SHOULDER AND ELBO...
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STARTED WITH ACUTE LEFT ARM PAIN WITH DIFFULTY RAISING LIMB, PAIN EXTENDED TO LEFT SHOULDER AND ELBOW, FEVER, GENERALIZED JOINT PAIN, FATIGUE. TOOK PERCOGESIC AND ACETAMINOPHEN
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| 56 | 2021-01-10 | headache, fatigue, dizziness, fever, nasal congestion |
Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. A...
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Severe headache, Fever 100.9F, Dizzy, Nausea, Heart Palpitations, Head congestion, severe fatigue. All lasting approximately 12 hours.
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| 56 | 2021-01-10 | chills, fever, headache, fatigue |
Shaking chills on 12/8/21 and low grade temp of 99.7 headache and body aches on 12/9/21 body aches a...
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Shaking chills on 12/8/21 and low grade temp of 99.7 headache and body aches on 12/9/21 body aches and fatigue on 12/10/21 local arm tenderness that started on 12/9/21
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| 56 | 2021-01-10 | dizziness |
feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta ...
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feeling flushed elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
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| 56 | 2021-01-10 | fever, chills |
fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symp...
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fever, body aches, chills, and red halo around injection site. Had vaccine on 01/07 and adverse symptoms began on 01/09 have continued through 01/11 but have gotten better.
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| 56 | 2021-01-11 | chills, headache, dizziness |
Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hou...
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Dizzy, nauceous, headache, arms tingling, tops of legs tingling, bottom lip numb, cheeks numb 10 hours after injection. 5 days after injection; chills and major lower back pain.
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| 56 | 2021-01-11 | dizziness, chills, headache |
Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling wit...
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Dizzy, nauceous, headache, upper arms tingling, lower lip numb, cheeks numb, upper legs tingling within 10 hours after injection. 5 days after injection resulted in massive lower back pain and chills.
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| 56 | 2021-01-11 | body temperature increased, sweating, headache, dizziness |
I got extremely hot with sweating, I got a massive headache that started at the base of my neck tha...
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I got extremely hot with sweating, I got a massive headache that started at the base of my neck that effected my vision. I was dizzy, BP was high over 140, temperature increased. I had some tingling in my upper extremeties. I had really bad GI pains, I had itching and a light rash. I had to go to the ED where I received a cocktail.
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| 56 | 2021-01-11 | dizziness, chills, shortness of breath, fatigue, headache |
Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tirednes...
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Initially what seemed like a muscle spasm involving entire left arm/neck/chest. Followed by tiredness. Approximately 2.5hrs later developed generalized muscle aches, tired, chills. Next morning muscle aches were less, new headache and dizziness. took Tylenol which helped, about 5 hrs later symptoms worsened, improved with sleep and Tylenol. Awoke this morning with some chest pain similar to initial response, some headache and dizziness, improved with Tylenol, now returning (noon). occasionally feels like I need to take a deep breath. I believe its mostly muscular pain gets a little worse with deep breathing. Sent home from work day of vaccine, worked partial days next 2 days
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| 56 | 2021-01-11 | migraine |
Patient said they experienced a migraine after being vaccinated and also reported they are prone to ...
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Patient said they experienced a migraine after being vaccinated and also reported they are prone to migraines
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| 56 | 2021-01-11 | chills, fever | Shivers. Chills. Body aches , fever 101.2 tympanic Sore left arm |
| 56 | 2021-01-11 | throat irritation |
Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine dif...
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Within 90 minutes of receiving the 2nd vaccine dose patient reported developing a full body fine diffuse rash with mild lip swelling. The following morning she reported that the rash was gone but still had an itching sensation in her mouth and throat, no swelling just irritating itch.
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| 56 | 2021-01-11 | headache, chills | chills, elevated heart rate, headache, Sore Arm |
| 56 | 2021-01-11 | headache, chills |
full day of full body aches; chills; headache; miserable; This is a spontaneous report from a contac...
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full day of full body aches; chills; headache; miserable; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration at left arm on 04Jan2021 14:45 at single dose for COVID-19 immunization at a workplace clinic. The patient's medical history was reported as none, no known allergies to medications, food, or other products and no other medical history. Concomitant medication in two weeks included progesterone, testosterone, colecalciferol (D3), calcium, "C", "E", and "Ty". No other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. On 04Jan2021 the patient received the injection. And on 05Jan2021, the patient experienced full day of full body aches, chills, headache, and miserable. No fever. The events started on 05Jan2021 05:00. On 06Jan2020, the patient felt great. No treatment was received for the events. The outcome of the events was recovered on 06Jan2021.
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| 56 | 2021-01-11 | malaise, fatigue | sudden onset nausea, malaise, fatigue, later that day developed eye swelling |
| 56 | 2021-01-12 | headache, fatigue | 1/11 evening after 2nd injection nagging headache frontal, fatigue X 2 days took tylenol |
| 56 | 2021-01-12 | headache, fatigue, dizziness |
1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain towar...
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1/11/21 woke up feeling tired, muscle aches, took migraine medicine, and ibuprofen. Back pain toward the kidney, stomach area. Felt like she would pass out. Dizzy, nausea. Seeing a patient she had to leave the room and go sit on the floor. Blood pressure was very low, couldn't stand up. Painful to have clothes touching the skin all over. Felt like she need more air, panting. Didn't sleep 8-10 hours. Started with sever H/A and muscle pain. Sensitive to light and sound. Fatigue. Out of work 1/12-1/13. Skin sensitivity is gone. Talk big dose of ibuprofen. Still fatigue. H/A is better.
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| 56 | 2021-01-12 | chills, lethargy, lethargy, chills |
16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and p...
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16 hrs post 2nd COVID vaccination injection I experienced the following symptoms: severe aches and pains in joints, chills-cold hands,feet, lethargy, slight nausea, diarrhea. Symptoms subsided over the following 24 hours. Joint aches continue
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| 56 | 2021-01-12 | fatigue, fever, headache, chills |
20 minutes of fever, chills, headache, fatigue, back ache. Repeated at 8:00 PM. Called out of work S...
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20 minutes of fever, chills, headache, fatigue, back ache. Repeated at 8:00 PM. Called out of work Saturday 1/9/2021
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| 56 | 2021-01-12 | runny nose |
Arm was very sore. Lasted 2 days. On 24th Dec. woke up with very heavy nasal drainage; continued for...
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Arm was very sore. Lasted 2 days. On 24th Dec. woke up with very heavy nasal drainage; continued for several days and it went to my chest. I Medicated with: Mucinex and Advil sinus - but wasn't working. Telehealth call to DR. and He prescribed C-Pac - 250 mg - 5 day dose and decongestant: Guaifenesin 100 mg - 5 mg liquid - 10 ml every six hours by mouth as needed for 10 days and I took that decongestant for 6 days. Felt better at this point. Never had had this before.
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| 56 | 2021-01-12 | fever, throat pain, headache | Body aches, fever, chills, headache, nausea, sore throat, left ear pain, COVID exposure w/in 14 days |
| 56 | 2021-01-12 | respiratory tract congestion | Congestion, loss of taste/smell, diarrhea, ear pain, eye irritation |
| 56 | 2021-01-12 | fever, headache |
Experienced pain and swelling at the injection site. Developed mild fever, headache, body aches and...
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Experienced pain and swelling at the injection site. Developed mild fever, headache, body aches and sinus congestion.
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| 56 | 2021-01-12 | fever, chills, dizziness |
Felt lightheaded at work. Sent to ER had BP 183/101 hr 127, given IV fluids and discharged . Later t...
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Felt lightheaded at work. Sent to ER had BP 183/101 hr 127, given IV fluids and discharged . Later that evening had fever and chills.
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| 56 | 2021-01-12 | fever, chills | Fever chills 12 hours after shot, lymphadema in umderarm 48 hours later |
| 56 | 2021-01-12 | fatigue, fever, chills, headache |
Fever; Chills; Fatigue; Body Aches; Headache; Nausea; Other vaccine same date; Other vaccine same da...
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Fever; Chills; Fatigue; Body Aches; Headache; Nausea; Other vaccine same date; Other vaccine same date; This is a spontaneous report from a contactable other health professional (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Jan2021 12:00 PM at single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were none. On the 06Jan2021, other vaccine was vaccinated on the same date at left arm. On 07Jan2021 09:00, patient experienced fever, chills, fatigue, body aches, headache, nausea. Treatment of events "fever, chills, fatigue, body aches, headache, nausea" was unknown. Outcome of "Other vaccine same date" was unknown, while outcome of other events was recovering. Information on the lot/batch number has been requested.
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| 56 | 2021-01-12 | headache, runny nose, respiratory tract congestion, discomfort |
Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drai...
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Had a sore arm about 6 hours after. Four days after vaccine - 4:30 am woke up with severe nasal drainage and pressure. Headache. Very congested. Medicated with Mucinex and Advil Sinus. A couple days later went to my chest. Got medical care from Telemed visit - Z-Pac - took for five days - 250 mg and a liquid decongestant: Guaifenesin - 100 mg/5 mm once every six hours for 10 days as needed. I took it for six or 7 days. Resolved.
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| 56 | 2021-01-12 | headache, fatigue | Headache Fatigue |
| 56 | 2021-01-12 | chills, fatigue, headache, fever |
Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of adminis...
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Mild arm soreness started within 6 hrs of administration of vaccine. Within 12-16 hours of administration patient developed intermittent chills, fever 101.4 to 102.2 F , moderate to severe tension headache, mild muscle ache/joint pain, insomnia, severe fatigue, and mild nauseau. Fever lasted for approximately 48 hours. Other signs and symptoms resolved by 72 hours following vaccination. Patient also noticed mild fatigue as well as slight disorientation and slight loss of balance until 1/11/21. Patient was normal by 1/12/21. No specific treatments administered.
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| 56 | 2021-01-12 | fatigue, runny nose |
Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt sw...
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Received the vaccine at 330p. Began to have mild upper eyelid itching around 11:59p. Eyes felt swollen then began to feel nauseous (tried to vomit, but no food came up) and then a runny nose (clear fluid). I took another Claritin 10mg and also Zofran 8mg ODT which resolved the nausea. Had to blow my nose 2 times. Went to sleep with my Epipen at bedside but didnt have to use it. Woke up at 815am and only symptom remaining was arm soreness. Felt like my normal self and played 3 hrs of tennis. Arm soreness at injection site worsened during the day. By 72 hrs post-injection, arm soreness resolved.
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| 56 | 2021-01-12 | headache, lethargy, malaise, fatigue, fever |
Took advil starting on the 9th. 18 HOURS LATER - next day (10th) took tylenol for fever - woke up v...
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Took advil starting on the 9th. 18 HOURS LATER - next day (10th) took tylenol for fever - woke up very lethargic ; as day went on had severe fatigue. About six pm strike fever; headache and fatigue (fatigue was the worst). Muscle aches started on the 10th and through the 11th. Next day (11th) no more fever; still fatigue but not as bad (moderate). By 11th in evening was feeling better that night. But still did not feeling well at all. On 12th - joint pain on 12th; and swelling and redness and it had heat and some pain on injection site (maybe had before but I didn't notice before). Took advil through all of this. Still have a mild headache off and on and today as well. And feeling fatigue now, too. No longer taking Advil.
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| 56 | 2021-01-12 | fever, cough | cough (exposed to covid 19 had vaccine Monday) and fever (100.8) |
| 56 | 2021-01-12 | throat pain | exposure with ear pain , sore throat and eye irritation test negative |
| 56 | 2021-01-12 | malaise, chills, fatigue, headache |
significant body aches at night, 24 hours later headache,chills, fatigue, temp of 99.5, 48 hours lat...
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significant body aches at night, 24 hours later headache,chills, fatigue, temp of 99.5, 48 hours later fatigued in general not well-being, chills, fatigue, injection site pain, malaise new or worsened join and muscle pain
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| 56 | 2021-01-12 | shortness of breath | throat closing and shortness of breathe. given epinephrine 0.3IM |
| 56 | 2021-01-13 | dizziness, thirst |
"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began t...
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"Pfizer-BioNTech COVID-19 Vaccine " I, the client sitting 5 minutes after receiving vaccine began to feel dizzy and drank the provided bottled water. The dizziness lasted for 2 hours. Within 10 minutues I also started having numbness and tingling from my right elbow to my hand, anterior and posterior. This continued throughout the day. After being observed by staff, after 30 minutes I was given Benadryl tablet25 mg by mouth. The adverse event has also been reported to my manager and employee health.
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| 56 | 2021-01-13 | weakness, shortness of breath, dizziness |
56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine....
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56 yo female from pharmacy presented to the observation room at ~1116 after receiving COVID vaccine. She reports feeling weakness and dizziness. She states she fellt sensation to her neck immediately after she got the vaccine. Pt appears very anxious. Provided cold pack behind her neck and vital signs taken 152/90 with HR 98 O2 SAT 98%. Pt then taken to the gurney to lay down. Pt continued to feel weak with short of breath, tingling finger tips. 100% NR mask provided, Dr notified and arrived immediately. vital signs taken every 5-10 min with b/p trending down within 20 minutes. Pt states felt better around 1150. Attempted to sit up but states felt weak again. Pt felt anxious and wanted to speak to her husband, Medic, called husband and was able to speak to him. Pt continues to feel weak. Continue to monitor and comfort provided. Discussed with medical team that patient need to be sent to the ER for further observation. 911 called at 1215 and arrived within few minutes, report given to EMS. Patient transferred to ER at 1230 via gurney. 1117: 152/90,HR 103, O2 sat 98% 1121: 144/72, HR 89, O2 SAT 99%-applied O2 100% non rebreather mask 1126: 153/88, HR 80 1142: 160/92, HR 85, O2 SAT 100% 1147: 147/85, HR 77, O2 SAT 100% 1152: 136/85, HR 70, 02 SAT 100% 1202: 133/81, HR 68, 02 SAT 99%
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| 56 | 2021-01-13 | headache |
ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, m...
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ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; headache; Minimal pain at injection site; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiry date: unknown) intramuscular (left arm) on 07Jan2021 at 15:30, at a single dose, for COVID-19 immunization. Relevant medical history included hypertension (HTN), hypothyroid, and early pulmonary HTN. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) intramuscular (left arm) on 17Dec2020 at 15:15 for COVID-19 immunization. The patient previously received bactroban ointment and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 5:00 a.m. the patient's entire body hurts, including joints and muscles and also had severe headache and minimal pain injection site (less sore than first shot). Patient confirmed that she did not have any of these symptoms with the first dose. Patient took ibuprofen but did not seem to help. Patient is a registered nurse working in a small, rural hospital. Outcome of the events headache and minimal pain at injection site was unknown, while for the remaining events was not recovered. The patient has not been tested for COVID-19 since vaccination.
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| 56 | 2021-01-13 | headache, body temperature increased |
Felt sore arm (deltoid), developed headache (20 hours after vaccine), body aches, chills (developed ...
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Felt sore arm (deltoid), developed headache (20 hours after vaccine), body aches, chills (developed 30 hours after vaccine). Temp 100.1, (approx 32 hours after vaccine). All resolved 43 hours after vaccine.
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| 56 | 2021-01-13 | headache, fever, dizziness, cough |
Fever 103 Tylenol able to control fevers. Dizziness when standing headache and cough. Fever lasted ...
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Fever 103 Tylenol able to control fevers. Dizziness when standing headache and cough. Fever lasted 48 hours, Dizziness and cough lasted 1 day longer
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| 56 | 2021-01-13 | skin warm | Had flushing and warm BP elevated to 158/98 pulse 68 for 30 min and resolved on own |
| 56 | 2021-01-13 | shortness of breath, headache |
PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREAT...
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PATIENT HAS SWOLLEN, RED FACE, HEADACHE, INCREASE BLOOD PRESSURE, INCREASE HEART RATE, TROUBLE BREATHING AFTER 2 HOURS OF ADMINISTRATION OF VACCINE. PATIENT WENT TO THE ER AND GOT EPIPEN AND ORAL BENADRYL AND ORAL ATIVAN. PATIENT IS RECOVERING NOW.
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| 56 | 2021-01-13 | headache, body temperature increased |
Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck ...
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Temp 99.6, headache, body & muscle aches, nausea, eye pain, injection site pain radiating into neck and arm
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| 56 | 2021-01-13 | sweating, shortness of breath |
The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling ...
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The patient received the vaccine at 11:36am. One to two minutes after injection, she began feeling like her heart was racing and short of breath. She was diaphoretic, had a notable tremor and reported anxiety as well. Patient was transported to the Emergency Department where the patient was monitored. Ultimately, patient felt better, with a normal EKG. Patients states this reaction felt similar to anxiety attacks she has had in the past. ED Physician felt this was likely an anxiety attack. Patient remained stable throughout ED course and was discharged from the ED in stable condition.
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| 56 | 2021-01-13 | shortness of breath |
Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. ...
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Vaccine administered at 10:41. Monitored in vaccine clinic before returning to work area in PACU. Upon return to PACU at 10:57, felt foggy and didn't feel right. Employee sat down. Left upper lip started to tingle, patient experienced palpitations and difficulty breathing, requiring surgical mask to be removed. Code EMA (code for non-patient called). Employee taken to emergency department for evaluation.
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| 56 | 2021-01-13 | weakness, chills |
approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to fee...
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approximately 20 hours after vaccine woke with generalized myalgia. Throughout the day began to feel weaker and getting confused. C/O legs weighing 500 pounds and leg weakness with difficulty walking. Intermittent chills.
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| 56 | 2021-01-13 | fatigue, dizziness, headache |
left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; ...
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left arm/shoulder soreness; Left arm/shoulder soreness; headache; light headedness; fatigue; aches; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 56-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 07Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, allergic to certain types of chocolates. Concomitant medication included Levothyroxine and vitamins. The patient was also allergic to Quinine, tramadol, Dilaudid, Msg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left arm/shoulder soreness, headache, light headedness, fatigue and aches on 07Jan2021 11:45 AM. The patient received Tylenol and bed rest as treatment. Events outcome was not recovered. Information about lot/batch number has been requested.
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| 56 | 2021-01-13 | dizziness |
patient was extremely dizzy and nauseous after receiving vaccine. stated room was spinning. after 15...
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patient was extremely dizzy and nauseous after receiving vaccine. stated room was spinning. after 15 minutes and having a glass of water she felt better
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| 56 | 2021-01-14 | fatigue, chills, fever, headache |
"Felt great until 36 hours after shot. It just hit suddenly, felt exhausted, chills and body aches. ...
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"Felt great until 36 hours after shot. It just hit suddenly, felt exhausted, chills and body aches. Very bad from midnight to 230am. Got up a 6am with a very bad headache, at 9am I took tylenol. I got up at noon and felt great until midnight that night, same symptoms but much less severe. had fever/chills, no body aches. when i got up at 7am i had a headache but not as bad as previous."
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| 56 | 2021-01-14 | chills, fatigue |
"within 1 hour I was exhausted, Friday night and Saturday I had severe back aches, chills, fatigue. ...
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"within 1 hour I was exhausted, Friday night and Saturday I had severe back aches, chills, fatigue. By Sunday I felt better"
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| 56 | 2021-01-14 | chills |
Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable health...
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Chills; Insomnia; soreness at injection site; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 09Jan2021 12:15 in left arm at single dose for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and unknown if ongoing. There were no concomitant medications. On 09Jan2021 12:45, the patient experienced chills, insomnia and soreness at injection site. No treatment was given to the patient for the events. The outcome of the events was recovering. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
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| 56 | 2021-01-14 | fever, fatigue, chills | Fever chills fatigue arm pain upset stomach bradycardia |
| 56 | 2021-01-14 | fatigue, body temperature increased |
Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injec...
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Large erythematous area over site of injection 7cm x 5cm; Large erythematous area over site of injection 7cm x 5cm, blanching; Large erythematous area over site of injection 7cm x 5cm, Pruritic; Large erythematous area over site of injection 7cm x 5cm, Tenderness (mild)/Area painful for first 24 hours after injection; Large erythematous area over site of injection 7cm x 5cm, Induration (mild); Generalized fatigue; Joint pain; Slight increased temperature 99.3F for about 12 hours; This is a spontaneous report from a contactable physician (patient). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via intramuscular on 05Jan2021 08:45 at single dose in left arm for covid-19 immunisation. Medical history included asthma, diabetes. Concomitant medication included metformin, rosuvastatin, empagliflozin (JARDIANCE), omeprazole, vitamin c (ascorbic acid), ergocalciferol (VITAMIN D), paracetamol (TYLENOL), ibuprofen (MOTRIN), naproxen (NAPROSYN) and Multivitamin. The patient had known allergies to sulfamethoxazole, trimethoprim (BACTRIM) and experienced rash; raltegravir potassium (ISENTRESS) and experienced rash; emtricitabine, tenofovir disoproxil fumarate (TRUVADA) and experienced rash. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via intramuscular on 15Dec2020 13:30 at single dose in right arm for covid-19 immunisation. It was reported that on 07Jan2021 the patient experienced large erythematous area over site of injection 7cm x 5cm, blanching, pruritic, + tenderness (mild), + induration (mild). Area painful for first 24 hours after injection, that has gotten better, area of erythema is slowly getting larger, pruritus started 1 day ago and is slightly worsening (also starting to have slight generalized pruritus). After injection on 05Jan2021, the next morning (on 06Jan2021) had slight increased temperature 99.3F for about 12 hours with generalized fatigue and joint pain for about 24 hours on 07Jan2021. The area in question started to get red and indurated after that time period. The fatigue and joint pain have resolved completely. The patient received treatment for events included topical 1% hydrocortisone ointment, diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had been tested for COVID-19, included nasal swab and SARS-COV-2 RNA PCR on 22Dec2020 with negative result. The outcome of the events area painful for first 24 hours after injection was recovering, the outcome of the events fatigue and joint pain were recovered on 08Jan2021, the outcome of the event slight increased temperature 99.3F was unknown, the outcome of the rest events was not recovered.
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| 56 | 2021-01-14 | dizziness |
She reports symptoms of dizziness. Patient rates her dizziness at 1 (1-10 scale), her dizziness does...
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She reports symptoms of dizziness. Patient rates her dizziness at 1 (1-10 scale), her dizziness does not change with position or activity. She reports "I only have a little dizziness, nothing else". She reports she her contacts are in place and her vision is unchanged. She questioned if this was in her head because someone she knows had dizziness after her COVID vaccine". Speech and behavior normal. ? Injection time 0814 Observation time 0814-0853 ? Treatment/intervention - Patient stayed in observation area >30 minutes, drank 480 ml of water while resting. Patient denied need for further evaluation. Husband is driving her home (this was pre-planned prior to injection).
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| 56 | 2021-01-14 | throat swelling | Throat swelling |
| 56 | 2021-01-14 | dizziness, throat swelling, headache | dizziness, headache, nausea, "puffy thoat", BP 123/59, O2 sat 100%, HR 70 |
| 56 | 2021-01-15 | dizziness |
vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizzines...
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vertigo-type dizziness, especially severe in the morning; queasiness (may be related to the dizziness); a heightened sense of taste, sensitivity to light, and increased startle reaction to sudden sounds
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| 56 | 2021-01-16 | headache, dizziness |
I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lighthead...
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I got the vaccine at 5:45 Friday night was having symptoms of arm pain headache dizziness lightheadedness and nausea upon awakening Saturday morning. Saturday night was having increased nausea and lightheadedness. Got up to use the bathroom at 1 AM Sunday morning was very dizzy and nauseous and passed out on my hallway floor. I woke choking on vomit, crawled to the bathroom, continued to vomit. Sustained bruised lump to forehead, bruised nose, split lips. Went back to bed. Later Sunday felt better.
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| 56 | 2021-01-17 | pneumonia, shortness of breath, cough, throat irritation, fever |
A few days after the vaccine I began to have a cough about mid morning which changed to SOB. Covid ...
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A few days after the vaccine I began to have a cough about mid morning which changed to SOB. Covid test on 12/27 which was neg. I went to work on 12/28 but woke up 12/29 with a low grade fever and felt like my throat was on fire. so on the 29th I went and got a Strep and flu test which were negative. I was feeling so bad so on the 6th of Jan do I went to the stand alone ER and got a chest xray and CT scan which revealed I did have pnemonia. I went back home but was feeling worse and was taken to and admitted in hospital for 2 days. Initially I was admitted into the COVID unit but never was diagnosed COVID positive so I was moved off the COVID unit. I was given albuterol pills to try to help with the symptoms but didnt work causing me to have to be admitted and was given several doses of steorid and other antibioics and had to use O2 at night because my stats kept falling.
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| 56 | 2021-01-17 | fever, chills, headache | CHILLS, FEVER, HEADACHE. TOOK TYLENOL |
| 56 | 2021-01-17 | weakness, dizziness, fatigue |
Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reporte...
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Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reported for herself, a 56-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Dec2020 at a single dose with lot number: EJ1685, and the second dose via an unspecified route of administration on 10Jan2021 at a single dose with lot number: EL3248, for COVID-19 immunization. The patient had no medical history nor concomitant medications. When patient had the first vaccine on 20Dec2020, she experienced dizziness, weakness and tiredness which lasted for 4 days. The outcome of the events was recovered with sequelae, patient received the second dose of the Covid-19 vaccine on 10Jan2021, she was also having dizziness, weakness and tiredness which were ongoing at the time of report.
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| 56 | 2021-01-17 | dizziness, weakness |
Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the ob...
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Pt. C/o dizzyness and weakness about 5-10 minutes after receiving her vaccine while seated in the observation area. Her husband and I walked her over to the cot and medical treatment area. Her pulse felt thready and weak while walking and her gait was unsteady. As soon as she sat, then lay on the cot she lost consciousness and did not respond to verbal or noxious stimuli over the next few minutes. I gave her one dose of an epi-pen into her left mid outer thigh but she still did not regain consciousness so we called a "Rapid Response code" for transport to the E.R. for further treatment and stabilization.
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| 56 | 2021-01-18 | malaise, headache, weakness, dizziness |
Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side ...
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Felt hot and cold on and off; 10 minutes after I felt a little lightheaded/dizzy.; entire left side from neck, down back into hip and leg in severe pain(muscles tense); entire left side from neck, down back into hip and leg in severe pain(muscles tense); felt ill; felt extreme weakness; sneezed about 20-25 times; eyes turned red; The spinning and unable to focus continued for about 6 hours; The spinning and unable to focus continued for about 6 hours; Headache was coming and going; This is a spontaneous report from a contactable other health professional (other HCP) (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EH9899) via an unspecified route of administration at left arm on 31Dec2020 at 08:30 AM at a single dose for COVID-19 immunization. Medical history included known allergies (allergies to medications, food, or other products), and no other medical history. The patient was not pregnant. Concomitant medications the patient received within 2 weeks of vaccination included vitamins/supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at facility. 10 minutes after the patient felt a little lightheaded/dizzy. At 20 minutes after her entire left side from neck, down back into hip and leg in severe pain (muscles tense), at 30 minutes she sneezed about 20-25 times, felt extreme weakness and her eyes turned red. She felt ill. The spinning and unable to focus continued for about 6 hours. Headache was coming and going. She felt hot and cold on and off. All events with start date on 31Dec2020 at 08:45 AM. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
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| 56 | 2021-01-18 | headache, shortness of breath | itching, hives, short of breath, numbness and tingling to lips with hives to bottom. headache. |
| 56 | 2021-01-19 | weakness |
At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling naus...
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At first nothing but muscle soreness at the site, but I woke up soon after going to bed feeling nauseated almost threw up, also felt drunk (balance, lack of clear thinking, a little weak, etc). That lasted from about 8 hours after the shot (when it started) to 20 hours after the shot was administered.
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| 56 | 2021-01-19 | throat irritation, chills, cough, dizziness, headache |
From the evening of the day I have received the vaccination, my left arm started to feel dull contin...
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From the evening of the day I have received the vaccination, my left arm started to feel dull continuous pressure pain, progressed stronger and stronger as the time goes. No treatment given. Following day, the pain was worse and stayed same. The IM insertion site was also painful to touch or pressure. Then afternoon of the same day, I started nausea, light headache, dizziness, and occasionally chills as well as occasional dry cough accompanied by itchy throat or without itchy throat. At this point, I took Advil 200mg 1 tab around 3pm. The muscle pain on my left arm and headache is eased but other symptoms stayed same at this time, 4:30pm.
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| 56 | 2021-01-19 | headache |
Hours 6 to 18 -Worse than usual headache on the front and top of my head. Hours 24 to 36 - Acute p...
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Hours 6 to 18 -Worse than usual headache on the front and top of my head. Hours 24 to 36 - Acute pain in left lower back / kidney area Hours 36 to 48 - Acute pain in right lower back / kidney area
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| 56 | 2021-01-19 | fatigue, body temperature increased, chills |
I received my 1st vaccine dose 12.22.20 The next morning, I awoke with EXTREME fatigue. By the time ...
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I received my 1st vaccine dose 12.22.20 The next morning, I awoke with EXTREME fatigue. By the time I arrived to work, my temperature was greater than 101 degrees Fahrenheit and I was told to go home. By the time I arrived home (40 minutes later), extreme chills and body aches. I have never experienced anything like it. The fever, chills, and body aches persisted throughout the day despite Tylenol. Fever broke around 2AM on 12.24.20, slept and felt perfectly fine later that morning.
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| 56 | 2021-01-19 | sweating | PATIENT REPORTS TINGLING IN HANDS, NAUSEA, AND SWEATING WITH THE FIRST DOSE |
| 56 | 2021-01-19 | dizziness |
Patient reports that she got her second COVID-19 vaccine dose today at 1100 hours. She states that s...
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Patient reports that she got her second COVID-19 vaccine dose today at 1100 hours. She states that she woke up from a nap around 1500 hours with constant, midsternal chest pain. Chest pain is non-exertional, non-pleuritic, and non-radiating. She states chest pain is exacerbated by certain movements. Patient endorses lightheadedness.
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| 56 | 2021-01-19 | sweating | Patient reports tingling in hands, nausea, and sweating with the first dose. |
| 56 | 2021-01-19 | sweating |
Severe, painful abdominal cramping, sweating, and pooping. Felt like childbirth. So painful it was d...
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Severe, painful abdominal cramping, sweating, and pooping. Felt like childbirth. So painful it was difficult to hold back tears or regulated my breathing. A lot like a severe "spastic colon attack". 2 1/2 hrs later, a dozen or so toilet flushed and it's not over with yet!
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| 56 | 2021-01-19 | dizziness, shortness of breath |
Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination....
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Tachycardia, light-headed, chest pain, left arm numbness occurring within 10 minutes of vaccination. Patient said she felt like she couldn't breathe. Taken to ED for further evaluation.
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| 56 | 2021-01-19 | fatigue |
acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7...
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acute stabbing pain in left arm, moved to left chest area and left side - intermittent stabs for 5-7 minutes then stopped - 30 minutes after injection given blurry vision - 30 minutes after injection given mild shaking - following morning lasting for about 2 hours extreme fatigue - lasting for 48 hours - Sunday evening through Tuesday evening
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| 56 | 2021-01-19 | headache, chills, fever | fever extensive muscle and bone pains headache soreness at injection site lack of appetite chills |
| 56 | 2021-01-19 | fatigue | sore arm, gastric upset, tirednessn/a |
| 56 | 2021-01-21 | headache, chills, fever | Chills, couldn?t get warm! Whole body couldn?t stop shaking, Pounding headache, Fever, & Vomiting. |
| 56 | 2021-01-21 | fever |
Fever, joint and muscle pain, swelling and redness at injection site began 24 hours after injection....
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Fever, joint and muscle pain, swelling and redness at injection site began 24 hours after injection. Arm increasingly red, inflamed and hot to touch at 72 hours post injection.
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| 56 | 2021-01-21 | dizziness | Flushing, dizziness, throat tightening, difficulty swallowing |
| 56 | 2021-01-21 | headache | HA, BODY ACHES, JOINT PAIN |
| 56 | 2021-01-21 | headache |
Received 1st Covid vaccine on 12/30/2020 and did not have any problems. Received 2nd Covid vaccine ...
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Received 1st Covid vaccine on 12/30/2020 and did not have any problems. Received 2nd Covid vaccine at 08:30 about 22:00 that night, started getting moderate headache, moderate nausea, mild joint pain, gassy and moderate reflux. 5 days later, I still have mild -moderate headache and mild-moderate nausea.
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| 56 | 2021-01-21 | headache, cough, shortness of breath, throat pain, fever |
Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ea...
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Shortly after received her vaccine she had developed a fever, dry cough, sore throat, body aches, ear ache, nausea for one day, headache, and shortness of breath with coughing and stairs. She had a telemedicine appointment with her MD office and they recommended her not to work and to use her inhaler and some cough medicine.
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| 56 | 2021-01-24 | chills, dizziness |
2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started f...
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2 hrs after vaccine began to feel chills, did not have good appetite and didn't eat lunch. Started feeling lightheaded 3 hrs post vaccine. Able to stay at work until 4pm, went home, felt lightheaded, ate a meal and felt somewhat better. Got up around 9:30pm, was on feet for a couple of minutes, went to kitchen and reached for a plate on top of the refrigerator. Had presyncopal aura, then fainted. Apparently fell on buttocks, which are sore. No other symptoms. Constitutional symptoms have resolved. Evaluated in ED today.
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| 56 | 2021-01-24 | shortness of breath |
Patient informed medic while sitting in the observation area that she was experiencing chest pain, d...
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Patient informed medic while sitting in the observation area that she was experiencing chest pain, difficulty breathing and throat tightness. Patient was taken to medic area vs=179/89, pulse 121, o@ sat 99%
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| 56 | 2021-01-24 | skin warm |
Sudden intense itching on back of left leg, right at/below back of knee. It felt hot and it swelled....
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Sudden intense itching on back of left leg, right at/below back of knee. It felt hot and it swelled. Next morning it was pink and still itched but not as bad. I took pictures. The following evening I also took pictures. By then it was a dark red, looked like a bruise and followed the shape of my vein.
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| 56 | 2021-01-24 | throat pain, throat swelling |
Swollen throat glands + sore throat, beginning January 1, 2021 through January 7, 2021. Stiff and s...
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Swollen throat glands + sore throat, beginning January 1, 2021 through January 7, 2021. Stiff and sore right shoulder and neck (muscular and joint pain), mid-January through present. Multiple Canker Sores on lower lip, January 22 through present.
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| 56 | 2021-01-24 | body temperature increased, chills |
chills, body aches, fever with a tmax of 101.3 started the next day. Treatment none, resolved by da...
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chills, body aches, fever with a tmax of 101.3 started the next day. Treatment none, resolved by day 3. Aleve was taken after symptoms resolved. Outcome: Complete resolution of symptoms, did not interfere with ADL's.
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| 56 | 2021-01-24 | dizziness |
significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness;...
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significant dissociation; developed hot flashes in sternum; anxiety; dizziness and light headedness; muscle weakness/lower leg feel shaky and weak and tingly; depersonalization; shakey/lower leg feel shaky and weak and tingly; mild nausea; arm pain; The caller would touch her hand but couldn't feel her hands, it was like they weren't hers; lower leg feel shaky and weak and tingly; hand on that same side was painful, but not unbearable, just uncomfortable; emotional; tearful; felt completely overwhelmed; This is a spontaneous report from a contactable consumer. A 56-Year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 12Jan2021 about 9:15am at single dose for COVID-19 immunization. Vaccination facility type was hospital. Medical history and concomitant drugs were not reported. Weight: 175-180 lbs. No additional vaccines administered on same date of the Pfizer suspect vaccine. No prior vaccinations within 4 weeks. Past drug included rivaroxaban (XARELTO) been using the product more than 10 years and never had a problem with it, she didn't think that was related to her experience. Patient received first vaccine yesterday 12Jan2021. 45 minutes after receiving vaccine (12Jan2021 10 AM), she developed hot flashes in sternum (flushing sensation in her sternum or upper chest area. It was like when she had a dye injected), anxiety, dizziness/ light headedness, muscle weakness, significant dissociation, depersonalization, shakey, mild nausea, arm pain. The patient explained that this was why she was in the MRI scanner (Jan2021). This came a couple of times yesterday and had not been experienced this today (13Jan2021). It (dizziness) was ongoing and sporadic and had happened couple times yesterday and today. There were a few hours yesterday 12Jan2021 where she felt like herself but then it all started again last night. The patient reported feeling disassociated from her body, this was within about 20 minutes of the flushing and went in and out of being more or less alarming. She stated she felt disconnecting from where she was and space she was in, mentally. She knew where she was but could feel no connection to where she was or her body. The patient would touch her hand but couldn't feel her hands, it was like they weren't hers. This was during the half hour of the events occurring. She had mild nausea, this started not long after the flushing and it came and went a little bit but it was not too troublesome. The patient felt disconnect from her body and had shakiness like her lower leg feel shaky and weak and tingly. This happened on and off since the episodes started. The patient reported she slept great and had a few hours yesterday where she felt good. Her arm was tender, this might have been yesterday but she thought it was this morning and was only tender to touch. The hand on that same side was painful, but not unbearable, just uncomfortable. The patient apologized for being emotional and tearful. She felt completely overwhelmed. She couldn't believe that she put herself in this position and she was perfectly fine before the shot. She did contact her doctor. No AE required a visit to emergency room/ physician office. There had been no treatment, she didn't know what to do. She remarked she was not going back for the second dose. Outcome of event dizziness was not recovered, and the rest of events was unknown.
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| 56 | 2021-01-25 | chills | Chills 1/23 Swollen lymph nodes in axillary of arm vaccine was administered |
| 56 | 2021-01-25 | headache, dizziness |
Dizziness; nausea; headache; abdominal pain; body aches; This is a spontaneous report from a contact...
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Dizziness; nausea; headache; abdominal pain; body aches; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: BEL-3246), intramuscular in left arm on 10Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included allergies to blue dye from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Versed, Parafon Forte and experienced allergies. On 10Jan2021 11:30 AM, the patient experienced dizziness, nausea, headache almost immediately followed by abdominal pain and body aches within 6 hours. No treatment given for the events. The patient recovered from the events on unspecified date. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19.
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| 56 | 2021-01-25 | chills, fever, headache, fatigue, dehydration |
FATIGUE ON DAY OF VACCINE. SYMPTOMS SET IN AROUND 9:30 PM ON 1/19 - CHILLS, SWELLING, MILD HEADACHE,...
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FATIGUE ON DAY OF VACCINE. SYMPTOMS SET IN AROUND 9:30 PM ON 1/19 - CHILLS, SWELLING, MILD HEADACHE, EXTREME FATIGUE; FOGGINESS AND FEVERISH. SYMPTOMS BECAME MILDER AOUND 8PM ON 1/20 - TEHN OVERHEATED BUT CLEARERE. GRADUALLY GETTING BACK TO NORMAL TODAY 1/21. VERY DEHYDRATED. TOOK ADVIL. DRANK LOTS OF FLUIDS
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| 56 | 2021-01-25 | chills, headache, fever |
Fever on evening of second vaccine - highest was 100 - Fever between 98-99.6; Body aches throughout ...
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Fever on evening of second vaccine - highest was 100 - Fever between 98-99.6; Body aches throughout body Headache; Body aches throughout body Headache; Chills; This is a spontaneous report from a contactable Other HCP. This 56-year-old female Other HCP (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: EL3246), via intramuscular at left arm on 12Jan2021 09:30AM at single dose for COVID-19 immunization. Medical history included known allergies: penicillin. Concomitant drugs included ascorbic acid (VITAMIN C). Historical vaccine included the first dose of BNT162B2 (Lot number: EH9899) on 22Dec2020 10:30AM via intramuscular at left arm for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. On 12Jan2021 08:00pm, patient had fever on evening of second vaccine -highest was 100 -Fever between 98-99.6 next day and evening, body aches throughout body, headache, chills, fever gone after 40 hours or so. No treatment for AE. Outcome of events was recovered in Jan2021.
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| 56 | 2021-01-25 | fever, headache |
Joint pain; GI symptoms; Headache; Muscle ache; Temperature of 102.9; This is a spontaneous report f...
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Joint pain; GI symptoms; Headache; Muscle ache; Temperature of 102.9; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date Intramuscularly at single dose for COVID-19 immunization. Medical history included she did have the Virus itself in December and concomitant medications were reported none. Nurse stated, she just was not sure what you really wanted to know as far as adverse reactions for the Covid 19 Vaccine. She just had kind of the whole gambit. Patient experienced temperature of 102.9, GI symptoms, muscle ache, joint pain, headache. And she did not receive any treatment, other than home Motrin type medication, may be some Maalox type. The only thing to know was she did have the Virus itself in December and she did not know if it was because she had such antibodies still on board that she had such a severe reaction or more extreme that was all. That was her only thing she reported and her symptoms came latently like she had it on the 25th or the 5th she mean, her symptoms really did not start until the following day and lasted for several, 2 and half days. The outcome of the events was unknown. There was a reasonable possibility that the adverse events were related to suspect drug by reporter. Information about lot/batch number has been requested.
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| 56 | 2021-01-25 | runny nose, headache |
Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all o...
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Runny nose; Left arm is hurting; Severe headache; Nausea; Pain all over, can hardly move; Pain all over, can hardly move; This is a spontaneous report from a contactable consumer reported for self. This 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via unspecified route of administration on 12Jan2021 between 13:30 and 14:00 at single dose in left arm for COVID-19 immunization. Patient worked in EVS. The patient medical history included rheumatoid, asthma, artery disease, gastroparesis. There is no family medical history. The patient concomitant mediations not provided. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 22Dec2020 at single dose in left arm for COVID-19 immunization. The patient had a headache with the first dose of bnt162b2 and a little bit of chest pain (stated she had heart troubles) (AER 2021050910). The patient experienced severe headache, nausea, and pain all over, can hardly move from 12Jan2021. Pain all over, can hardly move started at the night of 12Jan2021. It hurts so bad. The patient also experienced runny nose and left arm is hurting from unspecified date. There is no relevant tests. The outcome of events severe headache, nausea, and pain all over, can hardly move was not resolved. Nausea and pain all over, can hardly move was reported as worsened. The outcome of others event was not reported. Information about lot/batch number has been requested.
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| 56 | 2021-01-25 | fever, headache |
The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted ...
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The first covid vaccination I had symptoms of being flush and a heaviness in my chest. This lasted 4 3-4 days. I did seek medical attention at the emergency room day 3 and was hospitalized 1 day. I was found to have unexplained and unregulated hypoglycemia. The second shot I had body aches, headache, fever. I was able to manage my symptoms with Tylenol and Advil.
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| 56 | 2021-01-25 | headache |
Within two hours of the second dose, I experienced a severe headache. It has been two weeks since ...
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Within two hours of the second dose, I experienced a severe headache. It has been two weeks since the injection and I still have a severe headache. Blood pressure has also been elevated resulting in physician prescribing blood pressure medication.
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| 56 | 2021-01-25 | fatigue, throat irritation, chills, cough, fever, malaise, headache, dizziness |
little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense ...
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little nauseous, queasy; low grade temperature; chills and shakes; scratchy throat; decreased sense of smell; decreased sense of taste; everything she eat or drinks has a metallic taste to it; muscle stiffness; Fatigue; arm soreness/right arm was still tender to touch/The first shot hurt way more and hurt all over the whole arm, it was throbbing; sinus pressure and congestion; sinus pressure and congestion; felt really lightheaded; low grade headache; chest feeling tight/chest tightness; she is not feeling good; wheeze; cough; This is a spontaneous report from a contactable nurse (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular (IM) in right deltoid on 07Jan2021 15:30 at second single dose for preventative. The patient medical history was not reported. There were no concomitant medications. The patient previously took H1N1 flut shot in 2015 or 2016 for immunisation and experienced muscle stiffness and fatigue, first dose bnt162b2, via IM in left deltoid for preventative on 18Dec2020 at 18:00 and patient was tender in her left arm, the first shot hurt way more and hurt all over the whole arm, it was throbbing. No additional vaccines administered on same date of the pfizer suspect. No prior other vaccinations administered within 4 weeks. The patient took the second dose of the Pfizer Covid vaccine on Thursday 07Jan2021 at 15:30. She called employee health and was advised to call Pfizer to report side effects since she is not feeling good. She had never had the covid diagnosis. On Friday (08Jan2021) she worked all day and felt arm soreness and sinus congestion but nothing out of the ordinary. The patient reported her right arm was still tender to touch, if she rotated her arm she can feel that she had the shot and she was still tender in her left arm from the first shot. The first shot hurt way more and hurt all over the whole arm, it was throbbing. On 08Jan2021 evening she felt really lightheaded, she thought maybe it was her sinuses since it is dry due to winter. She felt like a truck hit her. She had a low grade headache. On 09Jan2021, she felt a little nauseous, queasy, no vomiting. On Saturday (09Jan2021) she had a low grade temp of 100.3 degrees F. She had the chills and shakes on Saturday and most of yesterday. She got up today (reported on 12Jan2020) at 5:30 am, she checked her temperature and it was 97.2 after the shower, an hour later it was 98 degrees F. She felt like she had to keep clearing her throat, her chest felt a bit tight which started Friday evening, the chest tightness was not terrible but it was there. She was not wheezing but when she took a deep breath she felt a little like a wheeze and she had to cough, she had a scratchy throat on 09Jan2020. She stayed home from work yesterday. The patient did not feel lightheaded today, felt it yesterday and did not notice it at all this morning, reported it has resolved. The sinus pressure and congestion started Friday night, she felt stuffy. She had a decreased sense of smell and taste on 09Jan2021. Unless something is right in front of her, she could not smell anything. She felt quite nauseous this morning but at the moment her nausea is under control. She had a decreased sense of taste, everything she ate or drunk had a metallic taste to it, on 09Jan2021. She felt that all the side effects mentioned were related to getting the vaccine. On 08Jan2021, she also experienced muscle stiffness and fatigue which had improved after a hot shower, that helped. She felt like she had a bad flu shot. The only time she ever felt similar to this was when she received the H1N1 flut shot in 2015 or 2016. She did not have lot number, NDC, or expiration date to provide. Treatment included: took Tylenol on Saturday. The events did not require a visit to emergency room and physician office (she is trying to get an appointment to see the doctor). Outcome of the event lightheaded was recovered on 12Jan2021, of events low grade headache, chest tightness, scratchy throat, sinus pressure and congestion, decreased sense of smell, decreased sense of taste, everything she eat or drinks has a metallic taste to it, arm soreness was not recovered, of events chills and shakes, muscle stiffness, fatigue was recovering, of other events was unknown. Information about Lot/Batch has been requested.
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| 56 | 2021-01-26 | fever | Aches, nausea vomiting and Fever |
| 56 | 2021-01-26 | headache |
Headache with the first COVID-19 Vaccine; A little bit of chest pain; Heart Troubles; This is a spon...
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Headache with the first COVID-19 Vaccine; A little bit of chest pain; Heart Troubles; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported that she the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) at single dose for vaccination on 22Dec2020. Relevant medical history included Rheumatoid, Asthma, Artery disease, Gastroparesis. Relevant concomitant drugs were unknown. The patient had a headache with the first COVID-19 Vaccine and a little bit of chest pain. Stated she has heart troubles. Outcome of events was unknown.
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| 56 | 2021-01-26 | fever, malaise, throat pain |
High fever, malaise, sore throat, went from independent to help with assistance in feeding, red sor...
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High fever, malaise, sore throat, went from independent to help with assistance in feeding, red sore arm, ROM affected.
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| 56 | 2021-01-26 | fever, headache, dizziness |
headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision ...
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headache; fever; L Arm (injection site) pain/severe left arm pain; dizziness; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; blurred double vision and couldn't function; eyes wouldn't focus, Couldn't function; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Jan2021 15:00 at a single dose in the left arm for COVID-19 immunization. The patient received the vaccine in a skilled nursing facility or long term care facility. The patient received no other vaccinations recently. Medical history included attention deficit disorder diagnosed at least 5 years ago for which the patient was taking Ritalin; hypothyroidism diagnosed a long time ago, probably 10 years and depression diagnosed a long time ago, probably at least 25 year, she takes a cocktail of anti-depressants for this (no further details provided about her anti-depressants). The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus before when her doctor put her on an antibiotic (unspecified). The patient was also very overweight. Concomitant medications included methylphenidate hydrochloride (RITALIN; lot: unknown, expiry: 28Jul2021) for attention deficit disorder and the patient takes a cocktail of anti-depressants (unspecified) for her depression. The patient received the first dose of the covid vaccine on 11Jan2021 at 3 PM and by 5PM she was experiencing bad headache, fever, L arm (injection site) pain that was severe. Later that evening she had blurred double vision and couldn't function. She also got a fever of about 100 degrees Fahrenheit, was dizzy and her eyes could not focus and were almost like double vision but not quite, it was hard to explain. She just remembered that she had a similar reaction with her eyes before, when her doctor put her on an antibiotic. She cannot recall what antibiotic that was. The patient also experienced dizziness on 11Jan2021. The patient treated her side effects with ibuprofen and most of these improved. The injection was given in her left arm, her non-dominate one. She says that the pain was so bad it woke her up, and she doesn't take any pain meds, but that was really bad. She says that she took some Ibuprofen (lot: P113671, exp: Jan2022), about a total of 800mg over a few hours. Her fever had started pretty fast, by 05:00PM on the 11th, and it was better after taking the Ibuprofen, as was her arm pain, and headache. She says that the dizziness went away probably around 02:00AM the following day (12Jan2021). She says her eyes can focus again as well. The patient thinks that these effects are medically significant, mostly that her eyes were not able to focus, it was very scary. The patient stated that the purpose of this call is to have this documented, and possibly find out if there are recommendations that she should not get the second dose, since she had to call out of work because she couldn't function. The outcome of the event "blurred double vision and couldn't function; eyes wouldn't focus, couldn't function" was recovered on an unspecified date and dizziness recovered on 12Jan2021 at 02:00. The outcome of the event "she had to call out of work because she couldn't function" was unknown while the other events were recovering. Information on the lot/batch number has been requested.; Sender's Comments: The 56-year-old female patient had medical history included attention deficit disorder; hypothyroidism and depression and she takes a cocktail of anti-depressants for this. The patient also had a similar reaction of blurred double vision and couldn't function/eyes could not focus. Based on information reported, the reported double vision and difficulty focusing eyes were more likely due to pre-existing condition (s); and less likely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The rest events fever, headache, vaccination site pain and dizziness were likely causally related to the use of vaccine due to plausible temporal relationship and known safety profile of this product. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-27 | migraine |
On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw ...
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On 1/12 -1/15 worst migraine and left eye pain of my life. Saw retinal specialist 1/15. On 1/15 saw my PCC provider. Woke up 1/17 with blurry vision and continued eye pain. Talked to my Rheumatologist 1/19. I saw my PCC in person 1/20. Got sent to ER got admitted. Had an MRI and a lumbar puncture. I was diagnosed with optic neuritis by the neurologist. I continued to do 5 days of out pt iv steroids.
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| 56 | 2021-01-27 | lethargy |
On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point ...
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On Sunday, 1/17/21, patient was nauseous and vomiting and could not keep anything down at one point vomit was dark in appearance. Patient receives home dialysis when nurse came to home on Monday, 1/18, saw condition of patient and sent them to the hospital. At the hospital it was noted she had redness throughout body, no hives or blisters. Patient was lethargic, received antiemetic and medication for rash, does not know what medications were. On Tuesday, 1/19, she received 2 liter transfusion, discharged on Thursday, 1/21. Today, Thursday 1/28 patient still feels lethargic and states rash is peeling.
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| 56 | 2021-01-27 | malaise, sweating, chills, fatigue |
Severe low back and hip pain; Severe low back and hip pain; malaise; woke up soaking wet in the midd...
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Severe low back and hip pain; Severe low back and hip pain; malaise; woke up soaking wet in the middle of the night with chills; Extremely tired; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EK5730), intramuscularly on 07Jan2021 10:30 at a single dose in left arm for COVID-19 immunization. The patient is not pregnant. Medical history included hypothyroidism, hypertension, known allergies: penicillin. The patient previously took first dose of bnt162b2 (lot number: EK5730) via intramuscular on 18Dec2020 13:30 at a single dose in left arm for COVID-19 immunization. There was no other vaccine administrated in four weeks. Concomitant medication included losartan, bupropion hydrochloride (WELLBUTRIN), levothyroxine, colecalciferol (VITAMIN D 3), estradiol (ESTROGEN), and progesterone. On 09Jan2021 15:45, the patient experienced severe low back and hip pain along with general malaise, woke up soaking wet in the middle of the night with chills, and extremely tired. No fever. The adverse event did not result in 'doctor or other HCP visit or emergency room or urgent care, hospitalization or prolongation, life threatening illness, disability or death or congential anomaly'. No treatment received for adverse event. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of events was recovered on an unspecified date in Jan2021.
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| 56 | 2021-01-28 | skin warm |
10 minutes into 30 minute observation post vaccination client reported feeling warm with erythema de...
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10 minutes into 30 minute observation post vaccination client reported feeling warm with erythema developing on her chest.
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| 56 | 2021-01-28 | shortness of breath |
She became acute short of breath. Called EMS. On their arrival she was nearly unresponsive. Bagge...
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She became acute short of breath. Called EMS. On their arrival she was nearly unresponsive. Bagged. NOT hypotensive. HYPERCARBIC. Difficult intubation. Transferred to our facility on VENT with bilateral pulmonary infiltrates, wheezy with size 6 ETT from outside facility.
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| 56 | 2021-01-28 | dizziness |
close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken ...
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close to passing out; felt "heat waves" throughout my body; tingling; palpitations; My BP was taken and it was 166/86 (my normal BP is usually 100/60).; This is a spontaneous report from a contactable Physician (the patient). A 56-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm, second dose, on 15Jan2021 14:30 at SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism and gastrooesophageal reflux disease, both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID), esomeprazole magnesium (NEXIUM), estradiol, norethisterone acetate (AMABELZ), estradiol, levonorgestrel (CLIMARA PRO). Patient previously received the first dose of BNT162B2 in left arm, on 24Dec2020 08:15 AM. No other vaccine in four weeks. Vaccination Facility type: Hospital. No COVID prior vaccination. COVID was not tested post vaccination. No Known allergies. On 15Jan2021 about 5 minutes after the vaccination the patient experienced close to passing out, felt "heat waves" throughout my body, tingling, palpitations, blood pressure (BP) was taken and it was 166/86 (her normal BP is usually 100/60). No treatment was given. The symptoms slowly resolved over the next 45 minutes, with BP returning back to normal. Information on Lot/Batch has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "close to passing out". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-01-28 | dizziness |
experienced numbness on right arm (vaccinated arm) to fingers; dizziness; This is a spontaneous repo...
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experienced numbness on right arm (vaccinated arm) to fingers; dizziness; This is a spontaneous report from a contactable nurse. A 56-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular on arm right from 14Jan2021 08:30 to 14Jan2021 08:30 at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Jan2021 08:35, 5 minutes after receiving vaccine experienced dizziness which lasted several hours, 10 minutes after receiving experienced numbness on right arm (vaccinated arm) to fingers which lasted into evening. The patient was given Benadryl by mouth, 25 mg. Tablet by nursing staff. The patient was not pregnant at the time of the report. Outcome of the events recovered with sequelae.
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| 56 | 2021-02-01 | lethargy |
Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spo...
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Shingles rash; did have lethargy and was dragging; did have lethargy and was dragging; This is a spontaneous report from a contactable healthcare professional reporting for self. This 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on 11Jan2021 at left deltoid at single dose for COVID Prevention. Medical history and concomitant medications were none. Her health had improved over the last six months and she was on no medications, and her labs had been good. The patient previously received first dose of BNT162B2 (lot number: EJ1685) via IM injection into the left deltoid on 23Dec2020 at single dose for COVID Prevention. She stated that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time. She confirmed that she received no other vaccines on the same day as either her first dose, nor her second dose of the vaccine. The patient experienced shingles rash starting on 14Jan2021. It was reported that the patient received her second dose of vaccine last Monday (11Jan2021). The Thursday following that (14Jan2021), she noticed a small patch of a rash on her right side, and she did not think much of it at first, because she had been gardening. But she stated that by Friday, it was clear that she had the initial onslaught of Shingles. She stated that over the weekend, the rash had taken a very predicable course, where it is now in circles around her body. She had had no other sentinel events, she had not been sick, she was not stressed, the only thing was that four days prior to the rash, she got the last COVID shot. She just wanted there to be accuracy in known side effects because she was 56 years old, but she was not immunosuppressed at all, and she knew that it would be given to people 65 and older soon. Patient stated that she was no sick as a dog, but two days after receiving the second dose, she did have lethargy and was dragging on 14Jan2021. She thought after the second dose, the vaccine may have hit her immune system. The outcome of shingles rash was not recovered and reported as worsened, outcome of other events was unknown. The reporter considered the event shingles rash was serious as medically significant and was related to the vaccine.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of shingles rash cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021092332 same patient/drug, different event separated with time
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| 56 | 2021-02-01 | headache, fatigue, sweating, malaise, weakness, fever |
sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; se...
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sleeping a lot; she sweated overnight; Fever; Headache; Fatigue; Feeling of total lack of energy; severe abdominal pain; Nausea; Injection site pain; This is a spontaneous report from contactable other hcps (including patient herself). A 56-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid19, lot number EL3248) , via an unspecified route of administration 08Jan2021 17:30 at single dose on left deltoid for covid-19 immunisation. Medical history included covid-19 the first time in Oct2020 to an unknown date , then from 16Nov2020 to an unknown date and experienced "every symptom except for vomiting". The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 18Dec2020 for covid-19 immunisation and experienced neck hurting, Shingrix Vaccine on 04Dec2020 for immunization and experienced no adverse effect. The patient experienced severe abdominal pain, nausea, Injection site pain on 12Jan2021, headache, fatigue, feeling of total lack of energy on 13Jan2021, fever on 16Jan2021. She had severe abdominal pain and nausea for three days (as reported). The caller stated she took Zofran for her nausea. The caller stated she had a rapid COVID-19 Virus test that was negative, but continued to feel queasy. She stated she had 100.5-101.8 degree fevers over the weekend, and has been sleeping a lot. Reported she woke at 4:00AM on Tuesday, 12Jan2021, with severe abdominal pain. She said the abdominal pain is better but not completely gone. Abdominal Pain Treatment: Declined any. Reported she hasn't discussed with her doctor the adverse events she has been experiencing since receiving the second COVID-19 Vaccine dose. She stated she had injection site pain for 2-3 days after receiving the second COVID-19 Vaccine dose. She said she didn't have any injection site soreness with the first COVID-19 Vaccine dose. She said she thought she was good after receiving the second COVID-19 Vaccine dose, but then on Tuesday, 12Jan2021, she woke at 4:00AM with severe abdominal pain. She said the abdominal pain came in waves. She described the abdominal pain as an 8 out of 10, clarifying the abdominal pain would be sharp and then fade away, and then the abdominal pain would cycle back around. She said she found herself standing over her toilet a few times because the abdominal pain was so severe, she thought she was going to throw-up. She clarified she had nausea and took and old prescription of Zofran she had received for vertigo years ago. She stated she did not have the Zofran NDC, Lot, and Expiration Date. Reported her abdominal pain and nausea went away by Thursday, 14Jan2021, saying the abdominal pain and nausea was less and less each day. She clarified the abdominal pain and nausea were intermittent, saying all of a sudden she would not feel good. She said her nausea has been better for the past 2-3 days. She clarified she called off work on Tuesday, 12Jan2021, and on Wednesday, 13Jan2021, she had a Rapid COVID-19 Virus Test before she started work that day (13Jan2021) to make sure that she wasn't positive for the COVID-19 Virus. She said she had a headache, no energy, and felt fatigued at work on Wednesday (13Jan2021), and Thursday (14Jan2021), but didn't take her temperature during that time. She said she didn't work on Friday (15Jan2021), but continued to have the headache, fatigue, and feeling like she had no energy. She said she didn't check her temperature until Saturday, 16Jan2021. She said she woke up Saturday (16Jan2021) at 9:40AM and went back to sleep until 11:30AM. She said she woke back up at 1:42PM and her husband told her she felt hot to the touch. She said she checked her temperature and it was 101.8 degrees. She said she checked her temperature first thing this morning (18Jan2021) because she could tell she sweated overnight, and her temperature was 100.3. She said she just checked her temperature again, and her temperature was now 99.3 degrees. She said by this afternoon, her temperature will be in the 101 range. Headache & Fever Treatment: Reported she took Naproxen (clarified as a prescription Naproxen 500mg tablet), and Tylenol (clarified as Equate brand Acetaminophen 500mg tablet) for her headache and fever on Saturday (16Jan2021). She said she took the Naproxen and Acetaminophen 500mg once in the morning, and again at night, before bed. She stated she did not take any Naproxen or Acetaminophen on Sunday, 17Jan2021. Acetaminophen 500mg tablet (Equate Brand): UPC Number: Unknown, Lot Number: 0HV1335, Expiration Date: May2022 Naproxen 500mg tablet (Prescription dispensed in round, pharmacy bottle): No NDC, Lot, or Expiration Date Reported she had another COVID-19 Virus test performed on Sunday, 17Jan2021, at 11:40AM at a drive-thru test site at Pharmacy. She clarified it was a "send-out" PCR COVID-19 Virus test, and she had not received her test results yet. She said her belly doesn't hurt anymore. She said she doesn't have a gallbladder and appendix. She said if she had the flu, the flu lasts for 3-5 days, and she is not coughing. She said she feels like now, what she felt like when she had the COVID-19 Virus the first time in Oct2020. She said she had a 12 days of severe fatigue when she had COVID-19 in Oct2020. She said her COVID-19 Virus symptoms started on 14Oct2020 with nasal congestion, and by 16Oct2020 she couldn't taste her yogurt. She said she got tested later in the day on 16Oct2020 for the COVID-19 Virus. She clarified she definitely had no sense of smell or taste on Friday, 16Oct2020. She said on Thursday, 15Oct2020, she kept falling asleep in the evening, saying that never happens. She said on Friday, 16Oct2020, she had a fever of 100.3, as well. The outcome of the events severe abdominal pain, nausea was resolved on 14Jan2021, of Injection site pain was resolved on an unspecified date, of sleeping a lot and she sweated overnight was unknown, of other events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of abdominal pain, nausea and other events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-02 | sweating, weakness, chills, shortness of breath |
syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck througho...
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syncopal event; unable to move; increased respiratory rate; severe pain radiating from neck throughout body; unable to turn head; generalized weakness; hypotension; shortness of breath; unable to speak; chills; diaphoresis; severe pain radiating from neck throughout body; This is a spontaneous report from a contactable nurse (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 18Jan2021 10:45 at single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, shellfish. Concomitant medication included celecoxib (CELEXA), levocetirizine dihydrochloride (XYZAL), acetaminophen, ibuprofen, naproxen sodium. There were no other vaccines received in four weeks. The patient did not have Covid tested post vaccination. Upon awakening early morning after injection on 19Jan2021 04:00, the patient had severe pain radiating from neck throughout body, unable to turn head, generalized weakness, syncopal event, hypotension, increased respiratory rate, shortness of breath, unable to speak, unable to move, chills, diaphoresis, emergent to emergency department, received Intravenous NS bolus as treatment. Electrocardiogram (EKG), BMP, complete blood count (CBC), labs were Within Normal Limit on 19Jan2021, discharged home, slept all day. Feeling much better second day after injection. The reported events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of unable to move, syncopal event, increased respiratory rate, severe pain radiating from neck throughout body, unable to turn head, generalized weakness, hypotension, shortness of breath, unable to speak, chills, diaphoresis. The outcome of the events was recovered in Jan2021.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-04 | fatigue |
chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site...
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chest soreness/pain; pain with breathing/hurt to breathe; severe fatigue; soreness at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp), reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot ELO142) , on 18Jan2021 at 09:00 intramuscular in Right arm at single dose for COVID-19 immunization.Medical history included allergy to Shellfish. Patient was not pregnant. Concomitant medication included ibuprofen (ADVIL) prophylactically, at 2DF daily on 18Jan2021 and at 2 DF each day through on 19Jan2021; vitamin D3; fish oil; ascorbic acid (VITAMIN C) and cyanocobalamin (VITAMIN B12). The patient experienced chest soreness/pain, pain with breathing/hurt to breathe, severe fatigue, soreness at injection site, on 14Jan2021 (as reported). Events were also described as follows: patient prophylactically took 2 ibuprofen 30 minutes before vaccine on 18Jan2021 at 08:30 am and got the vaccine on 18Jan2021 at 9am. She just had soreness at injection site that evening. She kept up with the ibuprofen (only 2 doses each day) through on 19Jan2021. On 21Jan2021 she felt severe fatigue and later in the evening she started to feel chest soreness/pain and pain with breathing. It felt muscular but she went to emergency department (ED) because it hurt to breathe. They did a cardiac and PE work up which was negative. The pain was relieved by Toradol IV. She was discharged from emergency department (ED) . She took more ibuprofen on 22Jan2021 when she started to feel the same, but lesser, symptoms and the pain went away. On 23Jan2021, so far patient felt okay. The final outcome of the events was reported as recovering.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events "chest soreness/pain, pain with breathing/hurt to breathe". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 56 | 2021-02-05 | cough, shortness of breath |
56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her secon...
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56 y.o. female with a history of a latex allergy, cancer and childhood asthma who received her second dose of the Pfizer COVID-19 mRNA vaccine and subsequently developed generalized pruritis five minutes after. She developed similar symptoms 6 hours after receiving the first dose, but this time was more severe. She arrived to the emergency department and after 15 minutes began to develop a cough, increased work of breathing, and voice changes. She received 0.3 mg epinephrine subcutaneously and albuterol nebulizers. Over her three hours in the department she received famotidine, 125mg methylprednisolone, diphenhydramine, an additional dose of epinephrine and 4x albuterol nebs. However, he dyspnea continued to return, and she was admitted. Improved overnight and was discharged HD2. widespread pruritis initially 5min post-Pfizer vaccination (2nd dose). Progressed to severe coughing, dyspnea requiring repeated doses of epinephrine and albuterol. Admitted to intermediate unit for further cares. Noted to have had mild delayed pruritis prior to first dose of pfizer vaccine.
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| 56 | 2021-02-07 | chills, shortness of breath, fatigue, headache |
Tachycardia; shortness of breath; rigors; muscle pain; fatigue; headache; This is a spontaneous repo...
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Tachycardia; shortness of breath; rigors; muscle pain; fatigue; headache; This is a spontaneous report from a Contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=Fl3249), via an unspecified route of administration in left arm on 19Jan2021 13:00 at first single dose for COVID-19 immunization. Medical history included high cholesterol, gastrooesophageal reflux disease (GERD), dry eye syndrome, covid-19 (covid prior vaccination). Known allergies: No. Concomitant medication included atorvastatin, fish oil, pantoprazole. No other vaccine received in four weeks. The patient experienced tachycardia, shortness of breath, rigors, muscle pain, fatigue, headache, on 20Jan2021 02:30 AM. Events resulted in: Emergency room/department or urgent care. Events treatment inluded: Fluids, tylenol, clonazepam. Covid was not tested post vaccination. Outcome of the events was recovering.
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| 56 | 2021-02-08 | shortness of breath |
at 8:45 patient reported that the "site itches" and reported it was "hard to breath". Patient instur...
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at 8:45 patient reported that the "site itches" and reported it was "hard to breath". Patient insturected to "take a deep breath". She had her own benadryl and took it. Given epinephrine at 8:50 AM. BP was 140/84 and pulse was 64. At 8:55 patient reported relief from hard to breathe. Ambulance arrived at 9:00 AM.
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| 56 | 2021-02-09 | headache, fatigue |
within first 24 hours: headache, loss of appetite. within 36 hours: increased headache (moderate-sev...
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within first 24 hours: headache, loss of appetite. within 36 hours: increased headache (moderate-severe), fatigue, loss of appetite. within 72 hours symptoms subsided
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| 56 | 2021-02-11 | shortness of breath |
Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1...
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Anaphylaxis, itching, tightness of the throat, shortness of breath, low oxygen levels Treatment: 1 Benadryl 1130am, 1 Epipen 1155am, 1 Epipen 1225, steroids intravenously 1pm Outcome: Released home
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| 56 | 2021-02-20 | fever, chills, lethargy |
Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea,...
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Fever, Severe chills, Muscle weakness and aches, lethargy, metallic taste, loss of appetite, nausea, vomiting
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| 56 | 2021-02-21 | fatigue, headache |
After first COVID-19 vaccine, patient experiencing prolonged fatigue, joint and muscle pains, headac...
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After first COVID-19 vaccine, patient experiencing prolonged fatigue, joint and muscle pains, headache and nausea. Symptoms have lessened over the course of 3 weeks, but are still present. Patient has about 2/3 the normal physical function, and feels to be working at about 1/2 of their normal working capacity. The patient followed up via phone call the COVID-19 nursing line, COVID test taken, negative, and was advised supportive care and acetaminophen if needed.
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| 56 | 2021-02-21 | dizziness, somnolence, fatigue, headache |
After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water o...
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After vaccine in the waiting area, my blood sugar went up to 250 and that was after drinking water only since the night before and no food. I stayed about 1/2 hour, no one could say if this happens, About 12:30 or 1pm I wanted to sleep and slept 4 hours. The next dayi experience sensitivity to light sound headache nausea dizzy and ringing in the ears. I had to take off work at 12:30 and every since then I have had a headache after trying to work only a few hours. I couldn't keep my head set on, cant talk or train because the headaches are too bad. My doctor prescribed Imitrex. The Imitrex didn't even tough the headache, it just made me tired.
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| 56 | 2021-02-21 | dizziness | I have been dizzy and my head feels cloudy and I can't stand up well without falling over. |
| 56 | 2021-02-21 | shortness of breath, chills, dizziness, throat irritation |
Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was cal...
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Pt had a reaction to PFIZER vaccine felt flush and dizzy and fast heart rate, Emergency room was called to transport pt to ED and pt was given a epi pen in observation area where pt received epi pen, pt vitals were BP Right arm: 135/81 HR:117 O2 SAT: 100% on RA 9:18AM 56 y.o. female with a past medical history of hypothyroidism, GERD, anxiety, and Hashimoto's thyroiditis (on levothyroxine) presenting with reported allergic reaction. Patient reports that she had received the COVID vaccine today and 10 minutes later, started to have room-spinning dizziness to the point that she thought she was going to fall out of her chair. She also reports that she started to shake, had shortness to breath, and felt her heart rate increase. Patient had notified staff at the vaccination center and was immediately administered an Epi pen to her left thigh and brought down to the ED. She states that she then started "twitching everywhere" and notes chills as well as a scratchy throat, which are still present. She denies any previous similar symptoms as well as any feelings of anxiety prior to the vaccine or difficulty breathing. She reports an allergy to bees and seasonal allergies, but denies any other known drug allergies. No evidence of anaphylaxis or airway compromise. Discussed rebound potential; feel home observation reasonable. Instructed on antigen avoidence. Patient reports she received the vaccine and epinephrine around 9am. She was observed in the ED for 4 hours post injection without complication. Reports shakiness and tingling after epi has resolved. Patient feels better by 1pm and goes home.
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| 56 | 2021-02-21 | headache, dizziness |
Pt received injection, first dose. of Pfizer vaccine at 10:27am. Pt was taken to observation stati...
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Pt received injection, first dose. of Pfizer vaccine at 10:27am. Pt was taken to observation station in mall area of hospital for 15 minute observation, by another nurse.. At approx. 10:32, when observing nurse questioned pt about any headache, nausea, vomiting or other reactions, , pt c/o headache, then dizziness, nausea and ultimately started attempting to vomit, having "dry heaves" only. This nurse calls Code RRT to location of event.. Pt was taken to ER via stretcher.
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| 56 | 2021-02-21 | weakness |
Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness ...
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Pt reports 4 days after taking the Pfizer COVID vaccine she developed unrelenting pain and soreness to her left arm followed by general myalgias to her body and weakness. She states she sx have not resolved and has only been taking ASA. Rx Voltaren gel and Tizanidine refill given.
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| 56 | 2021-02-22 | cough |
Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes...
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Chest tightening; moist non productive cough; tightening of the throat; facial flushing; hot flashes; This is a spontaneous report from a contactable nurse. A 56-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3302) via intramuscular, on right arm on 02Feb2021, 10.30 at single dose for COVID-19 immunization. The medical history included allergies to bees and nickel, GERD (Gastro-oesophageal reflux disease). The concomitant medication included diphenhydramine hydrochloride, paracetamol (TYLENOL PM) on an unknown date in 2021. The patient previously received historical vaccine, first dose of bnt162b2 (Brand: Pfizer, Lot number: EL0140) via intramuscularly on left arm at 9.30 on 12Jan2021 for COVID-19 immunization. It was reported that at 10.45 on 02Feb2021, the patient experienced chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes. The patient was not pregnant at the time of vaccination. The patient received most recent COVID-19 vaccine at nursing home/senior living facility. The patient didn't receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient received Tylenol Pm within 2 weeks of vaccination. The patient visited emergency room for the events. Therapeutic measures were taken because of events via oral and subcutaneous. The patient had not diagnosed with COVID-19 prior to the vaccination and since the vaccination. The outcome of the events was recovered on an unknown date in 2021.; Sender's Comments: The association between the events chest tightening, moist non-productive cough, tightening of the throat, facial flushing, hot flashes with BNT162B2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 56 | 2021-02-22 | headache |
Reaction happened 20 minutes after. Itching. A little headache. Lasted a few hours. Followed up at...
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Reaction happened 20 minutes after. Itching. A little headache. Lasted a few hours. Followed up at ER and was discharged after an hours observation.
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| 56 | 2021-02-22 | headache | fairly severe, headache, lymph node swell |
| 56 | 2021-02-23 | chills, headache |
severe soreness at the injection site; soreness at the injection site was so severe that she was una...
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severe soreness at the injection site; soreness at the injection site was so severe that she was unable to sleep or lift her arm; soreness at the injection site was so severe that she was unable to sleep or lift her arm; Chills; mild headache; Nausea; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC324U), via an unspecified route of administration on 11Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. Concomitant medications included unspecified daily vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via intramuscular on an unspecified date at 12:00 pm at 56- years of age on the left arm for COVID-19 immunization and had only mild muscle soreness at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, at eight hours post injection, the patient experienced severe soreness at the injection site. The patient stated that the soreness at the injection site was so severe that she was unable to sleep or lift her arm. On the same day, the patient also had chills, mild headache and nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event mild headache was not recovered while the other events was recovered on an unspecified date in Jan2021.
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| 56 | 2021-02-23 | throat irritation, fatigue, fever, headache |
sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft pala...
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sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-02-24 | runny nose |
Itchy; Runny nose; swelling on site; Very little redness when I got the vaccine/ very red; This is a...
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Itchy; Runny nose; swelling on site; Very little redness when I got the vaccine/ very red; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: unknown), via an unspecified route of administration on the left arm on 05Feb2021 at 09:30 at a single dose for COVID-19 immunization. Medical history included palpitations controlled by medicine. The patient has no allergies to medications, food, or other products. Concomitant medication included metoprolol (METOPROLOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had a little swelling on the site and very little redness when she got the vaccine. However, on the 8th day it was a bigger area, itchy and very red. No pain or other symptoms. The patient did start with a runny nose the day after the vaccine and still have, but not sure it's related. No treatment administered for the events. The events had not resolved. Information on the batch/lot number has been requested.
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| 56 | 2021-02-25 | fatigue |
15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport ...
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15 minutes after receiving shot, extreme fatigue, blurry vision, bp 250/200. ON the medic transport to ER, Left side weakness, loss of speech. Er evaluated for sudden onset left sided weakness, facial droop.Code stroke was called CT angiography was unremarkable and patient admitted for bp control. Bp normalized with Clonidine , neurological exam is stable. Md felt that thus was a combination adverse reaction to vaccine in combination with Wellbutrin. Discharge after 24 hours
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| 56 | 2021-02-25 | fever, chills |
Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-o...
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Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female nurse received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 25Jan2021 at 08:15 AM (at the age of 56 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypothyroid and had BNT162B2 vaccine dose 1 on unknown date, lot unknown, administered at 10:45 AM on right arm. The patient had known allergies: Ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), sertraline hydrochloride (ZOLOFT), liothyronine sodium (CYTOMEL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received levothyroxine, sertraline hydrochloride, liothyronine sodium within 2 weeks of vaccination. On 25Jan2021, at 12:00 PM, the patient experienced Itching, Fever, Chills. No treatment was received for the events Itching, Fever, Chills. The outcome of the events Itching, Fever, Chills was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
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| 56 | 2021-02-25 | dizziness, fatigue |
burning pain in my left armpit/burning pain in both armpits; extreme fatigue; muscle pain; dizziness...
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burning pain in my left armpit/burning pain in both armpits; extreme fatigue; muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration on 11Feb2021 09:00 at single dose in left arm for COVID-19 immunisation. She received the first dose BNT162B2 (lot number: EL8982) in Left arm on 22Jan2021 06:00 PM for COVID-19 immunisation. Medical history included depression, high blood pressure, thyroid disorder, obesity. The patient was allergic to codeine and pennicilian. The patient was not pregnant at the time of vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC), lisinopril, levothyroxine, bupropion hydrochloride (WELLBUTRIN), omeprazole (OMEP). The patient previously took the first dose of Shingrix (lot number: 5816001912) 50 mcg on Dec2020 in left arm for immunisation. On 12Feb2021 09:00, 24 hrs post 2nd vaccine BNT162B2, the patient experienced extreme fatigue, muscle pain, dizziness and 36 hrs after the second vaccine (12Feb2021 21:00) she also started having burning pain in her left armpit, and the next morning also burning pain in both armpits. No treatment received for the adverse event. Events outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.
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| 56 | 2021-02-25 | fatigue, headache |
mental fog; Headache; fatigue; pain in armpit; This is a spontaneous report from a contactable consu...
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mental fog; Headache; fatigue; pain in armpit; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 05Feb2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and patient's concomitant medications were not reported. Patient is not pregnant. Patient has no covid prior vaccination. It was unknown if patient got tested post vaccination. It was unknown if patient had vaccine in four weeks and unknown if other medications in two weeks. The patient experienced mental fog (medically significant); headache, fatigue, and pain in armpit. All the events occurred on 06Feb2021. It was reported that the events were continuing after 6 days. No treatment was provided for the events. Facility type vaccine was nursing home. Outcome of the events was not recovered. Information about lot/batch number has been requested.
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| 56 | 2021-02-26 | shortness of breath, cough, fatigue |
Developed fatigue, cough, and shortness of breath 1 day after 2nd dose of vaccine. Started on anti...
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Developed fatigue, cough, and shortness of breath 1 day after 2nd dose of vaccine. Started on antibiotics and steroids empirically prior to admission 02/15. Initial CT with diffuse centri-lobular tree and bud opacities. Infectious (including BAL) and autoimmune work-up without clear explanation for infiltrate. Underwent VATS wedge resection for tissue diagonsis. Post-op developed hypoxia requiring up to 10L O2 and worsening infiltrates on CT in a pattern consistent with organizing pneumonia (possibly drug reaction). Started empirically on steroids for concern for organizing PNA/hypersensitivity pneumonitis. Pathology returned with organizing pneumonia with increased eosinophils. Timing of onset of symptoms is concerning for a hypersensitivity reaction to the COVID vaccine. Symptoms are improving with steroids (started 02/26). Recovery to be determined but I am optimistic for a good recovery.
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| 56 | 2021-02-28 | malaise, shortness of breath |
Shortness of breath; heart palpitations; Muscle soreness (left arm); overall unwell feeling; This is...
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Shortness of breath; heart palpitations; Muscle soreness (left arm); overall unwell feeling; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL 9262 and expiration date: unknown), via an unspecified route of administration on the left arm on 27Jan2021 at 09:15 at a single dose for COVID-19 immunization. Medical history included systemic lupus and shrimp allergies. The patient had no other vaccine in four weeks and no other medications in two weeks. There were no concomitant medications. The patient had no COVID prior vaccination. The patient experienced muscle soreness (left arm), heart palpitations, shortness of breath and overall unwell feeling on 27Jan2021 at 10:00, which resulted in a doctor or other healthcare professional office/clinic visit. No treatment was administered for the events. The patient has not tested for COVID post vaccination. The events were resolving.
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| 56 | 2021-02-28 | malaise, dizziness, fatigue, chills, cough, headache |
Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; f...
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Sinus pain congestion; Sinus pain congestion; coughing; tiredness; headaches; chills; muscle pain; feeling unwell; back pain; achy all over; very dizzy; nausea; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318 and expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 18:45 at a single dose for COVID-19 immunization. Medical history included High BP, diverticulosis, vertigo and blood clot in artery (healing), allergy to red licorice, hayfever dogs and cats. Patient was not pregnant at the time of vaccination. Concomitant medication included doxycycline, aspirin [acetylsalicylic acid], Multi vit, fiber gummy, and BP meds. There was no other vaccine in four weeks. The patient previously took hydrocodone and prednisone, and experienced allergies. The patient experienced sinus pain and congestion, coughing, tiredness, headaches, chills, muscle pain, achy all over, nausea, felling unwell, very dizzy and back pain on 26Jan2021 19:30. No treatment was received for the events. Outcome was unknown. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
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| 56 | 2021-02-28 | dizziness, cold sweat |
almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very ...
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almost passed out; dizzy; clammy; hot; kept taking my Blood Pressure and pulse ox. Both very, very low; kept taking my Blood Pressure and pulse ox. Both very, very low; This is a spontaneous report from a contactable other healthcare professional. A 56-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot: reported as 96.8), via an unspecified route of administration in the left arm on 31Jan2021 14:15 at a single dose for covid-19 immunization. The patient's medical history included Lupus, Fibro, Hyperthyroidism, Hashimoto's, IBS all from an unknown date. Patient has no known allergies. Concomitant medication included pantoprazole, xylometazoline hydrochloride (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]), vitamin c [ascorbic acid], vitamin d3 and calcium (CALCIUM). 15 minutes after the shot while waiting, 8 minutes into it the patient felt dizzy, clammy, hot, and almost passed out. Nurse gave patient oj, oxygen, Epipen, checked sugar, and kept taking her blood pressure and pulse ox. Both very, very low until it came back up within 20 minutes. The patient declined hospital due to feeling better. Called the doctor next day to discuss what happened. She recommended no 2nd shot. The outcome of the events was recovered. The patient has not had Covid prior to vaccination and patient has not tested post vaccination.
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| 56 | 2021-03-01 | fatigue |
abdominal pain; mild muscle soreness at site; Fatigue; never feels rested or wants/needs to sleep; T...
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abdominal pain; mild muscle soreness at site; Fatigue; never feels rested or wants/needs to sleep; This is a spontaneous report from a contactable Consumer (patient). A 56-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm (at age of 56-year-old) on 21Jan2021 as a single dose for COVID-19 immunisation, lot number: EL8982. Medical history included gall bladder, liver disease (diagnosed in 2008, 2017 exam fully functional), Umbilical (umb) hernia and ulcer. Patient had allergy-severe hives caused by plasma transfusion. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Other medications within two weeks prior to the vaccination was reported as not applicable (N/A). On 21Jan2021 patient received the first dose, following day (22Jan2021) mild muscle soreness at site, ongoing fatigue, never felt rested or wanted/needed to sleep, a lot. Noticed abdominal pain, did not connect the two. All events considered serious due to disability or permanent damage. No treatments received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for Covid post vaccination. Since the vaccination patient had not been tested for COVID-19. Patient had not recovered from the event fatigue and recovered with sequel (recovered with lasting effects) from the other mentioned events.
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| 56 | 2021-03-02 | chills, headache, fatigue |
Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontane...
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Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.
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| 56 | 2021-03-02 | fatigue, headache, fever |
Injection site pain; Fever of 101.3; Tired; Headache; This is a spontaneous report from a contactabl...
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Injection site pain; Fever of 101.3; Tired; Headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), via an unspecified route of administration on 18Jan2021 20:00 (at the age of 56 years old), at a single dose in the left arm for covid-19 immunisation. Medical history included allergies: dust, mold, trees & grass; and diagnosed with covid-19 on unspecified date. Concomitant medications included escitalopram oxalate (LEXAPRO) and fexofenadine hydrochloride (ALLEGRA 24 HOUR). The patient previously took augmentin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has not been tested for covid-19 since the vaccination. On 19Jan2021 20:00, the patient experienced injection site pain for seven days and fever of 101.3 which lasted for 12 hours; tired and had a headache for two days. The patient did not receive any treatment for all the events. Outcome of all the events was recovered on unspecified date. The events were reported as non-serious.
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| 56 | 2021-03-03 | dizziness |
Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one...
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Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiry date not reported), via an unspecified route of administration at the right arm on 20Feb2021 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EL9265, expiry date: not reported) in the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization but experienced face numbness and swelling throat/ear canal on right side. It was reported that the second dose was even worse than the first time and involved continued eye twitching and significant dizziness. The patient had not sought medical attention yet, but if it continued to get worse, she would call her doctor or (helpline number). The patient reported that it almost feels like Bell's Palsy on an unspecified date. It was unknown if treatment was received for Bell's palsy. Clinical outcome of Bell's palsy was not recovered, while for eye twitching and dizziness was unknown.
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| 56 | 2021-03-03 | throat swelling |
swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbnes...
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swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration at the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 30Jan2021 10:45, both times the patient had right face numbness (felt like Novocaine) that started in her right cheek and spread to her lips and up into her eye and ultimately radiating throughout her head, and also swelling throat/ear canal on right side. It was unknown if treatment was received for the events. Clinical outcome of the events was not recovered.
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| 56 | 2021-03-09 | fatigue, headache, chills, fever |
Lymphadenopathy in the glands of the armpit were the first and second shot were given; Strong headac...
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Lymphadenopathy in the glands of the armpit were the first and second shot were given; Strong headache; Mild tiredness; chills; low fever; This is a spontaneous report from a contactable Consumer. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 (Lot Number: EW 5318) via an unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL 3248) on 13Jan2021 without expected adverse event (arm pain and tiredness). The patient had lymphadenopathy in the glands of the armpit were the first and second shot were given on 05Feb2021. Strong headache (not improving with Acetaminophen 500 mg on 04Feb2021, Mild tiredness, chills and low fever on 03Feb2021. The patient started Tylenol for the common symptoms expected after the shot that day (as recommended by the vaccination center). Tiredness started that day. The strong headache started late afternoon of 04Feb2021 (less than 24 hrs. from reporting). On 05Feb2021 around 8:00 the armpit swollen. There was not a sudden but a progression of symptoms. The patient didn't report the events aware that are common from vaccination, and reported (1 hour, 25 minutes) about the armpit swollen. The patient stated that the tiredness was indicated as a common effect so not report it Tylenol was recommended. The strong headache started late on 04Feb2021 and the armpit swollen the day after 05Feb2021 (Early in the morning). The patient took rest on the weekend and changed from Tylenol to Naproxen. Headache and swollen armpit (left side where the shot was given) disappeared. Feeling well since yesterday (currently without medication). The outcome of the event strong headache and Lymphadenopathy in the glands of the armpit were the first and second shot were given was recovered and outcome of all other events was unknown. No follow-up attempts are possible. No further information is expected.
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| 56 | 2021-03-14 | headache |
Muscle ache in left arm/soreness in left arm; heaviness in left arm; headache off and on on right si...
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Muscle ache in left arm/soreness in left arm; heaviness in left arm; headache off and on on right side,brain hurt in the back left side of head; muscle tension in left side of neck; 2 boil in buttocks; This is a spontaneous report from a contactable healthcare professional (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date not reported), intramuscular at the left arm on 29Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included high cholesterol, obesity and arthritis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. On 03Feb2021 03:00, the patient experienced muscle ache in left arm, heaviness in left arm, soreness in left arm, headache off and on on right side, brain hurt in the back left side of head, muscle tension in left side of neck and 2 boil in buttocks. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 11Jan2021. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering.
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| 56 | 2021-03-14 | sweating |
annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonre...
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annoying feeling in her chest; allergic reaction; Her pressure was low then normal then high.; nonresponsive for a few moments/was asked a question and did not respond; sweats; high blood pressure; annoying pain; itching; hives on the arms and chest; Hot flashes; This is a spontaneous report from a contactable consumer (patient) A 56-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EN5318 at left arm on 16Feb2021 at SINGLE DOSE for covid-19 immunisation . Age at vacciantion 56 years.Vaccination Facility Type: Workplace Clinic. Medical history included ongoing allergies (5-10 years). She had a flu shot in Oct2020. There were no concomitant medications.Immediately after the vaccine she became nonresponsive for a few moments, broke out in sweats, had high blood pressure, annoying pain, and has been having itching and hives on the arms and chest.Clincal course was reported as follows: On 16Feb she had hot flashes,pruritus and blood pressure has not been right .On17Feb she developed annoying feeling in her chest.Then , it was added as follows: she received the first dose of the Covid-19 vaccine on 16Feb2021. She had an allergic reaction. The second dose was due 09Mar2020. She was under the impression that she has to take the vaccine she was told she needed a cocktail to get the shot.She had hot flashes and was itching. Her blood pressure has not been right. Her pressure was low then normal then high. She has an annoying feeling in her chest. The itching has stopped after she was medicated. She can't take Benadryl and she was given something else. She applied hydrocortisone cream and it helped. She had a flu shot in Oct2020. She went to the ER on 20Feb2021 because her blood pressure was spiking too high. She had an EKG which was normal. When she went to the ER her blood pressure was 167/100. Yesterday her blood pressure was 167/102. She was nervous about taking the second dose. Her blood pressure usually ranges from 119-120. It was off the charts at 130/80 and 150/99. Pateint was treated for pruritus.She was wondered if she can get the second dose .Events reported as non serious.Lab data included:EKG on20Feb2021:normal.Blood pressure measurement (16Feb2021): has not been right. Her pressure was low then normal then high , blood pressure measurement: 167/100 on 20Feb2021 , blood pressure measurement: 167/102 on 24Feb2021.Patient's recovered from pruritus while the outcome of the other events was unknown.
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| 56 | 2021-03-17 | shortness of breath | blood clot leading to brain stem stroke, intubation, shortness of breath and chest pain |
| 57 | 2021-01-01 | fever | Fever 101.2, body aches, joint pain, nausea |
| 57 | 2021-01-01 | fatigue, chills, weakness, fever |
On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all n...
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On the evening of Sunday December 27th I became violently ill. I began vomiting and continued all night long. I had severe body aches and chills. I was unable to find my thermometer so am not sure of tempertature. I had lower back pain so severe I couldn't lie down. I tried to take Tylenol but was unable to keep it down. By morning I got access to Tylenol suppositories, Dramamine, and a thermometer. My temperature before Tylenol was 104.4. These symptoms continued over the next 3 days though vastly improved with Tylenol, Dramamine and IV fluids. I received a negative COVID test on Thursday. I have only been this ill once before in my life. By Thursday I was not longer febrile, only weak and exhausted. I have to now determine whether or not to get the second vaccination. I know this seems to be a somewhat delayed reaction. Any advice would be appreciated.
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| 57 | 2021-01-01 | fatigue, fever, weakness, dizziness |
Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired....
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Very sore arm, weakness and dizziness after an hour. Next day, feverish, body aches, overall tired. Arm bruised and more sore than regular I'M injection. Feeling "off".
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| 57 | 2021-01-02 | weakness |
Patient received vaccine and was fine through her 15 minute observation period. She left the clinic ...
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Patient received vaccine and was fine through her 15 minute observation period. She left the clinic and came back about 40 minutes later complaining of tingling in her tongue and weakness in her legs and felt like she needed to sit down. Her blood pressure was taken and it was elevated and a decision to take her to the ED was made. In the ED, she denied shortness of breath and did not have any other signs of anaphylaxis. She was given diphenhydramine 50 mg (at 11:36AM), famotidine 20 mg (@11:36AM) and prednisone 50 mg (at 11:43AM). At 12:23PM, documentation from the ED notes that tongue symptoms resolved, but patient still felt weak.
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| 57 | 2021-01-03 | fatigue, fever, headache, chills |
7-8 hours after the vaccine on (12/30/20) I started feeling tired and sluggish. Next day (12/31/20) ...
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7-8 hours after the vaccine on (12/30/20) I started feeling tired and sluggish. Next day (12/31/20) at 9:30 am I started with body aches, chills and headache. I got a fever of 100.2 at 4:00 pm. I took 800mg of Ibuprofen at 4:00 pm and 9:30 pm and fever broke at 12:00 am. Next day (1/1/21) I still had a tiny headache and felt very tired. I didn't start feeling better until Saturday (1/2/21). On Sunday (1/3/21) I felt better and was able to go outside for some fresh air.
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| 57 | 2021-01-03 | headache, malaise, fever, chills | Fever, Chills, Headache, Malaise |
| 57 | 2021-01-03 | shortness of breath |
On 12/22 went to the ER prescribed Prednisone still exp sob unable to walk up a flight of stairs. M...
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On 12/22 went to the ER prescribed Prednisone still exp sob unable to walk up a flight of stairs. My reaction continued 5 days after the vaccine.
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| 57 | 2021-01-03 | headache |
Pfizer-BionTECH Covid-19 Vaccine EUA Patient reports headache beginning approximately 2 hours after ...
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Pfizer-BionTECH Covid-19 Vaccine EUA Patient reports headache beginning approximately 2 hours after vaccination and present continuously since vaccination date (12/21/20) to date of report (1/4/21). She notes that is has been present constantly and is worse at times but is not relieved despite use of ibuprofen, acetaminophen, naproxen, Excedrin Migraine, or eletriptan 40 mg dose. She states that this headache is similar to the headache she had with previous Covid infection in March 2020 and July 2020, which also was not relieved with any medications that she tried. Also reported heart palpitations awakening from sleep on 12/30/20. Advised to seek medical care from primary care provider. On 1/4/21 patient states that she believes headache is improving but is not resolved.
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| 57 | 2021-01-03 | dizziness, headache, malaise |
right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headach...
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right after the injection, I got really hot.Then I got very dizzy and shaky. I got a instant headache. I also had a chlorine taste in my mouth. I told the nurse I wasn't feeling well. she sat with me and was asking about how I was feeling. I the started trying to clear my throat. it felt like I had something in my throat. I kept trying to swallow and it just felt like my throat was getting tighter and tighter. that's when they got me on a stretcher and took me to the ER
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| 57 | 2021-01-04 | weakness, dizziness |
01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss conscio...
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01/04/2021 pt was feeling light headed and not "herself"' prior to 09:00PM pt fell and loss consciousness. Pt was aroused by Spouse to awake after fall and checked pt blood pressure 115/63 and sugar levels 93. Pt feeling weakness afterwards, pain in back and neck from fall. Awaiting calls from PCP and Neurologist for appointments.
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| 57 | 2021-01-04 | chills, fever, throat pain, somnolence |
24 hours after vaccine I started feeling body aches, fever of 102.2 and chills. I went to bed and n...
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24 hours after vaccine I started feeling body aches, fever of 102.2 and chills. I went to bed and next day I had a sore throat, joint pain, body aches and slept all day. Fever lasted 18 hour (went down to 99.8 by morning). Symptoms lasted 36 hours. Was fine after that.
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| 57 | 2021-01-04 | lethargy, headache, fever, migraine |
48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 1...
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48hr Headache which evolved into a migraine with vomiting,lethargy and pain at injection site 12 hour after the injection, fever 99.1
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| 57 | 2021-01-04 | fever, fatigue | 99 fever , major fatigue |
| 57 | 2021-01-04 | fatigue | DEVELOPED SORENESS IN ARM, EXTREME FATIGUE, AND BODY ACHES. |
| 57 | 2021-01-04 | dizziness, chills | Dizziness, Chills and Pale |
| 57 | 2021-01-04 | fever, headache |
First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I ...
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First day I was unable to work due to severe headache. BP went crazy. I was having palpitations. I also experienced headache, nausea, diarrhea and fever. I continue to have tingling in my face. I called employee health, and they told me to isolate. Because they were trying to rule out if it was COVID, but test was negative.
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| 57 | 2021-01-04 | chills, nasopharyngitis, headache, fatigue |
Headache; Really really tired; Really really cold; Chills; Nausea; This is a spontaneous report from...
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Headache; Really really tired; Really really cold; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient herself). This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685, Expiration Date Mar2021), via intramuscular, on 28Dec2020 at 13:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. Age at vaccination was 57-year-old. Relevant medical history included anxiety and fibromyalgia. The patient was receiving concomitantly a drug (unspecified) at dose of 60 mg daily from Sep2020. This patient stated that she is not a healthcare professional but works in the diet area/kitchen of which is a hospital. On 29Dec2020 she felt really really tired, got really really cold, had chills, nausea. On 30Dec2020, in the morning, she had onset of headache. She still had a slight headache and a little nausea, but did not have the chills. She did not knowif this has anything to do with the vaccine but wanted to report the information. She did not plan to change her dose; she was scheduled to get the second dose on 15Jan2021 at 1:00pm which she still plans to get. The outcome of 'really really fatigue' and 'really really cold' was unknown; the event 'chills' recovered in Dec2020; the outcome of 'nausea' and 'headache' was recovering.
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| 57 | 2021-01-04 | chills, fever, headache |
Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diar...
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Patient received her Vaccine on 12/16/2020. Afterwards she developed symptoms of fever, chills, diarrhea, nausea, vomiting and headache that became worse over time and on day os presentation to our hospital on 1/2/2021 she was having photophobia. Current headache at time of admission had been persistent for over a week. Patient has no immunocompromising risk factors and was diagnosed with confirmed CMV meningitis. She was also admitted with transaminitis.
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| 57 | 2021-01-04 | dizziness |
Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes...
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Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes. Then the patient felt dizzy and her BP was elevated (SBP ~135 mmHg) than her normal which is around 90/60 mmHg.
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| 57 | 2021-01-04 | fever |
Rhonchi, frothy sputum, low grade temp, elevated HR, 12/30 MD assessed 1:00PM and increased predni...
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Rhonchi, frothy sputum, low grade temp, elevated HR, 12/30 MD assessed 1:00PM and increased prednisone and added Cefdinir. Sent to hospital 12/30 at approximately 6:30PM with worsening symptoms
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| 57 | 2021-01-04 | dizziness |
Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure a...
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Shortly after vaccination developed dizziness and nausea. Within 30 minutes had low blood pressure and pulse. Taken to ER. Also developed vomiting. Treated with epinephrine. Initially improved, then after 40 minutes heart rate dropped to low 40's and developed chest pain. Treated with 4 mg solumedrol, benadryl and more IV fluids. Slow recovery and observed over 5 hours. Went home.
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| 57 | 2021-01-04 | dizziness |
Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swel...
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Took aleve prior to receiving vaccine. Has known allergy to celebrex which causes mouth/lips to swell and break out in hives. Approx. 45 minutes later she became flushed, felt lightheaded/intoxicated/giddy/silly while driving home. She said she was extremely hungry ("like a big dose of steroids"). She states her ears were ringing and when she laid down at 2130 she could feel her heart beating throughout her body. This AM she reports feeling "hungover/groggy/nauseated". She denied any lip/tongue swelling, any lip or extremity tingling, difficulty breathing, any injection site redness/heat/swollen/painful area, fever, chills, or ever having a vaccine reaction previously. Spoke with individual w/pharmacy. Advised to report to VAERS. Not an expected reaction. Possibly related to aleve vs. covid vaccine.
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| 57 | 2021-01-04 | chills |
allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and i...
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allergic reactions; rash on all my chest and in abdomen; Itchiness; Eyes got red; eyes got red and itch; Chills; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (Lot: EH9899), via an unspecified route of administration on deltoid right on 22Dec2020 at single dose for COVID-19 immunization. Medical history included blood pressure high, hypothyroidism, and environmental allergies. Concomitant medications included amlodipine besilate (NORVASC) at 10 mg, daily for blood pressure high, and levothyroxine sodium (TIROSINT) at 112 mcg (ug) for hypothyroidism. Patient got Covid Vaccine on Tuesday (22Dec2020) night and was fine on Wednesday (23Dec2020). She expected the normal side effects like maybe a little fever like that but she believed she was having allergic reactions. It started from 24Dec2020 and she got a rash on all her chest and in abdomen and also just like itchiness feeling all over. So she took some diphenhydramine hydrochloride (BENADRYL) and a PPI 'a cup of' them on 24Dec2020 and she thought that she only had to do that one's today (25Dec2020) and the only thing she noticed when she got the shot (Covid Vaccine) they kept her there for like 15 minutes and her eyes got red and itch. She didn't scratch them but they felt like itchy and she never had that before. She never had a problem with the vaccine before. She didn't know if that was the true allergic reaction to the vaccines or if it just something she had internal allergies and she just didn't know what it was. But she was okay at the time of the report. She took some diphenhydramine hydrochloride a little while before and a PPI (unspecified medication). She was still itchy but it was not that bad and she seemed to be doing fine. Her arm was fine. She was not having any (unspecified), except sometimes. 24Dec2020 she had chills which she expected and she was all good but the side effects whatever happened that way was not the allergic portion. She tried to contact the doctor. The doctor just switched his clinic only for geriatric patients. She had to find another doctor. She knew a Doctor whom she could try and call and she actually went to the infectious disease physician and he said she should go to get the vaccine, now she was trying with that too. She got allergic to anything. Covid Shot was the only thing new that she had in her life but like she was not sure if it was triggered by something out like (unspecified) because she had always environmental allergies too. She didn't know because she was going to consult the Physician on Monday. She was just going to see the regular doctor. She was just seeing that first that anything because she knew it didn't happen very often but the Covid vaccine she just wanted to make report. She was going to the Physician on Monday because right now she thought she didn't know how long it lasted like. Outcome of the events was unknown.
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| 57 | 2021-01-04 | malaise, cough, nasal congestion, headache, fever, chills |
cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebr...
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cough; change in taste and smell; change in taste and smell; injection site pain; feverish but afebrile; chills; intense headache; nasal congestion; malaise; This is a spontaneous report from a contactable nurse (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection; lot number: EKS730, expiration date: unknown), via an unspecified route of administration on the left arm on 18Dec2020 at 13:00 at a single dose for COVID-19 immunization administered at the workplace clinic. Relevant medical history included hypertension (HTN), hypothyroidism, high cholesterol, and COVID-19 prior to vaccination. The patient had no known allergies. Concomitant medications included levothyroxine, amlodipine, and pravastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain on 19Dec2020 at 12:00. The events were assessed as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered with sequelae/lasting effects from the events "feverish but afebrile, chills, intense headache, nasal congestion, malaise, cough, change in taste and smell, and injection site pain" on an unspecified date.
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| 57 | 2021-01-04 | dizziness, headache |
metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs...
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metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
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| 57 | 2021-01-05 | headache |
10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes wh...
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10 hours later severe pain in the tragus of both ears which woke me up; Headache within 5 minutes which lasted until the next day; This is Spontaneous report from a contactable Other-HCP (patient). A 57-years-old female patient (No pregnant) received first dose bnt162b2 (BNT162B2, lot: EL1284), via an unspecified route of administration on 30Dec2020 17:00 at single dose on Right arm for covid-19 immunisation. Medical history was none. Concomitant medication included celecoxib (CELEBREX), black cohosh [cimicifuga racemosa] (BLACK COHOSH [CIMICIFUGA RACEMOSA]) and multivitamins. The patient previously took erythromycin and experienced drug hypersensitivity. The patient experienced Headache within 5 minutes (30Dec2020 17:05) which lasted until the next day, then about 10 hours later (31Dec2020 03:00) severe pain in the tragus of both ears which woke her up. It felt like someone was grabbing them with pliers. Still recurs mildly from time to time. No treatment received. The events were reported as non-serious.
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| 57 | 2021-01-05 | dizziness | Dizziness |
| 57 | 2021-01-05 | dizziness, headache, fatigue |
Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at les...
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Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect); Intermittent dizziness after an hour; H/A after an hour; that diminished over the next 12 hours but slightly lingered; Metallic taste in the mouth after an hour; Nausea after 8 hours (diminished by the next morning); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on the left arm on 29Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included Hashimoto. Concomitant medication included omeprazole, rosuvastatin calcium (CRESTOR), levothyroxine, magnesium and ascorbic acid, retinol, tocopherol (OCUVITE). The patient previously took zinc and experienced allergies. On 29Dec2020, the patient experienced intermittent dizziness after an hour, metallic taste in the mouth after an hour, H/A (headache) after an hour (that diminished over the next 12 hours but slightly lingered) and feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect), and nausea after 8 hours (diminished by the next morning). No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovered with sequel.
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| 57 | 2021-01-05 | headache, fever | Fever, muscle aches, body aches, headache |
| 57 | 2021-01-05 | fever, night sweats, chills |
Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccinatio...
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Mild URI symptoms started approximately 4 hours post vaccination. By 6 p.m. (5 hours post vaccination), severe chills and fever of 105. Took 800 mg of Ibuprophen and 50 mg of Benadryl. Temp down to 102 by midnight. Fevers persisted, especially at night with extreme night sweats for 11 days often requiring a change of clothing up to 6 times through the night. No further respiratory symptoms past initial presentation. Night sweats have persisted but with less severity as of Day 15. Please note, I am also a healthcare provider and infectious disease epidemiologist, hence enterring my own VAERS.
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| 57 | 2021-01-05 | throat irritation |
Patient c/o tongue swelling minutes after vaccine. Also c/o itchy throat. No shortness of breath. gi...
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Patient c/o tongue swelling minutes after vaccine. Also c/o itchy throat. No shortness of breath. given IM Benadryl and symptoms resolved. Previous similar reaction to crab.
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| 57 | 2021-01-05 | dizziness, headache, sweating |
Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left ey...
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Patient had redness and flushing around the neck and sweaty palms. Patient reported pain in left eye and left forehead above the eye. The patient reported feeling ?out of sorts? with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face. She felt light headed when standing and her feet hurt. She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better . Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
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| 57 | 2021-01-05 | body temperature increased, dizziness, headache, chills |
Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a h...
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Racing heart within 15 min. and kind of whoozy. And then okay. Came back to office and developed a headache about one hour after. Took 1000 mg of Tylenol; and I was feeling okay. Just arm was sore. Not extremely sore. 8 pm at night - started shaking; knees were knocking together; severe chills; and it took a few minutes to recognize what was happening - took temp. 99.4; took another 1000mg tylenol; went to bathroom and without notice - puked; woke up an hour after going to bed with worsened chills; 10:30 pm - temp 102.4; too early to take more Tylenol and so took pharmacy's version of Nyquil. Slept through the night after Nyquil but woke up with chills continuing - temp 103. 8 at 4:30 am; and then sat at side of bed and took tylenol 1000 mg and got up to go to bathroom and couldn't walk forward and felt my arm hurt really really bad; couldn't walk forward; I leaned against the wall and bounced against the next wall and kept walking and grabbed a bedroom doorknob and got into the bathroom and fell on toilet and then crawled to couch because I couldn't walk straight. Stayed on a couch for two hours and then it was gone. Fever and chills continued that whole day on 24th. Didn't eat/had no appetite. Christmas day -no fever. Felt shaky though - like I'd been super sick. No appetite still. Felt woozy and shaky inside (felt shaky inside) and that lasted for several days. Appetite still remains poor. 02 stats were low through all of it - four liters (up two liters than normal. Contacted: a pulmonologist - Dr. and she helped with O2 questions.
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| 57 | 2021-01-05 | weakness, headache, dizziness, throat irritation |
Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakn...
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Rapid heart rate, shakiness, headache, rash, scratchy throat, raspy voice, dizziness, extreme weakness
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| 57 | 2021-01-05 | dizziness, headache |
got lightness in my head/I have been dizzy; Headache; This is a spontaneous report from a contactabl...
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got lightness in my head/I have been dizzy; Headache; This is a spontaneous report from a contactable consumer nurse assistant (patient). A 57-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EH9899) at single dose on 28Dec2020 for covid-19 immunisation, administered at the hospital she worked at. Medical history included cholesterol. The patient reported taking unspecified concomitant medications. The patient got lightness in my head, had been dizzy and experienced headache in Dec2020. No treatment received. The outcome of events was unknown.
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| 57 | 2021-01-05 | fever | nausea, diarrhea, vomit x 1, low grade fever 10 days after vaccine given |
| 57 | 2021-01-05 | cough |
post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporti...
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post nasal drip; cough; Hoarse voice; This is a spontaneous report from a contactable nurse (reporting for herself). A 57-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EK5730, expiry date not reported), intramuscular in 29Dec2020 12:00 at a single dose in the left arm as Covid vaccine. Medical history included diagnosis is hypothyroidism, and patient have had reaction to almost all medications, wherein PCP (primary care provider) thinks patient have a reaction to the coating on tablets and to capsules. Patient had no covid prior vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. About 20 minutes after receiving on 29Dec2020 12:00, started with post nasal drip, which caused a cough; hoarse voice. These symptoms lasted about 2 hours. Since they are not listed as side effects just wanted to share. Patient did have a negative covid test on the day of the vaccine (covid tested post vaccination on 29Dec2020). No treatments received for the events reported. The events were reported as not serious (not resulting in death, not life threatening, did no caused/ prolonged hospitalization, not disabling/Incapacitating, not congenital anomaly/birth defect). The outcome of the events post nasal drip, cough and hoarse voice was recovered on 29Dec2020 14:20.
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| 57 | 2021-01-06 | shortness of breath |
After being given the vaccine the patient was asked to wait 15 minutes before returning to work. Aft...
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After being given the vaccine the patient was asked to wait 15 minutes before returning to work. After 5-10 minutes she reported shortness of breath and an anaphylactic type reaction. Patient was administered an Epi-pen by a nurse and the facility, and reported feeling "a little better." She was also given oxygen and put on a pulse oximeter. Her O2 sat was 99% throughout. She reported before that she had no allergies and no adverse reaction to a vaccine in the past, but after this happened she said something similar also happened in the past with a flu shot. Patient believes this reaction was due to anxiety and not an allergy. 911 was called and arrived about 15-20 minutes after administration and patient was taken to the hospital. A nurse called the hospital 2 to 3 hours later and they reported she was "doing fine" and would be discharged home later today.
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| 57 | 2021-01-06 | chills, headache, fever | CHILLS, FEVER, BODY AND HEAD ACHES |
| 57 | 2021-01-06 | fever, headache, chills | Chills, body aches, fever, headache |
| 57 | 2021-01-06 | throat irritation, cough |
CoughWheeze c/o chest congestion. Hx. of asthma. Used her Albuterol inhaler and "felt better" Vaccin...
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CoughWheeze c/o chest congestion. Hx. of asthma. Used her Albuterol inhaler and "felt better" Vaccinated at 1041 AM, c/o "feels like chest congestion, tickling in throat" at 1117. Hx. Asthma; used her Albuterol inhaler PRN at home and used it at 1117. after 2-3 minutes she said she felt better. BP148/71, P 88, R 16, O2Sat 96% at 1117; at 1125 BP 140/72, P 84, R 18, O2 sat 99%.
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| 57 | 2021-01-06 | nasopharyngitis, fever |
I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever w...
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I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever which progressed to a head cold and further progression to full Upper Respiratory infection, viral in nature. 168 hours later, lost sense of taste and smell and had some GI discomfort.
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| 57 | 2021-01-06 | chills, fever | Myalgia, Fever, chills |
| 57 | 2021-01-06 | fever, headache, dizziness, chills |
ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZ...
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ON 12/31/2020 I HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS, DIZZY AND LIGHTHEADED THAT LASTED FOR 3 DAYS. SINCE THEN I HAVE A BAD HEADACHE, FEELING NAUSEA AND VERY LIGHT HEADED AT TIMES.
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| 57 | 2021-01-06 | body temperature increased, migraine, chills |
On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early a...
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On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches. Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous. Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone 97.4.
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| 57 | 2021-01-06 | weakness | Patient reported pain and weakness |
| 57 | 2021-01-06 | fatigue, body temperature increased, chills, dizziness |
Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on...
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Pfizer BioNTech COVID 19 vaccine EUA 0530 on 01/06/21 took naproxen for injection site pain. 0600 on 01/06/21 reports extreme fatigue and continued sore arm at injection site. 1000 started having chills and generalized muscle aches. Temperature elevated to 101.2 at 1545, took Tylenol and temp went down to normal range with 1-2 hours back to 100.0 at 1815. Reports dizziness during that time as well.
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| 57 | 2021-01-06 | runny nose | Received vaccine on 1/6/2021 at 10:30 AM. Sneezing and runny nose since 1/6/2021 10:00 PM. |
| 57 | 2021-01-06 | malaise, headache |
Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in...
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Vomiting/threw up; Headache; muscles got rigid and tight in her neck; muscles got rigid and tight in her neck; sick; She doesn't know if she had the flu bug or not; She also had very high blood pressure. It was through the roof/Blood pressure was high and she was concerned she would have a stroke; Muscle soreness; Arm soreness; This is a spontaneous report from a contactable healthcare professional (physical therapist). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on the left arm on 21Dec2020 08:15 at a single dose for COVID-19 immunisation; and sumatriptan from 25Dec2020 to an unspecified date at unknown dose and frequency (standard unknown dose/ She only gets 9 pills a month) for migraine. Medical history included ongoing migraine, obesity (She would say she was kind of obese), coeliac disease (She had Celiac disease and cannot eat gluten which was diagnosed since she was 4), chronic back pain (this was diagnosed a couple of years before she took the COVID vaccine), spinal stenosis (this was diagnosed a couple of years before she took the COVID vaccine), and pain (she took hydrocodone for pain but did not take any that day). Concomitant medication included hydrocodone for pain. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. The patient had the vaccine on 21Dec2020, and she got sick on Christmas day. She was vomiting at 14:00 and did not know if it was a side effect or not. She did have arm soreness muscle soreness at 15:00, that evening and the next day too. She normally gets a migraine once a month. She does not normally throw up with a headache though. The vomiting started when she threw up twice on 25Dec2020, then once on morning of 26Dec2020. She also had very high blood pressure. It was through the roof. She did not know if that was related to drug for migraine or vaccine. She also had the headache at 14:00 the whole time. She believed she threw up before she took Sumatriptan. The muscles got rigid and tight in her neck and she doesn't think she took it. She threw up and then she took it. She did not have a lot or expiration. There was no ER nor physician's office required. She would have it if her car was not buried in snow. Her blood pressure was high and she was concerned she would have a stroke. It was usually around 110/70 and was always very low usually. She did not know if it was accurate, but it was 165/124 at one point and she did know her pulse was accurate. She did not provide her pulse rate. She did not know if she was throwing up because her blood pressure was high and did not know if blood pressure was high because of Sumatriptan. She only gets 9 pills a month. She did not know if high blood pressure was one of the side effects. It was not a real safe medication to take once a day. She only took it once a month and only once that day. She had never thrown up with migraines before and was just concerned. She doesn't usually take her blood pressure and doesn't know if the Sumatriptan always makes it go up or not. She doesn't know if she had the flu bug or not. The action taken in response to the events for bnt162b2 was not applicable, while for sumatriptan was unknown. Clinical outcome of sickness and influenza was unknown, for headache was recovered on 27Dec2020, while for the other events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the elevated BP and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-06 | dizziness |
at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on ar...
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at 4:08 pm, 10 minutes after receiving vaccine pt reports feeling dizzy and has bilateral rash on arms. pt was evaluated by EMS. BP 124/80, P 82, O2 Sat 100%. pt reports feeling better and declined EMS transport to hospital and left AMA 4:26
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| 57 | 2021-01-06 | dizziness |
pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt s...
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pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt sat in view of Rn for extended time period. VS 198/108 HR92 SPO2 97. Pt VS rechecked BP 148/90 SPO2 97 HR 94 pt stated she felt better. Pt ambulated independently, RR even and unlabored, NAD noted, Skin NFR. Pt declined transport to ED.
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| 57 | 2021-01-07 | cough |
Approx 20 mins after vaccination, just after leaving observation, pt began to complain of itching at...
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Approx 20 mins after vaccination, just after leaving observation, pt began to complain of itching at scalp. She mentioned this to one of the vaccination nursing staff. This author arrived as discussion was taking place. Itching increasing to torso, began coughing. Denies dyspnea. Placed in wheelchair and taken to ACC without delay. ACC notifed of arrival and was taken directly to Triage. Arrival vitals: 131/85 81 98.5 R- 20 SPO2= 99 RA At ACC - treated with: - Benadryl 25mg IV - Famotidine 20mg IV - Solumedrol 125mg IV - Albuterol Inhaler Improved after meds.
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| 57 | 2021-01-07 | dizziness, fever, headache |
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: R...
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Dizziness, Headache, Myalgia, Fever, NauseaVomiting, Intermittent jaw pain and rib pain Narrative: Recommended that she seek emergent care
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| 57 | 2021-01-07 | fatigue, dizziness, headache | Dizziness, Headache, NauseaVomiting, arm sore at injection site,fatigue Narrative: |
| 57 | 2021-01-07 | shortness of breath, headache | Elevated heart rate, shortness of breath, headache |
| 57 | 2021-01-07 | headache, chills, fever |
Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol...
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Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol, benadryl Next day at time of report, symptoms had not resolved.
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| 57 | 2021-01-07 | nasal congestion, cough, headache |
Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection ...
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Getting sick; I am so upset; typical body aches; headaches; cough; nasal congestion; Pain injection site; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid-19 Vaccine, lot E"JI"1685 but not clarified), via an unspecified route of administration on 21Dec2020 at single dose, for Covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included levothyroxine. The patient got her first Covid Vaccine on 21Dec202 and got the minimal pain at the injection site which was no big deal but about 10 days later (31Dec2020), she started getting sick. She was getting sick with Covid type symptoms, so she was off of the work and get swabbed yesterday and waiting her result to come out. She had typical body aches, headaches, cough and nasal congestion everything was along with that. She does not think these were side effects of the vaccination but just "quite" (not clarified) wondering how you she felt. She was so upset. She took Ibuprofen and Alcazar. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events vaccination site pain and headache were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other reported events with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-01-07 | fever, dizziness, headache |
Headache; Dizzy; Fever; Nausea; This is a spontaneous report from a contactable Other HCP (patient h...
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Headache; Dizzy; Fever; Nausea; This is a spontaneous report from a contactable Other HCP (patient herself). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unknown route, on 30Dec2020 at 08:45 at single dose for COVID-19 immunisation. Vaccine location was arm right. The patient was not pregnant. Relevant medical history included hypothyroidism, osteoporosis and COVID-19 (prior to vaccination). No known allergies. Relevant concomitant medications included levothyroxine and alendronate sodium (FOSAMAX). The patient was vaccinated at Workplace Clinic, age at vaccination was 57-year-old. No other vaccine was received in four weeks. Since the vaccination, the patient has not been tested for COVID-19. The patient developed nausea 20 minutes after vaccine (on 30Dec2020, at 09:05), then headache, dizzy, fever started about 2 hours after (on 30Dec2020, at 10:45). The patient was not treated for the events. The outcome from the events was unknown.
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| 57 | 2021-01-07 | headache, fever | Pt report body aches, headache and fever of 101.5. Treated with Tylenol with mild improvement |
| 57 | 2021-01-07 | headache |
Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Sym...
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Soreness, redness, itching to injection site Severe headache Nausea, vomiting and diarrhea Symptom last about 24 hours.
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| 57 | 2021-01-07 | weakness, throat irritation, fatigue, headache |
burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swe...
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burning upper nose/throat; burning upper nose/throat; heart racing; headache; numbness; tingling swelling in left arm; tingling swelling in left arm; pain left groin left leg with muscle weakness; pain left groin left leg with muscle weakness; vomiting; tiredness; weak; This is a spontaneous report from a contactable Nurse. This 57-year-old female Nurse (patient) received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: unknown; Expiration date was not reported) on 29Dec2020 08:00 (at the age of 57-years) as single dose, Intramuscular in left arm for COVID-19 immunization. Medical history included allergies to penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant. Concomitant drugs included ASA (ASA), Famotidine (FAMOTIDINE), ergocalciferol (VIT D), ascorbic acid (VIT C), zinc (ZINC), magnesium (MAGNESIUM). The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient did not test for COVID-19 after vaccination. On 29Dec2020 15:00 the patient experienced 'Burning Upper Nose/Throat', 'Heart Racing', 'Headache', 'Numbness', 'Tingling Swelling in Left Arm', 'Pain Left Groin Left Leg with Muscle' 'Weakness', 'Vomiting', 'Weak', and 'Tiredness'. The patient did not received treatment as a result of the event. The outcome of event 'Burning Upper Nose/Throat' was recovered on unspecified date, 'Heart Racing' was recovered on an unspecified date, 'Headache' was recovered on unspecified date, 'Numbness' was recovered on unspecified date, 'Tingling Swelling in Left Arm' was recovered on unspecified date, 'Pain Left Groin Left Leg with Muscle' was recovered on unspecified date, 'Weakness' was recovered on unspecified date, 'Vomiting' was recovered on unspecified date, 'Weak' was recovered on unspecified date, and 'Tiredness' was recovered on unspecified date. Information on the lot/batch number has been requested.
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| 57 | 2021-01-07 | headache |
had intermittent abdominal pain that hit at 72 hours (late last night, early this morning); began wi...
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had intermittent abdominal pain that hit at 72 hours (late last night, early this morning); began with nausea and it comes in waves/continues in waves along with the nausea, it comes and goes from moderate severe to low grade; headache; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID 19 vaccine on Wednesday close to noon and reported that, "I didn't notice any symptoms until yesterday morning (02Jan2021), I began with nausea and it comes in waves. I did have headache that began Friday evening (01Jan2021) and continues in waves along with the nausea, it comes and goes from moderate severe to low grade. I then had intermittent abdominal pain that hit at 72 hours (late last night, early this morning, 03Jan2021). No diarrhea associated with it. I can't find abdominal pain on the paperwork that was provided to me. is this also one of the expected or reported side effects?" The outcome of the events was unknown. Information on the lot/batch number has been requested.
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| 57 | 2021-01-08 | fever | Arthralgia & Fever |
| 57 | 2021-01-08 | fever, chills | Fever Sore arm around 12 noon; chills 10pm for an hour, then fever 101-3F; relieved with tylenol |
| 57 | 2021-01-08 | weakness, fever, malaise, headache |
Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick ...
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Four days after vaccine, I began to feel sick, weak, headache, bodyaches, fever of 100.4, and thick nasal/sinus mucus.
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| 57 | 2021-01-08 | headache |
Headache began about 5 minutes after injection and lasted until the next day. About 10 hours after r...
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Headache began about 5 minutes after injection and lasted until the next day. About 10 hours after receiving the vaccine, I was awakened by intense pain in the tragus of both ears, as if they were in a vice grip. I finally took acetaminophen which mostly resolved it, but I continued to have similar, intermittent pain over the next 2-3 days. It has now resolved.
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| 57 | 2021-01-08 | fever, fatigue |
I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, ...
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I am a physician and I got dose 2 at 1:30pm on Jan 4. Next afternoon, Jan 5, I got severe myalgias, fever up to 100, severe fatigue, went home after work and slept til the next morning, went to work, took ibuprofen, and the myalgias improved and felt better. But around 3 pm, Jan 6, I got mild vertigo. By about 7pm Jan 6, I noticed my L ear didn't hear well. I changed the battery in my hearing aide and cleaned it but It made no difference. I woke up on Jan 7 with severe vertigo and hearing loss. I did Epley's maneuvers with no effect. I have had similar episodes. I went to work, but gave up when I could not hear patients talking to me. I went to the Emergency Dept and got admitted. I was too unsteady on my feet. Audiogram showed profound hearing loss both ears and almost complete loss of discrmination in R ear. I was put on high dose steroids. Also having tinnitus (mostly whooshing sound of my own pulse). MRI negative. Blood work negative. Some mild improvement now, after 1 dose steroids.
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| 57 | 2021-01-08 | malaise |
On Christmas day I did not feel well. I tested positive for Covid on 12-27-2020. Went to the hospi...
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On Christmas day I did not feel well. I tested positive for Covid on 12-27-2020. Went to the hospital and got infusion and after that I came home and quarantined an returned to work on 01-05-2021.
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| 57 | 2021-01-09 | fever, headache, chills |
Fever, chills, severe body joint aches, headache started 10am day of injection lasting until 1/10/21...
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Fever, chills, severe body joint aches, headache started 10am day of injection lasting until 1/10/21. Improvements started 01/09/21 late afternoon. Some aches remain on 1/10/21 but minimal in comparison
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| 57 | 2021-01-09 | fever, chills, headache |
Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/202...
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Painful arm 12/27/2020 Headache 12/28/2020 Low grade fever,severe headache, chills,nausea 01/06/2021
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| 57 | 2021-01-09 | chills, fever, headache | Rigors, fever nausea, vomiting. diarrhea Severe muscle spasming/contraction, headache |
| 57 | 2021-01-09 | migraine | Severe Migraine |
| 57 | 2021-01-10 | fever |
5 days after vaccine developed hives. Day 6 and 7 was really really bad hives. Did a tele appt. List...
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5 days after vaccine developed hives. Day 6 and 7 was really really bad hives. Did a tele appt. List of meds: Pepcid - 20 mg 2 x/day; Satirazine - 10 mg 1 day per day; benydryl 25 mg - several times a day - took over the weekend (over the counter). On 28th they prescribed Prednisone: 20 mg two times/day for five days. There was a fever with the hives so I wasn't allowed to work; off work for six days (three scheduled and three were scheduled off). Resolved after prednisone. Still a bit itchy but no hives.
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| 57 | 2021-01-10 | chills, fatigue |
Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shakin...
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Approximately 15 hours after injection, was awoken with very severe chills and incontrollable shaking. Was so cold, had to get a heating blanket to put over me, along with 2 blankets. Was shaking so bad, could hardly walk. Was slightly disoriented at the time. This lasted for 4 hours. Temperature is normally 95.6, did rise to 98.7. Had severe body aches that lasted until the next day, but were not as severe. the following day was very tired and muscles were achy. I did take tylenol, which seemed to help.
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| 57 | 2021-01-10 | headache | Body Aches, headache, Swollen Lymph nodes |
| 57 | 2021-01-10 | lethargy, dizziness | Dizziness, body ache, lethargic, lump at site of injection for about 5-7 days |
| 57 | 2021-01-10 | shortness of breath |
Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled...
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Her voice became raspy, she could hardly talk, she could barely talk; her hand and whole arm swelled up; her hand and whole arm swelled up; Trouble breathing; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) (lot# EK9231, exp date Apr2021), via an unspecified route of administration in the right arm, on 29Dec2020, at single dose, for COVID-19 immunization and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration, at unknown posology, on 29Dec2020 (20 minutes prior to taking bnt162b2), for anaphylactic reaction. Medical history included ongoing thyroid disorder. Concomitant medications included apixaban (ELIQUIS), diltiazem (unknown trade name), losartan (unknown manufacturer), rosuvastatin calcium (CRESTOR), levothyroxine (unknown trade name), ongoing levothyroxine sodium (SYNTHROID) for thyroid disorder and metformin (unknown trade name). Previously the patient received unspecified influenza vaccine (reported as flu shot) for immunisation, on unspecified date, and experienced anaphylactic reaction treated with Benadryl. On 29Dec2020, an hour after getting the vaccine, the patient experienced her voice became raspy, she could hardly talk, she could barely talk with outcome of unknown, her hand and whole arm swelled up with outcome of unknown, trouble breathing with outcome of unknown. The reporter stated that her voice and everything reacted and made her go to the emergency room on 29Dec2020. She reported that had adverse effect more than normal. The event "Her voice became raspy, she could hardly talk, she could barely talk" caused patient's hospitalization on unknown date. The action taken as a result of the events with diphenhydramine hydrochloride was post-therapy. Therapeutic measures were taken at the emergency room as a result of the events and included treatment with Topcid and Benadryl every 6 hours, 2x 40 mg of steroid. The information on the lot/batch number has been requested. Follow-up (02Jan2021): New information received from the same contactable healthcare professional reporting for herself includes: patient's details, medical history, events updated, vaccine lot# and exp date, concomitant, seriousness of event "Her voice became raspy, she could hardly talk, she could barely talk" added as hospitalization, historical vaccine, suspect Benadryl details, therapeutic measures updated.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-01-10 | dizziness | Lightheaded, dizzy. Vitals okay. Symptoms resolved. |
| 57 | 2021-01-10 | headache, chills, fever |
Low grade temp, chills, headache and body ache. Started early morning and were resolved within 12 h...
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Low grade temp, chills, headache and body ache. Started early morning and were resolved within 12 hours of onset
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| 57 | 2021-01-10 | fatigue, headache | Pfizer-BioNTech COVID-19 Vaccine Headache, fatigue for 36 Hours |
| 57 | 2021-01-10 | fever, headache, fatigue, chills, malaise, respiratory tract congestion |
Received Phizer COVID 19 vaccine on Tuedsay, January 5, 2021. Friday am did not feel well, Congestio...
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Received Phizer COVID 19 vaccine on Tuedsay, January 5, 2021. Friday am did not feel well, Congestion, HA and CP. Friday evening shaking chills and fever with extreme fatigue. GI symptoms and congestion Saturday. Feeling better by Saturday evening.
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| 57 | 2021-01-10 | chills, fatigue, headache, fever |
Same exact signs and symptoms as Covid disease in April 2020. Fever, extreme headache, muscle pain, ...
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Same exact signs and symptoms as Covid disease in April 2020. Fever, extreme headache, muscle pain, chills, joint pain, extreme fatigue, weakness, GI symptoms, muscle cramps,
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| 57 | 2021-01-10 | nasal congestion |
Second Dose: Felt nasal congestion after receiving the shot, then 24 hours later, I started feeling ...
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Second Dose: Felt nasal congestion after receiving the shot, then 24 hours later, I started feeling aching all over. Then the next day, I awoke with a warm area around injection site. Warm to touch, and is very tender.
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| 57 | 2021-01-10 | nasal congestion |
Second dose; received on Friday 01. .21. On that evening, I had nasal congestion, which is no bi...
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Second dose; received on Friday 01. .21. On that evening, I had nasal congestion, which is no big deal. I had some redness, then on the next day, Saturday I started having body aches everywhere, I took two tylenol, and then I was fine. Then when I awoke the next morning, my arm was really sore. The injection site is red and warm and is tender, but not bad bad. The warmth of it is the worst part.
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| 57 | 2021-01-10 | headache, body temperature increased | Severe body aches, severe headache, elevated temperature (highest 100.3F) |
| 57 | 2021-01-10 | headache | Site Pain, HA, Fever, Joint pain, Body Aches |
| 57 | 2021-01-10 | runny nose, productive cough, headache, throat pain | Sore throte, headache, body aches, wet couph, glands are swollen, and runny nose |
| 57 | 2021-01-10 | throat irritation | c/o burning/ warmth to throat |
| 57 | 2021-01-10 | headache | headache swollen glands in throat injection site soreness |
| 57 | 2021-01-10 | chills, headache, fatigue, malaise, dizziness |
injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, l...
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injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, lymphadenopathy, blurry vision, dizziness; Tylenol 1 tab X 3 times per day during 3 days
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| 57 | 2021-01-10 | chills, fever | muscle aches chills fever right knee where quad is, is numb |
| 57 | 2021-01-10 | weakness, headache, chills, dizziness |
nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day ...
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nausea, dizziness, feeling uneasy after 20 min. Feeling elated as if am drank lasted the whole day the vaccine was given. injection site pain swelling, severe headache, developed chills at night joint pains, rashes on my face, feeling weak as if I dont have energy. At night time i went to the restroom 5 times with an interval of 5-10 minutes and i cannot even control my bladder it comes out continuously. Slow to comphrend or response. I stayed fully awake the whole night on the night when the vaccine was given to me and was able to sleep only the following day (sat) at 5 pm.
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| 57 | 2021-01-10 | throat pain, fatigue, headache |
onset of trigeminal neuralgia in V1, V2 and V2 within 24 hours of 2nd dose. Notably pt has hx of in...
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onset of trigeminal neuralgia in V1, V2 and V2 within 24 hours of 2nd dose. Notably pt has hx of intermittent trigeminal neuralgia (3-4 previous flares in her lifetime) believed to be secondary to HVS infection. Sx have been present for 2 days and associated with headache, fatigue and mild sore throat. Pt will treat per usual with acyclovir 400 mg TID x 3-5 days.
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| 57 | 2021-01-11 | dizziness |
At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describ...
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At approximately 08:39, patient with complaint of dizziness and general "fogginess". Patient describes sensation as tingling throughout her head and body. Denies shortness of breath, difficulty swallowing, tingling of the tongue or lips or lip/tongue swelling. Denies palpitations or tachycardia. Patient states that she did not eat breakfast this morning. Initial BP 151/92, HR 62, 96% on RA. Patient states that she did take her morning dose of metoprolol. Response team was called for patient to be further assessed. Repeat blood pressure at 08:42 was 124/82, HR 62, 96% on RA. Team assessed patient. Patient provided water and crackers. Physician instructed patient to be monitored for 20-30 minutes. 08:56, BP 136/82, HR 66, 97% on RA. Patient verbalizes resolution of all symptoms. Patient discharged from clinic ambulatory and stable at 09:25.
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| 57 | 2021-01-11 | fatigue, headache | Extreme pounding headache through out the evening and next day. Also, I felt extremely tired |
| 57 | 2021-01-11 | fever, headache, fatigue | Fever, Headache, body aches, fatigued |
| 57 | 2021-01-11 | throat pain, chills | Loss of taste/smell, sore throat, chills. Positive swab for Covid 12/29/20 |
| 57 | 2021-01-11 | dizziness, headache | Mylgias, light headed, headache |
| 57 | 2021-01-11 | fatigue, headache |
Pain at injection site (two days) Joint pain, predominantly in shoulders and knees (three days) Head...
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Pain at injection site (two days) Joint pain, predominantly in shoulders and knees (three days) Headache (three days) Diarrhea (three days) Extreme fatigue (three days)
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| 57 | 2021-01-11 | throat irritation, throat pain, headache |
Patient received vaccine around 10 am. She waited 30 minutes in the clinic with staff due to history...
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Patient received vaccine around 10 am. She waited 30 minutes in the clinic with staff due to history of numerous allergies (zantac, demerol, amoxicillin, paxil, gluten). After patient left the site, she returned around 11:18am reporting she was feeling poorly (specifically with nausea, headache, and itchy/sore throat). No lip swelling , shortness of breath, hives noted. Vital signs were monitored and were stable. Diphenhydramine 50mg given orally and EMS notified as per our company protocol. Patient left via ambulance at 11:32 in stable condition to Hospital .
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| 57 | 2021-01-11 | throat irritation, throat swelling |
Symptoms: About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine, Patient went to...
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Symptoms: About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine, Patient went to ER with complaints of sensation of ?foreign body? in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Treatment: Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition.
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| 57 | 2021-01-11 | dizziness |
dizzy; Felt hot; acutely numb; This is a spontaneous report from a contactable other healthcare prof...
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dizzy; Felt hot; acutely numb; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 13:45 at a single dose on left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took cortisol [cortisone acetate]. The patient felt hot and acutely numb and dizzy within first few moments on 06Jan2021 13:45. The outcome of the events was recovered 06Jan2021 13:45. No treatment received for the adverse events. The reporter assessed as the events as non-serious. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Batch/lot was not available/provided to reporter at the time of report completion. Information about lot/batch number has been requested.
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| 57 | 2021-01-11 | fever, fatigue, headache | nausea, headache, fatigue, low grade temp |
| 57 | 2021-01-11 | fever, headache |
too sick; Fever; muscle aches; headache; body aches; This is a spontaneous report from a contactable...
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too sick; Fever; muscle aches; headache; body aches; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; unknown lot number and expiration date), via an unspecified route of administration left arm on 04Jan2021 19:30 (07:30 PM) at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medication included escitalopram oxalate (LEXAPRO) and ergocalciferol (VIT D). The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The most recent COVID-19 vaccine was administered in a hospital. The patient experienced fever, muscle aches, headache and body aches on 05Jan2021 09:00 PM (21:00). The patient was too sick to get out of bed to find lot details. The patient did not received treatment for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The events were reported as non-serious. The outcome of the event sickness was unknown while the outcome of the other events was recovering. Information on the lot/batch number has been requested.
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| 57 | 2021-01-12 | fever, headache, chills |
10:30pm, fever began along with chills. Fever 101.6 degrees via thermometer. on 01/12/21 at 8am, bod...
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10:30pm, fever began along with chills. Fever 101.6 degrees via thermometer. on 01/12/21 at 8am, body aches and head ache occurred. Fever reduced but was consistent all day at 100.7 degrees. Tylenol was taken 01/12/21 at 1am and 8am. called the vaccine hotline via UConn Health at 9am and it was advised to stop Tylenol. on 01/13/21 at 1am. all symptoms were gone. temperature normal, no more body aches or chills.
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| 57 | 2021-01-12 | dizziness |
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red ...
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1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms, blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to be all systemic.
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| 57 | 2021-01-12 | headache | Arm soreness headache |
| 57 | 2021-01-12 | headache, fever, chills | Chills, fever, headache, body aches, upset stomach, pain in arm of vaccine |
| 57 | 2021-01-12 | fatigue |
Minor reaction, still came to work. General muscle/join soreness and fatigue. injection site pait, ...
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Minor reaction, still came to work. General muscle/join soreness and fatigue. injection site pait, site redness, swelling and new or worsened joint and muscle pain
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| 57 | 2021-01-12 | fatigue |
Minor reaction, still came to work. General muscle/join soreness and fatigue. Injection site pain, r...
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Minor reaction, still came to work. General muscle/join soreness and fatigue. Injection site pain, redness and swelling and new or worsened joint and muscle pain.
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| 57 | 2021-01-12 | headache, shortness of breath |
Patient received shot at 10:18 AM, started experiencing nausea at 11:09 AM, was administered epi-pen...
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Patient received shot at 10:18 AM, started experiencing nausea at 11:09 AM, was administered epi-pen at 11:30 AM followed by 50mg of benadryl. Noted that patient had headache, nausea, high blood pressure, trouble breathing and went by ambulance to ER
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| 57 | 2021-01-12 | headache, dizziness, chills |
Sore arm almost immediately, lightheadedness for a few hours, then onset of severe headache, body ac...
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Sore arm almost immediately, lightheadedness for a few hours, then onset of severe headache, body ache and shaking chills. Improved with Tylenol. Today still achy but I've continued the Tylenol.
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| 57 | 2021-01-12 | dizziness |
immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs ...
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immediately after vaccination had flushed feeling. dizziness, and "jittery. diarrhea started 18 hrs after
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| 57 | 2021-01-12 | headache | severe pain in right arm, and diffuse body aches, headache |
| 57 | 2021-01-13 | fever, chills, fatigue |
Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; Th...
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Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 06Jan2021 16:45 at a single dose on right arm for COVID-19 immunization. Medical history included, lactose intolerance. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.), probiotics (PROBIOTICS), clarithromycin (MACROBID [CLARITHROMYCIN]), ibuprofen (MOTRIN [IBUPROFEN]), paracetamol (TYLENOL). The patient previously took Parafon Forte and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730) on 17Dec2020 17:15 at a single dose on left arm for COVID-19 immunization. The patient experienced aches, chills, menstrual like cramps, fatigue, eye burning, and low grade temp on 07Jan2021 15:00. The outcome of the events was recovering. The events were assessed as non-serious. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
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| 57 | 2021-01-13 | fatigue, migraine |
Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, ...
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Adverse effect from the first shot was extremely tired and fatigued. Second shot migraine headache, fatigued, body aches, nausea, pain throughout whole body.
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| 57 | 2021-01-13 | chills, cough |
COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID v...
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COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; COVID virus/on 29Dec2020 tested positive/symptoms of cough, chills, lost of taste and smell; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number EJ1685, expiration date: 31Mar2021), intramuscularly on 20Dec2020 17:43 at left deltoid, at single dose for vaccination. Medical history included asthma and diabetes. There were no concomitant medications. The patient received the first dose of vaccine on 20Dec2020. On 22Dec2020 she was exposed to Covid, on 28Dec2020 developed symptoms of cough, chills, lost of taste and smell, she had onset of COVID virus symptoms on 28Dec2020 with positive COVID result from COVID nasal swab test performed on 29Dec2020. She has already completed her Bamlanivimab infusion therapy to treat COVID virus on 31Dec2020. Her 2nd dose is due on 10Jan2020 and she wanted information on the use of antibody therapy with the Covid-19 vaccine. She asked if she should still get the second dose of Pfizer-BioNTech COVID-19 Vaccine as scheduled on 10Jan2021 relative to these events. She reported she still has COVID symptoms which have improved, but the symptoms she can't taste or smell are ongoing and persistent. Seriousness criteria: she thought it was serious but she was not injured or anything with it; she thought event was offset it by taking some medication and the Bamlanivimab infusion. In addition to Bamlanivimab infusion for treatment of the COVID virus she was also prescribed Azithromycin for 5 days started on 29Dec2020 which she completed; and Prednisone for 7 days started on 29Dec2020 which she stopped after 5 days of therapy because she did not like how it made her feel. The outcome of the event was recovering. Event relatedness between Pfizer-BioNTech COVID-19 Vaccine and COVID virus was unrelated.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
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| 57 | 2021-01-13 | fever, chills, headache |
Fever, chills, body aches, headache, sinus drainage, soreness at vaccine sight. All symptoms start...
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Fever, chills, body aches, headache, sinus drainage, soreness at vaccine sight. All symptoms started 10 hours after receiving the vaccination.
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| 57 | 2021-01-13 | fever, weakness, headache |
Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous r...
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Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering. Information on the lot/batch number has been requested.
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| 57 | 2021-01-13 | fever, fatigue |
Got vaccine yesterday 01/11/2021. Tuesday 01/12/2021: chill, fever, fatigue. Took Tylenol. Today ...
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Got vaccine yesterday 01/11/2021. Tuesday 01/12/2021: chill, fever, fatigue. Took Tylenol. Today 1/13/21 still a little fatigue. at work today. COVID negative 1/11/21 negative, getting tested every week. denies COVID exposure.
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| 57 | 2021-01-13 | sweating, headache, dizziness, chills, fever | Headache, chills, fever, dizziness, sweating |
| 57 | 2021-01-13 | fatigue, headache, weakness |
I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and...
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I had fatigue, headache, pain, weakness and I was so miserable decided to go to ER on (12/24/20) and then was transferred to hospital admitted (12/25/20) one day - discharged on 12/26/20 at night
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| 57 | 2021-01-13 | chills, fever, headache, fatigue |
Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nau...
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Injection pain/tenderness at site, tiredness, HEADACHE, muscle pain, chills, joint pain, fever, nausea, feeling body aches
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| 57 | 2021-01-13 | shortness of breath, headache, fatigue |
LATER THAT DAY PT STATES SHE STARTED EXPERIENCING INCREASED SOB, FATIGUE , HEADACHE, AND MENTAL FOG....
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LATER THAT DAY PT STATES SHE STARTED EXPERIENCING INCREASED SOB, FATIGUE , HEADACHE, AND MENTAL FOG. THE SOB DID RESOLVE AND SHE WAS NOT SEEN IN ED
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| 57 | 2021-01-13 | headache |
Positional vertigo and headache leading to vomiting lasting 9hrs total. I took meclizine, Tylenol, a...
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Positional vertigo and headache leading to vomiting lasting 9hrs total. I took meclizine, Tylenol, and Zofran 4hrs into symptoms which helped stop the progression.
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| 57 | 2021-01-13 | headache |
Positional vertigo and headache leading to vomiting. I took Tylenol, meclizine, and Zofran 4hrs i...
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Positional vertigo and headache leading to vomiting. I took Tylenol, meclizine, and Zofran 4hrs into the symptoms. This helped stop progression of the symptoms.
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| 57 | 2021-01-13 | shortness of breath, throat irritation, throat pain |
Pt received covid vaccination (per pt, Pfizer vaccine) at a non-KP affiliated clinic. Within 10 min,...
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Pt received covid vaccination (per pt, Pfizer vaccine) at a non-KP affiliated clinic. Within 10 min, pt reports sore, pruritic throat, hoarse voice, difficulty breathing. Pt administered her own EpiPen and received a nebulizer treatment before transfer to ED. At ED, minimal residual symptoms but received prednisone and prn diphenhydramine.
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| 57 | 2021-01-13 | fever, fatigue | Swollen injection site, muscle aches, fever (104), fatigue, mild nausea, swollen taste buds |
| 57 | 2021-01-13 | cough |
This staff member, with a known history of severe allergies and history of anaphylaxis, experienced ...
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This staff member, with a known history of severe allergies and history of anaphylaxis, experienced tightness in chest and cough starting about 15 minutes after receiving the covid vaccine. Tightness in chest continued to worsen and she was administered her own Epi pen at 10:42AM. EMS was called and she was transported to the emergency department for further observation.
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| 57 | 2021-01-13 | fever, chills, headache |
Upon arising at 7AM I had tunnel vision. Just a little headache that morning. By 1:30pm I was chilli...
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Upon arising at 7AM I had tunnel vision. Just a little headache that morning. By 1:30pm I was chilling and could not get warm. Fever reached 101 degrees. I took 2 Tylenol every 4 hours. While I had a fever, I could not seem to drink enough water. I consumed about 90 ounces of water from 2pm til 9pm. The fever and chills became less prevalent by 9pm. Continued the Tylenol through 7AM the morning of 1/12/21. My chills were gone and I had no fever by then.
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| 57 | 2021-01-13 | nasopharyngitis, fatigue, somnolence |
exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay ...
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exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay down and go to sleep; freezing cold; slightly nauseous; not feel as zippy as she normally do; Arm hurting a little; This is a spontaneous report from a contactable consumer (patient herself, a dental hygienist) via Medical Information team. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date: Mar2021, NDC number was unknown), via an unspecified route of administration on the right arm (also reported as upper shoulder) on 07Jan2021 at 11:30 30 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported she was feeling exhausted, freezing cold, slightly nauseous, and did "not feel as zippy as she normally do" on 08Jan2021. She wanted these effects recorded, and would like to know if they were normal, and would they happen to the same or higher intensity with the second dose. The patient further reported she had no adverse reaction on 07Jan2021 other than her arm hurting a little. Starting on 08Jan2021, she had felt exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous. She had been reading and was sure or was guessing this was normal, but wanted to verify that. She was not running a fever as of yet. Every time she tried to get up, she just laid back down. She felt fairly decent when she woke up, these events started later at the time of the report on 08Jan2021. She would not say these events were life threatening, but the CDC patient vaccine record card said to call to report any adverse events. She was scheduled for a second dose on 28Jan2021 and at this time did not plan to change dosing unless event worsening would occur. The patient had the vaccination, because she was always coming into contact with people with COVID at work. The patient had no investigation assessment. The reporter assessed the events as non-serious. The patient was recovering from the event "arm hurting a little," she was not recovered from the events "exhausted/exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous," while the outcome of the event "not feel as zippy as she normally do" was unknown.
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| 57 | 2021-01-13 | weakness |
throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Wa...
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throat tightening/Throat tightened up; metallic taste in her mouth; Turned red; Nausea; Diarrhea; Was pretty weak; This is a spontaneous report from a contactable nurse(patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899), via an unspecified route of administration in the right arm on 17Dec2020 at single dose for covid-19 immunization; diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included high blood pressure from 2008 and ongoing. Concomitant medication included amlodipine from 2017 and ongoing at 5 mg at night for high blood pressure, losartan from 2017 and ongoing at 12mg once in the morning for high blood pressure. Following her 1st dose of the COVID vaccine on 17Dec2020, the patient had throat tightening, metallic taste in her mouth. She was scheduled to have her 2nd dose today (07Jan2021) and would like to know what to do and if she was still covered 80% from the 1st dose of her COVID vaccine shot. When she got her first COVID shot 3 weeks ago she got a metallic taste in her mouth and her throat tightened up a little. Throat tightening happened right after she got the shot and lasted about less than 2 minutes. She also turned red when she got it. Then about 14 hours later, on the same day she got nausea, diarrhea, and was pretty weak. This lasted until about 20Dec2020 as well. She was supposed to get 2nd dose today (07Jan2021). Before her first shot she had taken paracetamol and hydrochloride prior. She also took both of those today (07Jan2021). But then she was reading through the paperwork and it says that a severe reaction includes tightening of the throat. She was not sure if what she had was truly a reaction or not. She did not have other allergies. She had many flu shots and never had any difficulty with those. She was a nurse, she wanted the second dose, but she was concerned about the throat tightening, and it getting worse with the second dose. She was unsure of seriousness. She figured that she would get aches and pains. Everyone else who got it said their arm hurt, but nothing else. She thought it was weird. She was just wired differently she guesses. The action taken in response to the events for paracetamol and hydrochloride was unknown. The outcome of events throat tightening, turned red was recovered on 17Dec2020. The outcome of event metallic taste in her mouth, nausea, diarrhea, and was pretty weak was recovered on 20Dec2020.
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| 57 | 2021-01-13 | sweating | tingling and numbness in Right hand (5 min) sweating and anxiety felt foggy 20 min. |
| 57 | 2021-01-13 | dizziness |
tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; g...
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tingling to face, tongue and lips; lightheaded; no swelling; hr normal; observed extra 30 minutes; given water& crackers - lightheadedness subsided but states is itching all over; offered to call 911 - refused. stated is going to primary care physician. total observation 45 min
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| 57 | 2021-01-14 | body temperature increased, dizziness, headache |
Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt ...
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Approximately 4-6 hours post vaccine I experienced site soreness and felt my hands were stiff, felt swollen, especially the right. Within a few more hours my arm became heavy and I had some general muscular achiness. By approximately 11pm I had intense muscular pain on the back of my legs making it difficult to stand. It felt like I had been hit repeatedly with 2x4s. About that time my posterior ribcage hurt also. I couldn't sleep, turning frequently as my hips hurt. This is what I felt like when I had COVID. Intense pain. At 0630 (1/14) I got out of bed and felt I was going to faint, was extremely nauseous (I did not vomit) and had a very bad, global headache. I had to lay down again. My temp was 100.1 orally. I could not go to work. I was able to take Tylenol. It helped the pain but two hours later my temp was 100.8. I could not get out of bed until 6pm, I felt delirious when I tried. I was able to go to work on 1/15. Of note, following my first dose of COVID vaccine (Pfizer BioNtech Lot #EH9899 on 12/23/20) I had site soreness, heaviness of my left arm, T of 99.5 same day (about 10-12 hours post vaccination), and mild body aches for about a day.
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| 57 | 2021-01-14 | fever, chills, headache |
Body Aches (mostly low back and leg), chills, fever (100.7), headache. (A given..Injection site sore...
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Body Aches (mostly low back and leg), chills, fever (100.7), headache. (A given..Injection site soreness) Symptoms resolved by the next day with ibuprofen.
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| 57 | 2021-01-14 | fatigue |
Confusion (encephalopathy) and fatigue. Onset about 10 hrs after shot. Did not know how to dial a ...
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Confusion (encephalopathy) and fatigue. Onset about 10 hrs after shot. Did not know how to dial a cellphone, did not realize I did not have glasses on, sent pt prescription to wrong pharmacy. Was also extremely fatigued. Slept most of 1/14/21. Confusion resolved 1/15/21, but still tired although better by 60% at 10 am on 1/15/21.
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| 57 | 2021-01-14 | headache, dizziness | Dizziness, Body ache Teary eyes pain to right arm Headache |
| 57 | 2021-01-14 | headache, dizziness |
Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramp...
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Headache, slight dizziness and stomach cramping started later that day of vaccination. Stomach cramping and Headaches continued intermittently. I took Excedrin as needed for symptoms. Itchiness started after a week and rash developed on 1/14/2021. I am waiting for return call from my Primary Doctor. I started taking Benadryl 25mg for rash/itchiness as needed.
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| 57 | 2021-01-14 | headache, dizziness, shortness of breath, throat pain |
difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness...
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difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient). A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation. Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported. Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection; 9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-14 | fever |
low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body ac...
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low grade fever Shakes Cold numb hands fingers blanch white blood pressure drop 70/40 severe body aches diarrhea nausea
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| 57 | 2021-01-15 | discomfort |
Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain,...
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Day after 2nd shot fatigue Day 4 after 2nd shot mild and pain Day 5, woke up 3 am, severe abd pain, unable to sleep, vomited once, took Tylenol, went to walk in at 7 am, did blood work, urine and Covid screen, all normal and negative, pain improved after about 15 hours Day 6 , today, pain came back, mild at 10 am and then severe at 11, nausea, vomited once, took Tylenol at 11 and feels better but still quite uncomfortable. Able to drink, normal stool, no other symptoms
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| 57 | 2021-01-15 | dizziness | Debilitating dizziness and vision impairment |
| 57 | 2021-01-15 | fatigue, weakness |
Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled a...
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Myalgia, weakness, fatigue, rash at injection site Left deltoid red area moving outside of circled area
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| 57 | 2021-01-15 | fatigue, respiratory tract congestion, fever, malaise, headache |
On 12/22/2020 the day of vaccination in the evening around 6:30pm when I was driving I started havin...
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On 12/22/2020 the day of vaccination in the evening around 6:30pm when I was driving I started having visual disturbances. The next morning 12/23/2020 I woke up with a bloody eye it was my right eye it lasted one day. On the following Monday on 12/28/2020 I was not feeling good I started getting headaches, feeling aching, at night I started getting fevers, congestion, & fatigue. It went away on 1/1/2020. Seen doctor on 12/29/2020
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| 57 | 2021-01-15 | chills, nasopharyngitis, fatigue, malaise | Very painful injection site. Cold, chills, fatigue, overall unwell feeling, exhaustion |
| 57 | 2021-01-16 | headache |
Constant headache began approximately 1 hr after receiving vaccine. Awoke this morning with blood cl...
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Constant headache began approximately 1 hr after receiving vaccine. Awoke this morning with blood clots on my tongue
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| 57 | 2021-01-16 | skin warm |
Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficul...
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Developed severe bilateral leg pains from pelvis to feet, sharp,cramping,burning, pain made difficulty walking , skin self like bad sunburn when touched. lasted approximately 36 hrs. For approx 12 more hrs moderate symptoms, then 24hrs minor symptoms. Started on Tuesday night resolved by Saturday morning.
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| 57 | 2021-01-16 | headache, chills, fever |
injection site (immediate), headache, chills, nausea, slight fever (within 12 hours), vomiting (with...
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injection site (immediate), headache, chills, nausea, slight fever (within 12 hours), vomiting (within 24 hours). All symptoms disappeared within 36 hours.
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| 57 | 2021-01-17 | fatigue | sore mouth and tongue was stiff and extreme fatigue feels tired even a week later |
| 57 | 2021-01-19 | cough, throat irritation |
40 minutes after injection she described a funny feeling in her throat. O2 sat was 100% and she was...
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40 minutes after injection she described a funny feeling in her throat. O2 sat was 100% and she was swallowing with no problem. 15 minutes later she began to cough and we took her to the ED.
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| 57 | 2021-01-19 | chills, fatigue, headache |
Chills, body aches, fatigue, headache, chest pain. Went to ER on 1/19 for chest pain. Cardiac workup...
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Chills, body aches, fatigue, headache, chest pain. Went to ER on 1/19 for chest pain. Cardiac workup neg. Was advised that chest pain may be muscular pain from vaccine. Chest pain resolved. Continues to have fatigue, headache.
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| 57 | 2021-01-19 | headache, chills, dizziness, weakness, fever |
Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday...
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Chills; 102.9 once, but ever since Im having low grade temps 99.2 99.9 even to 100.4 almost everyday; Slight nausea; Some dizziness; Headaches; Slight body weakness; Diarrhea 3x since; Unable to work; Not completely well to function daily chores and activities; This is a spontaneous report from a contactable nurse reporting for herself. This 57-year-old female patient received on 29Dec2020 11:00 am first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) at single intramuscular in the left arm for COVID-19 immunization. Medical history included hypertension, asthma, Type 2 diabetes mellitus, high cholesterol. The patient had an allergy with lisinopril. Concomitant medication included hydrochlorothiazide, atenolol, lovastatin, fenofibrate, melatonin, colecalciferol, ascorbic acid, tocopherol, acetylsalicylic acid (ASPIRIN 81). Starting from 30Dec2020, the patient had chills, 102.9 F once, but ever since she was having low grade temps 99.2 99.9 F even to 100.4 F almost every day and came in the late afternoon or evening, slight nausea, some dizziness, headaches, slight body weakness, had episode of diarrhea 3x since, and it was still on going for almost 11 days now. Unable to work. I was mobile at home but not completely well to function daily chores and activities. No treatment was provided. Outcome was not recovered. On 08Jan2021 the patient had a nasal swab with an unknown result.
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| 57 | 2021-01-19 | nasopharyngitis, headache, fever |
Developed fever and headache after receiving vaccine. 1st vaccine had fever after 72 hours, develope...
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Developed fever and headache after receiving vaccine. 1st vaccine had fever after 72 hours, developed cold symptoms and intestinal issues after 6 days. 2nd vaccine fever developed 26 hours after receiving, now 28 hours later having aches and headache and abdominal pain.
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| 57 | 2021-01-19 | fever | Fever 101, abdominal cramps, diarrhea, nausea. |
| 57 | 2021-01-19 | fever, lethargy, headache | Fever, lethargy, pain in arm around injection site, headache |
| 57 | 2021-01-19 | headache, malaise | Headache Body aches Malaise |
| 57 | 2021-01-19 | fatigue, chills, body temperature increased, headache, dizziness |
I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I w...
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I received my vaccine at noon and after a couple of hours I had severe muscle pain in both legs. I was very fatigued the rest of the day and had a headache. During the night I had chills and was dizzy. My temp was only 99.1 but I felt awful. I still had a temp this morning (day 2) No dizziness but I do have an awful headache and my arm is very sore where I received the injection.
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| 57 | 2021-01-19 | cough, runny nose, headache |
On the next day i started feeling like allergy symptoms come on, had a terrible headache and starte...
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On the next day i started feeling like allergy symptoms come on, had a terrible headache and started coughing. I also had a runny nose uncontrollably and was coughing as well which lasted four days then eventually it stopped. I started to feel better as the days went by.
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| 57 | 2021-01-19 | chills, sweating | Recipient reported waking up with chills and drenched in sweat. |
| 57 | 2021-01-19 | sweating |
Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, f...
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Systemic: Nausea, Systemic: Vomiting, Systemic: palpitation, sweating, tingling on arms and hands, face turned pale for few mins, hyperventilating
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| 57 | 2021-01-19 | body temperature increased, fatigue, headache |
Temperature 99.3; nausea; headache; body aches; fatigue; left hip pain; This is a spontaneous report...
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Temperature 99.3; nausea; headache; body aches; fatigue; left hip pain; This is a spontaneous report from a contactable healthcare professional (patient) reported for herself that a 57-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685), via intramuscular at left arm, on 31Dec2020 12:30, at single dose for COVID-19 immunisation. Medical history included ongoing chronic fatigue syndrome, fibromyalgia, sun allergy and lactose intolerant (allergy). Concomitant medications were not reported. Patient did not have COVID prior vaccination. Patient did not receive other vaccine in four weeks nor other medications in two weeks. The patient experienced temperature 99.3, nausea, headache, bodyaches, fatigue, left hip pain, all on 01Jan2021 15:45, no treatment was received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered in Jan2021.
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| 57 | 2021-01-21 | chills, headache | AT 3PM, DEVELOPED HEADACHEAND CHILLS THAT LASTED 24 HOURS. |
| 57 | 2021-01-21 | dizziness, headache | Headache, dizziness and severe pain at injection site |
| 57 | 2021-01-21 | cough, shortness of breath, throat irritation |
Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irri...
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Patient immunized approximately at 0748. Patient complained of difficulty breathing and throat irritation while in waiting area. Monitor personnel promptly identified patient?s condition and notified the team while staying with the patient ensuring she kept talking while the provider arrived. Officer in Charge was notified during the process and was at patient?s side approximately 0756; provider followed within seconds. Decision was made for immediate transport to ED. While in route patient stopped talking, coughed and grabbed throat prompting CPT to deliver x1 dose of Epinephrine to left deltoid at 0758 with provider?s consent. Shortly after dose administration patient resumed speech but continued to complain of dry and tight throat. Patient was able to continued speaking reciting ABCs and personal information when prompted. Patient did not experience altered mental status or loss of consciousness. Arrived to Emergency Department (ED) at 0805; report given to nurse and patient was checked in promptly. ED provider plan included observation until 1100 and discharge pending follow up assessment.
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| 57 | 2021-01-21 | body temperature increased, headache |
Patient self-reported through the hospital adverse drug reaction reporting system. Pt. received the...
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Patient self-reported through the hospital adverse drug reaction reporting system. Pt. received the second dose of COVID-19 vaccine on 1/20/21 @ 0742. After receiving the second dose, Pt. reported around 1700 the onset of "severe headache, joint pain, vomiting, and a Temp of 101.7 degrees F".--patient's own words and description.
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| 57 | 2021-01-21 | headache, body temperature increased | Temps 101-102.5, headache, body aches, lasted 18-20h, treated w ibuprofen and rest |
| 57 | 2021-01-21 | chills, headache | chills, headache, body aches, pain and swelling at the injection site |
| 57 | 2021-01-21 | headache, shortness of breath |
received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/...
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received the first dose of vaccine/tested positive for COVID-19; received the first dose of vaccine/tested positive for COVID-19; irritable all day; the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on.; eyes were also hurting; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284; expiration date not provided), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the vaccine on 04Jan2021 and yesterday (11Jan2021) she tested positive for COVID-19. Patient would like to know if she should follow-up for the second dose of the vaccine on 25Jan2021. Patient mentioned that maybe she should follow up with the second dose. It was also reported that the patient wanted to know if the vaccine could have given her COVID-19 and tested positive. Patient further clarified it to be the Pfizer BioNTech COVID-19 Vaccine. Patient mentioned she is a caregiver and received the vaccine on last Monday (04Jan2021). On Friday (08Jan2021), the patient started to notice she was getting headaches. The headache started in the morning. Patient realized she was irritable all day and as a caregiver, this is not an attitude to have. Patient did not feel great that day. Patient also realized that the sun had been bothering her eyes as she was driving, it was some eye sensitivity going on. That night patient got home and was able to eat, but the next day on Saturday (09Jan2021), she did not have any sense of taste or smell. Patient had lost her sense of taste and smell. Patient realized this when she woke up at 6 am for coffee and could not taste or smell it. Patient was calling to find out if there was any way one could get Coronavirus only after the first shot and if she still needs to go and get her follow-up vaccine on 25Jan2021. Patient stated she forgot the name of her HCP. Patient also mentioned she has chest pressure. Patient noticed it about an hour ago, later stated it was like 11 something. It comes and goes. Patient mentioned that it was like shortness of breath. Patient would breathe in a little bit and it will bring the chest pressure back down. Patient would also walk around a bit to get the blood pumping back through. Patient also added, that due to these symptoms, she's locked off in a different room away from her husband. Patient stated they are both quarantining since her husband was exposed too and has not had the shot yet. Patient's eyes were also hurting, but that is due to the headache. Patient also stated that her eyes hurting has gone away. Patient will be getting to get a Coronovirus test done later today. When probed for the time of vaccination, patient that she was not sure. She knew she had to wait 30 minutes under observation because she had allergies. Patient initially stated that she would guess she received the vaccine thirty minutes prior to 3:55. Patient later clarified and stated it was possibly 2 something when she got it. Patient tested positive for COVID-19 on 11Jan2021 (COVID-19 virus test positive). Outcome of the event 'eyes were also hurting' was recovered, while unknown for the remaining events.
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| 57 | 2021-01-24 | headache |
Approximately 48 hrs. after 1st dose on 1/22/21, body aches, especially the back muscles and nausea....
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Approximately 48 hrs. after 1st dose on 1/22/21, body aches, especially the back muscles and nausea. Also headache.
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| 57 | 2021-01-24 | headache |
Daily headaches; This is a spontaneous report from a non-contactable consumer. A 57-year-old femal...
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Daily headaches; This is a spontaneous report from a non-contactable consumer. A 57-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EK9231) at single dose at left arm on 05Jan2021 for Covid-19 immunisation. Medical history included long QT syndrome, depression, anxiety. The patient had not experienced Covid-19 prior vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA), nadolol (NADOLOL), doxycycline (ORACEA). The patient previously took bacitracin and experienced allergy. Patient vaccine history included the 1st dose of bnt162b2 (BNT162B2, Lot # EH9899) at single dose at left arm on 15Dec2020 for Covid-19 immunisation, administered at hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient experienced daily headaches on 06Jan2021. No treatment received. Covid was not tested post vaccination. The outcome of event was not recovered. No follow-up attempts are possible. No furhter information is expected.
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| 57 | 2021-01-24 | malaise, weakness, cough, shortness of breath, head discomfort, headache, fever |
Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contacta...
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Drug ineffective; Positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer for herslf. A 57-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EL1284) vaccine , intramuscular in the right arm on 30Dec2020 10:30 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. Since 03Jan2021, the patient has been sick. Her fever started out at 99.7 degrees Fahrenheit with a terrible cough and then it just kept getting worse. This weekend it was 102.7 degrees Fahrenheit all weekend. Her cough improved. She took some Delsyn one day. The cough improved but is not gone away. Headaches started on day 4 or 5. Lot of pressure in forehead and eyes. Fever kept going up day after day been up to 101.2°F and then up 102.7°F all weekend. Then she just felt weak all weekend. Just walking to bathroom is short of . Yesterday fever was 101.5°F and she went to doctor and they did a rapid COVID test and it came back positive. Slept a lot more this weekend. Done nothing but slept. She did not think it would make her this sick. only vomited once. she is supposed to get second dose on Saturday. She is afraid to get second. The patient also reported the following information: Fever 08:30 Terrible Cough 08:30 Headache 10:00 Weakness 12:00 Shortness of breath when walking 12:00 Increased sleepiness 12:00 Positive for Covid 09:21 Diarrhea 08:00 Vomiting 14:00 The patient underwent lab tests and procedures which included body temperature: 99.7 Fahrenheit; 102.7 Fahrenheit; 101.2 Fahrenheit then up 102.7 Fahrenheit ; 101.5 Fahrenheit. Sars-cov-2 test: positive on 11Jan2021 . Further information has been requested
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| 57 | 2021-01-24 | fatigue |
I received the second dose on 1/20/2021 at 630 am. I felt very fatigued on 1/21/2021 and slept most...
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I received the second dose on 1/20/2021 at 630 am. I felt very fatigued on 1/21/2021 and slept most of the day, and at 730 pm I noticed a large, moveable, painful swollen lymph node above my left clavicle .
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| 57 | 2021-01-24 | chills | Nausea, diarrhea, chills |
| 57 | 2021-01-24 | lethargy, fatigue, cold sweat | Nausea, vomiting , cold sweats , throat warm, lethargic fatigue. |
| 57 | 2021-01-24 | fatigue |
Patient called Occ Health Office on 1/21 and was advised to be seen by HCP given the length of time ...
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Patient called Occ Health Office on 1/21 and was advised to be seen by HCP given the length of time that had passed since she received the vaccine. She was seen in urgent care. Notes from that encounter states, "...presents for swollen lymph nodes x 3 days, received second covid vaccine on 1/13/21 and had dental procedure that day, just finished bactrim. Physical exam as above; non-toxic, well-appearing, afebrile in NAD. Cervical adenopathy present along with L>R inguinal lymphadenopathy, bilateral inguinal lymphadenopathy. She has received the second covid vaccination and this seems consistent with post vaccination adenopathy. No dental abscess/infection or evidence of tonsillar exudates to suggest strep pharyngitis. Upon discussion with ED staff physician, she reports she has been working excessively and feels fatigued. She was encouraged to take the day off of work today and was given a work note. Encouraged PCP follow up to ensure improvement in symptoms. The ER research team was contacted and will chart review and follow up regarding adenopathy after second covid vaccine. Reviewed return to ED precautions. In ED labs were drawn, EE was given Ibuprofen and advised to follow up with PCP is symptoms persist or worsen.
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| 57 | 2021-01-24 | body temperature increased, headache |
Reported tightening in throat, stridor, Fever of 100.3F, headache and myalgia. Symptoms managed with...
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Reported tightening in throat, stridor, Fever of 100.3F, headache and myalgia. Symptoms managed with zantac, benadryl, tylenol and motrin
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| 57 | 2021-01-25 | throat swelling |
Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaint...
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Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling; Intermittent episodes of acute sharp back pain; This is a spontaneous report from a contactable pharmacist reported that a 57-year-old female patient (no pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EL1284 and Expiration Date unknown) via Intramuscularly on 30Dec2020 03:00 PM (Left arm) at single dose for covid-19 immunisation. Medical history includes mild asthma, B-Cell Thymoma (Resected), multiple allergies. Diagnosed allergies included Sulfa drugs-swelling; Celebrex-Itchy; Clindamycin- Unknown reaction; Doxycycline- Sick to stomach; Iodinated radiocontrast dyes- Iodinated radiocontrast dyes cause generalized swelling (takes diphenhydramine prior to contrast use when needed); Keflex- Rash; TDAP Vaccine; Levofloxacin- Unknown Reaction; Penicillin; Prednisolone- Itchy; Septra- Eyes get glossy and lips swell.The concomitant medication was not reported. There is no other vaccines within 4 weeks prior to the COVID vaccine. About 4 Hours after receiving 1st (of 2) doses of Pfizer COVID-19 Vaccine (30Dec2020 30Dec2020 08:00 PM), Patient went to Emergency room (ER) with complaints of sensation of "foreign body" in throat and feeling of throat/tongue swelling. Also had intermittent episodes of acute sharp back pain while in ER. Upon arrival in ER, patient received routine precautionary care with peripheral IV placement. She was kept under observation in ER for approximately 5 hours until subjective symptoms resolved. On exam patient did not have objective signs of throat obstruction. Vitals were stable and O2 saturation on Room Air was within normal limits. Patient did not receive any medications, oxygen, fluids, or any interventions other than observation. Once symptoms resolved, patient was discharged from ER in improved condition. The outcome of event was recovered on an unknow date without treatment. There is no covid tested post vaccination.
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| 57 | 2021-01-25 | fever | Fever of 102.7--day after vaccine, came down with tylenol |
| 57 | 2021-01-25 | dizziness |
Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her hea...
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Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing. Patient was taken to the medic location. VS= 192/116, HR 152, O2 sat=99%
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| 57 | 2021-01-25 | shortness of breath |
Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no ...
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Sat. 1/23 knuckles very red, Sun. 1/24 Knuckles red and dry, Mon 1/25 Knuckles red and swollen, no pain. Tues. 1/26 had 30 seconds where it was hard to breathe, "like gasping for air".
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| 57 | 2021-01-25 | headache, fatigue | Slight HA, exhausted, leg heaviness, nausea, resolved by the end of the day |
| 57 | 2021-01-25 | chills, fever |
Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This...
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Soreness at injection site; joint pain; muscle pain; chills; Loss of appetite; Low-grade fever; This is a spontaneous report from a contactable other hcp. A 56 year old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EH9899), intramuscular on the left arm on 21Dec2020 09:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. Concomitant medication included progesterone (PROGESTERONE), estradiol (ESTRADIOL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient experienced soreness at injection site, joint pain, muscle pain, chills, low-grade fever and loss of appetite on 21Dec2020. The outcome of the events was recovered.
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| 57 | 2021-01-25 | shortness of breath |
Tachypnea, Palpitations, HYPERtension & Angina Narrative: 12 HOURS AFTER VACCINE PT DEVELOPS TACHYCA...
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Tachypnea, Palpitations, HYPERtension & Angina Narrative: 12 HOURS AFTER VACCINE PT DEVELOPS TACHYCARDIA, CHEST PAIN, AND SHORTNESS OF BREATH. TREATMENT AT ER/ HOPSPITALIZATION FOR TWO DAYS.
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| 57 | 2021-01-25 | dizziness, weakness, chills, fever, fatigue |
chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired fe...
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chills fever (evening) nausea vomiting (1x) diarrhea (3 days) body aches dizziness weakness tired feeling
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| 57 | 2021-01-25 | chills, headache, fever |
fever, chills and body aches - took Tylenol and drank a lot of fluids - fever gone today, small res...
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fever, chills and body aches - took Tylenol and drank a lot of fluids - fever gone today, small residual headache and small amt of body aches
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| 57 | 2021-01-26 | fatigue, headache |
Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; pati...
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Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; This is a spontaneous report from a contactable consumer reported for self. This 57-year-old female patient received the first dose of BNT162B2 (Lot number ELD140, Expiry Date Mar2021) via unspecified route of administration on an unspecified date at single dose, and second dose of BNT162B2 (maybe the same Lot/ Expiry date as the first dose) via unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything. The patient clarified that she was tested positive at work. The patient had the nose swab 12Jan2021 at job and the patient had the second dose of the shot (vaccine). The patient stated that she felt tired in the morning and had headache and arm was sore, other than that the patient felt she was fine. The patient didn't have any chills or anything. The outcome of the events was unknown.
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| 57 | 2021-01-26 | fever, sweating, influenza like illness, shortness of breath |
Flu-like symptoms started immediatedly and continued after the expected days (1-2 days). The rest of...
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Flu-like symptoms started immediatedly and continued after the expected days (1-2 days). The rest of the week I experienced fever, body aches, shortness of breath and sweats. On Saturday 1/23/21 I took COVID19 test and the results were positive. I had no symptoms before the vaccine.
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| 57 | 2021-01-26 | headache |
Headache since second injection also had mild headache with first Injection but eventually went away...
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Headache since second injection also had mild headache with first Injection but eventually went away not so much this time around
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| 57 | 2021-01-26 | headache, fatigue |
Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post inje...
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Nausea, body aches, headache, exhaustion, pain in left armpit/axillary area started 2 days post injection, pain and tenderness around injection area.
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| 57 | 2021-01-26 | cough, shortness of breath, headache, fatigue | Reported shortness of breath, cough, headache, muscle pain and fatigue. |
| 57 | 2021-01-26 | fatigue, headache, chills | Severe fatigue, radiating arm pain, chills and mild headache |
| 57 | 2021-01-26 | headache, malaise, throat pain | all symptoms somewhat mild: headache, achiness, sore throat, malaise |
| 57 | 2021-01-27 | headache, migraine, influenza like illness, weakness |
generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulde...
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generally weak; Pale; Headache; migraines; feels foggy; Hard time concentrating; pain in her shoulder, she thought it was cause of the injection site/muscle pain from the injection; pain in shoulder immediately after getting the injection and it was really swollen; body is in pain/lot of pain all of her body; achy like she is having flu like symptoms; injection was administered higher in her left shoulder; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 (16:00) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) injection in left deltoid/shoulder on 22Dec2020 at single dose for Covid-19 immunization. The patient's medical history was reported as "none". There were no concomitant medications. It was reported that the patient received the first dose on 22Dec2020 and the second dose on 12Jan2021. After she received the second dose of the vaccine, she immediately had pain in her shoulder, she thought it was cause of the injection site (12Jan2021 16:00). She had the pain in shoulder immediately after getting the injection and she got it at 4pm, and it was really swollen now. She mentioned this injection was administered higher in her left shoulder (pending clarification) and it feels like they may have gotten the injection in more of the arm muscle and she was thinking that is why she had muscle pain from the injection. She added that it was like her body is in pain, achy like she is having flu like symptoms that started the evening she got the vaccine, like 6PM or 7PM. The next day, yesterday (13Jan2021), she had a lot of pain all of her body. She also started to have a headache yesterday at noon (13Jan2021 12:00PM). The headache started at noon on 13Jan2021 and it continued for at least 8 hours and it was constant. It started to subside over the next 12 hours. She mentioned she also suffers from migraines (pending clarification). It feels like she is having residual migraine, like she is coming off of having a migraine. It is presenting, but she is not in severe pain. It is a feeling like she is coming off her migraine medication even though she did not take her migraine medication. She went to work yesterday (13Jan2021) even though she did not feel like it. She went home a few minutes early. She let her supervisor know she was in severe pain and had a headache. She was advised to stay home today and has not gotten better. However, the headache subsided. She feels foggy, like she could not just quite wake up. It is like she is in a daze or haze. She is having a hard time functioning. She continued to reiterate she was having a hard time concentrating. Now (14Jan2021) she is generally weak and is pale. In addition, the pain has not gone away. She stated she is weak, very weak. She felt it most of the day and it is worse today. She feels like she can hardly stand. She is trying to get fluids in her and trying to make coffee, however, it is a struggle. She stated, she has not gone yet, but she will call her doctor's office next and the health nurse as well to advise them she has been having symptoms. She stated she did not have a fever last night. Her temperature during the call was normal for her, 97.3. The outcome of events vaccinations site pain, vaccination site swelling, general body pain, flu like symptoms, weak, and pale was not recovered; while the outcome of other events was unknown. Information on lot/batch has been requested.
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| 57 | 2021-01-28 | malaise, fever, headache |
COVID-19 Vccine stomach aches, low fever, headaches, general malaise for 3 days. Currently, I am ...
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COVID-19 Vccine stomach aches, low fever, headaches, general malaise for 3 days. Currently, I am still having stomach aches all day/night.
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| 57 | 2021-01-28 | chills, cough, fatigue | Chills, body ache, cough, severe fatigue; 12 hr duration; treated with Ibuprofen |
| 57 | 2021-01-28 | headache |
Headache and body ache started on 01/29/21 after the Second Covid-19 vaccine was administered on 01/...
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Headache and body ache started on 01/29/21 after the Second Covid-19 vaccine was administered on 01/28/21
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| 57 | 2021-01-28 | headache, cough, fever |
fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected ar...
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fever 103.9F at 12 hours; Constant Coughing; severe body pain; numbness in hand (vaccine affected arm); numbness in hand (vaccine affected arm) with edema of hand; broke all the blood vessels in both eyes; O2 saturation's dropped to 86%; Headache within 1 hour; This is a spontaneous report from a contactable nurse. A 57-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on arm right from 14Jan2021 12:00 to 14Jan2021 12:00 at SINGLE DOSE for covid-19 immunisation. Medical history included End-Diastolic Heart Failure, osteopenia and arthritis. Concomitant medication included losartan, furosemide (LASIX [FUROSEMIDE]), metronidazole (FLAGYL [METRONIDAZOLE]) and omeprazole. The patient took his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), from 22Dec2020, 09:00 AM to 22Dec2020, 09:00 AM on Left arm (patients age: 57 years). The patient previously took tetracycline and erythromycin and had known allergies. On 14Jan2021, the patient had headache within 1 hour, then also on 14Jan2021, at 23:00 the patient also had fever 103.9F at 12 hours, constant coughing, O2 saturation's dropped to 86%; broke all the blood vessels in both eyes; severe body pain; numbness in hand (vaccine affected arm) with edema of hand. Outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for reported events broken blood vessel in eye and oxygen saturation low. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-28 | migraine | headache like a migraine |
| 57 | 2021-01-28 | fatigue, shortness of breath, chills, malaise |
increased heart rate after that it started getting worse; a warm feeling in her chest like tingling;...
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increased heart rate after that it started getting worse; a warm feeling in her chest like tingling; kind of short of breath; left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand; Chills; Fatigue; GI problems; still have some issue, did not feel good, off and on; SARS Covid antibodies test says positive; This is a spontaneous report from a contactable other nurse (patient) from a Pfizer sponsored program Pfizer First Connect. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose (lot number: EJ1685) on Deltoid Left for covid-19 immunisation. Medical history included Paroxysmal supraventricular tachycardia. The patient's concomitant medications were not reported. The patient experienced a warm feeling in her chest like tingling; kind of short of breath, it went away like she said it was just breath it was like for couple of minutes and then it went away and then she was just fine till it's been long here honestly about 3 or 4 days later; got shot in her right arm but left hand start swelling up first a little bit and then her left arm start swelling up and it's just and then that's the base and then her right hand start very, very mild swelling in her right hand. The hospital think there as some clot or something weird but she did not and then that started going down after that it just started going down and went away and never had swelling since then but this was going to long but this was something weird happened to her. She got chills, She got fatigue. She had increased heart rate after that it started getting worse. She had Paroxysmal supraventricular tachycardia, she had that always but it's been control. She walked 5 miles daily a day, she was in shape, she had lot since then, so it's been under control, she never had problem with it until after she got the shot, her heart rate was she had to add medication, she never have to add. She took metoprolol (Treatment) so she added that and she added more and that's thing get it under control and then she take herself back off because she felt like it was under control but she had GI problems since, now she was getting better now, still have some issue, did not feel good, off and on. The patient underwent lab tests and procedures which included blood test: good on 04Jan2021 (blood work to see if something was going on to her heart, because she had short breath, and everything was good), weight: 166 or 164, SARS Covid antibodies test IgM on 04Jan2021: positive. Treatment: Nurse stated, "No, not now, I had a heart-rate monitor, it's what for see what is my heart rate, to locate and see what's going on." Outcome of left hand start swelling up first a little bit and then her left arm start swelling up/ her right hand start very, very mild swelling in her right hand was recovered.; Sender's Comments: There is not a reasonable possibility that event heart rate increased is related to BNT162B2. The event is most likely due to underlying paroxysmal supraventricular tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-01-31 | lethargy, weakness |
Patient states felt hot flashes following injection in waiting room went home became lethargic that ...
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Patient states felt hot flashes following injection in waiting room went home became lethargic that evening having difficulty answering questions at night patient states she became apneic and husband had to watch her breathe. Did not go to the ER. Patient states fully recover the next day and fully recovered 5 days later. No rashes fever generalized weakness that resolved.
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| 57 | 2021-01-31 | fatigue, fever |
The next morning after vaccine, patient ran a fever, vomited, and was very tired. Mom laid her down...
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The next morning after vaccine, patient ran a fever, vomited, and was very tired. Mom laid her down to sleep and when she checked later, patient had passed away.
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| 57 | 2021-02-01 | headache |
Subconjunctival hemorrhage of right eye due to new onset hypertension; Subconjunctival hemorrhage of...
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Subconjunctival hemorrhage of right eye due to new onset hypertension; Subconjunctival hemorrhage of right eye due to new onset hypertension; headache; This is a spontaneous report from a contactable Nurse. This nurse reported for self that the 57-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer, lot number: EK9231, exp date and batch were not reported) via unknown route of administration on 13Jan2021 10:00 AM on Left arm at a single dose for covid-19 immunization. She is not pregnant. Medical history included known allergies: Sulfa (Sulfonamide Antibiotics), Hypothyroidism, Hx Atrial Flutter ablation resolved, Hx Hysterectomy. Concomitant medications included Estradiol, Propranolol, levothyroxine/liothyronine (NP THYROID), Aspirin [acetylsalicylic acid], MVI. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19 Covid-19 mRNA vaccine/Pfizer, lot number: EK5730, exp date and batch were not reported) via unknown route of administration on 23Dec2020 08:00 AM on Right arm at a single dose for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in fourweeks. The patient experienced Subconjuctival hemorrhage of right eye due to new onset hypertension, headache from 13Jan2021 06:00 PM. Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received and started on Lisinopril. No covid prior vaccination. Covid tested post vaccination. The outcome of the event was recovering. Covid test post vaccination included covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid rapid test on 15Jan2021 with covid test result: Negative. on 17Jan2021, covid test type post vaccination was Nasal Swab, covid test name post vaccination was Covid with covid test result: Negative.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events conjunctival haemorrhage and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-03 | somnolence, fatigue, weakness |
Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over an...
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Patient report generalized body aches, numbness, and tingling. Pt. reported feeling weak all over and states that her right leg is weaker than her left leg. Pt. was brought to ER by her husband, because husband states that she was to weak to walk on her own to the bathroom. upon evaluation pt. appears tired and slightly drowsy but answers questions appropriately. The patient can state her name, where she is and the current month and year.
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| 57 | 2021-02-03 | malaise, fatigue |
she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 w...
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she may have already had COVID 19 with the symptoms she has now; she may have already had COVID 19 with the symptoms she has now; was feeling bad; she lost her taste and her smell; she lost her taste and her smell; tired; sleeping all the time; she is sick; She still hasn't eaten a whole meal since Friday; not able to eat; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL0142, exp date not reported), intramuscular (by injection once left arm, below shoulder blade in muscle) on 13Jan2021 for COVID-19 immunization (because of job). Medical history included two stroked from 1998 and 2005. Concomitant medication included oral donepezil started taking 3 months ago (Oct2020) for something having to do with muscles because of stroke. She takes a blood thinner, as she had 2 strokes; and takes muscle relaxers too. By 15Jan2021 (Friday morning) the patient was feeling bad, she couldn't go to work, she lost her taste and her smell, part of smell. Part of taste was back at the time of reporting, but she was tired and sleeping all the time (onset date reported as 15Jan2021). She saw her neurologist because she had 2 strokes, they referred her to Pfizer, as they said she may have already had COVID 19 with the symptoms she has, but as far as she knows, she didn't have it, she took a test with the center a month before giving the vaccine, she took the vaccine because of her job, because of the kind of job she has, and they wanted her to let Pfizer know she was sick. She doesn't know if she wanted to get the other dose, as she was not feeling well at all. She was laying down sleeping every day. Her doctor said to tell Pfizer what was going on. She still doesn't feel good the day of reporting. She still hasn't eaten a whole meal since 15Jan2021. She thinks she was probably getting better, but was getting better slowly, she has no taste, she was not able to eat, no smell at all, which was really not a good thing. She can't tell the outcome of no smell she thinks. She can't smell nothing at all. She can't smell what she was cooking. It was the same as taste, she thought that is probably why she can't eat, she can't taste what she was eating. Taste was improved, but not well enough for her, it is hard to explain, you know how you enjoy food, like how it tastes, and if you can't taste, you can't eat. She sleeps all day, she was up now, but is probably going to go to sleep, she feels tired and needs to lay down. She told her doctor she will call and see what Pfizer says, they will go from there. She doesn't know if she will have to go see if she has COVID 19, or what was going on. No further investigation assessment was performed. The patient took a test a month before (results unknown). No taste was recovering (ongoing at the time of reporting) while outcome of other events was not recovered.
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| 57 | 2021-02-07 | shortness of breath, cough |
Ten minutes after the vaccine was administered the patient started with a persistent nonproductive c...
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Ten minutes after the vaccine was administered the patient started with a persistent nonproductive cough, hoarseness, chest tightness, shortness of breath. Vital Signs BP 128/77: P=96: R=19: O2 sat=100% Oxygen was administered by nasal cannula, Solumedrol 125mg IV and nebulizer therapy with Atrovent 0.2 x 1. Was kept under observation and after one hour the patient had recovered. Per the patient.
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| 57 | 2021-02-07 | shortness of breath |
hard time breathing; Rash all over body; This is a spontaneous report from a contactable pharmacist....
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hard time breathing; Rash all over body; This is a spontaneous report from a contactable pharmacist. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), intramuscular at arm left on 24Jan2021 at 13:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Jan2021 at 13:30, the patient experienced rash all over body and hard time breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and EPIPEN. The patient outcome of the events was recovering.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dyspnea and rash cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-09 | fever, skin warm, body temperature increased |
103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it wa...
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103.5 fever; severe back pain; body aches; Nausea; felt horrible; a girl touched her arm, said it was burning; This is a spontaneous report from a contactable nurse reported for herself. A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) by injection once to right deltoid on 25Jan2021 at single dose for COVID-19 immunization. Medical history included she had COVID, she was diagnosed, was positive on 29Dec2020, and spent 9 days in the hospital. concomitant mediation was none. Patient calling about the COVID vaccine; her boss texted, she had to leave work, she had a 103.5 fever (26Jan2021), she felt horrible, she got her first COVID vaccine yesterday, and woke up this morning and felt horrible. a girl touched her arm, said it was burning, and she was very nauseous, and was trying to pass meds, and took her temperature and it was 103.5, and the thing is when you come into the facility, they took her temperature and it was 97.2, but those thermometers suck and she has an oral thermometer, and it was 103.5. It's improving. Also has severe back pain and body aches, she was scared with the fever. Felt nauseous this morning (26Jan2021), had chicken noodle soup and crackers, but it was pretty bad to point she had to pull the trash can behind her. she was on a ventilator in March for a week, not with COVID, she doesn't want to die, she thought she was going to die with COVID, she had every symptom. No Investigation Assessment. The last outcome of 103.5 fever, nausea and severe back pain was recovering, body aches was not recovered, outcome of other events was unknown. Reporter seriousness for 103.5 fever was Medically significant. For severe back pain, body aches and Nausea was Not serious. Relatedness of drug to reactions/events 103.5 fever, severe back pain, body aches and Nausea per source of assessment of Primary Source Reporter and Method of assessment of Global Introspection with drug result of Related.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product BNT162B2 to reported event pyrexia and remaining events cannot totally be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-10 | nerve pain |
bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid ca...
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bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands; This is a spontaneous report from a contactable physician. A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3284), intramuscular into the left arm on 11Jan2021, at 16:00 as second single dose for covid-19 immunization. Medical history included Obstructive sleep apnea from an unknown date, oligodendroglioma from 1996 (noted as history of oligodendroglioma status post resection 25 years ago with stable follow up and no residual deficits). The patient had no known allergies to medications, food, supplements or herbal remedies. There were no concomitant medications; Patient was not taking any OTC medications, prescribed medications, supplements or herbal remedies at the time as well as in the period prior to her vaccinations. The patient previously received BNT162B2 (lot number EH9899 ) on 22Dec2020. On 18Jan2021, at 08:00, the patient experienced bilateral feet, left worse than right, burning, itching sensation, which progressed up to her mid calves and to a slight extent in both hands, which was medically significant and had not recovered, as it was persisting. This was elaborated as follows: patient experienced one week following 2nd Pfizer covid-19 vaccine patient developed bilateral feet, left worse than right, burning, itching sensation. the symptoms progressed up to her mid calves and to a slight extent. The events were considered medically significant. Details were as follows: The symptoms were quite intense and interfered with her life, requiring gabapentin prescription for control of neuropathic complaints. Patient denied any significant weakness, low back pain, neck pain, balance problems, dizziness, bowel or bladder involvement. Patient saw physician who performed workup for common associated etiologies of polyneuropathy, which were negative. Patient underwent EMG/NCS which were normal, and subsequently skin bx (skin biopsy) to rule out small fiber neuropathy (results pending). The patient further described the incident as a week after receiving the second dose of the covid vaccine, the patient experienced new onset bilateral feet burning that went into her upper legs, mid calves and to a slight extent in both hands. The burning was experienced more in the left foot than the right foot. Reports it was severe enough for the patient to reach out to her primary care provider. (PCP) to start Gabapentin for neuropathic pain. PCP ordered labs to rule out infection and other causes for neuropathy which all came back negative. Patient has no known underlying risk factors that would predispose her to neuropathy. Neurologist did an EMG which showed no evidence of neuropathy. The patient went into to the office, and she had a skin biopsy to rule out small fiber neuropathy. She does not have results to provide for the skin biopsy at this time, however, the neurologist feels if the skin biopsy is positive, there may be an association with the vaccine in regards to the burning pain the patient is experiencing. She is calling to ask if this is a reported side effect. Treatment was confirmed as gabapentin was prescribed by PCP, and the patient started on it a few days after the onset of the burning pain. Outcome was noted as it has not improved, and has not resolved. No COVID tested post vaccination was noted. The outcome of the events was not recovered; the condition was persisting. Causality for the events was noted as related.; Sender's Comments: Based on a compatible temporal association contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events pruritus, burning sensation, condition aggravated cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-10 | chills, headache, dizziness, fatigue, weakness |
dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness...
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dizziness; jittery; shaky; headache; fluid in her ears; wake up in the middle of the night; Weakness; chills; tired; This is a spontaneous report from a contactable registered nurse (patient). A 57-year-old female nurse received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) injection at single dose via an unknown route in the left deltoid on 20Jan2021 for Covid-19 immunization. Medical history included hypothyroidism. Concomitant drug included ongoing levothyroxine sodium (EUTHYROX) started about 12 years ago as of 27Jan2021 at 75mcg once a day for hypothyroidism. Patient had first dose on the 20Jan2021, Wednesday and the last two nights (as of 27Jan2021) patient had chills. Onset date of chills was 25Jan2021. She assumed it would be sooner than further out close to the second one getting side effects. She also experienced weakness and was really really tired. Onset date of tired was 24Jan2021. She was unsure if she should get the second dose, or if she needs to contact her provider about this. She did not know if these are normal side effects or not. She looked at the side effect list, which said chills and headache, which she has experienced both. She also had dizziness. She used Flonase for the fluid in her ears. She thought the headache and dizziness was from fluid from pressure or something. The FLONASE helped with that. She had no fever. She was a week out from getting the dose and was wondering if she should still be having these side effects. Headache/ dizziness and weakness started a few days after she got the vaccine. She thought the weakness started that Friday or Saturday. If she got enough sleep she was okay, but she would wake up in the middle of the night. She thought the chills were from the weakness. She was also jittery and shaky as part of the weakness. Patient was always being really really tired later in the day. She thought that if she were working full time she would be missing work and that was medically significant. Treatment included FLONASE and took paracetamol (TYLENOL) for the headache early on. The events (chills, weakness, tired, headache and dizziness) were reported as serious with seriousness criteria of other medically important condition. No Investigation Assessment performed. Outcome of the events chills, weakness, tired was not resolved. Outcome of headache and dizziness was resolved. Outcome of the other evens was unknown.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect vaccine BNT162B2 to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-02-10 | chills, dizziness, fatigue, headache, weakness |
rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp...
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rectal bleeding; Severe chills; hot flashes with temp remaining at 95 degrees; hot flashes with temp remaining at 95 degrees; stomach pain; dizziness; weakness; severe fatigue; severe headache; nausea; injection site pain; lack of appetite or thirst; lack of appetite or thirst; This is a spontaneous report from a contactable other healthcare professional. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date was not reported), intramuscular on 07Jan2021 15:30 at single dose on the left arm for covid-19 immunization. Medical history included PTSD, CRPS, anxiety, and chronic pain. The patient has no allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) and clonazepam. On 21Jan2021 at 16:00, the patient experienced severe chills and hot flashes with temp remaining at 95 degrees, stomach pain, dizziness, weakness, severe fatigue, severe headache, nausea, injection site pain, lack of appetite or thirst. On 26Jan2021, the patient experienced rectal bleeding (medically significant). It was reported that the patient received Zofran and she missed her work days. The patient had a clinic visit to her doctor. It was reported the patient was not diagnosed with COVID-19 prior to vaccination. The patient had Nasal Swab on 25Jan2021 with negative results. The patient has not recovered from all of the events at the time of the report.
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| 57 | 2021-02-12 | cough, shortness of breath, fever, chills |
Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CH...
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Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CHILLS,SOB, COUGH., DIARRHEA, BLOOD CLOTS, FLUID AROUND HEART. Narrative: Other Relevant History:
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| 57 | 2021-02-14 | somnolence |
Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain...
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Nerve Damage Symptoms; its achy all on the left side; shoulder pain; Being lower back pain; the pain in shoulder went to the arms, back across to the front of the chest; dull aching pain; she didn't sleep; groggy; The pain in shoulder went to the arms, back across to the front of the chest; This is a spontaneous report from a contactable consumer (patient). A 57-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK9231) (at the age of 57-years-old), via an unspecified route of administration on 20Jan2021 as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient medical history included acid reflux She has been good for last 2 months. She was on Pepcid but not anymore; uterine polyp removal in 2019 (reported as 2 years ago) polyps removed from uterine wall, it was done outpatient but they still put her to sleep, but it had took her 2 weeks to get over the reaction of being put to sleep, it was the anesthesia, it wasn't pain, but she was very tired and groggy after. She does not know the name of the Anesthesia or have any Lot or Expiry; receives flu shot every year with no issue. The patient was not taking any concomitant medications. She has had No positive antibody or Covid test prior to the vaccine. She took the first shot last Wednesday 20Jan2021, she had a weird, not the usual reactions like she had read about. She even went to the Nurse Practitioner yesterday because of it. She was told she has nerve damage from the shot and a high immune response to the shot, which is a good thing, but her question is does she take the second shot. The nerve damage started at 10 o clock that night causing shoulder pain, back pain, being lower back pain, because of it she didn't sleep, only 3 hour Thursday night. She's a teacher and even had to miss school on Friday. It is just a constant dull aching pain. She was groggy. Some symptoms were typical. She never ran a fever, the pain in shoulder went to the arms, back across to the front of the chest, she can follow with the hand here, its achy all on the left side. She went to the Nurse Practitioner and she said it sounds like nerve damage. The NP did not do any test, she really just left the office hoping that it would resolve on its own. Caller states that this is not going away. She actually read to not even take Tylenol or Advil 2 days prior as it can lessen the effectiveness of the vaccine. That's why she didn't take Tylenol till Friday Afternoon on 22Jan2021. She toughed it out for 2 days. The doctor told her she can take Advil right now. The clinical outcome of the event: Low Back pain recovered; event Nerve damage was recovering; events achy all on the left side, Dull aching pain, shoulder pain, chest pain, Pain in arm, she didn't sleep, groggy unknown. She is scheduled for the second dose on 10Feb2021.
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| 57 | 2021-02-14 | fever, malaise, fatigue, weakness |
diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feelin...
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diagnosed with Covid; diagnosed with Covid; sore arm; more tired/Very fatigue; overall unwell feeling; slept all day long/; poor appetite/No appetite; slept all day long/Had no energy; severe aches; woke up with 102° temperature; diagnosed with strep; This is a spontaneous report from a contactable health care professional nurse, the patient (patient). A 57-years-old non-pregnant female patient (nurse) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), intramuscular in the left arm on 06Jan2021 at 16:30 as a single dose, Lot number Unknown for COVID-19 vaccination. The patient medical history was not reported. The patient has no know Allergies to medications, food, or other products. Concomitant medication included levothyroxine (LEVOTHYROXINE), alprazolam (XANAX). On 07-JAN-2021 at 12:00, the patient experienced diagnosed with Covid, sore arm, more tired/very fatigue, overall unwell feeling, slept all day long, poor appetite/no appetite, slept all day long/had no energy, severe aches, woke up with 102° temperature, diagnosed with strep. Adverse event start date was reported as 07JAN2021 at 12:00 PM However, the consumer reported the sequence of events as follows. Morning after the vaccination patients complaint was a sore arm. As the day proceeding, She became more tired. The following day was Friday. Very fatigue overall unwell feeling. On the weekend, Saturday and Sunday slept all day long. Had no energy. Very poor appetite. Once again overall unwell. Was able to work approximately half days on Monday Tuesday and Wednesday. She work Hospice and did enter a facility with known positive cases but was in Full PPE with every precaution as per my norm. On Thursday in the a.m. early she woke up with 102° temperature and severe aches. Was seen at the local urgent care and diagnosed with Covid. The adverse event result in Emergency Room Visit and Physician Office Visit The patient underwent lab tests and procedures which included body temperature of 102 on 07Jan2021 and ,SARS-CoV-2 test ( Nasal Swab) Positive on 14Jan2021. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Treatment received for the events were unknown but it was also reported 'she is on second round of antibiotics And steroids. Numerous exposures over last 10 month'. The clinical outcome of the events Covid-19, sore arm, more tired/Very fatigue, overall unwell feeling, Sleep excessive, poor appetite/No appetite, slept all day long/Had no energy, severe aches, fever was recovering; while Drug ineffective was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. ,
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| 57 | 2021-02-17 | nerve pain, fatigue |
R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; ...
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R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; R sided neck and facial swelling with nerve pain; decreased hearing to my R ear; The pain was worse in my R jaw- both upper and lower teeth pain; The pain was worse in my R jaw- both upper and lower teeth pain; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; Feeling of heaviness to my R eye, R cheek, R side of my tongue; decreased taste on the R side of my tongue; fatigue; muscle aches; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; woke up with painfull (pins and needle sensation) swollen hands; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL 3248, Expiration date: Apr2021), via an unspecified route of administration at the left arm on 14Jan2021 08:15 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. Medical history includes shrimp allergy. The patient was not pregnant at the time of vaccination. Concomitant medication was not reported. Historical vaccine includes 1st dose of bnt162b2 for COVID-19 immunization on 24Dec2020 09:30 AM, at the left arm, Lot number: EK9231 and Expiration date: Apr2021 at age of 57 years. The patient developed extreme fatigue, some muscle aches on 18Jan2021. She woke up with painful (pins and needle sensation) swollen hands. Took some TYLENOL and elevated them for a few hrs. The swelling subsided by the afternoon. On 19Jan2021, she developed R sided neck and facial swelling with nerve pain. The pain was worse in her R jaw- both upper and lower teeth pain, nerve pain extending from the side of my R ear up to my R eye and temple area. Feeling of heaviness to her R eye, R cheek, R side of her tongue, decreased hearing to her R ear (sounds muffled like being under water), decreased taste on the R side of heer tongue. Took benedryl and tylenol all day. On 20Jan2021, after a restless night due to the nerve pain (not relieved by tylenol) went to work but the swelling worsened so she was sent to the ED. They treated me with IV decadron, IV benedry, IV zofran- which immediately took away the swelling. The events result to Emergency Room/ Urgent Care Visit. Prior to vaccination the patient was not diagnosed with COVID-19. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient had Nasal Swab, PCR, covid test result was negative. The events were assessed as non-serious by the reporter, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-02-20 | throat pain, dizziness, shortness of breath, pneumonia, fever |
She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness...
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She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury
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| 57 | 2021-02-21 | fever, chills, fatigue |
Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours,...
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Extreme Abdominal Pain-8 hours, Extreme Arm pain (in the arm that didn't receive the shot)-24 hours, Extreme fatigue-5 days, Chills-8 hours, Fever-3 days (reducing in severity each day), arm pain in shot area- mild and continuous for 6 days.
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| 57 | 2021-02-21 | cold sweat | Rapid heart rate Burning through body Cold sweat Felt low blood pressure |
| 57 | 2021-02-22 | throat pain |
Approximately 10 minutes after vaccination (during post vaccination observation), patient reported f...
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Approximately 10 minutes after vaccination (during post vaccination observation), patient reported feeling ?off? and that her throat hurt. I was contacted via radio to aid with assessment. Upon my arrival, patient reported that that she was experiencing slight difficulty swallowing, was feeling ?off? and felt ?like her head was in a fog?. Assessment of vitals revealed an intial vital signs of respiration rate of 18 breaths per minute, pulse of 74 beats per minute, 97% oxygen saturation levels. Blood pressure was obtained prior to arrival and was reported as 121/74. Lungs were clear to auscultation bilaterally. Clear S1 and S2 were present upon cardiac auscultation with no mumurs or gallops noted. Patient appeared slightly pale with a slightly hoarse voice. Patient did not have noticeable pharyngeal edema upon examination. Patiney had no increased work of breathing and was not using accessory Muscles for breathing. Patient was given a swallow test using bottled water and then solid food and demonstrated intact ability to swallow with no regurgitation, choking or drooling noted. Continuous oxygen saturation monitoring revealed 02 that never fell below 96%. Continuous pulse monitoring revealed a pulse that was between 74-79. Given the stability the vital signs, demonstrated ability to swallow and inappropriately labeled IM medication in emergency kit (ie three loose syringes were not drawn up by myself. Medications were labeled by hand with no expiration date, route or dose), I elected to give the patient 25 mg of oral diphenhydramine. Patient declined to seek emergency medical attention several times. Patient?s daughter was then called so that the patient could be driven home. Patient was advised to seek emergency medical attention if her symptoms worsened, she developed increased difficultly breathing or otherwise felt unwell. Advised to follow up with PCP within next 24 hours.
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| 57 | 2021-02-22 | headache | Nausea, diarrhea, headache |
| 57 | 2021-02-22 | chills, headache, fatigue | Pounding headache. Chills. Joint aches muscle aches body aches fatigue |
| 57 | 2021-02-22 | weakness |
Three days after vaccine administration, patient indicates feeling weakness and involuntary movement...
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Three days after vaccine administration, patient indicates feeling weakness and involuntary movements in both legs.
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| 57 | 2021-02-22 | headache |
Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1...
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Very Bad nausea, Severe Vertigo, Bad Headaches, Blurred vision I was hospitalized at Hospital for 1.5 days. But the fields in question 21 would not allow me to enter the information when I checked Hospitalization. I received the vaccination at the Stadium in which was a State run POD.
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| 57 | 2021-02-22 | fever, chills |
developed rash 56 hours after covid vaccine and it lasted 24 hours. Rash was on both legs. she als...
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developed rash 56 hours after covid vaccine and it lasted 24 hours. Rash was on both legs. she also had fever, chills aches 10 hours after the vaccine and that lasted 24 hours.
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| 57 | 2021-02-23 | headache, fever, fatigue |
Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has ...
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Days 1-3 pain at site of injection much more than other vaccines that subsided but to this date has not gone away completely. Low grade fever and fatigue for about a week, lots of sleeping! Mild wheezing and sinus congestion, headaches. Day 4 I developed swelling in the lower legs and feet, that lasted about a week, still some fatigue and ongoing sinus congestion but feeling better, then a few days later in the 2/16 developed sudden onset moderately severe pain and tenderness in the upper right abdominal quadrant in the area of the live, gallbladder and pancreas up near and under the ribs and around to the flank and a small aspect of the back, with abdominal swelling belching and bile diarrhea and indigestion
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| 57 | 2021-02-23 | fever, headache, chills | Fever, chills, headache, joint pain, nausea, vomiting |
| 57 | 2021-02-23 | dizziness, malaise |
I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere;...
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I felt like I was going to pass out; suddenly all over my body under my skin was burning everywhere; my heart was pounding so fast; dizzy; seeing blurry; tongue was stinging; eye lids were burning; I didn't feel right the whole rest of the night.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231/212080597001), the first dose, via an unspecified route of administration on 31Dec2020 18:30 at single dose for covid-19 immunisation. Medical history included High Cholest. Type 2 Diabetes, High Blood Pressure, Fatty Liver, Overweight, and allergies to medications: Penicillin. Concomitant medication included levothyroxine sodium (UNITHROID), olmesartan medoxomil (BENICAR), rosuvastatin, empagliflozin, linagliptin (GLYXAMBI), escitalopram oxalate (LEXAPRO). After injections (on 31Dec2020) when to sit down, suddenly all over my body under my skin was burning everywhere and my heart was pounding so fast I thought it was going to come out of my chest. I got dizzy and was seeing blurry. At the end my tongue was stinging and my eye lids were burning. I felt like I was going to pass out. Then finally subsided but I didn't feel right the whole rest of the night.Therapeutic measures were taken as a result of all events. The outcome of events was recovered.Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The case considered non-serious (Seriousness criteria-Results in death: No;Life threatening: No;Caused/prolonged hospitalization: No;Disabling/Incapacitating: No;Congenital anomaly/birth defect:No). Follow-up attempts are completed. No further information is expected.
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| 57 | 2021-02-23 | fatigue, chills, fever |
arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area...
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arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like "ooh, my arm is sore". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.
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| 57 | 2021-02-28 | shortness of breath |
Pt reported SOB, asthma like exacerbation, wheezing, feeling like throat was closing about 1 hour af...
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Pt reported SOB, asthma like exacerbation, wheezing, feeling like throat was closing about 1 hour after vaccine. Reported taking home inhalers. Denied going to the emergency room or LOC Pt now feels good, at baseline
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| 57 | 2021-02-28 | fever, chills |
fever; had body aches; chills; This is a spontaneous report from a non-contactable non-healthcare pr...
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fever; had body aches; chills; This is a spontaneous report from a non-contactable non-healthcare professional (consumer) reported that a 57-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included lupus. The patient concomitant medications were not reported. The patient previously took the first dose of bnt162b2 for COVID-19 immunization. On an unspecified date after the second shot, the patient ran a fever and had body aches and chills, which took 2 days to recover. It was unknown if the patient received treatment in response to the event. The patient recovered from the events on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
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| 57 | 2021-03-02 | headache, chills, fatigue, shortness of breath |
About 3am woke up with chills; headache; Arm was very sore.; Saturday, was very tired/lethargic/Felt...
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About 3am woke up with chills; headache; Arm was very sore.; Saturday, was very tired/lethargic/Felt blah all day, tired; out of breath; This 57- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on Jan2021 at 12:00 PM (at the age of 57-years-old) as a single dose for COVID-19 immunization, in right arm. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included: allergy to pumpkin. Concomitant medication included: Osphena 60mg; VitD 2000IU; Vit C 1000mg; Zinc 50mg. Patient received dose 1 of Pfizer vaccine on a Friday at 12 noon. Felt fine all day. About 3am woke up with chills and a headache. Arm was very sore. Saturday, was very tired/lethargic all day. Slept 10 hrs, awoke with a headache (but no chills) and had breakfast, fell back asleep another 2 hrs, then another 2-hr nap early evening. Felt blah all day, tired and out of breath. Went to bed much earlier than normal. Felt good Sunday but arm still sore. It's Monday at 4pm and arm is still very sore to the touch. The clinical outcome of the events chills, headache, arm very sore, very tired/lethargic, out of breath were recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
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| 57 | 2021-03-02 | fever |
high fever 101 or something; her armpits and lymph nodes were very swollen.; her hand was kind of he...
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high fever 101 or something; her armpits and lymph nodes were very swollen.; her hand was kind of heavy; This is a spontaneous report from a contactable nurse (patient) reported that a 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on the left arm on 28Jan2021 at a single dose for Covid-19 immunization. The patient medical history included that she was diabetic, and she have had COVID and she have been in long term for COVID from Jul2020 and unknown if ongoing. Concomitant medication included metformin. The patient received the vaccine on Thursday morning (28Jan2021) and the next day (29Jan2021), her hand was kind of heavy and that night through Saturday (30Jan2021). On an unspecified date, the patient spike very high fever 101 (no unit reported) or something all through non-stop; her armpits and lymph nodes were very swollen. As treatment, patient took Tylenol for the events. The outcome of her hand was kind of heavy was recovered on 30Jan2021, high fever 101 or something was unknown, and armpits and lymph nodes were very swollen was not recovered. The patient stated that she would like to be tested for her immunity before receiving her second dose since she thought that she still have low immunity from Jul2020 because she have been in very long term of Covid.
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| 57 | 2021-03-03 | cough, chills |
Diarrhea; Chills; Cough; Sneezing; Nausea; This is a spontaneous report received from a contactable ...
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Diarrhea; Chills; Cough; Sneezing; Nausea; This is a spontaneous report received from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: unknown), via an unspecified route of administration on the left upper arm, on 30Jan2021, at single dose, for COVID-19 immunization, at a nursing home. Medical history included ongoing allergies which the patient was diagnosed before having the vaccine. There were no concomitant medications. The patient did not receive prior vaccinations within 4 weeks. On 30Jan2021, 2 hours after the vaccination, the patient experienced nausea. On 31Jn2021 at 03:00, the patient experienced chills, was coughing and sneezing. She stated that she was not coughing constantly, and it comes off and on. On 02Feb2021, the patient experienced diarrhea. She called her doctor and treatment included Tylenol and inhaler if needed. Her doctor would not give her prednisone so her lungs could get strong. The patient stated that she was scheduled to get her second dose on 20Feb2021. The patient recovered from nausea on 31Jan2021; was recovering from chills, cough and sneezing; and has not recovered from diarrhea.
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| 57 | 2021-03-05 | throat swelling, fever |
I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble sw...
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I began running a fever 3/2 of 101, notice swelling in lymph nodes on right side of neck. Trouble swallowing. Fever escalated to 103 at 1am 3/3. By 9am 3/3 neck was much more swollen and swallowing more difficult. By 3/4 fever down to 101.3 but throat so swollen difficult to talk, drink, unable to eat. Went to ER at 3:30pm 3/4.
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| 57 | 2021-03-08 | shortness of breath |
Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain...
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Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain. Oxygen Saturation was at 87 when I arrived. Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.
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| 57 | 2021-03-10 | nerve pain, dizziness, somnolence, weakness |
brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; ex...
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brain fog; sleepy; basophils are a little elevated; orthostatic hypotension; dizziness; weakness; extreme burning in her lower extremities and hands; nerve pain 9 out of 10; This is a spontaneous report from a contactable nurse. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ON5318), via an unspecified route of administration in the left arm on 08Feb2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. The patient has been having a lot of side effects. The patient experienced common weakness on 09Feb2021 which was expected, extreme burning in her lower extremities and hands but it was worse in her lower extremities which occurred 4-7 days after vaccination in Feb2021, orthostatic hypotension and dizziness on 12Feb2021, nerve pain 9 out of 10 in Feb2021 which has subsided as of 20Feb2021 or 21Feb2021, super weak, brain fog and sleepy on unknown date. As of 24Feb2021, patient still had orthostatic hypotension and weakness. Stated they have done a CBC on her and everything looks good, her basophils are a little elevated but it is nothing serious. The patient is concerned about the second dose, does not think patient is going to get it. Outcome of events weakness, orthostatic hypotension and dizziness was not recovered, events extreme burning in her lower extremities and hands and nerve pain 9 out of 10 was recovered in Feb2021. Outcome of other events was unknown.; Sender's Comments: The causal association between the reported event nerve pain which was 9 out of 10 according to the patient and the BNT162B2 COVID-19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
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| 57 | 2021-03-10 | chills, fatigue, nasopharyngitis, fever |
chills; fatigue/severe fatigue; subjective cold; myalgias; felt feverish, but always below normal te...
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chills; fatigue/severe fatigue; subjective cold; myalgias; felt feverish, but always below normal temperature; This is a spontaneous report from a contactable physician for herself. A 57-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248) on 11Jan2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization in the hospital. Patient's medical history included hyperlipidaemia from an unknown date and unknown if ongoing. The patient previously had erythromycin and had allergies. Concomitant medication included Lipitor (Atorvastatin calcium). Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730) on 16Dec2021 via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization. The patient did not have any other vaccine within four weeks. The patient did not receive COVID-19 vaccine prior to vaccination. The patient experienced chills, fatigue/severe fatigue, subjective cold, myalgias, felt feverish and but always below normal temperature in Jan2021. The patient was underwent COVID-19 (Nasal Swab) on 18Jan2021 which was negative. The patient didn't receive treatment. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.
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| 57 | 2021-03-14 | shortness of breath |
Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives...
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Flushing, pruritis Pt was in COVID Vaccination clinic and c/o itching, chest reddened, small hives noted on chest, ears itching, no respiratory symptoms or difficulty. Speech clear, no stridor noted. Pt stated does have a significant allergy history and sees an allergist. Medicated with Benadryl 50 mg po and immediately to ED, registered right away, pt then c/o head and back itching, and taken into triage for assessment by triage nurse. Per Hospital Note: Patient initially developed hives and itching with progression in symptoms to include shortness of breath and throat tightening. She reported feeling as though her tongue were swelling and having difficulty speaking and having difficulty swallowing. Concerns of impending loss of airway prompted administration of IV Solu-Medrol, Benadryl and 2 doses of intramuscular epinephrine which were unsuccessful and therefore emergent intubation was performed. Patient apparently has had prior anaphylactoid reactions in the past including bee stings and shellfish.
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| 57 | 2021-03-16 | headache, fever, malaise, chills, fatigue |
Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told ...
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Levels of TSH, among other indicators that pointed towards onset of hyperthyroidism. My doctor told me that this was acute thyroiditis. My heart rate was very high (122 bpm) when I visited my doctor's office and it was 130 bpm when I was triaged in the Emergency Room. Upon my doctor's advice, I went to the ER in the afternoon of 03/12/2021 where I was further tested. I was given medications to counteract inflammation, nausea and headache. In addition, I was given medication (beta blocker) to lower my heart rate. When my blood pressure was taken after a couple of hours, the readings revealed that my pressure had also started to fall. I spent overnight in the telemetry unit of the ER - I was given 2 liters of IV fluids to stabilize my vitals. The following day (03/13/2021), I met with endocrinologists who told me to what extent my thyroids were affected and what further medications to take. I had told them and other ER doctors as to what precipitated all of this. I was given anti inflammatory medication and a beta blocker that day before I was discharged in the evening. I have no history of thyroid issues or heart issues. I do not suffer from any chronic illness. I was not sick before I took the second dose of the vaccine. I started to feel ill within 5 hours of taking the vaccine shot, and the symptoms worsened over nearly the following two weeks. Now, following medical intervention, I am continuing treatment with various medications. I don't feel well yet, and I understand that the process towards recovery is going to be slow and unpredictable. I wanted to report this, since I feel that scientists and researchers should have this knowledge that thyroiditis can happen as an adverse reaction to the COVID-19 vaccine (Pfizer/BioNTech).
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| 57 | 2021-03-20 | fever, fatigue |
mental cloudiness; Febrile; fatigued; generalized aches; This is a spontaneous report from a contact...
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mental cloudiness; Febrile; fatigued; generalized aches; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration in the left arm (also reported as left deltoid) on 02Mar2021 12:15 as single dose for COVID-19 immunization. Medical history included obstructive sleep apnea (OSA), hypertension (HTN), obesity from and hypothyroidism. The patient had no known allergies. The patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID), estradiol and hydrochlorothiazide, losartan potassium (LOSARTAN HCT). No other vaccine in four weeks. The patient experienced mental cloudiness, febrile, fatigued and generalized aches on 03Mar2021. The patient received treatment for the events including Tylenol and work absence. No COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported event mental cloudiness cannot be completely excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 57 | 2021-03-21 | chills |
Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, so...
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Almost immediately felt vertigo like" bed spins". Then tongue began to swell against lower teeth, soon was unable to walk due to vertigo, then chills and extreme nausea like I would vomit but I did not.
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| 57 | 2021-03-22 | shortness of breath | Patient presented with progressive facial swelling and shortness of breath |
| 58 | 2021-01-01 | fever, chills, fatigue, headache |
I developed symptoms of the corona virus as I had in 3/2020 when I tested positive for COVID-19. I d...
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I developed symptoms of the corona virus as I had in 3/2020 when I tested positive for COVID-19. I developed a headache, fever, aches, chills and extreme tiredness. The symptoms last about 48 hours.
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| 58 | 2021-01-01 | shortness of breath | Peri-oral tingling, shortness of breath, nausea immediately after injection |
| 58 | 2021-01-03 | body temperature increased | 103 F temperature for 3 days after vaccine |
| 58 | 2021-01-03 | fatigue, shortness of breath |
12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI;...
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12/17/2020 VACCINE 12/18/2020 SWOLLEN LYMPHNODES IN GROIN, FATIGUE 12/21/2020 EXPERIENCED A STEMI; RUSHED TO ER; FELT LIKE COULDN'T BREATHE, INCREASED HR CARDIAC CATH
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| 58 | 2021-01-03 | shortness of breath |
15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood ...
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15- 20 min following injection - heaviness in chest, 2-3 hours later - became flush, elevated blood pressure 169/92, pulse 100. Increased difficulty breathing.
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| 58 | 2021-01-03 | dizziness |
30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain...
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30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; 30 minutes after receiving vaccine, patient reported heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness; This is a spontaneous report from a contactable pharmacist. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number= EH9899), intramuscular on 19Dec2020 07:00 at SINGLE DOSE at Left arm for covid-19 immunization. Medical history included breast cancer female and allergies to shell fish and Latex. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 30 minutes after receiving vaccine on 19Dec2020 07:30 am, patient reported 'heart racing, dizziness, flushing, burning pain in her chest, dizziness. tachycardia, nausea and throat tightness. Patient was taken to the ED where she received IV Benadryl and was observed for 4 hours. Patient was discharged home and symptoms subsided. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Outcome of the events was recovered in Dec2020.; Sender's Comments: There is a plausible temporal relationship between immunization and onset of allergic reaction in a subject with a positive medical history for allergy to food (shellfish); causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-03 | skin warm | Face rash, itchy for 2 days, (face and neck) Face warm to touch, Seen by NP no treatment |
| 58 | 2021-01-03 | head discomfort | Stuffed up head and sneezing. Started on 1-3-2021. I get this every year. |
| 58 | 2021-01-03 | fatigue, chills, headache |
The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the inject...
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The day of the vaccine I had a initial diarrhea and headache, minimum pain on the site of the injection but at 2AM on the 22nd I woke up from my sleep with chills, and shaking even my teeth were clacking. Took Tylenol and it got better around 30 min later. Felt very fatigued and still nauseated almost threw up. By the end pf the day it resolved itself.
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| 58 | 2021-01-03 | dizziness |
patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; ...
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patient began to experience dizziness/shakiness.; patient began to experience dizziness/shakiness.; This is a spontaneous report from a non-contactable other hcp reporting for a patient. A 58-year-old female patient received first dose of BNT162B2 (Pfizer product, lot number: EH9899), intramuscular on 21Dec2020 16:00 at single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 minute waiting period after the injection (21Dec2020 16:15), the patient began to experience dizziness/shakiness. This provider was notified of patient reaction and she was then transferred to the emergency bay via wheelchair where she was assessed. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, hypotension, dysrhythmia, chest pain and collapse. Treatment included no therapy, but did continue with vital checks at approximately 5 minute intervals. Patient discharge: stable to go home and follow up with PCP. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the compatible time association, the dizziness and shakiness are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-01-04 | fever, fatigue |
24 hours after vaccine developed fever (101), body aches, fatigue. 10 days later still with low gra...
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24 hours after vaccine developed fever (101), body aches, fatigue. 10 days later still with low grade fever (100.3) and fatigue.
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| 58 | 2021-01-04 | dizziness | Dizziness, Light headed, nausea |
| 58 | 2021-01-04 | headache |
Elevated heart rate, headache; Elevated heart rate, headache; This is a spontaneous report from a co...
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Elevated heart rate, headache; Elevated heart rate, headache; This is a spontaneous report from a contactable other Healthcare Professional (HCP, patient). This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730), intramuscular, on 29Dec2020 at 12:30 PM at single dose for COVID-19 immunisation. Vaccine location was right arm. The patient was vaccinated at hospital, age at vaccination was 58-years-old. No other vaccine was received in four weeks. Medical history was unknown. Concomitant medications included rosuvastatin calcium (CRESTOR) and lisinopril. On 29Dec2020 at 04:00 PM, the patient experienced elevated heart rate, headache. The event was reported as non-serious. Outcome was recovered on Dec2020. No treatment was received for the event. No follow up attempts are possible. No further information is expected.
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| 58 | 2021-01-04 | fatigue, chills, malaise |
Patient reports chills, joint and muscle aches, extreme fatigue, nausea, insomnia and a general se...
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Patient reports chills, joint and muscle aches, extreme fatigue, nausea, insomnia and a general sense of not feeling well.
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| 58 | 2021-01-04 | fatigue, dizziness |
Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health profess...
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Sore arm; fatigue; lightheaded; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 16:15 to 28Dec2020 16:15 at left arm, at single dose for covid-19 immunization. Medical history was none. Allergies to medications, food, or other products was no. Concomitant medication included bupropion hydrochloride (WELLBUTRIN). The patient was not pregnant at the time of vaccination. The patient experienced sore arm, fatigue, lightheaded on 29Dec2020 14:00. No treatment was received for all event. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. Information about Lot/Batch number has been requested.
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| 58 | 2021-01-04 | fatigue, lethargy, shortness of breath, dizziness |
Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was emp...
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Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.
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| 58 | 2021-01-04 | fatigue |
intermittent Heart palpitations that began at 0800; Severe fatigue that began 4 hours post injection...
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intermittent Heart palpitations that began at 0800; Severe fatigue that began 4 hours post injection and lasted approx 48 hrs; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received their first dose of BNT162B2 (lot number: Ek 5730; expiry date not reported), intramuscularly on the right arm on 26Dec2020 at 08:30 at single dose for COVID-19 immunization. Medical history included known allergies to milk and eggs. Concomitant medication included lisinopril. The patient experienced severe fatigue that began 4 hours post injection and lasted approx. 48 hrs on 26Dec2020 and intermittent heart palpitations that began at 08:00 on 28Dec2020. The patient recovered from severe fatigue on an unspecified date in Dec2020 (reported as approx. 48hrs) while the outcome of intermittent heart palpitations was unknown.
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| 58 | 2021-01-04 | headache, cough |
tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spont...
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tested positive for COVID-19; headache; cough; voice being hoarse; Drug ineffective; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect from a Contactable nurse reporting for herself. A 58-years-old female patient received bnt162b2 (BNT162B2; Lot # EK5730) vaccine , via an unspecified route of administration on 18Dec2020 10:30 at single dose for covid-19 immunisation . Medical history included hypertension from an unknown date and blood cholesterol increased. Concomitant medication included losartan (LOSARTAN), hctz (HCTZ), ezetimibe (ZETIA), famotidine (PEPCID). The patient started having a headache and cough on 25Dec2020 and these symptoms worsened on 26Dec2020 in addition to her voice being hoarse. On 26Dec2020 she went to get tested at an urgent center and tested positive for Covid-19. The outcome of the event was not recovered.; Sender's Comments: The association between the event "tested positive for COVID-19, headache, cough, and dysphonia" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-05 | dizziness |
Employee stated she felt dizzy shortly after receiving vaccine. Assessed by RN and EMT's and rested ...
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Employee stated she felt dizzy shortly after receiving vaccine. Assessed by RN and EMT's and rested for 30 minutes then went home.
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| 58 | 2021-01-05 | headache, dizziness |
Headache, dizziness, disorientation, upset stomach. Headache not resolved with tylenol. Symptoms r...
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Headache, dizziness, disorientation, upset stomach. Headache not resolved with tylenol. Symptoms resolved after 36 hours.
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| 58 | 2021-01-05 | headache |
Headache; My arm is sore; This is a spontaneous report from a contactable consumer. A 58-year-old fe...
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Headache; My arm is sore; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (BNT162B2, batch number:5926710001), intramuscular in the arm on 30Dec2020 at a single dose for covid-19 immunisation. The patient's medical history included bacterial infection from an unknown date and unknown if ongoing. There were no concomitant medications. On 30Dec2020, the patient got the vaccine and had a little headache and her arms were sore. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
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| 58 | 2021-01-05 | headache, fever |
Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spon...
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Left arm sore; headache; generalized muscle aches; Temp at home in evening was 101.2; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient receive first dose of BNT162B2 (lot number: EL1284) on left arm via an unspecified route of administration on 30Dec2020 15:45 at single dose for covid-19 immunisation. Medical history Environmental allergies, diverticulosis, uterine fibroids, and Known allergies: Broccoli and Bell peppers. The patient was previously diagnosed with COVID-19 prior to vaccination. Concomitant medication included omeprazole (PROTONIX), levocetirizine dihydrochloride (XYZAL), famotidine (PEPCID), fluticasone furoate (FLONASE SENSIMIST ALLERGY RELIEF). The patient experienced left arm sore around 4 am 31Dec2020. Gradual onset of generalized muscle aches and headache. Worse as day progressed. Xhills late afternoon. Temp at home in evening was 101.2. The patient received tylenol (self administered) for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
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| 58 | 2021-01-05 | headache, weakness | Pfizer COVID vaccine gine. Headsche weakness and extreme conjunctivitis present |
| 58 | 2021-01-05 | headache | Swelling deltoid muscle, headache, nausea |
| 58 | 2021-01-05 | dizziness | Tachycardia, palpitations, elevated blood pressure, feeling faint, nausea, flushing |
| 58 | 2021-01-05 | fatigue, throat irritation, headache |
scratchy throat; tired; headache; This is a spontaneous report from a contactable nurse (patient). ...
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scratchy throat; tired; headache; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 24Dec2020 11:30 at a single dose in the left arm as Covid vaccine. The patient had no medical history. The patient no known allergies. Concomitant medication included propranolol (within the two weeks). The patient had no prior COVID vaccination and was not tested for COVID post vaccination. On an unknown date, the patient experienced scratchy throat, tired, and headache. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events scratchy throat, tired, and headache was recovered with lasting effects. Information on the lot/batch number has been requested.
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| 58 | 2021-01-06 | sweating, dizziness |
Approx 2 min after getting vaccine I felt lightheaded. I noticed my heart was pounding and racing. ...
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Approx 2 min after getting vaccine I felt lightheaded. I noticed my heart was pounding and racing. I got help and Sat in office with nurse. My pulse was 140's ,I felt sweaty and shaky. Whole episode lasted approx 10 minutes
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| 58 | 2021-01-06 | headache, fever | Headache & Fever |
| 58 | 2021-01-06 | chills, fatigue, throat pain | Sore arm , sore throat, myalgia, chills fatigue |
| 58 | 2021-01-06 | fatigue |
Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third...
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Sore arm, following day fatigue , swollen lymph node right neck and sore axilla on right side. Third day, swollen lymph node to left neck lasting several days . Did not prevent me from doing anything.
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| 58 | 2021-01-06 | headache | Stiff neck severe headache severe diarrhea and nausea |
| 58 | 2021-01-06 | malaise |
Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset wors...
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Vaccinated on December 21, 2020. No arm pain, nothing. On December 27th at 4:00 PM sudden onset worst bone pain ever unrelieved with Tylenol, malaise and nausea. December 28th at 1:00 AM awoke in pain and "on fire" I have never been so hot, truly felt like my skin was on fire. Tympanic thermometer 99.0F. Awoke feeling fine and went to work thinking this was SE however symptoms recurred later that morning so I went for testing as I could not differentiate between SE vs illness. Covid negative. If this was a delayed response to vaccine, wanted to report: severe bone pain unrelieved w Tylenol , malaise, nausea, 48 hours. thanks, NP
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| 58 | 2021-01-06 | headache, throat pain, weakness | body aches, weakness, sore throat, headache |
| 58 | 2021-01-06 | headache, fever | low grade fever, headache |
| 58 | 2021-01-06 | runny nose, cough, headache | runny nose, cough, headache and body aches for five days |
| 58 | 2021-01-06 | chills, headache, sweating | sweats, chills, headaches |
| 58 | 2021-01-07 | fever, chills |
12 hrs post injection awoke with shaking chills with fever eventually 102. 2 more episodes of lesser...
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12 hrs post injection awoke with shaking chills with fever eventually 102. 2 more episodes of lesser chills in next 12 hrs, with gradual decrease in fever over 24 hrs to low grade 99. Had severe body aches/joint pains during this time which also slowly improved.
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| 58 | 2021-01-07 | dizziness |
5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizzine...
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5 minutes after injection, face red, sudden onset of flushing sensation in chest followed by dizziness and a feeling of rapid heart beat. Throat tightness and difficulty swallowing. Flushing sensation and feeling of rapid heart beat resolved within a few minutes, but left with nausea, flushing and difficulty swallowing/throat tightness.
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| 58 | 2021-01-07 | dizziness, headache, fatigue | Bad headache, dizzy, very tired, nausea, blurred vision. |
| 58 | 2021-01-07 | influenza like illness, fatigue, headache |
Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad t...
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Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown. Information on the batch/lot number has been requested.
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| 58 | 2021-01-07 | fever, fatigue, chills | Fever, to 101.8, chills, body aches, fatigue |
| 58 | 2021-01-07 | headache, fever, chills | Severe Headache Rash starting on neck and chest Chills Fever Vomiting |
| 58 | 2021-01-07 | cough, chills | Severe arm pain. Unable to open and close fingers. Back hurts Chills Cough |
| 58 | 2021-01-07 | cough, runny nose, headache, chills |
Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in...
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Severe bodyache with joint pain severe (Knee pain and upper back), chills, headache but more pain in right side headache with right ear tinnitus, sometimes cough, runny nose and metal taste in mouth.
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| 58 | 2021-01-07 | fatigue | Soreness , fatigue , Arm swollen , Sore to the touch . |
| 58 | 2021-01-07 | headache |
Start with the normal sore arm continues on day five, normal headache two days. On the second day, v...
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Start with the normal sore arm continues on day five, normal headache two days. On the second day, very stomach pain so bad could not sleep now for three days.
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| 58 | 2021-01-07 | fever, headache, chills, fatigue |
second day post vaccine woke w/102.2/ fever fever broke by day 3; first day after vaccine developed ...
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second day post vaccine woke w/102.2/ fever fever broke by day 3; first day after vaccine developed chills and the worst headache of my life along w/fatigue; first day after vaccine developed chills and the worst headache of my life along w/fatigue; first day after vaccine developed chills and the worst headache of my life along w/fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received first single dose of BNT162B2 (Pfizer, lot number: ett9899, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 30Dec2020 11:00 for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included osteoarthritis bilateral knees. The patient was not pregnant. Concomitant medication include amoxicillin, clavulanate potassium (AUGMENTIN), ascorbic acid (VITAMIN C ACID), meloxicam, and calcium carbonate (CAL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were no other medications within two weeks. On 31Dec2020 22:00, the first day after vaccine, patient developed chills and the worst headache of her life along with fatigue. On 01Jan2021, second day post vaccine, she woke with 102.2 fever; chills were gone, headache mild, fatigue present. The fever broke by day 3 (02Jan2021). No treatment was provided for the events. The events were considered as non-serious by the reporter. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. The patient recovered from the fever on 02Jan2021, chills recovered on 31Dec2020, while outcome of headache and fatigue was unknown.
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| 58 | 2021-01-08 | headache, fatigue, chills |
"Pfizer-BioNTech Covid-19 Vaccine EUA. Side Effects: nausea, body aches, chills, headache, fatigue. ...
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"Pfizer-BioNTech Covid-19 Vaccine EUA. Side Effects: nausea, body aches, chills, headache, fatigue. I took Ibuprofen. Symptoms lasted for approximately 36-40 hours.
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| 58 | 2021-01-08 | dizziness |
Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow....
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Approx 8-10 min after rec. shot, started to feel lip begin to swell and became difficult to swallow. At 5:34 pm when 15 min wait was done told staff what was happening. Was triaged by NP and MD on standby along w/EMT treated w/50 Benadryl/20 Pepcid/125 Solumedrol IVP. Waited in onsite Immediate Care and was given 1L 0.9 NS bolus. Transferred by ambulance to ER at 6:45 pm after experiencing tingling to chest and dizziness. Tingling changed to warmth in route to ER. Observed in ER and discharged home at 9 pm.
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| 58 | 2021-01-08 | dizziness, headache, fatigue | Bad headache, dizzy, blurred vision, nausea, very tired. vomiting. |
| 58 | 2021-01-08 | dizziness | Dizziness, kept patient in observation for 30 min. |
| 58 | 2021-01-08 | head discomfort, chills, headache |
Head ache with pressure/pain on top of head on 01/8/2021, woke 01/09/21 with nausea, progressed to h...
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Head ache with pressure/pain on top of head on 01/8/2021, woke 01/09/21 with nausea, progressed to headache and nausea so bad that I couldn't take migraine meds for fear of vomiting. Went to bed with chills. Woke with pain and stiffness in right shoulder joint. Nausea subsided and I took 50 mg immitrex. Could no longer lay down due to head pain, so slept sitting up two hours. Chills continued. Meds finally worked and headache subsided. Chills subsided. Mild nausea persists this evening.
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| 58 | 2021-01-08 | fatigue, headache, malaise |
Headache, Myalgia, Fatigue Narrative: Received vaccine on 12-21-20. Came to work the next day, by n...
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Headache, Myalgia, Fatigue Narrative: Received vaccine on 12-21-20. Came to work the next day, by noon was not feeling well. Headache, myalgia and fatigue. Left work at 2pm - which was 2 hours early. Slept it off, came to work the next day.
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| 58 | 2021-01-08 | cough, throat irritation |
Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, mya...
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Myalgia tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia Narrative: tingling and paresthesia of mouth, tongue , scratchy throat, mild cough, metallic taste, myalgia
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| 58 | 2021-01-09 | fever, influenza like illness, headache |
10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, ba...
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10 hours after shot - sore arm, 2 hours later headache, 2 hours later fever, muscle ache, chills, basically flu like symptoms. My skin hurt everywhere
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| 58 | 2021-01-09 | headache |
18 hours after vaccine wakened with severe headache lasted aprox 18 hours then was just mild for rem...
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18 hours after vaccine wakened with severe headache lasted aprox 18 hours then was just mild for remainder of 30 hours.
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| 58 | 2021-01-09 | chills | Chills, body aches Took Tylenol and advil. |
| 58 | 2021-01-09 | fever, fatigue, headache, chills, dizziness |
Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than ...
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Covid19 second vaccination dose at 1030am 1/8/21 into L arm, which became more sore and faster than the first dose. Tired in evening so went to bed early. Around 2100pm chilling/fever began lasting about 5 hours. This was associated with headache, nausea, and arthralgias. No sleep. All day on 1/9/21 very lightheaded, headache, and some nausea. Spent the day lying on the couch. On 1/10/21 while headache still there in am, much improved. Still some uneasiness of stomach. L axillary soreness. Over all feel much better though not fully normal on afternoon of 1/10/21.
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| 58 | 2021-01-09 | dizziness, weakness |
Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck followi...
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Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck following vaccination. Patient was sent home from work and symptoms persisted after rest.
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| 58 | 2021-01-10 | body temperature increased, headache, chills |
01/09/2021 0400 to 1100 severe muscle/joint ache, 99.4 temp, headache,chills/shivering. 01/09/2021 2...
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01/09/2021 0400 to 1100 severe muscle/joint ache, 99.4 temp, headache,chills/shivering. 01/09/2021 2100 muscle aches, 99 temp 01/10/2021 0500 mild muscle ache, mild headache
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| 58 | 2021-01-10 | cough, fatigue, runny nose |
Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye an...
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Bells Palsy 20days after dose. 1-08-2021 Right facial paralysis with frequent watering of the eye and nose on the right. Fatigue, cough
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| 58 | 2021-01-10 | chills | Chills Hip pain |
| 58 | 2021-01-10 | fatigue | Fatigue, muscle aches, mental fogginess, syncope, cold hands |
| 58 | 2021-01-10 | fever, chills |
Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to...
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Friday morning after the vaccination - fever, chills, body aches & nausea. Saturday morning, went to the ED with hives that went into her mount & swollen tongue - resolved as of 1/11/2021
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| 58 | 2021-01-10 | fever |
Had a fever of 101.2 for 24 hours. Difficulty getting fever down with both Tylenol and Ibuprofen. ...
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Had a fever of 101.2 for 24 hours. Difficulty getting fever down with both Tylenol and Ibuprofen. After 24 hours, fever was gone and no other symptoms.
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| 58 | 2021-01-10 | fever, malaise, headache | Patient refers developed general malaise, headache, feverish, joint pain, nausea and left arm pain |
| 58 | 2021-01-10 | chills, headache, fever, fatigue |
Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Sym...
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Second COVID immunization from Pfizer at 0930 sat. (No symptoms at all with first immunization) Symptoms of fatigue began approx. 12 hrs. late, then fever after midnight, chills, body aches, severe headache, abd cramping, and extreme fatigue. Highest fever recorded was 101.8 the next day (Sunday) around 4pm. Didn't take Tylenol or Motrin. As of writing this (Monday 12:07 pm) my fever is gone but headache and extreme fatigue remain. Injection site still sore and today I notice I have a very swollen and painful lymph node left axilla opposite injection site. I had to call in sick today and possible will tomorrow if the extreme fatigue and headache don't go away.
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| 58 | 2021-01-10 | dizziness, fatigue, headache | dizziness, fatigue, vomiting, diarrhea, headache |
| 58 | 2021-01-10 | chills, headache, fatigue, weakness |
tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head ...
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tired; no energy; low back pain; her fingers are hurting; passed out on toilet; Nauseated; hit head on wall, head just hurts; hit head on wall, head just hurts; Chills; she was very cold; could not sleep good; site of vaccine was sore; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer. A 58-year-old female patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK9231) by injection once to left arm, via an unspecified route of administration on 04Jan2021 12:30 at single dose for covid-19 immunisation. Medical history included thyroid disorder. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder; patient started it after she had her son, and her son is 18 years old. The patient had her vaccine yesterday (04Jan2021) at 12:30, and at nighttime, around 22:00, she started having chills, she was very cold, so she went to bed, she could not sleep good, she kept waking up, and the site of vaccine was sore, she had muscle pain, joint pain, she didn't have fever, but she got up late today (05Jan2021), around 11:00, and had breakfast and felt nauseated, so she stopped eating, and she went to the bathroom and passed out on the toilet, when she woke up, she had her nightgown inside the toilet, it was all wet, she felt better, so she stood up and then she woke up again, and was inside the tub, her legs were inside the basin, she was lying down with her back inside the tub, she thinks she hit her head on the wall, and it just hurts, it didn't bleed or nothing. The patient stated she had the paper she was given. Again stated she can not even function. Patient still feels Chills a little bit, not as bad as last night. She is awake now, but she feels very very tired, like she has no energy, she is laying down on couch right now. She kept waking up and noticed this morning, she had low back pain, in the muscles, even her fingers are hurting. Regarding hitting her head on the wall, states she has a terrible headache, not a little pain, she thinks it is because she hurt her head. The patient is supposed to get second vaccination on 25Jan2021. The outcome of events Chills, Joint pain and nauseated was recovering; of events site of vaccine was sore and muscle pain was not recovered; of other events was unknown.
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| 58 | 2021-01-11 | headache, fatigue, weakness |
1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headac...
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1//7/2021, day vaccine was administered; within a couple hours I began to experience fatigue, headache and R arm pain where vaccine was given.1000 mgs. Tylenol was taken, which offered very little relief. 1/8/2021; I awoke with extreme fatigue, unable to sit up, nausea, and diarrhea with stomach pain, headache, which wasn't unrelieved by 1000mgs of Tylenol, unable to raise R arm due to swelling and pain, aching and weakness all over body, joints, and muscles. It also caused a Fibromyalgia flare-up, which I wasn't experiencing prior to vaccine. It was 1/10/2021 before I was starting to feel better.
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| 58 | 2021-01-11 | fever, dizziness, headache | 99 fever, dizzy, nauseous, body aches and pain, headaches, diarrhea. Took Ibuprofen |
| 58 | 2021-01-11 | chills, headache, fever, discomfort |
About 12 hours after vaccination experienced chills, body aches, intermittent headache and general d...
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About 12 hours after vaccination experienced chills, body aches, intermittent headache and general discomfort. This lasted about 5-6 hours after which there was less aching but could tell that fever persisted, felt sluggish and warm. Temp was 99.9 at the highest over a 2-3 hour period. Ibuprofen was taken about 5 hours after the symptoms started, but only once. Late morning of 01/12 symptoms subsided and felt normal.
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| 58 | 2021-01-11 | chills, headache, fever |
Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grad...
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Aprox. 12 hours after receiving the vaccine, I developed the following symptoms: headache, low-grade fever, chills, muscle/body aches, nausea, vertigo, primarily muscle/body aches. My symptoms resolved aprox. 36 hours later. Aprox. 60 hours later, I had a couple of episodes of diarrhea, and was just feeling a little "spacey" and slightly tender behind my eyes.
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| 58 | 2021-01-11 | fever, fatigue, chills, dizziness, headache |
Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild...
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Chattering teeth, chills, fever 100.4, lightheaded, dizzy, black out fall to floor, body aches, mild headache, cotton headed, fatigue, left arm pain, neck/shoulder aches
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| 58 | 2021-01-11 | headache | Constant headache that began a day or two after I had been given the injection. |
| 58 | 2021-01-11 | headache | Muscle and joint pain. The worst headache I've ever had made me feel nauseous. |
| 58 | 2021-01-11 | chills, fatigue, fever |
Night after vaccine fever chills nausea and body aches Next day mild fever and body aches with fatig...
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Night after vaccine fever chills nausea and body aches Next day mild fever and body aches with fatigue Fatigue only two days after vaccine
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| 58 | 2021-01-11 | dizziness, chills, cough, shortness of breath, fever, malaise, body temperature increased, headache |
Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By We...
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Received vaccine on Monday by Wed afternoon lower abdominal cramping and feeling very unwell. By Wed evening had chills and low grade fever 99.4. Called out of work Thursday. Felt terrible. Thursday morning lower abdominal cramping consistent and pain scale between 4-5 with occasional spikes to 8. Also felt terrible. Had body aches, could only lay on couch. Called my gastroenterologist. Office returned call late afternoon and stated probably from vaccine and if it worsens or fever to call primary and to fill out VAERS form. Thursday evening had temp of 100.4 and started with a cough where it felt I couldn't take deep breaths. Only lasted a few hours. Abdominal pain persisted. Friday morning woke up and now have headache, but abdominal pain is now down to a 2 and I feel achy, but feeling a bit better. Had to call out of work still too sick to go in. No cough. No fever. Since I was feeling better my hope was since it was vaccine related that I would wake on Saturday and be totally fine, unfortunately, not the case. Saturday morning abdominal pain same at a 2 and headache was on and off through the day into the night. Still pretty much rested all day into the night. Sunday morning much better. Headache gone and abdominal pain down to a 1 and sometimes just vague. Although I'm feeling better my head feels out of sorts, kind of like my brain can't keep up with my eyes? And new symptoms? right ear crackling and teeth on right side feel sensitive also, pain under left armpit. It's tender and lasts through the day. Monday still feeling a bit lightheaded and fatigued and armpit pain still there but not worse and feel able to go to work to see if I can. Tooth sensitivity also still there but ear pain gone. Called primary doctor she suggests getting Covid test and have appointment for phone conference for Tuesday with doctor, also had Covid test today at work (was Covid tested last Monday also for work and negative) into Monday night head is still feeling "off". Tuesday armpit pain still same and dizzy head feeling same, mild abdominal pain comes and goes - Not bad enough to stop daily activity. Spoke with primary doctor and she said side effects could possibly last this long and let her know when yesterday's Covid test comes in.........
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| 58 | 2021-01-11 | shortness of breath, headache, chills, fever, fatigue |
Severe Body Aches and Pain, Headache, Chills, Low Grade Fever, Exhausted, Labored Breathing, Nausea-...
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Severe Body Aches and Pain, Headache, Chills, Low Grade Fever, Exhausted, Labored Breathing, Nausea- Covid-19 Symptoms
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| 58 | 2021-01-11 | head discomfort |
Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. ...
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Vaccine Adverse Event Reporting System, I received the first Pfizer Vaccine (EH9899) on 12/19/20. A few days later, I felt like my head, on the side of my right ear, had a great deal of pressure in it and it felt "funny " but it did not really hurt. It was uncomfortable and distracting. I waited to see if it would go away. I noticed my hearing was decreased . On 01/06/20 when I woke up, my hearing was completely gone in my right ear. I could hear nothing out of that ear. I had a noise in my head. Just a loud roaring noise. I had severe vertigo and could not walk across the room. I describe this as I felt like I was on a merry-go-round and someone was spinning me really fast. (continue) Additional information for Item 18: Vaccine Adverse Event Reporting System, continued: I also experienced severe vomiting and could not stop. My husband took me to the doctor. Since I could not get in to my regular doctor that day, we went to an ear doctor I had visited a couple of years ago because that was the only person I could find to see me on short notice. I had regular hearing test in the past and my hearing was normal last time he checked it. After doing a hearing test, he verified my Hearing was severely decreased in my right ear. I explained to him, I also feel "foggy" and I have problems concentrating, was having vertigo, and vomiting. I am not sure if that is because of the constant sound in my ear that distracts me but it is a definite problem and interferes with my work. I cannot concentrate. He started me on Steroids (Prednisone) 60 mg a day for 7 days, then 40 mg for 3 days, then 20 mg for three days, Antivert 12.5 mg three times a day as needed, and Zofran for the vomiting if I needed that. I have not experienced anymore vomiting and the Vertigo has been very limited. Mostly when I lay down now instead of when I stand up. My blood pressure has also been slightly elevated, but it could be from the Steroids. I was scheduled to take the 2nd Pfizer Vaccine on 01/09/21. Since I was receiving the high doses of Steroids, I was concerned that the vaccine would not be effective or may interact with the steroids so I went to my family doctor 01/08/21, for a visit. He said he would check and let me know if it was contraindicated for me to take the Vaccine on high doses of steroids. When I did not hear from him, because I had to take the vaccine the next day, I called the Pharmacy and talked to someone there and they told me the agency was still recommending you take the Vaccine even if you are on the steroids. I received the second Pfizer Vaccine on 01/09/21. My hearing is now coming and going but I can hardly hear anything out of that right ear. . There is a constant noise, like a roaring, in my head and I still have problems concentrating. I have had no more vomiting and my vertigo has hot been as severe but I have experienced some at times. I reported to the Pharmacy the day I received my vaccine, 01/09/21, about the things I had experienced this since my first vaccine. They took my information and said they would call me but today is 01/12/21 and I have not heard from them yet so I thought I would go ahead and report this. I am concerned this was an adverse reaction to the vaccine. I return to the doctor 01/20/21 for a repeat hearing exam. The Doctor expressed this condition could be a permanent and disabling issue but currently being treated and will follow up with more testing. I am also concerned about how the second vaccine affected me because I was receiving the high doses of Steroids at the time I received it. I am sending this from a work email so if you reply, please reply to personal email.
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| 58 | 2021-01-11 | fatigue, chills, headache, body temperature increased, malaise |
Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with...
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Very sore arm hours after vaccine and couldn't move arm during the night- took motrin at 3:30AM with some effect. Felt OK otherwise until 12 noon on 1/6/21 when I suddenly felt chilled and not well. Temp went up quickly from 99.4 at 12 noon to 102.4 at 5PM. Temp 101.5 at 9PM. Had abdominal cramping, general body aches and muscle pains, H/A and left breast tenderness as if I was going to get my period (which I haven't had for 8 years). On 1/7/21 at 7AM temp- 99.7 and 98.8 at 11AM, but still felt tired, H/A, malaise, no appetite. Back to normal good health on 1/8/21 AM. Left arm was sore for 4 days.
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| 58 | 2021-01-11 | throat swelling, dizziness |
c/o throat feels full and tight, dizzy, reacted same way with first vaccine, Benadryl 25mg po given ...
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c/o throat feels full and tight, dizzy, reacted same way with first vaccine, Benadryl 25mg po given at 1438. Patient left at 1505 with no changes in severity, patient states they are ready to go.
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| 58 | 2021-01-11 | weakness, chills, fever, headache, fatigue |
chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours...
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chills; body aches; fatigue; weakness; H/A; Temp was 99.4 and went up to 102.4 over the next 3 hours; very sore arm which became worse overnight to the point she couldn't move her arm; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246), via an unspecified route of administration at Left arm on 05Jan2021 14:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at workplace clinic. Medical history included covid-19 from 04Sep2020, Penicillin allergy. Concomitant medication in two weeks included lithium, sertraline, fish oil (OMEGA 3 FISH OILS), ergocalciferol (VIT D). There were no other vaccines administrated on same date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took metronidazole (FLAGYL) and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. On 05Jan2021 at 17:00, the patient experienced very sore arm which became worse overnight to the point she couldn't move her arm. On 06Jan2021 at 12 noon, she started to get the chills, body aches, fatigue, weakness and H/A. Temp was 99.4 and went up to 102.4 over the next 3 hours. The patient took ibuprofen (MOTRIN) 400mg at 3:30 AM with some effect. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.
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| 58 | 2021-01-11 | dizziness | dizziness, nausea taking meclizine . Still experiencing dizziness as of 1/12/2021. |
| 58 | 2021-01-11 | sweating, discomfort, malaise, fatigue, chills |
immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really swe...
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immune deficiencies; She said the joint pain felt like "flu" joint pain; She said she was really sweaty, so much so, that she had sweat under her eyes; thyroid problems; feels shaky inside; Numbness facial; Exhaustion; Foggy feeling in head/feeling rundown; felt exasperated; sweating like crazy and then gets chills; felt yucky/she didn't feel good at all; Joint pain; Nausea; Chills; after receiving the COVID-19 Vaccine on (Dated), she had left upper shoulder pain.; She clarified she had some injection site pain; and the injection site was a little itchy; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246), via an unspecified route of administration on 02Jan2021 14:30 at single dose in the left upper arm for COVID-19 immunization. Medical history included Pernicious anaemia from 2006 and ongoing, Hashimoto's disease ongoing, stated she was diagnosed with Hashimoto's disease in either 1994 or 1995. Psoriatic arthritis from Nov2020 and ongoing. Potassium low ongoing, reported she has had low potassium off and on for years. She said she can't remember when she didn't have low potassium. She said she normally finds out her potassium is low when she has blood work done. She stated she has had low potassium most of her adult life. IgA deficiency from Feb2019 and ongoing, Psoriasis ongoing, paralysis in her left trapezius muscle. Concomitant medication included B-12 for pernicious anemia. She said she had the typical reactions that one might get with a vaccine. She clarified she had some injection site pain and the injection site was a little itchy on 02Jan2021. She stated on the second day (03Jan2021) she had joint pain, felt yucky, had nausea, and chills. She said the next day (04Jan2021) she felt a little better, but still had chills. She said yesterday (05Jan2021) she thought she was feeling better, but by yesterday, clarified as late afternoon and evening, she crashed. She said she has a lot of autoimmune issues and immune deficiencies, saying she has pernicious anemia and Hashimoto's disease. She said yesterday evening she experienced extreme body temperature issues. She said she was really sweaty, so much so, that she had sweat under her eyes. She said she would get really hot and had chills. She said she was feeling really bad and was feeling shaky inside. She said she thought it was important that she report what she was experiencing to Pfizer. She stated she has psoriatic arthritis, too. Reported after receiving the COVID-19 Vaccine on 02Jan2021, she had left upper shoulder pain. She clarified that she had a previous history of paralysis in her left trapezius muscle and had surgery in 1998 on her left shoulder. She said she had a weird feeling that went around where her scar was from the surgery on the back of her left shoulder. She said maybe the left shoulder pain had to do with how she held her left shoulder. She said on Monday, 04Jan2021, she had a little bit of pain in her left shoulder and by yesterday night, 05Jan2021, there was not much pain at all. Clarified her joint pain was in her ankles, wrists, hips, neck, back, and knees. She said the joint pain felt like "flu" joint pain. She stated she normally has joint pain with the other issues she has, but this joint pain felt different. She said the joint pain she experienced after taking the COVID-19 Vaccine was all over her body. She said yesterday (05Jan2021) her joint pain felt so much better, but later in the afternoon she didn't feel right. She said she has pernicious anemia, and thought maybe she needs her B-12 shot. She said yesterday (05Jan2021) she experienced a lot more symptoms. She said she had numbness in her face, felt extremely exhausted, had a foggy feeling, and felt exasperated. She said the symptoms didn't start until late in the afternoon into the evening of 05Jan2021. She said she did not feel well and went to bed at 8:45PM, which is early for her. She said she did give herself a B-12 1mcg/ml shot intramuscularly yesterday. She provided the B-12 1mcg/ml NDC Number: 7006900510, Lot Number: C0495, and Expiration Date: Aug2022. She said the name (company name) was listed on the B-12 1mcg/ml packaging. She said she gives herself a B-12 shot every 10 days. She said she still has some joint pain, but the joint pain is not like it was on 03Jan2021. She said she still has a tiny bit of heaviness in her joints with a constant throbbing pain, which is a different joint pain from her normal. Reported last night (05Jan2021) she didn't feel good at all. She said she felt horrible, and had to go to bed. She said she felt shaky inside all night, and still feels that way now. She said she was sweating like crazy, and then would get chills. She clarified she is used to being hot and cold in her normal life because of her thyroid problems, but stated what she experienced last night was beyond that. She said her hot and cold issue was bumped up several levels last night. She said she was chilled or sweating all the time last night, but did not have a temperature. She clarified her normal body temperature is 96.7, and when she checked her temperature at one point, her temperature was 98 degrees. Reported the hot and cold with sweating and chills, and nausea come and go. She said if she has nausea, it is a mild feeling of nausea. Clarified if Sunday, 03Jan2021. was a work day, she would have called out sick. She said Monday (04Jan2021) and Tuesday (05Jan2021) she did go to work. Reported she has low potassium and made herself an electrolyte cocktail. Reported if her system feels off, she said her electrolytes maybe off. She said her heart felt like it may be shaky, so she ate a banana to get potassium in her system. She said she does her little routine before she would call her doctor to get blood work done. She said she had her blood work done not too long ago. She said she wasn't feeling this way before she had the COVID-19 Vaccine, and is feeling rundown now. She said she was feeling good before she had the COVID-19 Vaccine. She said she feels like something is going on with her body now. Reported her last blood work was done on 04Dec2020 and everything was kind of normal. She clarified her thyroid was a little off, and her doctor adjusted her medication. She said her potassium was a little down. Reported she was told when she got the COVID-19 Vaccine shot she has to be a little more careful, and she might not be as protected as some people. She said she was told there have not been enough studies on the COVID-19 Vaccine. She clarified she was told that information by a person at the site where she received the COVID-19 Vaccination, saying the person was helping her with the COVID-19 Vaccination authorization form. Reported she thought she was doing OK after she received the COVID-19 Vaccine, until after last night and yesterday afternoon. She said if she continues feeling the way she is, she will see her doctor. She said her system seems off. She said she normally tries everything she knows first, like drinking a lot of water, and drinking electrolytes, and will take potassium to see if that is the issue. She said those are her own things that she does before she calls her doctor. Clarified sometimes she has numbness in her face due to not having her B-12. She said she still has a little numbness in face. She said on 05Jan2021, the numbness went across her face from the bridge of her nose down through to her mouth. She said the numbness was nothing like paralysis in her face, but her face was really hot at the same time she had the numbness. Reported she took Tylenol (clarified as (company) brand Tylenol, stating she doesn't have the UPC, Lot and Expiration Date). She said the Tylenol wasn't kicking in, so she took Ibuprofen (clarified as (company)brand Ibuprofen, and she doesn't have the Ibuprofen NDC, Lot and Expiration date). She said she took her normal medications. Outcome of events "She clarified she had some injection site pain" "and the injection site was a little itchy" and Shoulder pain were recovered on an unspecified date, "Chills" and "feels shaky inside" were not recovered, "Joint pain" "Nausea" "Numbness facial" were recovering, while outcome of other events was unknown.
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| 58 | 2021-01-11 | runny nose, dizziness, shortness of breath, fatigue, headache, respiratory tract congestion |
tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste a...
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tested positive for COVID-19; tested positive for COVID-19; loss of taste and smell; loss of taste and smell; excruciating headache; runny nose; congestion; shortness of breath when she started talking; having aches and pains; lightheaded, experienced dizziness; tied; This is a spontaneous report from a contactable consumer(patient). The 58-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685, intramuscular injection ), intramuscularly in left arm on 23Dec2020 at single dose for COVID-19 vaccination in nursing home. Medical history included she had a right knee injury so she had some inflammation, She had stomach issues in the past- Barrett's syndrome, H. pylori(Helicobacter infection), GERD(Gastrooesophageal reflux disease), so, Pantoprazole is just a maintenance medicine, she was stable right now. She had a Vitamin D deficiency at one point. Ongoing concomitant medication included meloxicam for inflammation, thyroid for thyroid(Thyroid disorder), pantoprazole for stomach issues, colecalciferol (VITAMIN D 3) for supplementation therapy. There was no vaccination within 4 weeks. She received her first vaccine on 23Dec2020. There no other vaccine received in the same day. By 26Dec2020, she started with symptoms and then she tested positive for COVID-19 on 29Dec2020. She felt horrible with an excruciating headache and was wondering if she was going to die now. She can really feel for the residents she works with who get it. Right now, she was hopefully going back to work next week, but she was wondering about the second vaccine. People are saying she got COVID-19 because of receiving the first vaccine and she was hoping it was not the case. Is it going to be an issue getting the second vaccine after testing positive? The caller declines to include her healthcare professional for this report, stating she has been talking with her doctors over the week. Her symptoms included runny nose, congestion, and what seemed like shortness of breath when she started talking. She started having aches and pains over the weekend. By Monday, 28Dec2020, there was loss of taste and smell, it was totally gone. She also was lightheaded, experienced dizziness, was tied. She went through a lot of symptoms which was shocking to her. She clarified these symptoms first began the morning of the 26Dec2020. Christmas she was fine, and then she to go out to get snow off of her car and do some running around on 26Dec2020 and she noticed she started having symptoms. When probed for outcome, the caller state she was most definitely feeling better. She was having some excruciating headaches and she has worked with her doctor on what they needed to do. She is still working with the doctor on her lightheadedness. She has set up a follow-up appointment, but she was feeling better. There was no emergency room nor physician office. Relevant test was none. It was also reported lot number was either EJ1685 or EJ1085, she can't tell. Outcome of loss of taste and smell was recovered, of dizziness was not recovered, of other events was recovering.
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| 58 | 2021-01-11 | chills, headache |
very bad joint pain; headache; chills; body pain/body aches; back pain; This is a spontaneous report...
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very bad joint pain; headache; chills; body pain/body aches; back pain; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 28Dec2020. On 01Jan2021, she had very bad joint pain, headache, body pain/ body aches and chills; but no fever, most have gone away but still have back pain. She doesn't have any shortness of breath or fever. She added that she was confused if this was from the vaccine or from Coronavirus and queried what she should I do. She confirmed that she did not get tested for corona virus. She did read that her symptoms could be from vaccine. She also asked that, since she received the vaccine, if it will affect the results of test for corona virus i.e. false positive. The outcome of the events very bad joint pain, headache, body pain/ body aches and chills was recovered on an unknown date in Jan2021 while not recovered for back pain. Information about Batch/Lot number has been requested.
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| 58 | 2021-01-12 | fatigue, chills, headache, body temperature increased |
1/12/21 1:00 AM violent chills, 5:00 AM temperature 102.6, took Acetaminophen. Exhaustion, throbbin...
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1/12/21 1:00 AM violent chills, 5:00 AM temperature 102.6, took Acetaminophen. Exhaustion, throbbing joints. 2:00 PM temperature 101.8, took Acetaminophen, chills, headache, horrible pounding joint pain. 7:00 PM temperature 100.9, chills and exhaustion, took Acetaminophen . 1/13/21 4:00 AM, chills, temperature 100, took Acetaminophen. 9:00 AM exhaustion, massive body aches. 4:00 PM temperature 98.9, chills, exhausted. Have slept about 36-40 hours and lost 2 days of work.
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| 58 | 2021-01-12 | headache, fatigue, fever |
7 hours after 2nd inj developed fever 101, headache, exhaustion and severe body aches nausea. lasted...
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7 hours after 2nd inj developed fever 101, headache, exhaustion and severe body aches nausea. lasted 24hour, better now
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| 58 | 2021-01-12 | shortness of breath, headache, dizziness |
After about 10 min from administration, pt c/o dizziness, and headache with sharp pain to L side of ...
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After about 10 min from administration, pt c/o dizziness, and headache with sharp pain to L side of head. GIven apple juice. Transferred to wheel chair. B/P: 162/105. Pulse ox 98, heart rate 93. . Transferred to bed in holding room. Remained dizzy with headache, B/P 155/93. Pulse ox 100%, heart rate 90. Complained of difficult to breathe laying flat. Elevated HOB to 30. Patient states feeling lik eshe could breathe better. Complains of nausea, but taking sips of water.. Pt has history of hypertension with self-reported baseline of 135/90's. Given water, allowed to rest. At 1421, BP 141/93 but remains dizzy, despite dark environment. At 1427. patient verbalizes still dizzy. Verbalizing stomach upset, nausea. AT 1437, Pt Vomit. B/P 158/105. Report given to ER nurse. Pt transferred to ER at 1450.
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| 58 | 2021-01-12 | malaise, headache, chills | Chills, Headache, Feeling Unwell, Sore Arm |
| 58 | 2021-01-12 | fatigue, fever, chills | Fever, chills, body aches, fatigue |
| 58 | 2021-01-12 | fever, headache, fatigue, chills | Headache , Chills, aches and pains, muscle pains, joint pain. Fatigue , had a fever for 18 hours |
| 58 | 2021-01-12 | headache |
ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, AND INJECTION SIGHT PAIN. LASTE...
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ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, AND INJECTION SIGHT PAIN. LASTED 48-72 HOURS BEFORE RESOLVING.
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| 58 | 2021-01-12 | headache |
ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, INJECTION SITE PAIN LASTING 48-7...
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ON 12/31/20, DEVELOPED MID BACK PAIN, JOINT PAIN, MASSIVE HEADACHE, INJECTION SITE PAIN LASTING 48-72 HOURS.
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| 58 | 2021-01-12 | chills, fatigue, headache, fever |
Received vaccine at 4:40pm. Approximately 8pm I started with stomach cramps and had those for a few ...
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Received vaccine at 4:40pm. Approximately 8pm I started with stomach cramps and had those for a few hours. During the night I tossed and turned and my hips were very achy. I woke with a fever that went as high as 101 and was very shivery all day. Fever reduced with Ibuprofen around 6 in the evening. Seemed to feel better. Very restless though the night and hips achy and awoke with a fever. Took Iuprofen. Fever reduced and slight headache. Tired but much better today.
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| 58 | 2021-01-12 | chills, fever, fatigue |
Red, hot and raised at injection site.; Red, hot and raised at injection site.; Red, hot and raised ...
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Red, hot and raised at injection site.; Red, hot and raised at injection site.; Red, hot and raised at injection site.; Chills; Low grade fever; Fatigue; Body ache; This is a Spontaneous report from a contactable nurse (reported for herself). A 58-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), intramuscular on 04Jan2021 12:30 at single dose at right arm for COVID-19 immunization. Medical history included Vasculitis, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included azathioprine (IMURAN [AZATHIOPRINE]), chlorthalidone, duloxetine hydrochloride (CYMBALTA), hydroxychloroquine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 14:00, the patient experienced red, hot and raised at injection site. 18 hours after receiving, she developed chills, low grade fever, fatigue and body ache on 05Jan2021. Treatment received for the adverse events included Tylenol. This report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
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| 58 | 2021-01-12 | dizziness, chills |
Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (pat...
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Systemic: Chills-Mild, Systemic: Vomiting-Mild, Systemic: hypotensive, heat flashes, dizziness, (patient recovered before leaving for ER, only sent due to past cardiovascular events)
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| 58 | 2021-01-12 | headache | arm discomfort and mild headache |
| 58 | 2021-01-12 | fatigue |
fatigue; patient received the second dose in less than 21 days from the first dose; tenderness in t...
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fatigue; patient received the second dose in less than 21 days from the first dose; tenderness in the arm; This is a spontaneous report from contactable nurse, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the left arm on 04Jan2021 (at the age of 58-years-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), vitamin B complex (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), ascorbic acid (VIT C), and multivitamins (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 on 17Dec2020 at 08:00 (Lot Number: EK5730; at the age of 58-years-old) for COVID-19 immunization in the left arm and experienced severe arm pain. The patient did not receive any other vaccines within four weeks prior to the second vaccination (except the first vaccination). On 04Jan2021, the patient had tenderness in the arm. The patient took acetaminophen (MANUFACTURER UNKNOWN) which helped. On 05Jan2021, the patient experienced fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the tenderness in the arm and fatigue were recovered on unknown dates in Jan2021.
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| 58 | 2021-01-12 | chills, fever | spiked fever of 101.5 severe uncontrollable chills full body aches nausea |
| 58 | 2021-01-13 | headache, dizziness |
"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When...
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"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When I awoke on Saturday the 9th my arm was very sore at injection site but later went away. I had a dull headache, nausea, I was yawning all day, muscle fatigue, esp my quads, lightheaded enough to lay on the floor a few times during day. These symptoms did not stop me from painting, but I did feel horrible but I pushed through it. Sunday still nauseous, just feeling not my self..... I awoke on Monday morning and I was 100% fine!"
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| 58 | 2021-01-13 | headache, dizziness | Arm soreness, headache , body aches, dizzy, ears ringing |
| 58 | 2021-01-13 | headache | Body Aches, Headache, Sore Arm, Diarrhea |
| 58 | 2021-01-13 | malaise |
Employee had irritated skin and rash extending down her trunk area and sides. Employee took liquid b...
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Employee had irritated skin and rash extending down her trunk area and sides. Employee took liquid benedryl for the minor allergic reaction.
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| 58 | 2021-01-13 | respiratory tract congestion, throat pain, fatigue, chills |
Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches ...
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Heart Palpatations started first lasted about 15 minutes, then sore throat, congestion, body aches and severe fatigue, injection site pain and chills.
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| 58 | 2021-01-13 | dizziness, headache |
Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lighthead...
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Within minutes of receiving first COVID vaccine, patient experienced a feeling of warmth, lightheadedness and elevated blood pressure of 210/110. BP down to 170/100 at the time of leaving appointment (20 minutes after shot). The next day she felt nausea, Ha, body aches and burning sensation down the arm of the injection.
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| 58 | 2021-01-13 | malaise, headache |
sick to stomach and headache within 15 minutes, then about 1/2 hour later broke out in hives and had...
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sick to stomach and headache within 15 minutes, then about 1/2 hour later broke out in hives and had to go to emergency room and get some Benadryl and stay and be monitored for hour.
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| 58 | 2021-01-13 | skin warm | swelling, redness, warmth |
| 58 | 2021-01-13 | body temperature increased | woke 15 hours after vaccine with temp 101.5 and body aches. symptom subsided in 8 hrs |
| 58 | 2021-01-14 | dehydration, dizziness |
1/12-N/V was vomiting every 15 mins. Started about 1300 after getting the vax. by 1430 starting vomi...
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1/12-N/V was vomiting every 15 mins. Started about 1300 after getting the vax. by 1430 starting vomiting uncontrollably. HA. Sx worsened through the night. Felt extremely dehydrated and dizzy. Went to ER on 1/13 in the AM, got IVF, Zofran IV, Phenergan IV, Benadryl, Toradol, Dilaudid. D/C'd home 1/13 Thurs-no nausea, felt achey 1/14 Friday (today)-sore. Feels ok, working from hom.e
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| 58 | 2021-01-14 | headache, dizziness |
After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizz...
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After 15 minutes felt dizzy when got up to walk. Sat back down for about half hour. Still felt dizzy, but went home. Began to feel nauseated and headache which continued from Saturday through currently. On Wednesday 4:00 a.m woke up to feeling of itchyness in chest. It spread to stomach, then legs, arms, face, back head in about an hour and a half. Took a shower and then felt burning. called doctor next morning at 10:30 and told to start benadryl and allegra. Stared about 1:00 pm. very drowsy and increased headache and nausau. Could still feel burning. Continued with about 3 does. Work up 12:38 on Thursday morning with increased burning and itching and benadryl was last taken 7 and half hours before. Did not take benadryl on Thursday due to drowsyness. Did not work Wednesday or Thursday. Friday early morning hours, woke up several times with itchiness and burning. This is all over my body. No rash at any time. Continued headache and nausea.
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| 58 | 2021-01-14 | runny nose, chills, fever | Full body aches, fever to 101, shivers, runny nose Tylenol and Advil |
| 58 | 2021-01-14 | chills, malaise, fever |
Intense shivering that lasted for about 1/2 hr, though I was not cold and did not have a fever. Aft...
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Intense shivering that lasted for about 1/2 hr, though I was not cold and did not have a fever. Afterwards, muscles ached all over body. Took 200mg of ibuprofen and felt better but not entirely back to normal. Malaise continued next day.
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| 58 | 2021-01-14 | headache, chills, fatigue, fever |
Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever...
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Left arm pain from shoulder to elbow; extreme fatigue; headache; joint pain; chills; low grade fever; nausea; This is a spontaneous report from a contactable Other HCP reported for herself (patient). This 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via an unspecified route of administration from 07Jan2021 at 15:45 at single dose on left arm for COVID-19 immunisation. Medical history included COVID-19 and was sick for 17 days, no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. The patient experienced left arm pain from shoulder to elbow, extreme fatigue, headache, joint pain, chills, low grade fever, nausea on 07Jan2021 at 21:00. Symptoms started five hours after injection and did not abate until about 64 hours after vaccination. No treatment was received for the events and all considered as non-serious. The outcome of the events was recovered in Jan2021.
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| 58 | 2021-01-14 | fatigue |
Patient is concerned about lymph nodes, says that they developed under her arm as swollen and tender...
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Patient is concerned about lymph nodes, says that they developed under her arm as swollen and tender. Slight fatigue
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| 58 | 2021-01-14 | headache, fatigue | Severe headache, nausea, fatigue, bodyaches. Unable to work that day after receiving vaccine |
| 58 | 2021-01-14 | body temperature increased, fatigue, headache |
Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle ach...
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Within 10-12 hours after vaccine administration, Pain/burning in left arm and severe body/muscle aches (8/10 on pain scale). Headache (4/10). Fatigue. Temperature 100.1. Took Ibuprofen and Tylenol 1st through 5th day. Temperature was under 99.0 by 4th day. Above side effects were bearable with Ibuprofen by 4th day and only arm soreness by 5th day. **Of note, I was diagnosed with COVID on September 11, 2020 and had since recovered.
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| 58 | 2021-01-14 | headache | vomiting, headache, nausea, joint pain. called in sick to work. |
| 58 | 2021-01-15 | dizziness, chills, fever |
Chills,fever,almost fainting,numbness in hands ,arms,shins,hyperventilating. Symptoms started the ni...
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Chills,fever,almost fainting,numbness in hands ,arms,shins,hyperventilating. Symptoms started the night of the vaccine. Went by ambulance to ED
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| 58 | 2021-01-15 | fever, chills | Fever chills aching and nausea and diarrhea and fever blister |
| 58 | 2021-01-16 | headache, body temperature increased, chills, dizziness |
1/15/21 at 0900 injection. some mild headache between then and 2300 when I had chills, headache, bod...
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1/15/21 at 0900 injection. some mild headache between then and 2300 when I had chills, headache, body aches, Nausea, T 100.2 F. 1/16/21 0200 took Tylenol 500mg nausea, chills HA T 100.8 at 0410 symptoms continue and I i still had insomnia (that is not uncommon for me) symptoms were a bit milder. 0420 took 500mg Tylenol, 1030 500 mg tylenol HA nausea dizzy T 100.8F. 2345 bad again. took 1000 mg Tylenol and a 3mg tab of Lunesta. body aches HA nausea chill dizzy T 100.7. Overnight I had a bout of terrible night sweat and the bed and pillow and night clothes were soaked (not menapausal related) 1/17/21 0830 T 97.8 feel a bit better. as the day goes on I notice when I move around, especially quickly I have a horrible pain in my head and dizziness. at 1700 T99.9 nausea, dizzy HA.
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| 58 | 2021-01-16 | fever | Fever Muscle aches |
| 58 | 2021-01-16 | skin warm, fatigue, headache, nasopharyngitis, body temperature increased |
Immediately after injection, felt itching. I had taken 400 mg ibuprofen prior to my injection. 12hr...
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Immediately after injection, felt itching. I had taken 400 mg ibuprofen prior to my injection. 12hrs later, stiffness in right upper trapezius and shoulder, took 440 mg naproxen and felt great! 24 hours after 2nd dose, redness. Itching and swelling at injection site. Tired, cold, temp 100.4. Applied ice 20 min on/off throughout day, took ibuprofen 1/16/21. Today 1/17/21, still red, warm to touch and itchy. I took a photo because I couldn?t tell if red area bigger. temp 99.4, slight headache
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| 58 | 2021-01-17 | fever | ARM PAIN, FEVER 101, JOINT PAIN FOR 24 HRS. TOOK TYLENOL 500MG 2 TABLETS |
| 58 | 2021-01-19 | shortness of breath |
1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21...
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1/4/21- Patient stated she had tenderness on the back of her left lower leg with redness then 1/8/21 started to have shortness of breath and made a doctor's appointment for 1/13/21. Seen by provider on 1/13/21 and was sent to ED and admitted to the hospital [ICU] with NSTEMI, acute deep, occlusive venous thrombosis left femoral vein and saddle embolus of pulmonary artery. Transferred to another acute care hospital for removal of thrombosis. Patient started on Eliqus and no intervention for removal of the thrombosis.
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| 58 | 2021-01-19 | chills | Chills, seizure like activity, body aches, injection site soreness |
| 58 | 2021-01-19 | fever, headache, fatigue |
Fatigue, headache, fever (99.9- 100.9), body aches Fatigue started 5 hours after receiving vaccine; ...
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Fatigue, headache, fever (99.9- 100.9), body aches Fatigue started 5 hours after receiving vaccine; Fever, body aches & headache started about 8- 10 hours after receiving vaccine. Lasted until 36 hours after receiving vaccine
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| 58 | 2021-01-19 | fever, malaise, sweating |
I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet w...
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I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive.; I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day; I woke up at midnight and felt extreme malaise; I was covered in sweat; vomited; I checked my temp and it was 99.7°F; sore; I think I had either a seizure or a vasovagal response.; This is a spontaneous report from a contactable nurse (patient). This 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular at single dose in the left arm on 09Jan2021 06:00 for Covid-19 immunisation. Medical history included atrial fibrillation on unknown date (1 episode), allergic to Keflex. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot EJ1685 or FJ1685), intramuscular in the left arm on 22Dec2020 for Covid-19 immunisation. On 10Jan2021 01:00 AM, the patient experienced: I began to pass out and yelled for my husband, he said when he came in i was sitting on the toilet with my head back, eyes rolling back not responsive (loss of consciousness) (medically significant), I had my 2nd vaccine at work early sat the 9th and felt increasingly worse all day (feeling abnormal), Iwoke up at midnight and felt extreme malaise (malaise), I was covered in sweat (hyperhidrosis), vomited (vomiting), I checked my temp and it was 99.7°F (pyrexia), sore (pain), I think I had either a seizure or a vasovagal response (seizure). No treatment required. The outcome of the events was recovered. The events were described as follows: I am healthy RN with no active medical problems. I had my 2nd vaccine at work early Sat the 9th and felt increasingly worse all day, I expected this so was not alarmed and went to bed around 10pm. I woke up at midnight and felt extreme malaise and went to the bathroom in case I might vomit, etc. and I tried to have a BM. I began to pass out and yelled for my husband, he said when he came in I was sitting on the toilet with my head back, eyes rolling back not responsive. He yelled at me for about 10 seconds and I came to, I was covered in sweat. I asked him to walk me back to the bedroom where I again passed out, fell to the floor and hit the bed, then was unresponsive again for about 10 seconds then came to again and vomited. After this I felt completely relieved of my malaise. I checked my temp and it was 99.7°F. After this I was sore but otherwise completely okay, the next day I had a temp of 99.5°F. Today I am back to normal. I think I had either a seizure or a vasovagal response. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination.; Sender's Comments: Based on the close temporal relationship, the association between the event "began to pass out" with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 58 | 2021-01-19 | discomfort |
Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort d...
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Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort developed during the late night following injection.
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| 58 | 2021-01-19 | chills, headache |
On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home,...
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On Tues, 1/12 I started feeling like I was getting a cold because I got the chills when I got home, but not the flu because I had my flu shot in Oct.2020 Wednesday 1/13 I left work because I started with vomiting, diarhhea , a light headache and my arm was real sore. That continued on through that night and into the next morning. So I had to call in at work that morning 1/14. I finally started feeling better by friday night, 1/15. The headache was gone and the chills were only slight and I could finally keep some toast down. Before that I could only slightly keep liquids down.
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| 58 | 2021-01-19 | fatigue |
Reported nausea, but it went away. Feels tired. After conversation, possibly just anxiety. COVID ...
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Reported nausea, but it went away. Feels tired. After conversation, possibly just anxiety. COVID call center advised return to work.
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| 58 | 2021-01-19 | fatigue, headache |
Tiredness; Headache; This is a spontaneous report from a contactable consumer. A 58-year-old non-pre...
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Tiredness; Headache; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at 12:00 at single dose in left arm for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tiredness and headache on 12Jan2021 at 16:00. The patient did not receive treatment for the events. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 with Nasal swab on an unspecified date since the vaccination, with unknown result. The outcome of the events was resolved in Jan2021. Information on the lot/batch number has been requested.
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| 58 | 2021-01-21 | headache, dizziness | Bad headache with severe dizziness began a little over 24 hours after my second shot. |
| 58 | 2021-01-21 | headache, fever | Fever, Nausea, Headache |
| 58 | 2021-01-21 | chills, dizziness |
Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, v...
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Lightheadedness, dizziness, blurred vision, elevated BP with normal respiration and pulse, nausea, vomiting, chills, drop in body temp to 96F. Onset 10 mins post injection, increasing over the subsequent hour, subsiding x 1 hr then peaking 5 hrs later, resolved after 12 hours.
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| 58 | 2021-01-21 | fatigue |
Morning after vaccination noticed rash of small red areas and blisters on bilateral upper arms. Thur...
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Morning after vaccination noticed rash of small red areas and blisters on bilateral upper arms. Thursday rash had spread to legs, back, and neck. Pruritic rash that is tender to touch. Diarrhea began Thursday, 4-5 episodes in 1 day. Fatigue also began Thursday. Has tried 25mg benadryl on Wednesday and Thursday with no relief. No fever.
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| 58 | 2021-01-21 | headache |
On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen ...
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On 1/20 21 2nd injection around 10:00am sore left arm. around 2:45pm right eye slightly swollen - slight headache. On 1/21 3:45am right eye swollen, (but not swollen shut) a little ache -slight headache.
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| 58 | 2021-01-21 | dizziness |
Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy bu...
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Pt. developed itching of her upper palate almost immediately after the vaccine, transiently dizzy but that resolved quickly . Over the next few minutes she also developed erythroderma of bilateral forearms and hands, slight swelling of hands, reddened palms. We assessed her vital signs below, kept her in observation over the next 40 minutes. She denied difficulty breathing, she questioned if her voice was different, but was not detectable to 2 observors. Lungs remained clear, no stridor, no capillary refill delay. Gradually symptoms improved, erythroderma and hand swelling resolved over about 15 minutes. Pt. then noted possible tongue swelling, on the sides at 25 minutes post vaccine but again, no difficulty with breathing or swallowing. Vital signs continued to improve, pt. then stated itching was gone and tongue felt better so she was released and advised to return to E.R. in event of change. Pt. is a phyician.
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| 58 | 2021-01-21 | headache, migraine, malaise | Sick to stomach, migraine head ache |
| 58 | 2021-01-21 | dizziness, headache, fatigue, cough |
This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-o...
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This is a spontaneous report from a contactable other healthcare professional (Patient). A 58-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number provided as: LAB-1451-0.7), via an unspecified route of administration on 06Jan2021 14:30 at single dose in Left arm for COVID-19 immunization. Medical history included covid-19 from Mar2020 to an unknown date (the patient was sick with the COVID and was super tired). There were no known allergies. The patient's concomitant medications were none (there were no other medications received in two weeks). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, first 2 days dizziness, tiredness extreme, a little cough which all started from 06Jan2021 14:30. The patient also had pain on 2nd and 3rd day (onset date: 07Jan2021). The patient experienced heart beat fast everyday which started from 06Jan2021 14:30. The patient still had her left arm itching and hot as of 11Jan2021 but better with other side effects. Event onset date for her left arm hot was in Jan2021. No treatment received for the adverse events Itching more in the arm in the shot area, extreme joint pain, bones pain, headache, dizziness, tiredness extreme, a little cough, pain, heart beat fast, left arm hot. The patient stated she got the vaccine on Wednesday (06Jan2021) and after that she was feeling this thing but she was thinking was because of the Normal Saline, but in a little bit in the night she was very tired, super tired. Next day on 07Jan2021 she was to getting pain in her bones, very hard on her leg like when she was sick with the COVID last. The next day on 08Jan2021, she was having pain in her joints and her bones and muscles and she got the pain in her arm where she got the vaccine and was red and was like a big bump in her arm there. And next day she thought it was a Sunday morning on 10Jan2021, she had a little red, she had like redness in her face and itchy all her arms. So, and the patient feel very tired, super tired like when she was sick with this COVID-19 last March. She felt much better on 10Jan2021, the pain was a little less and her arm was much better and still itchy. The patient underwent lab test which included heart beat: fast on an unknown date. The outcome of events heart beat fast, got the pain in arm where the patient got the vaccine and was red and was like a big bump in her arm there and Redness of face, pain in muscles was unknown, the outcome of event itchy all her arms was not recovered, the outcome of the other events was recovering. This case reported as non-serious.
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| 58 | 2021-01-23 | fever, headache |
On Jan 22 I had fever, body aches and headache. Woke up on Jan23 and felt fine, no symptoms. At ar...
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On Jan 22 I had fever, body aches and headache. Woke up on Jan23 and felt fine, no symptoms. At around 2:30 on Jan 23 I had an argument with someone and felt my heart race for a minute and then chest pain radiating to my back. Went to the hospital at 7pm and was being ruled out for an MI.
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| 58 | 2021-01-24 | headache, chills, weakness, fatigue |
24 hours post vaccine developed heavy fatigue, chills, body aches, headache, and weakness for 8 hour...
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24 hours post vaccine developed heavy fatigue, chills, body aches, headache, and weakness for 8 hours, then slight headache and weakness continued an additional 12 hours.
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| 58 | 2021-01-24 | dizziness, chills |
Chills and dizziness for about 3 days after the shot, no medical treatment required but plenty of b...
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Chills and dizziness for about 3 days after the shot, no medical treatment required but plenty of bed rest and hot liquid.
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| 58 | 2021-01-24 | malaise, dizziness |
Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had ...
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Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had gastrointestinal issues; Nausea; Had allover muscle aches; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 10Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced dizziness that was bad the following morning, 11Jan2021. She said the dizziness was so bad, she had to have her husband take her to a dentist appointment because she did not feel safe driving. She said she was not feeling well, and was surprised her dentist even saw her that day. She said the dizziness resolved later that day by 7:00PM. Feeling Unwell Treatment: Reported she took 3 Equate brand Ibuprofen 200mg tablets (600mg dose) twice on 11Jan2021. Reported she didn't have a fever, but had a body temperature of 99 degrees Fahrenheit, saying her body temperature usually doesn't run that high. Reported she had gastrointestinal issues. She said she woke up yesterday, 11Jan2021, and was feeling bad. She said her symptoms hit all at once. She clarified she had diarrhea and nausea. She said the diarrhea remains as of this morning, 12Jan2021. She said as soon as she eats, the diarrhea is there. She said she is drinking PowerAde to keep her electrolytes going, but the diarrhea is wiping her out. She said she felt like she was hit by a Mack truck, or has a bad hangover. She said the nausea is gone, clarifying the nausea resolved this morning, 12Jan2021, upon waking up. Diarrhea Treatment: Reported she tried a generic Imodium, saying she took 2 generic Imodium tablets, and the generic Imodium didn't do anything. Reported she had allover muscle aches that started on 11Jan2021. She said her muscle aches improved, and she only has muscle aches remaining in her intestinal tract. Reported she told her doctor she felt horrible and was taking Ibuprofen for muscle pains and a slight fever. Outcome of event dizziness, Nausea was recovered, of Diarrhea was not recovered, of muscle aches was recovering, of others was unknown.
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| 58 | 2021-01-24 | fatigue | Fatigue, nausea, diarrhea, chest pain |
| 58 | 2021-01-24 | headache, cough | Headache, cough ,wheezing, stomach pain |
| 58 | 2021-01-24 | fever, headache |
Usual: aches, pain at site, headache Unusual: fever >103, gross hematuria (no history of UTIs or ki...
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Usual: aches, pain at site, headache Unusual: fever >103, gross hematuria (no history of UTIs or kidney stones)
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| 58 | 2021-01-25 | chills, dizziness, fever | Fever, chills, dizziness, all began 23 hours after 2nd dose, subsided 12 hours later at 10 pm |
| 58 | 2021-01-25 | cough, chills, fever, fatigue, headache |
First fatigue, then headache, progressing to chills with fever up to 102 lasting approximately 24 ho...
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First fatigue, then headache, progressing to chills with fever up to 102 lasting approximately 24 hours, body/joint aches, deep cough, felt like I couldn't get a deep breath (shallow breathing)
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| 58 | 2021-01-25 | nerve pain | Nerve pain on her back. It is in the same spot where she had previously had shingles pain |
| 58 | 2021-01-25 | dizziness, headache |
PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAI...
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PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS. SHE WAS PLACED IN A LOUNGE CHAIR AND VITALS WERE TAKEN. ALLERGIST CONTACTED AND ADVISED THE PT TO TAKE ZYRTEC NOW AND BID FOR THE NEXT 3 DAYS,. PT TOOK THE DOSE AND UNDERSTOOD THE INSTRUCTIONS. VITALS IMPROVED AND HER ITCHING SUBSIDED. HER ONLY REMAINING SYMPTOM WAS A HEADACHE THAT DEVELOPED AFTER TAKING THE ZYRTEC. SHE WAS GIVEN ICE PACK FOR HER HEAD AND ENCOURAGED TO DRINK FLUIDS. PT STATED SHE FELT FINE AND WANTED TO LEAVE TO RETURN TO HER UNIT SO SHE LEFT OBSERVATION AT 1:31PM.
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| 58 | 2021-01-25 | headache, weakness, chills, cold sweat, sweating |
This is a spontaneous report from a contactable consumer. A 58-year-old female patient received firs...
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This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.
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| 58 | 2021-01-25 | fatigue |
Tiredness/exhausted; injection site pain in her right arm; This is a spontaneous report from a conta...
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Tiredness/exhausted; injection site pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, unspecified lot number, reported as EH9899 or TH9899), intramuscularly at site of right arm at 10:00 on 20Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN, lot number: 300045; Expiration date: May2022) from Jan2021. The patient previously took cetirizine hydrochloride (ZYRTEC) daily for allergies forever. Clinical course: Patient received the first dose of the BNT162B2 on 20Dec2020, and was tired afterwards, she didn't feel tired continually. She began to feel tired on 21Dec2020, she was just exhausted, she was so tired and she just slept, she couldn't get out of her own way. On 22Dec2020, she was fine, but on 23Dec2020, she began to feel tired and exhausted again. By 24Dec2020, her symptoms were over. She also experienced injection site pain in her right arm that started on 21Dec2020 and resolved by the evening of the same day. No treatment received for this event. Vaccination Facility Type was in hospital. No vaccine administered at Military Facility. No emergency room visit needed. It was unknown that physician office visit needed. No prior vaccinations within 4 weeks. Adverse event(s) following prior vaccinations was N/A. Family medical history relevant to adverse event(s) was not provided. Relevant tests were none. The outcome of event 'tiredness/exhausted' was recovered on 24Jan2021; of event 'injection site pain in her right arm' was recovered on 21Dec2020. Information on the Lot/Batch number has been requested.
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| 58 | 2021-01-25 | influenza like illness |
body ache/ all over achy feeling; muscle aches; feeling like coming down with the flu; This is a spo...
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body ache/ all over achy feeling; muscle aches; feeling like coming down with the flu; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EJ1685), via an unspecified route of administration on left arm at 11:45 AM on 22Dec2020 at single dose for COVID-19 immunization. Medical history included Graves Disease and COVID-19 (Prior to vaccination, diagnosed with COVID-19). Concomitant medication included ibuprofen (MOTRIN), diclofenac sodium. The patient previously took percocet and experienced allergies, darvocet and experienced allergies. The patient experienced body ache and muscle aches the day after first shot also feeling like coming down with the flu all over achy feeling on unknown date that resolved in a days time. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was recovered on unknown date.
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| 58 | 2021-01-26 | headache |
Headache; congestion (sinus); severe vertigo; Vomiting; Nausea; This is a spontaneous report from a ...
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Headache; congestion (sinus); severe vertigo; Vomiting; Nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 06Jan2021, the patient experienced severe vertigo. Patient also experienced headache, congestion (sinus) on an unspecified date. On 05Jan2021, patient experienced vomiting and nausea. Patient stated that she went to her primary care and was given patch for nausea and was given a different sinus brand to clear up the congestion. Patient stated that with all these, she is pretty sure that she does not want the second dose. Patient stated that she has symptoms of the vaccine than rather COVID and wanted to know what were the recommendations. The outcome of the event congestion (sinus) was not recovered, vomiting was recovered 05Jan2021, while the other events was recovering.
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| 58 | 2021-01-26 | fever, migraine |
Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date ...
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Intense pain in left injection arm; Fever; Could not sleep; aches all over; other vaccine same date vaccine date on 04Jan2021; Day 6 -10 migraines hit; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 23:30 on 04Jan2021 at single dose for COVID-19 immunization and other vaccine same date vaccine date on 04Jan2021 on left arm. Medical history included allergies to penicillin, allergy to bananas, wheat (patient do eat products w wheat), dairy; Melanoma 3rd degree 1987 & 2005, allergies, sinus surgery resolved problems. Concomitant medication included venlafaxine, omeprazole, bupropion hydrochloride (WELLBUTRIN). It was reported that patient had no other vaccine in four weeks. The patient previously took ampicillin and experienced drug allergy. No issues until middle of night of first injection. The patient experienced intense pain in left injection arm; fever; could not sleep, other aches all over on 05Jan2021. Used ice packs & Motrin. Fever left after two days. Intense pain continued. 5th day switched to heating pad & took 2 tablets of Tylenol every 6 hours. Called patient's doctor on days 6 & 8. Suggested patient alternate Tylenol & Motrin every 6 or 8 hours. Day 6 -10 migraines hit. The outcome of event fever was recovered on 07Jan2021. The outcome of events migraine and Product use for unapproved combination was unknown. The outcome of rest events was not recovered. Information on the LOT/Batch number has been requested.
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| 58 | 2021-01-26 | cough, nasal congestion |
Until 12/26/20 no symptoms whatsoever, and I started feeling congested on the 26th early evening aro...
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Until 12/26/20 no symptoms whatsoever, and I started feeling congested on the 26th early evening around 6-7PM. The next evening I was actually talking to my sister and I coughed and she brought to my attention about my cough. It was late around 7PM. The next morning, around 4AM I woke up with a terrible ear ache. I called my doctor on the 28th and he suggested a COVID test at his office. On Thursday 12/31/20 in the morning he called me giving me positive results for COVID.
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| 58 | 2021-01-26 | dehydration | Vomitibg, diarrhea, nausea dehydration |
| 58 | 2021-01-26 | chills |
extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through ...
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extremely sore at the injection site. I had overnight chills starting at 9pm on 1/21/2002 through morning. I took my temp on 1/21 at 9am and it was normal. (98.4) Body aches, and nausea most of the day on 1/21/2021. treatment: Ibuprofen 600mg BID X 2 days.
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| 58 | 2021-01-27 | fatigue, fever |
Ran a low grade fever for about 3 hours followed by extreme tiredness. Tiredness lasted a couple of...
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Ran a low grade fever for about 3 hours followed by extreme tiredness. Tiredness lasted a couple of days.
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| 58 | 2021-01-28 | headache, fatigue | HA, BODY ACHE, FATIGUE |
| 58 | 2021-01-28 | shortness of breath, malaise, chills, dizziness, headache |
Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat...
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Headache; Chills; not feeling well; tingling all over her arms, face and legs; severe fast heartbeat; Dizziness; difficulty breathing; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0142, expiry: Mar2021), via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and no concomitant medications as the patient reported she was healthy. The patient experienced severe reactions, she was in the hospital twice. On 10Jan2021, the patient experienced difficulty breathing, severe fast heartbeat and dizziness. On 13Jan2021, patient had headache, chills, not feeling well, and tingling all over her arms, face and legs. The patient further stated that a week after getting the vaccine, last Sunday, she had a severe reaction and was hospitalized twice due to the events. Exactly one week after receiving the vaccine, on Sunday 10Jan2021, patient ended up in an ambulance due to dizziness, fast heart rate, and difficulty breathing which all started on 10Jan2021. She confirms that she was admitted to the hospital that day, and she was discharged the next day, on 11Jan2021 in the afternoon. On 13Jan2021, in the afternoon, the other symptoms of headache, chills, not feeling well, and tingling all over her arms, face and legs, started. Patient went back to a different hospital, to the emergency room, on Wednesday 13Jan2021, but was not admitted at that time. Patient mentioned the difficulty breathing was okay, but she does not want to say it was 100% better because she was still having a little bit of difficulty. Caller states that the dizziness and fast heart rate are still pretty serious. It was reported that the patient was hospitalized for the event fast heart rate from 10Jan2021 to 15Jan2021, and chills, not feeling well, and tingling all over her arms, face and legs on unspecified date. Patient was due to get the second dose on 24Jan2021, and she does not know if she should because she had side effects to the first dose. Patient seen several doctors and she had a cardiologist that was monitoring her, and she has had a stress test and labs and those are all normal. patient confirms that the product was no specifically prescribed to her, but it was given via workplace policy as she works for a hospital. The outcome of the events difficulty breathing was recovering and not recovered for all the other events. No follow-up attempts are possible; information about batch number has been obtained.
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| 58 | 2021-01-28 | thirst |
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the...
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Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
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| 58 | 2021-01-28 | body temperature increased, headache | Temo 101. body aches headache |
| 58 | 2021-01-28 | chills, fever, fatigue | chills, myalgias, fever, fatigue |
| 58 | 2021-01-28 | shortness of breath, fatigue | pt is having ear pain bilaterally, back pain, sob, fatigue |
| 58 | 2021-01-28 | headache, fatigue | sore body and muscles, vaccine site extremely sore headache and fatigue. |
| 58 | 2021-01-30 | shortness of breath |
After being observed for approximately 20 minutes and patient walked to her car without assistance I...
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After being observed for approximately 20 minutes and patient walked to her car without assistance I was called to assess the patient in the parking lot for troubles breathing. EMS was called as I made my way outside. Upon my arrival patient was leaning out of the car and stating that she could not breath. She was able to tell me that she was allergic to penicillin. Oxygen was immediately placed on the patient with minimal relief. Lung sounds were coarse throughout. She then began to vomit about every 20-30 seconds. Epipen was administered in the right leg with no relief. Patient continued to complain of troubles breathing and vomiting. A second epipen was administered in the patients right arm again with no relief. A few minutes later patient was given racemic epinephrine through the oxygen mask. There appeared to be mild improvement in her breathing as she appeared more comfortable, but still complaining of shortness of breath and vomiting. When EMS arrived patient was unable to transport herself to the stretcher. When EMS and clinical staff transferred patient to the stretcher she became unresponsive. She appeared to still be breathing. She did not respond to verbal stimuli. Per ED report large amount of fluid was suctioned from the patients lungs following intubation in the ambulance. When patient arrived to the ED she was extubated and re-intubated without difficulty and further fluid was suctioned. At that time patient was found to be in PEA, shock was delivered. Shortly thereafter no cardiac activity was found and patient pronounced dead.
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| 58 | 2021-01-31 | throat pain, headache, shortness of breath |
chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received E...
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chest tightness, shortness of breath, then went to throat sore throat, hoarseness patient received EPIPEN 0.3 mg 3 doses 5 min apart. then went to ER had two breathing treatments, albuterol, epinephrine, solumedrol one injection, 50 mg Benadryl reports rash at IV site from (Benadryl?) No rash anywhere else. Prednisone tapering dose and Benadryl 50 mg at night and 25 during day time. To follow up with PMD. Headache.
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| 58 | 2021-02-02 | malaise, fatigue, headache |
feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only wo...
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feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day; pain in injection site, spread within 6 hours to all joints; pain in injection site, spread within 6 hours to all joints; headache; severe pain all muscles; nausea; This is a spontaneous report from a contactable other health professional (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 31Dec2020 12:30 in right arm at single dose for covid-19 immunization. Medical history included asthma, fibromyalgia, perimenopause issues. The patient was known allergies: amlodipine; yellow jackets/hornets. The patient had COVID-19 prior vaccination. No other vaccine in four weeks were taken. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), zolpidem tartrate (AMBIEN), estradiol, mepolizumab (NUCALA) and oxycodone. Facility type vaccine was nursing home/senior living facility. On 01Jan2021, patient experienced pain in injection site, spread within 6 hours to all joints, then within 24 hours had headache, severe pain all muscles, nausea, and extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day. All symptoms persist. Day 18 not in bed, but patient felt unwell most of the day on 18Jan2021. Lots of rest was required not normal for her. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive on an unspecified date and nasal swab: negative on 15Jan2021. No treatment was received for events. Outcome of events at the reporting time were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fatigue and other reported events due to temporal relationship. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-02-03 | chills, fatigue, headache, body temperature increased |
white mucous stools with blood; abdominal pain; tenesmus; white mucous stools with blood; fatigue; c...
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white mucous stools with blood; abdominal pain; tenesmus; white mucous stools with blood; fatigue; chills; headache; temp 99.5; This is a spontaneous report from a contactable nurse. This 58-year-old female Nurse (Patient) reported that A 36-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19 pfizer, Lot#: EL3246), via an unspecified route of administration on 11Jan2021 01:00 PM on Right arm at single dose for COVID-19 immunisation. She is not pregnant. Medical history was none. Known allergies: NKA. Facility type vaccine was other. No other vaccine in four weeks. Concomitant medications included thyroid (ARMOUR THYROID), estrogens conjugated/medroxyprogesterone acetate (PREMPRO), Regular vitamin. 4:00 am on 20Jan2021 woke with abdominal pain, tenesmus, white mucous stools with blood, fatigue, chills, headache, Temp 99.5 called physician told it sounds like reaction. Took Tylenol 500 mg for symptoms. 21Jan2021 feel better but still mucous blood stools dr wants to see me monday 25Jan2021 if still having blood. AE resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered with lasting effects. Treatment received. No COVID prior vaccination. No COVID tested post vaccination.; Sender's Comments: Based on the information currently available and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of blood stool cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 58 | 2021-02-04 | weakness, headache |
Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospita...
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Syncope 5 - 10 seconds , Nausea, slight head ache, weakness after syncope 2/3 @ 10:15 am Hospitalized on 2/3 @ 11:30 am on 2/3/2021 2/5 @ 4 :30 pm Primary Care visit @ 3:30 pm on 2/5/2021
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| 58 | 2021-02-11 | shortness of breath | facial/ tongue swelling, hives, shortness of breath, trouble swallowing |
| 58 | 2021-02-21 | dizziness |
Pt began to fell dizzy about one minute after her injection. Patient remained at vaccine table. De...
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Pt began to fell dizzy about one minute after her injection. Patient remained at vaccine table. Denies any additional symptoms. Dizziness resolved after 5 minutes, vitals declined.
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| 58 | 2021-02-21 | migraine | soreness at injection site. then a mild migraine the following evening. |
| 58 | 2021-02-22 | headache |
Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discolorati...
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Nausea, Diarrhea, Headache (4 weeks), Joint Pain (Ongoing), Injection Site Injury - Skin Discoloration/Scab (On Going), Pain Injection Site (Ongoing)
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| 58 | 2021-02-22 | shortness of breath |
Received second Covid vaccine at ~1:45pm and was monitored x 15 minutes without difficulty. She repo...
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Received second Covid vaccine at ~1:45pm and was monitored x 15 minutes without difficulty. She reports that about 2:15pm while she was on her way home, she developed some chest fullness/tightness and some mild SOB. She returned to Vaccine clinic for evaluation. She was able to park and walk-in unassisted. Denies throat itching/swelling No rash Vitals: Initial set 115/66, HR 70, RR 18, O2 sat 99% Continuous pulse oximetry with oxygen sats 99-100% and HR 70-75. Â Gen: WDWN WF NAD, conversing easily without dyspnea. CV: RRR no MGR Resp: CTA bilaterally, no increased WOB Skin: warm, dry, not diaphoretic, no rash Neuro: afocal,MAE Â Fingerstick glucose: 89 Â Monitored x 15 minutes with significant improvement and resolution of chest discomfort and SOB Discussed with medical director and transferred to employee health for additional 30 minutes of monitoring. Monitored x 30 minutes in SEH. Complete resolution of symptoms. Vitals q 15 minutes x 2 @1513 133/69 HR 71 @ 121/65 HR 72 Cleared to return home. Discussed signs necessitating emergent treatment including chest pain, SOB, throat swelling/itching.
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| 58 | 2021-02-22 | cough |
began having itching inside ears and tongue, without tongue swelling; intermit cough within about 5 ...
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began having itching inside ears and tongue, without tongue swelling; intermit cough within about 5 minutes after administered. Pt took 25mg of personal benadryl. Pt continually monitored for 30 minutes following benadryl administration. Cough resolved after 10 minutes, other symptoms remain unchanged. 25 minutes following benadryl, patient stated symptoms resolved. Pt monitored another 5 minutes, vital signs rechecked. Pt sent home with spouse in stable condition.
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| 58 | 2021-02-23 | dizziness |
Patient felt warm and lightheaded upon standing. Walked with assistance to lie down on a cot in the ...
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Patient felt warm and lightheaded upon standing. Walked with assistance to lie down on a cot in the patient care tent. BP: 128/70, P: 90, Resp: 17. Patient drank some water and ate pretzels while sitting and denied dizziness after 20 minutes of sitting up. Patient left the building feeling well and denied any dizziness.
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| 58 | 2021-02-23 | chills, fever, headache |
had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that...
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had trouble raising her arm; numbness and pain in my left hand/hurts to touch the upper part of that arm; left arm she was vaccinated on was incredibly sore; left arm she was vaccinated on was incredibly sore, swollen; Patient do have autoimmune issues; Patient do have autoimmune issues; numbness and pain in my left hand; getting pins and needless; left wrist is a little swollen; whole arm hurts, including elbow joint, and shoulder joint; headache; chills; maybe slight fever, never took my temperature; body aches all over; kind of muscle weakness in her whole arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 11:49 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, rheumatoid arthritis, rosacea, periarthritis and frozen shoulder prior a little over a year ago. The patient's concomitant medications were not reported. Patient was vaccinated on Thursday morning, and her left arm she was vaccinated on was incredibly sore, swollen, she has pins and needles, her hand was going numb, she has a lot of pain, and kind of muscle weakness in her whole arm and it hurts to touch her arm still on Jan2021. The initial side effects in her left arm at injection site. The injection site symptoms started within an hour of getting it at 11:49 am on 21Jan2021. Patient received the vaccine and probably around 1pm on 21Jan2021 in the afternoon it was really sore, and had trouble raising her arm, and it hurts to touch the upper part of that arm. The pain was not exactly at the injection point, it's just below, where it hurts. On Jan2021, patient was getting pins and needless and numbness and pain in her left hand. It's like it's swollen, it has that tight swollen feel to it, even though it doesn't look like it, although her left wrist is a little swollen on Jan2021. Her whole arm hurts, including elbow joint, and shoulder joint. Once patient got the vaccine, it all of a sudden exacerbated what ever was going on. She was doing good until she got the injection, and now she feel like,it's gone backwards and has effected the muscles in her arms now. Patient do have autoimmune issues. She also had headache, chills, maybe slight fever, never took my temperature, body aches all over, joints hurt incredibly bad on Jan2021. Most effects were gone away, mostly concerned about the arm. Her concern was the arm. Outcome of the events was unknown. Patient was asking if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The reporter considered the events non-serious. Information on lot/batch has been requested.
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| 58 | 2021-02-24 | headache | Systemic: Brain aneurysm-Severe, Systemic: Headache-Severe |
| 58 | 2021-02-25 | migraine |
continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneou...
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continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneous report received from a contactable consumer (patient's husband). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history concomitant medications were not reported. It was reported that the patient got the COVID-19 shot in the morning of 25Jan2021 (yesterday) which developed into a migraine headache that has done nothing but gotten worse and on 26Jn2021, she had continued vomiting. The reporter asked if these were normal and how long will these last. The outcome of the events was not recovered. Information on lot/batch number has been requested.
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| 58 | 2021-03-02 | chills, fever, shortness of breath | Chills x 3 days and then fever, emesis, diarrhea and shortness of breath |
| 58 | 2021-03-02 | fever, headache |
High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and ...
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High temp, ache all over, severe headache,, head to toe all over body edema, systemic body rash and itching. Took Benadryl and caused elevated b/p. Went to ER and had steroids.
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| 58 | 2021-03-02 | chills, fever, headache, weakness |
slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a s...
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slight swelling; arm redness at injection site; chills; fever 103.8; weakness; headache; This is a spontaneous report from a contactable other health professional (patient). A 58-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9262 and expiry date unknown, via unspecified route of administration at the left arm on 28Jan2021 11:15 at single dose for Covid-19 immunization in a hospital. Medical history included high blood pressure, depression, asthma, wheat allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included lisinopril, paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]), cyanocobalamin (VIT B12), ergocalciferol (VIT D); all from unspecified date for unspecified indication. The patient previously took amoxicilin, morphine, vicodin; all experienced drug allergy. Historical vaccine included first dose of BNT162B2 lot number EH9899 at the left arm on 07Jan2021 11:15 AM for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 19:00, the patient experienced chills, fever 103.8 (temperature), weakness, headache, until 30Jan2021 6:30 am. Then again, on 30Jan2021 11 pm, the patient experienced fever, chills headache until 6:30 am. On 30Jan2021, the patient experienced arm redness at injection site. On 31Jan2021, the patient continued to experience redness and slight swelling (injection site). The patient has the patient been tested for COVID-19 since the vaccination. The patient did not received treatment for the events. The outcome of the events was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect.
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| 58 | 2021-03-03 | cough, fever, shortness of breath |
After vaccine, patient developed persistent cough, shortness of breath, and fevers. Was diagnosed wi...
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After vaccine, patient developed persistent cough, shortness of breath, and fevers. Was diagnosed with COVID via POCT on 2/25/21 and was discharged from ED given lack of symptoms. Returned 2/27/21 after oxygen saturation found to be ~50% at home. Admitted for severe COVID infection requiring dexamethasone and remains inpatient.
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| 58 | 2021-03-03 | chills |
Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom...
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Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom; the sores are underneath the lip by the cheek on top and bottom/sores being white on top and real red where the bump is, but on top of it, it's really white; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 30Jan2021 11:30 at a single dose for COVID-19 Immunization. Medical history included Hashimoto's thyroiditis and acid reflux. Concomitant medication included levothyroxine for Hashimoto's thyroiditis and pantoprazole for acid reflux. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL1283; expiration date: Apr2021) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 09Jan2021 at a single dose for COVID-19 Immunization. The patient reported that she got her second shot on Saturday 30Jan2021 and yesterday (01Feb2021), her lips were swollen, and she has sores inside the mouth, the sores are underneath the lip by the cheek on top and bottom. She further reported that swelling was on both top and bottom lips, it occurred yesterday 01Feb2021, she noticed it as soon as woke. The sores in the mouth also started at the same time. She added that the lips swelling is ongoing but getting better. The Sores in the mouth, she thinks that they are getting better but it does bother her more when she is eating, but it is getting better, she only experiences pain on the sores when she is eating but other than that there is no pain. She has not used anything to treat the swelling and sores. The sores are sensitive to touch. She described the sores being white on top and real red where the bump is, but on top of it, it's really white. She has had no positive COVID Test prior to the first dose. She has had no issues with vaccines in the past. She also added that she did have chills and body aches on Saturday (30Jan2021) and Sunday (31Jan2021), she thought she was doing great, but then on Monday the sores showed up. She wanted to report this because no one said to her that would happen. She clarified that she experienced the chills on the same day of getting the second dose on 30Jan2021, then the body aches came Sunday 31Jan2021. The outcome of the events chill and ache were unknown while the outcome of the other events was recovering.
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| 58 | 2021-03-03 | shortness of breath |
between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble ...
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between the first dose on 1/20/21 a week later I experience pain under my left rib cage and trouble catching my breath which I thought was due to shoveling heavy snow, then received my 2nd dose on 2/9/21 and on 2/14/21 I couldn't breathe and pain was so intense and went to Hospital at 9:30 PM and stayed overnight
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| 58 | 2021-03-03 | throat pain, chills, weakness |
zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous...
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zapped of energy; chilled; body aches; mild sore throat; slept about 15 hours; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN5318), via an unspecified route of administration single dose arm left on 29Jan2021 09:00 (at the age of 58) for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced zapped of energy on 31Jan2021 16:00, chilled on 31Jan2021 16:00, body aches on 31Jan2021 16:00, mild sore throat on 31Jan2021 16:00, slept about 15 hours on 31Jan2021 16:00. No treatment administered. The events outcome was recovered.
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| 58 | 2021-03-07 | fatigue, migraine, chills, dizziness, fever, sweating |
felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Simila...
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felt lightheaded; had a low grade fever; chills; sweating; light and sound was very painful - Similar to a migraine; tired; slept for a long time; light and sound was very painful; light and sound was very painful; This is a spontaneous report from a contactable consumer (reported for herself). A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration from 28Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included chronic sinus infections. Patient was not pregnant at the time of vaccination and the report. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included trazodone, xylometazoline hydrochloride (SUDAFED), cetirizine hydrochloride (ZYRTEC), and fluticasone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took clarithromycin (BIAXIN) and experienced allergies (reported as know allergies). About an hour after the injection, on 28Jan2021 11:00 AM, patient felt lightheaded, had a low grade fever, chills and sweating, light and sound was very painful - similar to a migraine even though patient have never had one previously, and patient was very tired and slept for a long time. These lasted for 5 days. The events required doctor or other healthcare professional office/clinic visit in response to the events. Patient received treatment for the adverse events and was reported as unknown. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events reported was recovering. Information on the lot/batch number has been requested.
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| 58 | 2021-03-09 | fever, headache |
Fever of 102.5 degrees lasting about 30 hrs; joint pain; Headache; This is a spontaneous report from...
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Fever of 102.5 degrees lasting about 30 hrs; joint pain; Headache; This is a spontaneous report from a contactable other health professional. A 58-year-old female patient received BNT162B2, (Solution for injection, Batch/Lot: EL3249), in right arm via intramuscular on 02Feb2021 10:30 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies. The patient's concomitant medications was not reported. Historical vaccine of BNT162B2 on 12Jan2021 for COVID-19 immunization, lot number: EK9231, administration time: 10:45 AM, route: Intramuscular, vaccine location: Right arm, dose number: one. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was yes. The patient had event fever of 102.5 degrees lasting about 30 hrs, joint pain, headache on 02Feb2021 at 08:45 PM. The treatment was not received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.5 degrees. The outcome of the events was recovering.
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| 58 | 2021-03-10 | headache, dizziness |
2/27. Spontaneous subdural hematoma. Occurred 30 minutes into a flight. Headache and dizziness be...
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2/27. Spontaneous subdural hematoma. Occurred 30 minutes into a flight. Headache and dizziness began one week prior to 2/27, but not sure if they are correlated.
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| 58 | 2021-03-14 | chills, dizziness, head discomfort |
First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure;...
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First chills; Vomiting; body aches; Head still doesn't feel normal; severe dizziness; head pressure; This is a spontaneous report from a contactable consumer. A 58 -year-old female (not pregnant) patient received her first dose on an unspecified date, second dose (lot number: EN2601) on 12Feb2021 of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), both via an unspecified route of administration (at the age of 58 -years-old), single dose for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication included clonazepam. The patient experienced First chills, vomiting, body aches, head pressure, severe dizziness and vomiting. Head still doesn't feel normal (The events were reported also to happen then 12 days later), all events started 23Feb2021 0600. The outcome of the events was recovering. The events were reported to cause 3 days hospitalization. No other vaccine in four weeks. AE Treatment: Meclizine, Zofran, EKG, MRI, CT of head. The patient had a covid swab test on 23Feb2021 with negative result.
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| 58 | 2021-03-18 | fatigue |
night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night ...
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night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night before second dose/exhausted; was tired but she didn't sleep the night before second dose/exhausted; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269; Expiration Date: 31May2021), intramuscularly, administered in left arm on 29Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (has a pre existing atrial fibrillation), patient also has under active thyroid from unspecified date. The patient's concomitant medications included magnesium taken daily from an unspecified date and for unknown indication, an unspecified medication for atrial fibrillation and an unspecified low dose medicine for cholesterol. The patient previously received the second dose of unspecified shingles vaccine on an unspecified date for immunization and felt sore arm maybe a little under the weather. On 22Feb2021, the night before the second dose of vaccine, patient reported she was in atrial fibrillation, she was tired but she didn't sleep the night before second dose because she was in atrial fibrillation and was exhausted. She took extra of her atrial fibrillation medications. She does not think she took Tylenol after first one. Does not think arm was sore after the first one. The patient was vaccinated at a mass vaccination site. The events did not require emergency room or physician's office visit. The outcome of the events was unknown.
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| 58 | 2021-03-21 | headache, malaise, fever, chills |
acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pai...
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acute appendicitis/severe abdominal pain; 102 fever; body aches; chills joint pain; chills joint pain; headache; nausea; Severe arm pain; feeling of unwell set in; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 28Feb2021 (Batch/Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included Sjogren's syndrome, mixed connective tissue disease, COVID-19 from Mar2020. Patient was not pregnant. Patient had no known allergies. Concomitant medications included estrogens conjugated (PREMARIN), tizanidine, hydroxychloroquine, acyclovir [aciclovir], all taken for an unspecified indication, start and stop date were not reported. 4 hours later (28Feb2021 20:30), severe arm pain & feeling of unwell set in. 24 hours later (01Mar2021 16:30) 102 fever, body aches, chills joint pain, headache and nausea for 15 hours and although it improved, patient never felt back to normal. Day 10 (10Mar2021 19:00) patient started having severe abdominal pain, nausea, headache and body pains. Day 11 (11Mar2021) it was worse and day 12 (12Mar2021) patient went to ER and was diagnosed with acute appendicitis and had surgery for appendix removal. Patient feel the vaccine caused this as patient had no issues that would allude to a problem and after receiving the vaccine never felt good. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. Patient was hospitalized for 1 day. Patient had nasal swab: negative on 12Mar2021. Outcome of the events was resolving.
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| 58 | 2021-03-22 | sweating, weakness |
faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a co...
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faint; blurred vision; vomit; diarrhea; hot sweats; weakness; This is a spontaneous report from a contactable consumer (patient herself). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration, administered in the left arm on 05Mar2021 at 16:00 as a single dose for COVID-19 immunization. The vaccination facility type was reported as health clinic. Relevant medical history included overweight from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and omeprazole (PRILOSEC); both were taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 05Mar2021 at 21:15, the patient experienced faint, blurred vision, vomit, diarrhea, hot sweats, and weakness. The patient did not receive any treatment for the adverse events (AE). The patient was recovering from all the events. Information on the batch/lot number has been requested.
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| 58 | 2021-03-28 | headache, malaise |
She received the vaccine on March 23. On March 28 she felt unwell and early on March 29, 2021 devel...
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She received the vaccine on March 23. On March 28 she felt unwell and early on March 29, 2021 developed severe headache and came to the Medical Center ER. She had a large intracranial hemorrhage. Platelet count was 4,000. She had a normal platelet count in December 2020. She had not received chemotherapy for her breast cancer, only radiation. The hemorrhage rapidly expanded. She was intubated and admitted to the ICU under my care. Her husband opted for palliative extubation and she died soon after.
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| 58 | 2021-04-01 | dehydration, lethargy, weakness, chills, headache, dizziness |
3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours afte...
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3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little. 3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27
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| 58 | 2021-04-08 | fatigue |
diagnosed with COVID-19/tested positive for COVID; diagnosed with COVID-19/tested positive for COVID...
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diagnosed with COVID-19/tested positive for COVID; diagnosed with COVID-19/tested positive for COVID; she was tired; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 58-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 17Mar2021 06:40 (at the age of 58-years-old) as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (lot: EL9266) in left arm on 22Feb2021 at about 07:30 (at the age of 58-years-old) for covid-19 immunisation. The vaccination facility type was stated that was like a wellness center, an urgent care, hospital clinic and the vaccine was not administered at military facility. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). There were no primary infection site, no predisposing factors, no culture performed and no antipyretic Use (around the date of vaccination). Medical history included did not have the best immune system and has some vitamin deficiencies. Concomitant medication included bamlanivimab. The patient's second vaccine was 23 days after the first vaccine. The patient received the second dose on 17Mar2021 and tested positive 20Mar2021 for the Covid virus. The patient stated that her husband tested positive for the Covid virus as well. The patient asked if she will need to get another vaccine. This Saturday (20Mar2021 at 18:00), they were diagnosed with COVID-19 and they were currently still battling it. The patient got the result on 20Mar2021 at 18:00, and describes as it got worse, but then it plateaued. The patient wanted to know if having COVID-19 at the time of vaccination lessen the efficacy of the vaccine. The patient wanted to know if she should take another shot because she has COVID-19 at the time of vaccination. The patient was not going to fill out her husband's report, she was tired. The height reported as 5 foot 1 and a half. The events did not require emergency room visit, no hospitalization as of yet. They gave her monoclonal antibodies at the Urgent Care. They scheduled that at the Urgent Care. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336109 same reporter/drug/event, different patient
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| 59 | 2020-12-31 | dizziness |
DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE...
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DIZZY, ANXIOUS, BILATERAL HAND TINGLING AND NUMBNESS. B/P149/68 @10:45 B/P 128/62 PATIENT STATED SHE FEELS FINE 20MINS AFTER THE EVENT.
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| 59 | 2020-12-31 | weakness |
High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness a...
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High injection site left deltoid resulted in moderately severe left shoulder joint pain, weakness and reduced range of motion causing reduced ADLs for 10+ days
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| 59 | 2021-01-01 | headache, fatigue |
Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore a...
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Got positive, testing for CoVid 19 on,12/30/2020. Symptoms started gradually on 12/19/20 w/ sore arms, fatigue then started getting brain fog , HA, body aches until current. my MD and I thought it was due to vaccine. Then add loss of taste and appetite on 12/30/20 along with rest of symptoms. I knew then I needed to get swab. Symptoms is still current.
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| 59 | 2021-01-01 | headache |
I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 h...
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I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 hours I felt soreness at a level of 2-3/10 at the injection site. Starting at - 19:00 the pain radiated down toward my elbow and up into my neck and base of skull. The soreness in my neck and base of skull was at a lever of 4/10. By 12/24/20 at approximately 18:00 the side effects had dissipated.
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| 59 | 2021-01-02 | chills, fever |
At 2 am woke to severe chills and hyperventilating. Took 45 minutes for everything to stop. (very s...
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At 2 am woke to severe chills and hyperventilating. Took 45 minutes for everything to stop. (very scary) At 6:30 am began running a temp of 101.1. Starting taking tylenol. Fever never did go away. Still had fever at 8 pm when I went to bed. Woke up next morning and was fine.
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| 59 | 2021-01-03 | fatigue, fever, chills |
Woke up achy all over with fever and chills. BP was high, so took meds, but didn't help even after t...
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Woke up achy all over with fever and chills. BP was high, so took meds, but didn't help even after taking again later. Contacted physician and advised to come in. Different BP med given that helped. Woke up tired the next morning.
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| 59 | 2021-01-04 | fever, headache, chills |
Development of tinnitus/ringing sensation/buzz as a "generalized sensation" that is generally not pl...
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Development of tinnitus/ringing sensation/buzz as a "generalized sensation" that is generally not pleasant. Within first 24 hours after administration patient had regular side effects including headache, fever (99.8) , and chills that disappeared after 36-48 hours.
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| 59 | 2021-01-04 | dizziness |
Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea ...
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Dizziness, Anaphylaxis, UrticariaPruritus & NauseaVomiting Narrative: Patient complained of nausea and numbness and tingling in fingertips 5 minutes after administration of vaccine and proceeded to bathroom. Patient with unwitnessed vomiting prior to RN assessment. RN assessed patient and taken safely to private evaluation room. AED pads applied per protocol. Epi-Pen administered. EMS called. Vital signs stable. Patient complained of itching and erythema in left arm around injection site. MD evaluated patient and advised to be further assessed in ER. Patient continuously evaluated by RN and EMS. Patient transported to ER in stable condition.
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| 59 | 2021-01-04 | fever, chills, fatigue, headache, runny nose |
Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose ...
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Fatigue, sinus pain, nausea , vomiting , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose Tenderness at the injection site.
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| 59 | 2021-01-04 | productive cough, throat swelling |
Fine raised red rash over her body; throat swelling; diarrhea; high pitched cough productive with cl...
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Fine raised red rash over her body; throat swelling; diarrhea; high pitched cough productive with clear thin secretions; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on left arm from at 12:30 PM on 23Dec2020 at single dose for COVID-19 immunization. Medical history included depression. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), triazolam (HALCION), fluoxetine hydrochloride (PROZAC), paracetamol (TYLENOL). The patient previously took Lamictal and experienced rash, codeine and experienced hallucination, lamictal for drug allergy, codeine and experienced drug allergy. On 24Dec2020 mid-day (11:00 AM), the patient developed the following S/S (signs and symptoms, which were similar to a Lamictal rash): Fine raised red rash over her body, but significantly heavier to face, neck and lower legs; throat swelling with a high pitched cough (with no difficulty breathing) productive with clear thin secretions; diarrhea. The patient took 6 Benadryl every 4-6 hours, Pepcid twice daily, and had an epi pen available (but did not need it). The cough and rash resolved by late Sunday evening (27Dec2020). The patient did not report to ED because she felt the symptoms were manageable at home. All events reported as non-serious. The outcome of events red rash and cough were recovered on 27Dec2020, the outcome of rest events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19.
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| 59 | 2021-01-04 | headache, fatigue, discomfort |
Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and sh...
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Very tired; Cold/head cold; upset stomach; she was not feeling well; it got her all congested and she got the head cold in Dec2020; little whooping cough; I had severe headaches and it was just too uncomfortable; my head was so congested; worst headache; it was just too uncomfortable; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female patient received BNT162B2 via an unspecified route of administration on 22Dec2020 at the 59-year-old at single dose for Covid virus. The medical history included Congested, head cold and Covid virus. There was no concomitant medication. The patient work at a hospital and she went for a Covid shot (clarified as Covid 19 vaccine) on 22Dec2020 and she got a very bad reaction from it which bothered her, she had severe headaches in Dec2020 and it was just too uncomfortable and on 24th she was very tired, she didn't had too much of upset stomach in Dec2020 but it was not all that bad by 9 in the clock by morning she was at work and everything and she was told by if she was not feeling well she can walk by a day, but her question and her concern was back on November okay she had called in sick around, she had a funeral that she gone too and people that were at the funeral, unfortunately were smoking outside and smoke bothers me very much, she get congested and she get head cold from it you know and I was thinking it's nothing it's just a cold and somebody told her no (name) you better go get yourself to the employee health office and get checked out and she didn't bother doing that, she said no it's just the cold she will be fine but then it just got worse down the road and she said to herself may be she better just to say she did it, so she called in sick on 24th because she had the cold still and she called and she went to employee health office on 25th she still had the headache and she still had the cold, however when she went to the health office they said to her well stay out of work and we will get back in touch with her and she said okay and she will do that so when they got back in touch with her they said they do have the Covid and she said ohhh she said okay so she stayed out of work and she went to work on the 07Dec so she was wondering whole time, so her confusion was this she was told if you already had the virus in her which at that time, she did not know what it was she just thought it was from cigarette smoke because it got her all congested and she got the head cold in Dec2020 and the whole thing that went along with it and the health employee officer know you had the virus and it's just the virus and she go oh great and that's when they told her to stay out of work and she said okay fine then she just have to that, so in the meantime everybody in the work said hi calling me checking up on her and she said it's so nice of you people, she appreciate it but then she went back to work she was still feeling you know much better than she was but she had little whooping cough in Dec2020 but that was not really that bad, so they said you going to get the shot or not, and she said she don't know she kind of debatable, she don't know if she should get it, because she work in the hospital or she should not get, she said she don't know she was kind of up and some people like she get it sometime your health was not that good but on the other hand everybody that is working here in the hospital working with patients because was work right in the ICU, all over the floor you know spreading right there so she said oh alright so she kicked myself and said go get the shot, get it just over with and get it out of here so that is when she took her shot that was on 22nd and on 24th she was very tired all day no she was tired all day but she was kind of dragging most of the day but she had on the 20th no that was fine on the 20th okay for some reason she guess it was after work that week on 19th, she came home and her head was so congested and she had the worst headache and she felt like a wand had hit her over the head, it was horrible and all she could smell was cigarette smoke, like is her neighbor smoking here so she went down the hall because in live in building that used to be hotel but now they turned that into Condominium and she walk up and down the hall and she was like was somebody smoking or why this or why smell this so strong and the all the lights off in a hallway and she don't want to offend anybody but they had to go to work and somebody elsewhere and she am like she can't stand this smell and they gave this shot and she went for this shot, and they told us to come back she think it was a week or something like that to get the second shot, and she am saying if this going to cost her going to feel this way again, she don't want to get the second shot, she told them that and they told her to call this number and talk to them.The only reason she got it because they encouraged to get it. Even though she had the Covid virus, people said if you already have the virus you don't need to get a shot but people were encouraging because that's she thought well she guess she will get it. But she was mad that she got because it made her sick in Dec2020. And because we already got it they want us to go back and get the second shot and what she was m trying to say to you is, without take and hour 3 hour of conversation here she just want to say she don't want to get back and get the second shot and if it is okay by you guys somehow send her a letter or whatever it is, whoever she have to talk to because she don't want to go back and get the second shot just because of getting sick. She took Excedrin because that works for my headache. She didn't understand why you need all this information history with all this when all she want to say was she didn't want to get a second shot. The outcome of events Head cold and Headache was not recovered, the other events was unknown. Information on the lot/batch number has been requested.
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| 59 | 2021-01-04 | headache, throat pain, malaise |
after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just fel...
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after the vaccine on the 19th I woke up with a bad headache and sore throat, not intense I just felt like I was getting sick I took Motrin, Over the weekend I had significant heart beating which was very out of the ordinary I saw my physician. It felt anaphylactic. Dr did not prescribe anything I was asked to watch my symptoms
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| 59 | 2021-01-04 | headache |
got a mild generalized headache; This is a spontaneous report from a contactable nurse (patient). A ...
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got a mild generalized headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on the right deltoid on 17Dec2020 at 11:00 at a single dose for COVID-19 immunization. Medical history included ongoing migraine headache - stated she was diagnosed with migraines at 12 or 13 years old. There were no concomitant medications. The patient previously received influenza vaccine in Sep2020 for immunization. The patient got a mild generalized headache on 18Dec2020 and still has a headache after all these days. The patient received the COVID-19 Vaccine at the hospital where she works on 17Dec2020 at 11:00AM. She said she went to Pfizer's website for the COVID-19 Vaccine, and the Pfizer website said a headache that develops after receiving the COVID-19 vaccine lasts a few days. She said no matter what medication she is using for her headache, the medication is not working, and she still has the headache. She stated she went to her employer's employee health department, and the employee health department had no information to give her about the COVID-19 Vaccine side effects and what to do about the side effects. Reported the COVID-19 Vaccine was offered as an elective vaccine at the hospital where she works, saying the hospital offered the COVID-19 Vaccine to all its employees. As for treatment, she has taken only over-the counter products to treat her headache. She said she has been taking Tylenol 500 mg caplets, UPC Number: Unknown, Lot Number: PFA044, and Expiration Date: Mar2023. She said she has been taking 2 caplets of Tylenol 500 mg almost daily to see if she can get the edge off of her headache. She said she keeps trying the Tylenol hoping the Tylenol will one day help her headache. She clarified that on most days she is taking 2 Tylenol 500mg caplets once a day, but there have been a couple days where she took 2 Tylenol 500mg caplets twice during the day. Reported she also tried (pharmacy name) brand Migraine Relief Caplets. Reported the headaches she is experiencing now are not like the headaches she has had prior to getting the COVID-19 Vaccine. She said she goes to a neurologist for her migraine headaches, clarifying the headaches she is having now are just a generalized, dull headache. She said she can function at work with the headaches she is having now. She said the headaches are just annoying and headaches don't go away. She said the headaches are not debilitating like her migraine headaches. She said with a migraine headache, she would have to call out at work, but with the headaches she is having now, she can still function. She said the headaches she is experiencing now are not like the migraine headaches she has had prior to getting the COVID-19 Vaccine. She said she goes to a neurologist for her migraine headaches. She said the headaches she is having now are just a generalized, dull headache, and she can function at work. She said the headaches are just annoying, and don't go away. She said the headaches are not debilitating like her migraine headaches. She said with a migraine headache, she would have to call out at work, but with the headaches she is having now, she can still function. The event had not resolved.
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| 59 | 2021-01-04 | headache, influenza like illness, chills |
pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit ...
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pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself. A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on 23Dec2020 10:30 at single dose for Covid-19 immunisation . Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE). The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids. Stated if condition goes on much longer or worse then she will have to go to the hospital. Lot/Batch and Expiration date has been requested.
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| 59 | 2021-01-05 | weakness, fatigue, dizziness, chills |
1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 ...
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1/5/20: 6:15 pm Became tired, chilling, afebrile, cold touch, soreness at injection site. 9:00 pm dizziness, tightness around right upper arm, swelling in right axilla. afebrile. 1/6/20: 5:00 am; chilling subsided. dizziness, weakness and jittery feeling in both legs, soreness at injection site, no redness, swelling in axilla slightly improved. Heart rate 72, respirations 16, 02 sat 96%. bp 129/75. 9:00 am: dizziness, right axilla swelling gone. Soreness in right axilla, weakness in lower extremeties improving. 11:00 am : weakness and jiters subsided, right axilla remains sore.
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| 59 | 2021-01-05 | chills, dizziness |
6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in righ...
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6:15 pm Chilling, cold to touch, afebrile. 10 pm woke up still chilling afebrile. Swelling in right axilla. Tightness around upper arm/axilla area. No redness at injection site. 5 am weakness in lower legs, shakey/jittery, and dizziness. Bp 129/75, HR 65, resp 16, O2 say 96. 9 am dizziness subsided 11 am weakness in legs subsided, axilla swelling subsided, soreness remains.
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| 59 | 2021-01-05 | dizziness | Extreme Dizziness, Blurry Vision, Near fainting and Nausea |
| 59 | 2021-01-05 | fever, weakness | Fever between 99.6-100 degrees fahrenheit for 24 hours. Weakness and mild nausea. |
| 59 | 2021-01-05 | fatigue, headache | I had tiredness, Headache , Muscle Spasms |
| 59 | 2021-01-05 | chills |
I received the injection at 3:10 pm on 1/5. In the middle of the night, I didn?t check the time, I h...
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I received the injection at 3:10 pm on 1/5. In the middle of the night, I didn?t check the time, I had severe rigors that lasted what felt like an hour maybe more. I did not have any other rigors since that episode.
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| 59 | 2021-01-05 | headache, dizziness |
It was like mild lower back pain like on the lower left part of my back on top of my buttocks; Pain ...
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It was like mild lower back pain like on the lower left part of my back on top of my buttocks; Pain just seems to be getting worse; Dizziness/Lightheaded; Headache; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Covid 19 Vaccine; lot number: EL3246; expiration date: unknown), via an unspecified route of administration left upper arm on 30Dec2020 11:30 AM at a single dose for Covid-19 vaccination. The patient has no medical history and concomitant medications. The patient reported that she got her first dose of Pfizer vaccine (COVID-19 Vaccine) yesterday (30Dec2020) and today (31Dec2020), she was having at first it was like mild lower back pain like on the lower left part of her back, on top of her buttocks and now it's getting worse. The patient inquired if it was like a side effect. The patient further stated that yesterday (30Dec2020), she had a side effects like the dizziness, lightheaded and the headache and that went away after she took Tylenol (treatment) but then today this pain just seems to be getting worse. The paracetamol (TYLENOL) was given to her at hospital yesterday for the headache and the dizziness. She hasn't taken anything today because she was not sure if it is okay for her to take Ibuprofen which is what she would prefer to take. She received her COVID-19 Vaccine at a hospital. The outcome of the events was not recovered.
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| 59 | 2021-01-05 | fever, chills |
On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very...
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On day after vaccine had chills and fever(99.7) for ~ 24 hours. Also had muscle and joint pain, very sore arm at injection site, mildly swollen lymph nodes. All noted on handout to be possible side effects. ***Day 2 after vaccine has very red rash all over neck, chest, abdominal and back areas with some itching that lasted ~ 72 hours but was less visible each day after initially noted. No medical treatment sought as resolved on its on
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| 59 | 2021-01-05 | weakness, lethargy, headache, shortness of breath, dizziness, chills |
Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness...
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Post vaccination I waited required 15 minutes. Upon exiting building, presented with sever dizziness, near syncopal episode, blurred vision, chest tightness, tachycardia, weakness, shortness of breath. . Returned to vaccination room, in obvious distress. Ushered by staff to chair. Unable to obtain BP via electronic machine, obtained manual , after about 10 or so minutes NIPB 106/69. Remained in room for 45 more minutes, symptoms slowly resolved. Remained with mild to moderate dizziness x 4 days. Headache, chills, chest tightness, weakness, lethargy, x 7 days..
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| 59 | 2021-01-05 | body temperature increased |
Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of...
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Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; Started with aches in the back NA increased tempswollen lump nodes under the arms and neckbottoms of the feet swollen; This is a spontaneous report from a contactable Other Health Professional (patient). This 59-year-old female Other Health Professional (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ej1685) on 21Dec2020 11:00 AM at single dose in Left arm for covid-19 immunization. Medical history was hypertension, hypothyroidism. Concomitant drug included levothyroxine/liothyronine (NP THYROID), HCTZ, Amlodipine. No other vaccine in four weeks. Started with aches in the back NA increased temp swollen lump nodes under the arms and neck bottoms of the feet swollen from 27Dec2020 with outcome was recovered. No treatment. No covid prior vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19: negative on 28Dec2020. No follow up attempts are needed. No further information is expected.
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| 59 | 2021-01-05 | dizziness, fatigue, shortness of breath |
This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had g...
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This is a 59-year-old female who's possible reaction to the Covid vaccine was as follows: She had gotten the vaccine at approximately 8:30 AM and had stayed at the vaccination area for about 15 minutes and felt okay. She got up to walk outside and started feeling dizzy. Her hands felt tingly. She also felt a little short of breath. She came back in and sat down and the symptoms did not seem to really improve. She states they have been about the same over the last 20 minutes or so. She was then escorted to the ED of the facility for evaluation & treatment if needed. Per the ED doctor's notes: " The patient did feel much better after just being observed here and after getting Benadryl." She was released home. Employee health followed up with her at 4:30 PM the same day & at 9:45 am 1/6/21--she reported that she was doing well at both follow ups, a little tired but had not had any repeat of previous symptoms.
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| 59 | 2021-01-05 | weakness, fever |
Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with...
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Total body and joints pain. On a scale of 1 to 10, most of the time 6 to 8. And also very weak with no stamina. Lasted until 12 /25/2020. Felt horrible like I also had a fever. Although I never did run a temp.
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| 59 | 2021-01-05 | fatigue, headache |
Woke up the following morning with terrible body aches, especially to upper back, neck, lower back a...
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Woke up the following morning with terrible body aches, especially to upper back, neck, lower back and legs. Headache, diarrhea, and tiredness. Was unable to "function", and slept most of the day. Was still having some of those symptoms the second day, but not as bad.
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| 59 | 2021-01-05 | fever | fever of 101.2 and joint pain |
| 59 | 2021-01-05 | headache |
headache; After she got the vaccine, she was exposed to someone who had Covid; This is a spontaneous...
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headache; After she got the vaccine, she was exposed to someone who had Covid; This is a spontaneous report via a Pfizer Sponsored Program, Pfizer First Connect from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the right arm 21Dec2020 at single dose for Covid prevention. Medical history included blood pressure and can't see to read without her glasses. Concomitant medication included amlodipine. The patient stated, "she got the Covid vaccine on 21Dec2020 and had a headache for 1-2 days. After she got the vaccine, she was exposed to someone who had Covid, and wants to know if she can still get the second dose. She has had no symptoms after being exposed (Dec2020) but is about to be tested just in case she gets the virus. Her co-worker was positive and they were all in the breakroom without a mask. A couple other nurses are also concerned and don't know whether to get the second shot. They test at the hospital every Wednesday and wanted to know if she still can be tested before she gets the second shot. She had slight headaches on the 22nd, so she took some EXCEDRIN and it went away". The outcome of headache was recovered on 22Dec2020 and other event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518688 same reporter/drug, similar event, different patient
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| 59 | 2021-01-05 | fever |
made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (p...
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made my arm really sore; fever; nervous; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization. The patient's medical history was concomitant medications were not reported. The patient stated, "where I got my shot made my arm really sore for about three days. On the third day, I ran a low-grade fever-100F. The fever lasted 12 hrs. Now I'm fine. I was a little nervous about traveling but read that there was a side effect." The outcome of the event was unknown. Information on lot/batch number was requested.
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| 59 | 2021-01-06 | chills | CHILLS, BODY ACHES |
| 59 | 2021-01-06 | fever | Fever that went away with tylenol. |
| 59 | 2021-01-06 | chills, fever | Fevers, chills, aches & pains |
| 59 | 2021-01-06 | throat irritation, headache |
Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,ho...
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Half of day after receiving the shot the left arm was sore after vaccine. Itchy on right on red ,hot and swollen after the allergy shot . Itching whole body and also the roof of mouth and the back of throat was itching . Head aches . No new symptoms.
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| 59 | 2021-01-06 | shortness of breath, dizziness, cough | Patient felt dizzy quickly progressed to hoarse voice, cough and expressed difficulty breathing |
| 59 | 2021-01-06 | headache, fatigue, head discomfort |
Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also r...
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Patient reported headache-like symptoms with pressure, tightness and extreme fatigue. Patient also reported worsening tinnitus which started 12/22/2020, prior to the vaccine administration date.
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| 59 | 2021-01-06 | shortness of breath |
SOB started Saturday 01/02/2021 continued SOB Sunday 01/03/2021 and on Monday 01/04/2021 went to cli...
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SOB started Saturday 01/02/2021 continued SOB Sunday 01/03/2021 and on Monday 01/04/2021 went to clinic and saw a provider. Resulted in bilateral pulmonary emboli treated with Lovenox and Coumadin.
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| 59 | 2021-01-06 | headache, fatigue |
Severe headache came on suddenly. Neck, shoulder and body aches Extreme fatigue NO elevated temperat...
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Severe headache came on suddenly. Neck, shoulder and body aches Extreme fatigue NO elevated temperature
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| 59 | 2021-01-06 | dizziness, fever |
stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore...
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stomach cramps, nausea, dizziness, subjective fevers, bilateral swelling cervical nodes, denies sore throat, mild headache, denies respiratory difficulties. States that with 1st vaccine had hives inside rt elbow and wrist,
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| 59 | 2021-01-07 | headache, fever |
1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body...
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1-7 middle of the night was achy and had headache. Thursday headache became more severe and had body aches. Thursday night had a low grade temp and the headache got severe and she developed lymph node swelling in R axilla. She continues with headache that is bad and body aches but no fever today 1-8-2021
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| 59 | 2021-01-07 | fatigue, fever, fatigue, fever |
3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and ...
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3 weeks ago tomorrow, The day after my shot I was really tired. I went to bed and when I got up and had a fever, horrible joint and leg pain, horrible leg pain, terrible bouts of nausea until I couldn't puke anymore. I went into the ER and got fluids and they ran tests and everything was normal. ER said it could be a moderate reaction to the vaccine.
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| 59 | 2021-01-07 | fatigue, headache |
CDC called and requested I complete this report, but I do see these reactions within the normal rang...
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CDC called and requested I complete this report, but I do see these reactions within the normal range reported to us prior to getting vaccine. 6 hrs after 2nd shot fever of 99, headache, and arm pain. 20 hrs after shot significantly worse headache, arm pain and fatigue to point of not getting up, not walking around, and not interested in eating until later in the day. 30 hrs after shot I was up and eating normally, but continued headache 46 hrs after shot but ibuprofen adequate to cover pain today.
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| 59 | 2021-01-07 | chills, fatigue, headache, fever |
Developed severe chills, body aches, mild fever of 100.5. Lasted about 30 hours. Treated with Tyleno...
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Developed severe chills, body aches, mild fever of 100.5. Lasted about 30 hours. Treated with Tylenol. Had to miss a day of work. Have lingering fatigue and headache after 2 days. Also morning after vaccination had about 5 minutes of tachycardia with HR of 165 bpm. Resolved after taking blood pressure which was 114/69 with HR of 85 bpm. No further episodes.
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| 59 | 2021-01-07 | headache |
HEADACHE STARTED1/7/2021 STARTED1/8/2021 WITH FACIAL AND NASAL REDNESS, PRURITUS NO SOB WAS TOLD TO...
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HEADACHE STARTED1/7/2021 STARTED1/8/2021 WITH FACIAL AND NASAL REDNESS, PRURITUS NO SOB WAS TOLD TO TAKE BENADRYL 50MGS STAT AND IF WORSENS WILL GO TO ER
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| 59 | 2021-01-07 | fever, fatigue, headache | Headache, Myalgia, Fever fatigue |
| 59 | 2021-01-07 | chills, headache, fever |
Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she ...
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Headache; Fever: She said that she started with kind of chills and shakes; Fever: She said that she started with kind of chills and shakes; she was not feeling too good; real high heart rate that were in the 110's that last for lasted for hours; Fever; This is a spontaneous report from a contactable nurse reported for herself. A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK9231 and expiration date unknown), via intramuscular on left deltoid on 03Jan2021 09:13 at single dose for COVID-19 prophylaxis. The patient medical history and concomitant medications reported as none. The reporter is a registered nurse that reported that she had the first Covid-19 vaccine yesterday morning on 03Jan2021 and she had side effects. She reported that she had a fever, headache, and a real high heart rate that was in the 110's that last for lasted for hours. She said that she started with kind of chills and shakes 11 hours and 40 minutes after receiving the vaccine. One minute she was fine and the next minute she was feeling chilled. By the time she got home from her mother's house, which is a hours drive, she was not feeling too good. Her fever broke today 04Jan2021 at around 04:00 and when she checked her temperature it was 98.7 degrees. She said that 100.2 degrees was the highest temperature she recorded. The patient said that it was a mild fever. Her headache started about 22:00 03Jan2021. The patient said that she still has the headache a little bit and she has been treating it with Tylenol and it has gotten better. She said that she wears a fit bit that tracks her heart rate and she can hear her heartbeat in her ears and she could hear it going fast. Caller said that her heart rate was down to 98 beats per minute at 06:30 this morning. She said that her current heart rate was Body temperature. Caller said that her high heart rate had her very concerned. She said that it is not normal. She is supposed to go back on 30Jan2021 to get her 2nd injection. Should she still plan on getting the second part of the vaccine? The reporter assessed event real high heart rate that were in the 110's that last for lasted for hours as serious with medically significant. Other events were assessed as non serious. The outcome of the events fever and real high heart rate that were in the 110's that last for lasted for hours was recovered on 04Jan2020, outcome of the event headache was recovering, outcome of the other events was unknown.; Sender's Comments: Based on the close temporal relationship, the association between the event high heart rate with BNT162b2 can not be completely excluded.
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| 59 | 2021-01-07 | fever |
Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontan...
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Low grade temperature that last 6 hours; Nausea; Vomiting; Diarrhea; Arm soreness; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events 6 patients. This is 2nd of 6 reports. A 59-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 29Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were none. This patient had a low grade temperature that last 6 hours, nausea, vomiting and diarrhea on 05Jan2021. She also experienced the arm soreness on 29Dec2020. patient says that they had employees get the COVID Vaccine on 29Dec2020. Most said that they maybe got a little arm soreness that lasted a few hours. They took tylenol and were fine. reporter confirmed that this patient is herself. She did not have a specific physician that she sees. She sees whoever is there that day. She received the vaccine on 29Dec2020. These symptoms hit her early this morning. They hit her, then she called out of work. She talked to her provider and they were going to revisit if they wanted to do another COVID test. she has already had two negative tests. Treatment was none. Patient states she just got off the phone completing a report of side effects from several of her employees that happened within 24 hours of receiving the Covid vaccine on 29Dec2020. reporter states several employees reported headaches, tiredness, and malaise. reporter would like to know if the onset and duration for these symptoms are expected. Her question it, since they all got the vaccine on 29Dec2020, would they be experiencing these side effects 7 days post injection, this far out. No Investigation Assessment. Patient was recovered from low grade temperature that last 6 hours, vomiting and diarrhea on 05Jan2021, recovered from arm soreness on 29Dec2020, recovering from nausea. Reporter seriousness of low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was not serious. The reporter considered the events Low grade temperature that last 6 hours, Nausea, Vomiting, Diarrhea and Arm soreness was related. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
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| 59 | 2021-01-07 | malaise, fatigue |
Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous re...
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Malaise and extreme tiredness; Malaise and extreme tiredness; Arm soreness; This is a spontaneous report from a contactable Nurse. This Nurse reported events for 6 patients. This is a 1st of 6 reports. A 59-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on 29Dec2020 at single dose, once by injection in the right arm, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm soreness on 30Dec2020 that lasted a few hours, malaise and extreme tiredness on 05Jan2021. Therapeutic measures were taken as a result of arm soreness included Tylenol. The patient worked in a healthcare facility and had not had COVID. The outcome of event arm soreness was recovered on 30Dec2020, and of malaise and extreme tiredness was not recovered. Reporter seriousness for arm soreness, malaise and extreme tiredness was non-serious. The reporter considered the events arm soreness, malaise and extreme tiredness were related to COVID Vaccine. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006243 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006329 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006376 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021006151 same reporter/ drug , different patient /AE.;US-PFIZER INC-2021005968 same reporter/ drug , different patient /AE.
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| 59 | 2021-01-07 | headache | Mild headache and injection site soreness |
| 59 | 2021-01-07 | headache | Mild headache and injection site tenderness |
| 59 | 2021-01-07 | migraine, chills |
Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse...
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Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 30Dec2020 10:30 at Left arm at single dose for covid-19 immunization. Vaccine was administered at hospital and not administered at military site. Medical history included ongoing spondylolisthesis diagnosed 15-20 years ago and overweight. Her vertebrae were not in physical alignment. The patient was given steroids, but it didn't help. Steroids didn't do anything. There was no name or NDC/Lot/Exp of steroids. The patient no longer has steroids. Her back will hurt when she gains weight. Height was now under 5 feet 5 inches (164 cm). The patient had no family medical history. There were no concomitant medications. No additional vaccines administered on same date of pfizer suspect and no prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient experienced multiple side effects 10 hours after the vaccine and lasted 20 hours. Side effects started 20:00 - 21:00 on 30Dec2020. Side effects were classified as: Nausea, migraine headache, chills, and joint pain. The events was waxing and waning. On 31Dec2020, side effects were 75% gone by 16:00. Joint pain was completely going by 22:00-23:00 on 31Dec2020. Chills were gone between 08:00-09:00 on 31Dec2020. Nausea and migraine headache stayed until 16:00-17:00 on 31Dec2020 and then it went away. At the time of vaccination, there was a low-pressure center coming through. There was also an ice and snowstorm. She was wondering if the headaches and joint pain were due to the weather. The patient took no medication or treatment for spondylolisthesis and wondered if that had something to do with it. The patient really want to have second shot in two weeks. Investigation assessment was no. The outcome of the events was recovered on 31Dec2020. Causality assessment by primary reporter via global introspection was unknown.
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| 59 | 2021-01-07 | dizziness, headache |
This 59 yo contractor was referred to for HA, dizziness and nausea after her first COVID vaccine. S...
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This 59 yo contractor was referred to for HA, dizziness and nausea after her first COVID vaccine. She received Pfizer COVID vaccine on 12/31/2020. She advised 8 hours later she developed a severe headache. She advised she took 800 mg Ibuprofen and 4 hours later took 1000mg Tylenol and was able to go to sleep. She awoke the next day with her headache persisting and was nauseated. She stated she would alternate Ibuprofen and Tylenol every 4 hours and drink gatorade/water (appetite was low and didn't eat). She denied any fever, rash, SOB, arthralgia, myalgia or other systemic symptoms. Day 4 post vaccination (1/4/2021) she cut med use down to every 8 hours. She stated use of Ibuprofen/Tylenol did resolve
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| 59 | 2021-01-07 | weakness, chills, fatigue |
Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slig...
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Upon awakening, exhausted feeling, severe weakness, total body aches, chills, temp 97.4 orally, slight nausea. Notified supervisor at work, took Tylenol 1000 mg and slept for 2.5 hours. Woke up with symptoms much reduced and went to work
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| 59 | 2021-01-07 | weakness, fatigue |
Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left ar...
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Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.
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| 59 | 2021-01-07 | chills, malaise, throat pain | body aches, sore throat, chills just doesn't feel well |
| 59 | 2021-01-07 | throat pain, malaise, chills |
sore throat and hives still from Covid vaccine bodyaches, sore throat, chills just doesn't feel well...
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sore throat and hives still from Covid vaccine bodyaches, sore throat, chills just doesn't feel well, hives
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| 59 | 2021-01-08 | chills, fever, headache |
About 6 hours after my second injection I started with a headache,bodyaches,low grade fever,chills. ...
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About 6 hours after my second injection I started with a headache,bodyaches,low grade fever,chills. They lasted about 48 hours. Still have pain in my armpit on left side.
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| 59 | 2021-01-08 | fever, chills |
Developed fever/chills next day and following day which resolved but also began having having purple...
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Developed fever/chills next day and following day which resolved but also began having having purple/blue fingertips - both pads and nails - when my hands are cold. This began on day after vaccine and continues to date.
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| 59 | 2021-01-08 | fatigue, discomfort, headache |
First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: Abou...
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First vaccine injection 12/19/2020. Symptom of fatigue. Second vaccine injection 01/07/2021: About 3 hours after receiving the 2nd injection, I had terrible headache requiring dosages of OTC Tylenol, terrible abdominal pain/pressure similar to menstral cramping, extreme fatigue requiring prolonged sleep, nightmares (which I never have). All symptoms lasted for approximately 38 hrs.
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| 59 | 2021-01-08 | headache |
Pt reported onset of "quivering" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted...
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Pt reported onset of "quivering" lips & Headache 15 min after vaccine. Vitals recorded. MD contacted & interviewed (Dr.) patient. Ambulance called. Vitals re checked Benadryl 25 mg PO given. Paramedic & Ambulance arrive 4:35 59 y/o who states she had anaphylaxis before her symptoms started the same as today. C/o quivering lips & H/A No rash or respiratory comp (EMT's exam - normal except ? movement. Assessment - Possible allergic RXN Plan - Ambulance transport to ED
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| 59 | 2021-01-08 | body temperature increased, headache, chills | temperature 100.2 chills and body ache and headache |
| 59 | 2021-01-09 | dizziness |
Does not have Lot #. Left it at work. Dizzy 15 mins after. BP was high. Dizzy rest of day. Worked th...
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Does not have Lot #. Left it at work. Dizzy 15 mins after. BP was high. Dizzy rest of day. Worked the next day was ok. Started driving the next day on interstate 12/25/20, and had chest pressure. Pulled of in to a hospital their and had testing done. Went home had dizziness still. Went to her MD, the doc changed her blood pressure meds. She doesn't have the dizziness and the chest pressure any more. Blood pressure is still high and monitoring it a few times a day.
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| 59 | 2021-01-09 | influenza like illness |
I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 210...
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I received the vaccine at 0615 am on 1/8/21. Had no symptoms (not even injection site pain). At 2100 on 1/8, began to develop a lot of pain at the injection site. Within 2 hrs of that time, I developed other symptoms, which include total body (bone and joint) pain (especially in my knees), and what I would describe as a "bad sunburn type" rash across my cheek bones, bridge of my nose, and orbital area. Small raised bumps to this area, with swelling, and a feeling of pins and needles stabbing me all across my face. My airway was fine, and at no time did I feel shortness of breath. I was unable to sleep due to the bone and joint pain, and felt the need to walk continually (it was more painful to stay in one position). These symptoms persisted throughout the day (Saturday 1/9/21), noting at 5pm I described myself "miserable" to my friends and family. All symptoms described above, were at their most elevated intensity between the hours of 1700 - 0400. At 0400 Sunday (1/10/21) I felt a gradual release of the body aches, enough so that I could sleep until 0800. At this time, 1300 (Sunday 1/10) I note that I still feel "flu type" body aches, but constant pain has diminished in intensity by estimated 50%. The sunburn type redness and swelling across my face/orbital area has also less by 50% (there is still redness, mild swelling, warmth, and some raised bumps across this area; pins and needles feeling is gone).
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| 59 | 2021-01-09 | fever, fatigue |
Lower back pain and slight fever beginning at 1am 14.5 hours after shot. Just tired and back achy by...
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Lower back pain and slight fever beginning at 1am 14.5 hours after shot. Just tired and back achy by 4:30 pm the day after the shot For a few hours about 8 hours after shot, arm where shot was given was quite sore, but that went away
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| 59 | 2021-01-09 | chills, fatigue | Reaction site pain, fatigue, chills and joint pain |
| 59 | 2021-01-09 | chills, body temperature increased | Temperature 99.4, severe body aches, chills, soreness at injection site |
| 59 | 2021-01-10 | fever, headache |
06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than t...
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06:fever, body aches, Headaches, soreness-left arm-99.7-T 07th:& 8th: Headaches & fever-more than the 6th, 99.9-T Sat the 9th vomiting 2 times---she took Tylenol 325mg times 2 for her fever-T-99.7 Sunday the 10th vomited 10 times-99.9 T This Am the 11th of January@0100-cramping--------99.1 T
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| 59 | 2021-01-10 | chills, headache | 40 hours of chills, and body aches and headache |
| 59 | 2021-01-10 | cough, headache, runny nose | Cough. Runny nose. Headache. Diarrhea |
| 59 | 2021-01-10 | fatigue, dizziness, chills | Dizzy, chills, tired, resolved with nap |
| 59 | 2021-01-10 | chills, fever | Fever and chills from Friday all day till Saturday afternoon (for 1.5 days). |
| 59 | 2021-01-10 | chills, headache, fatigue | In afternoon had chills headache fatigue injection sit deltoid sore down to elbow |
| 59 | 2021-01-10 | headache |
Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 ...
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Patient received the first dose of the COVID vaccine on 12/28/20, and the second dose on 1/8/21 (11 days later instead of 21 days). The patient reported experiencing right eyelid and cheekbone numbness and a minor headache after the first dose. She had numbness to her right cheek again on 1/8/21 and some nausea that has resolved. I spoke with the patient on 1/11/21 and she is feeling well.
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| 59 | 2021-01-10 | throat swelling | Rash entire body, throat swelling, extreme nausea. |
| 59 | 2021-01-10 | malaise, throat swelling |
She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsen...
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She is having an allergic reaction; Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened; From the time she got the vaccine to now, she has lost 20 lbs; shake/shaking; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; swelling in the lips, throat, and eye lids; She has been sick since Wednesday; itching all over from head to toe; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension and allergic to ace inhibitors. There were no concomitant medications. Patient was calling about the Covid Vaccine. She was having an allergic reaction. She did not know what to do to stop it. She went to the ER yesterday (04Jan2021). She had been sick since Wednesday (30Dec2020), she was itching all over from head to toe since 30Dec2020, she got a prescription for Prednisone, she took 2 doses yesterday, 1 dose today, and would take another this evening. She took Benadryl, an hour ago and had an episode, and so she had to jump in the shower and let the cold water run to stop itching, the itching did not stop but it has minimized. She put Benadryl gel and she was still itching, she had taken enough Benadryl. Patient asked what is the best way and if she needed an IV of something, she went to ER on Sunday, she was not seen by doctor, it was a nurse practitioner, she didn't do anything but just listen to her and she only looked at ankles to check for swelling. Patient stated that she had been drinking water and urinating, she had no appetite and lost 20 lbs. Patient confirmed that she got her first dose of the Covid vaccine on 30Dec2020 at 1 o clock, the itching started the same day at 5 o clock, the itching was from head to toe. She experienced swelling in the lips, throat, and eye lids, which started 02Jan2021. She began losing her appetite on 30Dec2020. From the time she got the vaccine to now (05Jan2021), she has lost 20 lbs. An hour ago (05Jan2020) she had an episode, which made her shake, and she did not have the shakes before, this was the first date she started shaking. Itching was reported as worsened/Swelling was reported as worsened/loss of appetite was reported as worsened. Her 2nd dose was scheduled in 21 Days. However, she may not get the second dose, patient stated that she could not get through this no more. She had no positive test for Covid prior to vaccine. She had no antibody test prior to the vaccine. She had not any issues with vaccines in the past. Patient stated that if she was still feeling this way, she would go to a different hospital. When she went to the ER, she was not hospitalized, they sent her back home the same day. Patient would like to know if there was anything that can remove the vaccine from the body. The outcome of the events itching all over from head to toe, loss of appetite, swelling in the lips, throat, and eye lids was not recovered, of the other events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-10 | chills |
That evening developed itching and had a rash over upper body and arms, still on arms in AM, went aw...
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That evening developed itching and had a rash over upper body and arms, still on arms in AM, went away on it's own, since then have episodes of chills and a trigger finger developed while sleeping on right #4 digit of Right hand, tightness in chest and last night developed pain in left arm and fingers that was very painful and did not respond to 800mg of Ibubrofen. Not sure if related.
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| 59 | 2021-01-10 | fatigue | nausea in the head, fatigue, muscle soreness-resolved |
| 59 | 2021-01-10 | headache, throat pain |
sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips o...
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sore throat, headache, swelling and very, very sore feeling in the left arm, tingling in the tips of fingers (feeling pricked in the fingertips).
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| 59 | 2021-01-10 | fever, fatigue |
soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 o...
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soreness around the injection site; Had severe arm pain; Had a fever on the night of the 31Dec2020 of 101.3; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; I have painful lymph nodes/the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes; had joint pains/knees and hip joint pain; severe fatigue; muscle pain; This is spontaneous report from a contactable nurse (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 30Dec2020 14:15 at first single dose (0.3 cc, but really uncertain of dose) for covid-19 immunization. Medical history included COVID virus from Nov2020 to 2020 (The patient was not hospitalized. It was a mild case and lasted about 10 days. she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue). The patient's concomitant medications were not reported. The patient did not receive any other vaccines at the same time or 4 weeks prior. No problems with vaccinations in past or events. Caller reported she had the first injection of the Pfizer BioNTech COVID-19 vaccine on the 30Dec2020 and having some side effect symptoms and her supervisor recommended for her to report these things, they are not life threatening, obviously, but things were still lingering. Side effect of severe fatigue started on the 31Dec2020 and lasted for 72 hours. It was so severe, now it is mild. The patient reported soreness around the injection site. Had a fever on the night of the 31Dec2020 of 101.3 and had that for 6 hours then it dissipated and was gone. Had never had a fever after injections before. Had severe arm pain that usually goes along with an injection. It started also that night of 31Dec2020. She had rolled over in the middle of the night and it hurt. That lasted for about 48 hours, but it has improved. Had some muscle aches since 31Dec2020 but that had improved and had joint pains since 31Dec2020. What was worrisome was the swollen lymph nodes under her right arm, the armpit area had swollen and painful lymph nodes, since 31Dec2020. The patient was still having that and that is why she was so concerned because shouldn't that have gone away after a week. Had knee and hip joint pain, but that had improved. Again, mentioned she had never had that before with an injection. The patient received vaccine at her workplace. Some of her coworkers got it the same day and no one else has this. Mentioned she did have COVID virus back in Nov2020 and wonders if this correlates with her getting the vaccine. Was not hospitalized or notified she had any positive antibodies at that time. Was off work for about 12 days and was very lucky to have had a very light case with fever, cough, cold, and super fatigue. This is the same way she felt back when she had the virus back in November. The patient was concerned about having these side effects would it be okay for her to get the next injection in 3 weeks. AEs did not require a visit to emergency room and physician office. No further details provided. Outcome of the events Fever was recovered, of event swollen and painful lymph nodes was not recovered, of events knees and hip joint pain, fatigue, muscle pain, severe arm pain was recovering, of event soreness around the injection site was unknown. The reporter considered the events severe fatigue, fever, swollen lymph nodes and pain under right arm, knees and hip joint pain as serious (medically significant). The reporter considered the events severe fatigue, fever, severe arm pain, muscle ache, swollen lymph nodes and pain under right arm, knees and hip joint pain as related to BNT162B2.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-11 | dizziness, headache |
1/5/2021 at 3am I woke up feeling very lightheaded and dizzy. Went back to sleep and At 7am woke f...
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1/5/2021 at 3am I woke up feeling very lightheaded and dizzy. Went back to sleep and At 7am woke feeling same. I took routine vitamins and 2 extra strength Tylenol. Symptoms lasted all day with difficulty walking due to the dizziness. Also had difficulty focusing, blurry vision. 1/6/2021 still a little lightheaded just a little dizzy. Headache ( I have routine headaches). lightheaded and dizziness decreased with each day.
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| 59 | 2021-01-11 | malaise, chills, weakness |
12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21...
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12/19 vaccination 12/20 10pm As soon as I lied down, room spinning. Went to sleep. Midnight on 12/21; woke up 'not feeling well'; weakness, faint, shaky. You contacted your brother and proceeded to the ER. 2am started to feel better 3:30 am dishcarged home. Wope up at 6:30 am. Chills, achy. Went to work; felt chilled all Monday into the evening until eventually subsided. **2 negative COVID in Nov **Flonase for allergies **2nd Pfizer vaccination on 1/9/2020. Milder symptoms for couple of days, into Tuesday. 1/12/2021; mild chills, mild body aches.
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| 59 | 2021-01-11 | headache, chills |
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I dev...
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After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit, numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin. My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet. On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
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| 59 | 2021-01-11 | fatigue | Arm aching Fatigue Minor hives for three days Treated with Zyrtec and Benedryl |
| 59 | 2021-01-11 | headache | Body aches, Headache, Nausea |
| 59 | 2021-01-11 | dizziness |
Feeling light headed and dizzy. Given water and crackers. Rested and monitored for 30 minutes. Left ...
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Feeling light headed and dizzy. Given water and crackers. Rested and monitored for 30 minutes. Left walking without difficulty.
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| 59 | 2021-01-11 | fatigue, headache | noted hard lump at injection site, warm, redden, sore Headache, very tired |
| 59 | 2021-01-11 | dizziness |
patient complained of arm heaviness, lightheadedness, dizziness after receiving 2nd dose of COVID va...
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patient complained of arm heaviness, lightheadedness, dizziness after receiving 2nd dose of COVID vaccine - her blood pressure was elevated as well - she reports she had not taken her blood pressure medication prior to the vaccine. Patient received Acetaminophen and Lisinopril in Emergency Dept afterwards and discharged home.
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| 59 | 2021-01-11 | shortness of breath, dizziness | pre syncope; difficulty breathing; dizzy - after 20 minutes of monitoring patient refused emt |
| 59 | 2021-01-11 | fever |
rash that started on her face and now it is going everywhere; temperature is 98.2/slight fever; This...
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rash that started on her face and now it is going everywhere; temperature is 98.2/slight fever; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown), intramuscularly on 05Jan2021 injection in left arm at single dose for preventative since she works in nursing home. The patient's medical history and concomitant medications reported as no. The patient was experiencing a rash that started on her face and now it was going everywhere on 05Jan2021. Rash was reported as worsened. She just took diphenhydramine hydrochloride (BENADRYL). Patient stated it was not serious at this point. She just took her temperature before she called and her temperature was 98.2 on 05Jan2021 and stated this was a slight fever since she was normally 97.4. The outcome of the event rash was not recovered, outcome of slight fever was unknown. The report was reported as non-serious. Information on the lot/batch number has been requested
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| 59 | 2021-01-12 | fever, fatigue, headache, runny nose |
-FEVER 101, BODY ACHE, HEADACH, FATIGUE, RUNNY NOSE , - Began within 6 hours Naprosyn helped, Tyleno...
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-FEVER 101, BODY ACHE, HEADACH, FATIGUE, RUNNY NOSE , - Began within 6 hours Naprosyn helped, Tylenol did not. TXT symptomatically with Pepcid, Claritin, tylenol, Naprosyn
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| 59 | 2021-01-12 | body temperature increased, chills, dizziness |
1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter...
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1/8/20201 2:30am lightheaded, chills 101 3:30am fingers/toes like ice had tylenol 7:30am felt beter 5:30pm Shivering muscle pain temp 101 took motrin 1/9/2021 Felt 80% ok 1/10/2021 and 1/11/2021 95% better Appetite decreased from 1/8/20201-1/11/20201 ( dry mouth, fever, chills, lightheadedness, muscle pain)
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| 59 | 2021-01-12 | throat irritation |
@0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient h...
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@0950 about 10minutes post vaccination, patient complaint of anxiety and rapid heart rate. Patient has a history of allergies - anaphylaxis. Vitals taken: b/p 197/116, hr 70, temp 97.5, 02 sat 99% on r/a. States she has HTN and takes meds. She did take her medication this morning. With meds she is around 140s/80s. Stayed with us for about 30 minutes. Repeat vs 186/104 hr 68, 98% RA. Still reporting anxiety but states she feels her b/p is high because she is anxious. She never experienced SOB, difficulty breathing. Stated at first a little bit of a scratchy throat but that went away shortly after. She stayed until she felt less anxious.
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| 59 | 2021-01-12 | headache, fatigue, chills | Fatigue. Injection site pain. Chills. Body aches, headache, nausea. Resolved. |
| 59 | 2021-01-12 | fever | Fever X 3 days. COVID positive in may 2020 |
| 59 | 2021-01-12 | fatigue, fever |
Fever- started at 99.4 (5:00 a.m.) increased to 100.8 within an hour. Roughly about 2 hr increments...
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Fever- started at 99.4 (5:00 a.m.) increased to 100.8 within an hour. Roughly about 2 hr increments the fever started to reduce 100.6, 99.6, 99.0, 98.7 to normal with no fever reducer medication. Body aches- started when temp got to 100.8 and lasted about 12 hrs. Tired- started after temp was reduced to normal and gradually got more tired as the day went on. Woke the next day with no symptoms
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| 59 | 2021-01-12 | headache |
Patient developed a sustained headache after vaccine, that has persisted to this day, though has got...
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Patient developed a sustained headache after vaccine, that has persisted to this day, though has gotten a bit better
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| 59 | 2021-01-12 | dizziness, dizziness |
Patient received her first dose of Pfizer vaccine on 1.12.2021. Patient reports that she woke up at ...
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Patient received her first dose of Pfizer vaccine on 1.12.2021. Patient reports that she woke up at 0230 on 1.13.21 with extreme dizziness. Patient says at 0530 she woke up again, still dizzy, but improved. Once she came to work at 0800, she felt normal again. Patient will call back again with any changes.
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| 59 | 2021-01-12 | sweating |
Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a ...
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Rash and swollen lymph node on my left side of my neck very painful to touch .Day before I had a check up with my doctor with no symptoms.. Injection on left high upper arm redness around . Muscles pain and tremors of my hands , tired Diarrhea for two days and sweats.
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| 59 | 2021-01-12 | malaise, sweating |
Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arou...
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Went to bed not feeling well. My husband came to check on me approx. 12:30 am. He was unable to arouse me. When he tried to get me up out of bed I collapsed and then had syncopal episode. He call 911. Paramedics could not get blood pressure and I was diaphoretic and body temp was cold. They rushed me to the hospital. My blood pressure was dangerously low along with my body temperature. I was given epinephrine and LEVOPHED to get a blood pressure. I was warmed up. Then I had GI issues of vomiting, diarrhea, nausea. I spend 4 days in hospital.
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| 59 | 2021-01-13 | chills |
1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking o...
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1/12/21 around 10:00 reports having nausea, abdominal cramping, weakness, and uncontrolled shaking of hands, chills and present at this time 1/14/21
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| 59 | 2021-01-13 | sweating, shortness of breath |
Day after shortness of breath ER and gave a breathing treat, blood pressure and sweating , Ebrudar...
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Day after shortness of breath ER and gave a breathing treat, blood pressure and sweating , Ebrudarol breathing and , magnesium and fluids.
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| 59 | 2021-01-13 | chills |
Erythema at site, tender and warm to touch from 8 hours after injection through today. Myalgia?s an...
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Erythema at site, tender and warm to touch from 8 hours after injection through today. Myalgia?s and chills 12 hours after injection lasting for 48 hours after. Took 800mg ibuprofen every 6 hours through 48 hours post injection with relief of myalgia?s and chills.
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| 59 | 2021-01-13 | chills, headache, fever, weakness |
Fever, chills, headache, major joint pain (hips, shoulders, knees, elbows, ankles), generalized weak...
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Fever, chills, headache, major joint pain (hips, shoulders, knees, elbows, ankles), generalized weakness
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| 59 | 2021-01-13 | shortness of breath, fatigue, chills, headache, runny nose |
Nausea; fatigue; muscle aches; chills; transient SOB; runny nose; weird headaches or fullness; This ...
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Nausea; fatigue; muscle aches; chills; transient SOB; runny nose; weird headaches or fullness; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), intramuscularly on 22Dec2020 at 15:00 on Left arm at single dose for COVID-19 immunization. The patient medical history included known allergies with Chloreseptic spray. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included ergocalciferol (VIT D); ascorbic acid (VIT C); probiotics (reported as probiotic); alpha-amylase swine pancreas, cellulase, lipase, protease nos (DIGESTIVE ENZYME); trazodone (reported as trazadone) for sleep; fluticasone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Nausea, fatigue, muscle aches, chills, transient SOB (Shortness of breath), and runny nose, weird headaches or fullness on 22Dec2020 at 19:00. Since the vaccination, patient had been tested for COVID-19 via Nasal Swab on 04Jan2021, result: Negative. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
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| 59 | 2021-01-13 | headache |
Patient began to experience neck pain on the same side she received her injection along with tightne...
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Patient began to experience neck pain on the same side she received her injection along with tightness and stiffness. Patient also experienced pressure, popping and burning in and around bilateral ears. Patient expressed she felt hot, and had a headache. Patient verbalized she had a lot of allergies to environmental substances.
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| 59 | 2021-01-13 | sweating, fever, chills, cough, runny nose, fatigue | Sweating and chills and coughing running noise, and over fatigue . Fever of 102. |
| 59 | 2021-01-13 | headache, fatigue |
Tired; headache; achy; This is a spontaneous report from a contactable other healthcare professional...
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Tired; headache; achy; This is a spontaneous report from a contactable other healthcare professional (hcp). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL1283, expiry date not reported), intramuscular in the left arm on 07Jan2021 11:45 at a single dose for Covid-19 immunization. The patient had no medical history. The patient had no known allergies; no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. The patient had no COVID prior to vaccination (not diagnosed with COVID-19). Concomitant medication included pantoprazole. The patient had the first dose of BNT162B2 (lot EK5730, expiry date reported) for Covid-19 immunization on 17Dec2020 16:00 at a single dose in the right arm intramuscularly. The patient had no other vaccine in four weeks. Both Covid-19 vaccinations were administered in the hospital. On 08Jan2021 12:00, the patient was tired, had headache, and was achy. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatment was received in response to the events reported. Since the vaccination (post vaccination), the patient has not been tested for COVID-19. The outcome of the events tired, headache, and achy was recovering.
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| 59 | 2021-01-13 | throat pain, fatigue, headache, somnolence |
wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; h...
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wanted to sleep; eyes being weak and hurting; eyes being weak and hurting; sore throat; tiredness; headache, muscle spasms in abdomen; headache, muscle spasms in my abdomen; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 02Jan2021 at a single dose in left arm for COVID-19 protection. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 18 or 19 years ago), COVID-19 previously and did not have side effects like this (the patient had COVID 19 last month and did not feel this bad at all. Patient was asymptomatic). Concomitant medication included ongoing liraglutide (VICTOZA), ongoing insulin detemir (LEVEMIR), both started about 2 or 3 years ago for diabetes Type 2. She received the product vial workplace policy, so it was not specifically prescribed to her. The patient received the first dose of the vaccine on 02Jan2021, and starting on 06Jan2021, she started with headaches, and muscle spasms all over her abdomen and back. Headaches was reported as worsened. The headache will not go away and even with Tylenol it still lingers. Muscle spasms all over her abdomen and back was reported as worsened. Her eyes were weak and hurting, started on 08Jan2021. She was so tired, she wanted to sleep. The tiredness, started on 06Jan2021, and it is like in the morning she is okay, but then during the day she just got worse and worse and worse. Her sore throat starting 07Jan2021 night, and this morning it was really bad. Throat was very sore was reported as worsened. She received no other vaccines on the same day at the COVID vaccine. The patient was wondering if those are side effects of the vaccine, because the patient had COVID-19 previously and did not have side effects like this. This is a non-serious report. The outcome of event eyes being weak and hurting, and wanted to sleep was unknown, outcome of the other events was not resolved.
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| 59 | 2021-01-14 | chills |
4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This ...
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4 hours after vaccine, soreness at injection site; severe whole body chills; whole body aches; This is a spontaneous report from a contactable other hcp. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, intramuscular on the left arm on 07Jan2021 17:45 at a SINGLE DOSE and intramuscular on the left arm on 17Dec2020 18:45 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included escitalopram oxalate (LEXAPRO). On 07Jan2021, it was reported that 4 hours after vaccine, there was soreness at injection site. 14 hours following vaccine, the patient experienced sudden onset of severe whole body chills and whole body aches lasting up to 18 hours. The outcome of the events was recovered. Information on the lot/ batch number has been requested.
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| 59 | 2021-01-14 | fatigue | After my second Covid vaccine dose, I felt fatigue, sore neck and shoulder muscles. |
| 59 | 2021-01-14 | cough, headache, shortness of breath |
At 09:30 am patient complaints of H/A, nausea, SOB and cough. Vitals signs BP 159/103 mmHg, HR 79 bp...
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At 09:30 am patient complaints of H/A, nausea, SOB and cough. Vitals signs BP 159/103 mmHg, HR 79 bpm and O2sat 100%. A rapid response code for an anaphylactic reaction was activated at 9:35am. Patient was transferred to the ER vital signs were BP 173/123mmHg , HR 106 bpm, Dxt 93 and O2sat 94%. One dose of Epinephrine 0.3mg IM, D5W 20g/250ml IV, Benadryl 50mg IV and Solu-Cortef 200mg IV were administrated.
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| 59 | 2021-01-14 | chills |
Diarrhea, chills on 1/12/21 - 1/14/21. Symptoms have stopped. On injection site there is a half doll...
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Diarrhea, chills on 1/12/21 - 1/14/21. Symptoms have stopped. On injection site there is a half dollar size red area which is hot to the touch with hardness or a knot at injection site. tHIS IS STILL PRESENT.
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| 59 | 2021-01-14 | chills |
Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare ...
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Diarrhea; severe chills; sore arm; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) then received the second dose (lot number: EK 9231, expiration date: not reported) on 08Jan2021 13:45 both via an unspecified route of administration on the left arm at a single dose for COVID-19 immunization. Medical history included that the patient had allergies to medications, food, or other products such as Penicillin, Sulfa drug and pork. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), ergocalciferol (VIT D) and biotin (BIOTIN). On 08Jan2021 22:45, 9 hours after vaccine the patient experienced diarrhea, severe chills and sore arm. As treatment, patient received ibuprofen (ADVIL) and fluids. The outcome of the events was recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number (first dose) has been requested.
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| 59 | 2021-01-14 | shortness of breath |
Five minutes after receiving injection patient experienced shortness of breath, itching and burning ...
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Five minutes after receiving injection patient experienced shortness of breath, itching and burning in left arm and hand, right arm. She reported taking 2 puffs of her Proair inhaler. She worried she would pass out as she was walking. She reported her condition to NP who did an assessment. At 9:40AM the patients vitals were BP: 147/104, HR=109, O2=98%, She was advised to lie down and was placed under observation for 15 minutes. Vitals were taken again at 9:55AM - BP=142/92, HR=103, O2=95%. The patient moved to the Travel, Immunization, and Allergy Clinic for further observation. Dr. examined the patient. He Heart rate was 116. The patient drank some water and juice and took an antihistamine (Claritin). She didn't want Benadryl as she didn't like the way it made her sleepy. After resting for 40 minutes, she stated that she felt better. Dr. checked on her again and said that she could go back to work if she felt OK and to be monitered by RN for the next hour. She rested and was checked at 10:30, 11:00, 11:30 AND 12:15 and reported feeling better.
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| 59 | 2021-01-14 | fatigue, headache, chills, body temperature increased |
I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had ...
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I received 2nd injection of Pfizer COVID-19 Vaccine at 1015AM on 1-12-21 and was doing great. I had taken one 325mg Tylenol and one 200mg Ibuprofen approximately 60 minutes prior to receiving vaccine (which is what I did prior to the first vaccine). I was doing great initially following the vaccine. I took another 325mg Tylenol and 200mg Ibuprofen when I went to bed at 2000 1-12-21. At 0300 1-13-21 I woke up feeling nauseated and when attempting to turn over to my right side I moaned loudly because I could not hardly move my left arm. My husband was woken and turned on the bedroom light and we noted a 3 inch bruise and large knot on my left deltoid at the injection site. He told me that I felt warm. I took my temperature that was 101.2 degrees. I took 650mg Tylenol and that time. At 0500 1-13-21 I was having chills, muscle and joint aches. I could not fully close my hands into a grip. My "brain" hurt, not a headache but literally it hurt to move my head. I would occasionally get a sharp pain in the front and back of my head. My temperature went to its highest at approximately 1500 1-13-21 to 102.5 degrees. I continued to offset Tylenol with Ibuprofen throughout the day. At 2000 1-13-21 my temperature was 101.8 and began to trend downward. I went to bed and when I woke up on 1-14-21 I felt 100% better with just a little fatigue from the inability to sleep the day prior.
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| 59 | 2021-01-14 | headache |
Injection site soreness 8/10, unable to raise arm laterally more than 25%. Body aches, low posterior...
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Injection site soreness 8/10, unable to raise arm laterally more than 25%. Body aches, low posterior head and neck ache, and chills.
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| 59 | 2021-01-14 | fatigue, body temperature increased, cough, dehydration, dizziness, sweating |
On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started...
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On 1/8 she took her 2nd dose of Pfizer vaccine around 3 PM. She went home in the evening and started sweating. She passed out. Her daughter was at home and she took her to the nearest hospital. Her BP was 60/34 and she had a temp of 100.3F on 1/8 during hospital admission. Her K was low. She received lot of fluids. She called our office on 1/10 and during the f/u she was still in the hospital. On 1/10 she has a temp of 98.4F and BP of 109/61. But she still has dizziness, nausea, anorexia and mild cough (Former smoker). COVID-19 test was done on 1/9, its negative. Dx was dehydration. Discharged from the hospital on 1/11, feels better but is tired. Will follow up with PCP on 1/16/21.
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| 59 | 2021-01-14 | fever, headache | Severe arm pain; severe body aches and headache. Fever |
| 59 | 2021-01-14 | dizziness | Tachycardia Hypertension (198/120) - no he of hypertension Lightheadedness |
| 59 | 2021-01-14 | dizziness |
Vasovagal reaction immediately upon administration of vaccine. Patient felt faint, requested to lie...
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Vasovagal reaction immediately upon administration of vaccine. Patient felt faint, requested to lie down on floor. Initial blood pressure reading approximately 5 minutes later was 92/54. Patient did not lose consciousness. Repeat blood pressure reading approximately 10 minutes after vaccine administration was 122/78 and patient reported feeling better. Patient was observed for an additional 20 minutes with improvement of symptoms.
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| 59 | 2021-01-14 | headache, weakness, chills, fatigue, fever | chills slight fever headache fatigue body aches no energy exhaustion |
| 59 | 2021-01-14 | headache |
soreness at injection site and sharp headache pain over my right eye that radiated to the back of my...
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soreness at injection site and sharp headache pain over my right eye that radiated to the back of my head, both started the night of the injection and through the next day
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| 59 | 2021-01-15 | headache, fever, chills | Fever 100.6 for 24 hours, muscle aches, chills, headache |
| 59 | 2021-01-16 | fatigue, chills, sweating, malaise |
About 2 hrs post vaccination, developed generalized muscle pain & malaise/fatigue . During the night...
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About 2 hrs post vaccination, developed generalized muscle pain & malaise/fatigue . During the night, had mild sweats and chills and moderately severe body pain, especially in legs and back. The next morning had no sense of taste or smell. Body pain and loss of taste improved over the day. ,
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| 59 | 2021-01-16 | fatigue |
left arm became red with rash that was raised like small pimples, I felt like something was prickin...
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left arm became red with rash that was raised like small pimples, I felt like something was pricking me from the inside out then felt a little uneasy and face was itching with a small hive on my right cheek. My arm became bright red, I took a 25 mg benadryl which subsided some of the redness. I finished my shift and drove home about 5 pm still felt like I had prickly heat I took another 25 mg benadryl slept. I was extremely tired the next day which I could not tell if it was from the vaccine or benadryl or both. I work in a doctors office .
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| 59 | 2021-01-17 | chills, headache, fever |
Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning w...
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Premedicated with Ibuprofen 400mg about 2 hours before injection yesterday. Woke up this morning with chills, low grade fever, mild nausea, a headache, and a very sore arm. By late morning I had a fever of 100.9 and a severe headache. Early afternoon fever went up to 102.1. At this time I took ibuprofen 400mg and sumaptriptan 100mg. Fever came down and heaeache lessened.
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| 59 | 2021-01-17 | headache, fever | fever ( 101.7); sever headache, neck pain, nausea/vomiting, diarrhea, rib,spine, hip pain |
| 59 | 2021-01-19 | dizziness, weakness |
Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minut...
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Experienced weakness and dizziness immediately after the injection, which subsided in about 20 minutes. Two hours later, itching began on left leg and arms. Noted red blotches to these areas. Face began to feel very prickly and flushed, felt lower lip swelling and left eye began to feel funny. Observed one hive to cheek. Was able to take a Benadryl 25mg capsule within about 10-15 minutes after this developed. Symptoms began to subside after this. Felt back to normal the next day. Just moderate injection site pain for 1-2 days.
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| 59 | 2021-01-19 | dizziness |
Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy ...
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Patient received Covid vaccine, had sudden onset of flushed feeling, nausea no emesis, "dizzy/Fuzzy head" feeling. Hypertensive at time BP left arm 171/95 HR 79, RR 26, 99% RA. Apple juice, and cracker provided, and emesis bag provided. Patient was already waiting for thirty minutes time (she was 15 minutes into her wait time). She reported having a progression of nausea and dizziness Repeat vital signs at 1345 139/100 HR 76, RR 24 Pox 96% RA. First responder was called and patient was assisted into wheelchair and taken to the ER for further evaluation.
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| 59 | 2021-01-19 | body temperature increased, headache | TEMPERATURE OF 100.7, BODY ACHES, EYES STINGING AND DRY, HEADACHE |
| 59 | 2021-01-20 | migraine |
I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my...
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I received the Covid vaccine on December 21. On December 30, I woke up and was unable to maintain my balance. I developed very severe migraine headaches and was hospitalized. I still have not regained my balance. I have had a couple of courses of prednisone and migraine medication. My neurologist is setting up IV I G transfusions feeling that I?m having an auto immune response to the vaccine.
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| 59 | 2021-01-20 | headache |
she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hur...
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she tested positive for the covid virus; she tested positive for the covid virus; her arm barely hurt (injection site); This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration in the arm on 02Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received her first Pfizer covid vaccine dose on 02Jan2021. She gets tested regularly at work. On 04Jan2021, she tested positive for the Covid virus. She had a headache, not feeling great on Friday, after she was diagnosed with the Covid virus, but no symptoms before. No side effects from vaccine, other than her arm barely hurt (injection site) in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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| 59 | 2021-01-21 | fever, malaise |
12/22 vaccination 12/23 8-10PM fever, feeling poorly, and vomiting thereafter. Rotated between the ...
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12/22 vaccination 12/23 8-10PM fever, feeling poorly, and vomiting thereafter. Rotated between the tylenol and motrin. Vomiting 1 episode. Fever 24-48 hours after vaccination. 2 days poorly.
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| 59 | 2021-01-21 | fatigue, headache, fatigue, headache | DEVELOPED HEADACHE, BODY ACHE, AND FATIGUE LASTING 24 HOURS. |
| 59 | 2021-01-21 | headache, fever | FEVER MAX 102,BODY AND JOINT ACHES,HEADACHE |
| 59 | 2021-01-21 | malaise, influenza like illness, fatigue |
Flu-like symptoms, worse than the first dose but not severe-myalgia, malaisia, fatigue, joint pain. ...
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Flu-like symptoms, worse than the first dose but not severe-myalgia, malaisia, fatigue, joint pain. No fever. lasted 48hr
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| 59 | 2021-01-21 | malaise | Mild myalgia, malaise, soreness of injected arm |
| 59 | 2021-01-21 | chills, headache |
Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Sys...
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Systemic: Anaphylaxis-Medium, Systemic: Chills-Severe, Systemic: Generalized Body Aches -Medium, Systemic: Headache-Severe, Systemic: Vomiting-Mild
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| 59 | 2021-01-21 | headache, fatigue, fever | fever, fatigue, muscle aches, head ache |
| 59 | 2021-01-21 | fatigue, fever, headache | fever, headache, fatigue, muscle ache |
| 59 | 2021-01-24 | chills, fever |
Body aches (approximately 36-40 hours), low grade fever (under 100 degrees) & chills (approximately ...
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Body aches (approximately 36-40 hours), low grade fever (under 100 degrees) & chills (approximately 36-40 hours). This am feeling back to normal.
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| 59 | 2021-01-24 | headache, throat pain, fatigue, fever, chills |
First day:chills, sore throat, nausea, fatigue, H/A starting about 2 pm Second day: fatigue, less na...
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First day:chills, sore throat, nausea, fatigue, H/A starting about 2 pm Second day: fatigue, less nausea, chills, H/A Third day: Extreme fatigue and Fever 100.9 oral
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| 59 | 2021-01-24 | fatigue, chills, fever, headache | PAIN INJECTION SITE, HEADACHE, CHILLS,PAIN ON JOINTS, TIRED,FEVER BODY PAIN. SINTOMES FOR 3 DAYS. |
| 59 | 2021-01-24 | fatigue |
Patient submitted MyChart message as below detailing her adverse reaction to COVID-19 vaccine: "Hell...
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Patient submitted MyChart message as below detailing her adverse reaction to COVID-19 vaccine: "Hello, I received my first Pfizer COVID vaccine on Friday Jan 22 at a health care program. On Friday I felt no arm discomfort, but had a stomach ache all day. Saturday I was very tired and in the evening I noticed my left shot shoulder/arm pit area, bra line area was swollen and uncomfortable. Woke up in the night feeling like my left arm pit, and breast area was more swollen and if I had to paint it I would describe it as tiny bubbles all enlarged underneath my skin. Guessing it is my lymph nodes? This unusual feeling has since spread to the left side of my neck inside my throat and out. It is not painful, I have taken a warm shower, only wearing loose, comfy clothing and am sitting with a warm bean pillow on my neck. I just wanted to report how I am feeling if others are having similar reactions."
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| 59 | 2021-01-24 | headache | Severe headache day of shot 1/21/21. |
| 59 | 2021-01-25 | headache, weakness, fatigue |
Achy legs/Sore arm; Weak and very tired; Weak and very tired; Slight headache; This is a spontaneous...
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Achy legs/Sore arm; Weak and very tired; Weak and very tired; Slight headache; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 14:45 at single dose for COVID-19 immunisation. Medical history included multiple sclerosis and Raynaud's phenomenon. Concomitant medication included natalizumab (TYSABRI) from 30Dec2020. The patient previously took and experienced allergies with celecoxib (CELEXIA), amoxicillin, desipramine and pantoprazole. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported), via an unspecified route of administration in the left arm on 21Dec2020 13:30 at single dose for COVID-19 immunisation. On 12Jan2021, the patient had achy legs. The patient was also weak and very tired that afternoon, with slight headache. She was much better on 13Jan2021. Her sore arm developed the day after vaccination after both injections lasted a day or two. No treatment was received for the adverse events. Clinical outcome of the events was recovered on Jan2021.
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| 59 | 2021-01-25 | chills, fever, fatigue |
Low grade fever; chills; body aches; fatigue; This is a spontaneous report from a contactable other ...
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Low grade fever; chills; body aches; fatigue; This is a spontaneous report from a contactable other health professional reporting for herself. A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK4176, expiry date: not reported), via an unspecified route of administration, on 11Jan2021 10:45 AM, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Medical history included COVID. The patient was diagnosed with COVID prior to vaccination. Concomitant medications included unspecified medications; the patient received other medications in two weeks. The patient previously took aspirin and experienced allergies. On 12Jan2021 06:30 PM, the patient experienced low grade fever, chills, body aches and fatigue. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovered on an unspecified date.
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| 59 | 2021-01-25 | fever, cough, dizziness, fatigue, headache |
Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint ...
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Pulsating headaches; Blurry vision; nausea; 102.2 fever; body aches; hand tremors; dizziness; joint pain; Cough; feeling of exhaustion; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (right arm) on 09Jan2021 11:00 at single dose for Covid-19 immunization. Medical history included asthma and hypertension. The patient received an unspecified medication in two weeks. The patient previously took codeine and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pulsating headaches, blurry vision, nausea, 102.2 fever, body aches, hand tremors, dizziness, joint pain, cough, and feeling of exhaustion on 09Jan2021 (12:00 PM). There was no treatment received for the events. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
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| 59 | 2021-01-25 | body temperature increased, fatigue, chills, headache |
Temp 100.2, chills, shivers, muscle and joint pain, fatigue, headache for 26 hours. Continue with h...
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Temp 100.2, chills, shivers, muscle and joint pain, fatigue, headache for 26 hours. Continue with headache and joint/ muscle pain. Treated with Advil
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| 59 | 2021-01-25 | throat pain, chills, cough, fatigue, headache, nasal congestion, nasopharyngitis, runny nose |
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/hea...
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ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
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| 59 | 2021-01-25 | nerve pain |
nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare...
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nerve pain began in feet, arms and hands; This is a spontaneous report from a contactable healthcare professional (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration in the right arm on 08Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included ongoing ideopathic neuropathy and high cholesterol. Concomitant medications included duloxetine (DULOXETINE), acetylsalicylic acid (ASPIRIN BP), and simvastatin (ZOCOR). The patient experienced nerve pain which began in feet, arms and hands on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the event was not recovered.
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| 59 | 2021-01-25 | headache, body temperature increased, somnolence, nasal congestion, chills |
received 1st dose on 1/22/21 at 3:45 PM. On 1/23/21 I developed muscle pain, severe headache, feve...
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received 1st dose on 1/22/21 at 3:45 PM. On 1/23/21 I developed muscle pain, severe headache, fever of 102.00 , extreme sleepiness, chills and stuffy nose. This continued through 1/25/21. On 1/26/21 these symptoms subsided.
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| 59 | 2021-01-26 | dizziness, throat pain, headache |
1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20...
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1/19/21 headache, sore throat, muscle and bone pain, neck pain, nausea. Everything resolved on 1/20 and 1/21. 01/22/21 awakened at 4am with "head itching", dizzy, headache, numbness in arms, nausea. In the evening hives started on hands/back/legs. 01/23/21 Went to Urgent Care because hands "felt like I had them on a hot plate, burning".
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| 59 | 2021-01-26 | migraine, chills, fever |
14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down,...
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14 hours later had 103 fever with chills, joint pain, migraine x 16 hours. The next day fever down, but has joint pain and dull headache.
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| 59 | 2021-01-26 | chills, fever |
20 1/2 hours after 2nd injection I developed chills, achiness in upper back and neck, headache and j...
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20 1/2 hours after 2nd injection I developed chills, achiness in upper back and neck, headache and joint aches. Fever developed rose to 101. Symptoms subsided after approx. 8 1/2 hours
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| 59 | 2021-01-26 | headache |
Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pai...
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Headache, left hand numbness, injection site inflammation and pain to right elbow, right scapula pain, diarrhea x2, nausea,
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| 59 | 2021-01-26 | fatigue, weakness | Nausea, stomach cramps, fatigue, and weakness |
| 59 | 2021-01-26 | dizziness, shortness of breath | Pt c/o SOB and feeling "woozy". Slightly off balance |
| 59 | 2021-01-26 | dizziness, shortness of breath |
Pt c/o feeling "woozy" and SOB. A little unsteady on feet. VS WNL for pt/per stated. BG 102. Pt ...
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Pt c/o feeling "woozy" and SOB. A little unsteady on feet. VS WNL for pt/per stated. BG 102. Pt stated that this is low for her. Given OJ and Peanut butter with crackers. Recovered. Sat for a while and then went to cafeteria to eat. Had not eaten today
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| 59 | 2021-01-26 | shortness of breath, fatigue, headache |
Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, an...
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Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, and it was 89 to 90; achy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration right deltoid on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 21Dec2020 via injection in left deltoid for COVID-19 immunization. The patient reported that she feels fine today (13Jan2021), but she received her second dose of the COVID vaccine on Saturday, 09Jan2021. She experienced side effects including headache, feeling tired, and joint aches on 11Jan2021. She also experienced shortness of breath on 12Jan2021. The shortness of breath started early Tuesday morning in the middle of the night. She would say that it was like her chest was hurting. She measured her oxygen at the time, and it was 89 to 90 (Jan2021). It gradually went up from there. This lasted about 3 hours. She is fine now. She would say these are all not serious as she knew it could be from the vaccine and she was keeping an eye on it. She could get up and do things she was just achy (Jan2021). It took her by surprise. She does not know if this is a known side effect or if it should be expected or if she should report this. The patient recovered from the events "oxygen at the time, and it was 89 to 90" on unspecified date; headache and joint aches on 11Jan2021; shortness of breath and "chest was hurting" on 12Jan2021; feeling tired on 13Jan2021; while unknown outcome for the remaining events. The events shortness of breath, joint aches, feeling tired, and headache were assessed as related to COVID vaccine by the reporter. The event shortness of breath, feeling tired, joint aches, and headache was assessed as non-serious Information on the lot/batch number has been requested.
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| 59 | 2021-01-26 | shortness of breath, throat irritation |
Six hours post injection throat started to become scratchy and wheezing in lungs. Wheezing and short...
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Six hours post injection throat started to become scratchy and wheezing in lungs. Wheezing and shortness of breath became more severe. O2 sat 89-90%. Immediately self administered back to back albuterol breathing treatments via nebulizer and 50 mg Benadryl. Continues breathing treatments for the next 36 hours until wheezing subsided and breathing and O2 sat returned to normal.
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| 59 | 2021-01-26 | dizziness, headache, throat swelling |
Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for al...
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Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for almost 2 weeks , headaches, dizziness Completely normal on 1/22/21
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| 59 | 2021-01-26 | chills, fever, headache, fatigue, shortness of breath |
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest...
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Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day. Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-26 | discomfort, fatigue |
VERBAL CONSENT OBTAINED, MONITORED FOR 15 MINPER POLICY, AT THE 15 MIN MARK PATIENT COMPLAINED OF M...
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VERBAL CONSENT OBTAINED, MONITORED FOR 15 MINPER POLICY, AT THE 15 MIN MARK PATIENT COMPLAINED OF MY BODY FEELS IMMEDIATELY TIRED AND WARM AN HEAVYBP 126/78 HR 74 POX 99 RA, KEPT FOR ANOTHER 15 MIN TO MONITOR
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| 59 | 2021-01-26 | body temperature increased, chills |
Woke up at around 3:10 am this am with extreme chills and body aches. Had a temperature of 101.4 an...
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Woke up at around 3:10 am this am with extreme chills and body aches. Had a temperature of 101.4 and felt awful. Took some ibuprofen (didnt have any tylenol) turned the heat up to 76 and at this time (7:54) am I feel a little better but I stil have a temperature of 101.2. I'm just sending this for your information
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| 59 | 2021-01-26 | fever, chills |
chills; achy back; low fever; injection site pain; This is a spontaneous report from a contactable o...
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chills; achy back; low fever; injection site pain; This is a spontaneous report from a contactable other health care professional. A 59-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el 3248 and expiration date not provided), intramuscular (right arm) first dose on 12Jan2021 12:00 at single dose for covid-19 immunisation. The patient's medical history included psoriasis, seasonal allergies, and If COVID prior vaccination: Yes. The patient's concomitant medication included oxymetazoline hydrochloride (CLARITIN EYE ALLERGY RELIEF), ergocalciferol (VIT D), vitamin c [ascorbic acid], and zinc. On 13Jan2021 07:00, the patient experienced chills, achy back, low fever, injection site pain. No treatment was given to the events. The outcome of the events was not recovered. No other vaccine was taken within four weeks and not tested for Covid post vaccination.
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| 59 | 2021-01-26 | weakness, lethargy | nause, stomach cramps, fever blisters, lethargic, weakness |
| 59 | 2021-01-26 | migraine |
severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable ...
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severe arthralgias; migraine headache; mild nausea; This is a spontaneous report from a contactable nurse. A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0142/expiration date unknown) dose number 2, via an unspecified route of administration on 08Jan2021 09:00 at a single dose on the right arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included asthma, arrhythmia, sulfonamide allergy, and latex allergy. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. Historical vaccine included BNT162B2 (COVID-19, lot number EJ1685, dose number 1) on 18Dec2020 06:30 on the right arm. There were no other vaccinations within 4 weeks. Concomitant medications included ASA, acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN), cyanocobalamin (VIT B12), ergocalciferol (VIT D), and cetirizine hydrochloride (ZYRTEK). The patient experienced severe arthralgias, migraine headache, and mild nausea on 08Jan2021 20:00. The outcome of the events was recovered in Jan2021.
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| 59 | 2021-01-28 | fever | Developed a persisten fever2 days after vaccination |
| 59 | 2021-01-28 | fatigue, influenza like illness, shortness of breath |
Short of breath; Fluish symptoms; Fatigue; This is a spontaneous report from a contactable nurse. A ...
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Short of breath; Fluish symptoms; Fatigue; This is a spontaneous report from a contactable nurse. A 59-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1283, expiry date: Apr2021), via an unspecified route of administration on the right upper arm, from 08Jan2021 at 11:30, at a single dose for Covid-19 immunization and progesterone at 700 mg, daily (takes 300mg in the morning and 400mg and night) and then 200 mg (yesterday took 200 mg and today she took 200 mg), at unspecified route of administration, from an unspecified dates, for perinatal menopause symptoms. Medical history included allergic reaction to Penicillin, ongoing borderline high blood pressure, sleep apnea, perinatal menopause symptoms, and allergic reaction also with Sulfa drugs, it is hives and wheals with Sulfa drugs and overweight. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced anaphylactic reaction, Diavan and experienced angioedema and allergic reaction, and first dose of bnt162b2 (lot number is EJ1685 with expiration Mar2021) on the right arm, on 18Dec2020 for Covid-19 immunization. The patient was calling about Pfizer COVID vaccine number 2. She knows she could go on the website but she also had a question she would like to see if she could be answered. She said she took the COVID vaccine 2 on 08Jan2021, Friday, and on 10Jan2021, Sunday she noticed she couldn't breath after taking her Progesterone. She takes Progesterone for perinatal menopause symptoms and she really needs it. She noticed about 20-25 minutes after taking her progesterone that she was short of breath and this has continued if not increased. It is not going away since then and she is wondering if there is any end in site. She went to a physician that is very knowledgeable and he said it is triggering an inflammatory response but she is really short of breath she is walking around with a O2 sat monitor on. She doesn't know if there is any end in site. She does not want to have to go in the hospital. Mainly after she takes her progesterone she is short of breath and she has gone down on her dosage a lot and she still having shortness of breath. She took the progesterone and 25 minutes later she became short of breath. The reaction has increased since it started on Sunday evening, 10Jan2021. She is noticing, she is still taking it and it has a long half life but even with dropping the dose a lot even with that it has stayed the same or gotten worse. She says she took her Progesterone on Saturday as she normally would. But Sunday morning when she took her 300 mg in the morning about 20 minutes or 25 minutes after she was very short of breath like she can't get a whole breath of air. She has reduced the dose she is taking now. Yesterday she took 200 mg and today she took 200 mg. She has been on it for 3 years and she has never had shortness of breath. She has never had shortness of breath before even though she is overweight she has not had shortness of breath unless she is running or some sort of exertion this is totally new. She said her initial side effects the fluish symptoms and fatigue began Friday evening on 08Jan2021 and had resolved completely on Saturday, 09Jan2021. Outcome of short of breath was reported as worsened (not recovered). The action taken for progesterone was dose reduced.; Sender's Comments: The event short of breath is more likely due to progesterone based on more close temporal relationship. However, a possible contributory role of BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-01-28 | fatigue |
Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside...
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Tiredness; mouth sores; it looked red and swollen and it hurt; patient cannot really eat; gum inside cheek have white spots on it; it looked red and swollen and it hurt; it looked red and swollen and it hurt; It was more of the cheek inside the mouth, that's painful; It was not open sore but it was just red; Tenderness of lymph nodes/Lymph node is kind of tender; swelling of the lymph node; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: not sure EL3249 or EU3249), via an unspecified route of administration on 11Jan2021 at single dose at left deltoid for covid-19 immunization. Medical history included hypertension, hypothyroidism, heartburn. Concomitant medications included levothyroxine for hypothyroidism, olmesartan, hydrochlorothiazide, amlodipine, omeprazole for heartburn, alprazolam. Patient had the tiredness, mouth sores or something like that in Jan2021. When patient look at her cheek, the gum inside cheek have white spots on it and it looked red and swollen and it hurt, especially the left side and that bothered patient because patient cannot really eat and it hurt. It was more of the cheek inside the mouth, that's painful. It's not open sore but it's just red and like tender. And also patient had a tenderness of lymph nodes on the left neck. For causality, the patient thought so because nothing has changed since before patient got the vaccine. Patient didn't have any of this, especially the sore in the mouth. Patient cannot eat on the left side because it hurt. But the rest of the symptoms which was the tiredness and the swelling of the lymph node, lymph node was kind of tender but it's only on the left side, that's listed as the side effects. But the sores in the mouth was not listed that's why patient was worried about that. Lab work: results were okay. The tiredness, it was like patient got it in the morning, so patient slept. Patient went straight after work, then patient slept. When patient started getting ready for work and the alarm went off, patient was extra tired so I called out sick, but patient was okay. For treatment, patient took naproxen sodium (ALEVE) and then, because patient was at work and yesterday it was really bothering patient because it was hurting. It started hurting really more when the evening was on. Then patient took paracetamol (TYLENOL), then the nystatin solution, patient tried to swish and it helped a little bit with the pain. Due date for the next dose was 08Feb2021. Outcome of events was unknown. Information on the lot/ batch number has been requested.
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| 59 | 2021-01-28 | dizziness |
slightly light headed for over an hour; This is a spontaneous report from a contactable healthcare p...
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slightly light headed for over an hour; This is a spontaneous report from a contactable healthcare professional (patient herself). A 59-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0140, expiry date unknown), via an unspecified route of administration (left arm), on 30Dec2020 12:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. Concomitant medications included estradiol; loratadine; paracetamol (TYLENOL); fish oil and; calcium. The patient previously took tetracycline, amoxicillin, sulfamethoxazole and trimethoprim (BACTRIM) and, erythromycin and experienced allergies to all these drugs. Immediately after receiving the first dose, the patient was slightly light headed for over an hour on 30Dec2020 12:00 PM. No treatment was received for the adverse event. The patient recovered from the event on 30Dec2020. The patient had no other vaccine in four weeks and had no Covid prior to vaccination. The patient had a Covid-19 nasal swab Covid-test post vaccination on 05Jan2021 with results of negative, on 11Jan2021 with results of negative and, on 18Jan2021 with results pending.
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| 59 | 2021-02-02 | dizziness |
45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilati...
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45 minutes aFTer vaccination starTed nausea/dizziness, Quickly escalated to vomiting, Hyperventilating, increased B/P 200+/130+, decreased Responsiveness, tunnel vision, pin point pupils and no response to verbal and tactile cues For about 10 minutes. Transported to Hospital. Have Residual HTN.
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| 59 | 2021-02-03 | migraine |
lost all sense of balance; developed very severe migraines; This is a spontaneous report from a cont...
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lost all sense of balance; developed very severe migraines; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, on 21Dec2020 13:00 at single dose in right arm for COVID-19 immunization. Medical history included Hypertension, Depression, PCN allergy, Topical Iodine allergy. The patient was not Pregnant at the time of vaccination. Concomitant medications included metoprolol, HCTZ, bupropion hydrochloride (WELLBUTRIN), methylphenidate hydrochloride (CONCERTA), omeprazole (PRILOSEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately eight days after receiving the Pfizer Covid vaccine, the patient lost all sense of balance on 30Dec2020. She developed very severe migraines. She was hospitalized for four days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was on multiple doses of steroids. She was now starting IV I G infusions. Treatment received for the events included Relpax, steroids, IV Infusions. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 since the vaccination. Lab data included Nasal Swab: negative on 30Dec2020. The outcome of both events was not resolved.; Sender's Comments: Based on the available information causality between events lost all sense of balance and very severe migraines and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-02-06 | chills |
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. T...
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Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest. Treatment: dexAMETHasone sodium phos (PF) given at 4:49 pm. diphenhydrAMINE (Benadryl) given at 4:46 pm. famotidine (PEPCID) given at 4:47 pm.
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| 59 | 2021-02-07 | dizziness |
Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry....
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Pt complaint of dizziness 2 minutes after getting the vaccine. Pt the stated her vision was blurry. BP 200/130 Pt stated she was feeling better. Medic rechecked BP 247-200/130. Medic rechecked 191/119, HR 68 @ 1310 Pt advised to go to ER. Pt doesn't want to go by squad. States she will call her daughter 1332 RN still monitoring pt. Pt sitting quietly waiting on her daughter to take her to ER as advised by medic. 1337 daughter of pt arrived. Rn supervisor walked pt to meet daughter and advised daughter take her to ER ASAP and to pull over squad if worsen. Pt advised to go to ER by medics & RN due to elevated BP, blurred vision, & dizziness.
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| 59 | 2021-02-11 | fatigue, chills |
Mouth sores on roof of mouth and cheek (white/very sore) about 1 week after injection. Tongue sores ...
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Mouth sores on roof of mouth and cheek (white/very sore) about 1 week after injection. Tongue sores (red/swollen/sore) on both sides and tip of tongue + a fizzing feeling on top of the tongue starting about 10 days after injection. Fizzing feeling on roof of mouth (opposite side to previous sore) at same time as tongue sores. At this date, the roof of mouth and cheek sores are healed, but the tongue sores have spread and make eating and talking challenging. Additional side effects - Increased asthma for 7 days after injection - treated with Albuterol and Dulera. Tiredness and chills within first 2 days of injection Sore upper arm for 2 days, followed by continued soreness in elbow.
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| 59 | 2021-02-14 | chills |
Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; A...
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Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; Adverse event: Anaphylaxis reaction. High blood pressure. Body shivering. Rash on neck and chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL9269), via an unspecified route of administration into left arm on 06Feb2021, at 15:15 as first single dose for covid-19 immunization. Medical history included high blood pressure from an unknown date, known allergies to peanuts, tree nuts from an unknown date (elaborated as allergies to peanuts, non-steroidal-anti-inflammatory drugs (NSAIDs), tree nuts, penicillin), from unknown dates. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) and unspecified multivitamins. No other-vaccines were given with four weeks. On 06Feb2021, at 15:45, the patient experienced adverse event: anaphylaxis reaction. high blood pressure. body shivering. rash on neck and chest. The events were serious as they were life-threatening. The events were noted as resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and was life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included blood pressure measurement: high on 06Feb2021. Therapeutic measures were taken as a result of the adverse events; dexamethasone sodium phos- diphenhydramine (BENADRYL), famotidine. No covid infection was noted prior to vaccination. No covid test has been administered post vaccination. The outcome of events was recovered in Feb2021.
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| 59 | 2021-02-17 | headache, dizziness, fever, nerve pain |
Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blu...
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Bell's Palsy; Occipital Neuralgia; Stroke; Fever 101 degree; Myalgia; Headache/severe cephalgia; Blurred vision; dizziness; neuropathic pain; This is a spontaneous report from a contactable Physician (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number ER9831, Intramuscular in left arm on 11Jan2021 08:20 at single dose for COVID prevention. Medical history included Asthma Moderate persistent on 20Jun2020. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 on 23Dec2020 and experienced Aches, Fever 102 degree, myalgia, and headache. The patient experienced 101 degree, myalgia, Headache after the second dose of BNT162B2. The patient experienced Bell's palsy and occipital neuralgia on 28Jan2021 10:00 which resulted in stroke woke up and will lead to time off work and further imaging of cervical spine and possible nerve blocks. She had blurred vision and dizziness in addition to severe cephalgia and neuropathic pain. Treated with Aleve, steroids, Acyclovir + neurontin. Duration unknown as still with symptoms. The events Bell's palsy and occipital neuralgia resulted in Emergency room visit. Lab data included CT head with illegible Head Contrast, CT Angiogram head and MRI Head on 27Jan2021 with Result: NI. The outcome of Bell's palsy was Resolved with Sequel. The outcome of the event Stroke was unknown. The outcome of Fever 101 degree, Myalgia was resolved. The outcome of other events was not resolved.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be completely excluded based on temporal association. The information currently available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020512578 Same patient/reporter,drug, different dose
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| 59 | 2021-02-19 | dizziness |
On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations,...
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On January 16th I started feeling very dizzy in my eyes got blurry very dry mouth and palpitations, and I almost passed out at home, my husband had to take me to Er. They wanted to keep me in the hospital but I told him I will follow up with my doctor on Monday, I did not want to stay on the floor with covid patients the test that they had ordered at the hospital were normal they did not order a CMP they only did a basic metabolic panel and that was normal, so I followed up with my doctor on Monday which was January 18th, and she ordered CMP and all the labs, when they threw my blood my liver enzymes were very elevated over the thousands LT ASG and the and others, then the doctor ordered a second set of blood works of CMP just to make sure it wasn't a fluke, they were even more elevated they were over 1,400.
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| 59 | 2021-02-21 | throat irritation |
"During monitoring period, pt experienced throat itching and slight difficulty swallowing. VS: 145/7...
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"During monitoring period, pt experienced throat itching and slight difficulty swallowing. VS: 145/70 given Benadryl 25mg by mouth @1400 by onsite provider. Patient was transferred to: home after additional monitoring and relief of symptoms, pt was given ER precautions
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| 59 | 2021-02-21 | respiratory tract congestion | Body aches and congestion after vaccine |
| 59 | 2021-02-21 | chills, fever |
Low fever, chills, slight aches in joints... sudden onset, reminded me of flu. (Pain at injection s...
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Low fever, chills, slight aches in joints... sudden onset, reminded me of flu. (Pain at injection site was expected!)
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| 59 | 2021-02-21 | chills, fever | chills body aches fever last for 24 hours |
| 59 | 2021-02-22 | cough, shortness of breath |
1. Throat closed up, could not breathe 2. Coughing 3. Nausea Treated with: EpiPen x2 Oxygen Nebuliz...
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1. Throat closed up, could not breathe 2. Coughing 3. Nausea Treated with: EpiPen x2 Oxygen Nebulizer Treatment
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| 59 | 2021-02-22 | fever, fatigue, chills |
1/4 left shoulder pain, rigors, joints pain and pain between shoulder blades, fever 100.8, fatigue,...
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1/4 left shoulder pain, rigors, joints pain and pain between shoulder blades, fever 100.8, fatigue, took tylenol100mg and Advil 400mg 1/5 shoulder pain subsided a little
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| 59 | 2021-02-22 | chills, fever | Chills and fever of 101 |
| 59 | 2021-02-22 | fatigue, chills | Chills, fatigue, body aches, no appetite Treated with Advil |
| 59 | 2021-02-22 | fever |
With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very dee...
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With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very deep sleep for 48 hours. I woke to drink water and use restroom only. On Monday morning I woke up soaked in sweat that smelled like vinegar and the fever was gone. My first shot I had a little soreness in my arm only.
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| 59 | 2021-02-23 | headache, head discomfort |
Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head thr...
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Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today; pain and pressure in head through today; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 20Jan2021 07:45 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines weeks prior to receiving bnt162b2. The patient was not pregnant. Prior vaccination, the patient was not diagnosed with covid. Medical history included prone to headaches. She had no known allergies. Concomitant medications included clarithromycin (CLARITIN), dextroamphetamine [dexamfetamine], fish oil, and "Olly multivit". On 20Jan2021 02:00 PM, the patient experienced very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today, Day 6 after vaccine, and counting. No corrective treatment was received. Outcome of the events was not recovered. The patient was not tested for covid post vaccination. Information on the lot/batch number has been requested.
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| 59 | 2021-02-23 | throat pain, fatigue, nasal congestion |
small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushe...
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small sore throat; little bit of congestion; lot of aches and pains; very tired; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EL1284, expiry date: 31Apr2021), via an unspecified route of administration on the left arm, on 15Jan2021 09:30, at single dose, for covid-19 immunization. Medical history included heart issues from an unspecified date, cardiac ablation in 2020, total knee replacements on 2001 (approximately 20 years ago) and 2009 (approximately 12 years ago), spinal fusion surgery in 2017 (3 fused disc in her back approximately 4 years ago). Concomitant medication included cortisone which started on 21Jan2021 (as reported, pending clarification) for an unspecified indication. In Jan2021 (reported as "Saturday morning"), the patient experienced small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired. She was calling because she didn't know if it was possible if she could be having a reaction. She stated she had one other symptom, her face was flushed and ordinarily she wouldn't think this was odd, but it was under her eyes, and she doesn't usually have under her eyes red too. Treatment for the events small sore throat, a little bit of congestion, a lot of aches and pains, and felt very tired included Mucinex Night Shift Cold and Flu syrup, Halls Relief lozenges and Advil. The patient reported that her symptoms have stayed about the same. The patient took her temperature on an unspecified date and reported that it was fine. She reported she did not any lab tests done for the events. The outcome of the events was not recovered.
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| 59 | 2021-02-24 | shortness of breath, dizziness, throat swelling |
Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and ...
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Difficulty breathing; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; swelling in face, neck, throat and tongue; elevated heart rate; rash on face, neck and chest; Enlarged lymph nodes; dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on right arm on 09Feb2021 at 15:45 at a single dose for COVID-19 immunisation in the hospital. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included furosemide (LASIX) and other blood pressure meds (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. On 09Feb2021, at 16:45 the patient had difficulty breathing, swelling in face, neck, throat and tongue, elevated heart rate, rash on face, neck and chest, enlarged lymph nodes and dizziness. The patient assessed the events as non-serious. Steroids, Benadryl, Pepcid, antibiotics were given as treatment in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the events.
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| 59 | 2021-02-24 | weakness, fever, fatigue, chills |
Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen...
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Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
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| 59 | 2021-02-28 | chills, fatigue, headache |
Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from...
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Body ache; Headache; Tiredness; Sore arm; Insomnia; Chills in eve; This is a spontaneous report from a non-contactable healthcare professional (patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 22Jan2021 (12:45) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient's medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium, magnesium, vitamin d nos (CAL MAG), calcium carbonate;colecalciferol;phytomenadione (VIT D+K) and fish oil (OMEGA 3). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730; Expiration date was not reported) on 30Dec2020 (when the patient was 59 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 22Jan2021, the patient had sore arm; insomnia; and chills in the evening ("eve"). On 23Jan2021, the patient had body ache, headache and tiredness. The patient did not receive any treatment for the events. The outcome of the events, 'sore arm', 'insomnia', 'chills', 'body ache', 'headache' and 'tiredness', was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.
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| 59 | 2021-02-28 | fatigue |
fatigue; swollen lymph nodes above the left clavicle that sore; swollen lymph nodes above the left c...
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fatigue; swollen lymph nodes above the left clavicle that sore; swollen lymph nodes above the left clavicle that sore; This is a spontaneous report from a contactable health care professional nurse, the patient. A 59-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL 3246), via unspecified route of administration in the left arm on 20Jan2021 at 13:00 (at the age of 59-years-old) as a single dose, for COVID-19 vaccination. Medical history included asthma (Chronic Asthma but controlled). The patient had no known allergies. Concomitant medication included Albuterol, Singular, Zyrtec, multi vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 25Jan2021, The patient experienced fatigue, swollen lymph nodes above the left clavicle that sore. Reported non serious adverse event of fatigue, swollen lymph nodes above the left clavicle that sore and still present on 27Jan2021. No treatment was given for the events. The clinical outcome of the events fatigue, swollen lymph nodes above the left clavicle that sore was not recovered.
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| 59 | 2021-02-28 | malaise |
nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest o...
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nauseated; increased heart rate; feeling very unwell; pain was more severe in the arm and the rest of the body; arm swelling and pain; arm swelling and pain / pain was more severe in the arm; This is a spontaneous report from a contactable health professional, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9263,), via an unspecified route of administration on 26Jan2021 12:00 (at the age of 59-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included penicillin allergy, congenital heart defect. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK4176) on 05Jan2021 at 16:00 (at the age of 59-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 27Jan2021 at 00:00 (on the 2nd day), the patient experienced arm swelling and pain. On 28Jan2021 (the 3rd day), the patient was nauseated, and the pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell. The events resulted in a doctor or other healthcare professional visit. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of arm swelling and pain, nauseated, pain was more severe in the arm and the rest of the body, increased heart rate and overall feeling very unwell was not resolved.
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| 59 | 2021-03-01 | throat pain, malaise, fatigue |
felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her neckl...
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felt sick; sore throat with blisters/ vesicles; had a really bad sore throat; tired; achy; her necklines were swollen; redness in back; she was exposed to someone who previously had Covid-19; This is a spontaneous report from a Pfizer-sponsored program and from a Pfizer-sponsored program. A contactable nurse (reporting for herself) reported that a 59-year-old female patient, received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0142), via an unspecified route of administration on 11Jan2021 (at the age of 59) as a single dose for COVID-19 immunization. The patient's medical history included depression from an unknown date. The patient's concomitant medications included duloxetine hydrochloride (CYMBALTA) from an unknown date as an antidepressant. The patient previously received first dose of BNT62B2 (Lot number EJ1685) on 21Dec2020. The patient experienced feeling sick for 3 days after receiving the second dose. The patient may have been exposed to someone who previously had COVID-19 on 27Jan2021 and experienced really bad sore throat with blisters and tiny bubbles on the back of her throat, redness back there and there was little vesicle (called it "Covid throat"); was tired and achy and her necklines were swollen a week later on an unknown date in Feb2021. The patient underwent lab tests which included Rapid COVID Test on 10Feb2021 and 12Feb2021 with negative results; herpes test on an unknown date with negative results and strep test on an unknown date with negative results. Therapeutic measures were taken as a result of the event COVID-19 exposure which included tetracycline on the 10th (stopped on the 12th as the tests negative). The outcome of the events throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19 was unknown. Follow up (16Feb2021): New information received from a contactable healthcare provider and from a Pfizer-sponsored program includes: product details (lot numbers, second dose information), new events (throat blister, malaise, sore throat, fatigue, achy, neck swelling, throat redness and exposure to COVID-19), and lab data.; Sender's Comments: Event blisters and tiny bubbles on the back of throat represents an intercurrent medical condition and unrelated to BNT62B2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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| 59 | 2021-03-01 | weakness, fever, headache, fatigue, chills |
racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break;...
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racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies. The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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| 59 | 2021-03-02 | throat irritation |
diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis...
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diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis on back abdomen arms and legs.; diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also pruritis on back abdomen arms and legs.; Mild scratchy throat; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249), via an unspecified route of administration on 29Jan2021 13:15 at single dose (right arm) for COVID-19 immunization. Medical history included occasional gastric reflux and allergies. The patient was not pregnant. Patient had unspecified concomitant medications which was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, at 20:00, the patient developed a diffuse pink rash with white bumps over back and abdomen, to a smaller degree on arms. Also, pruritis on back abdomen arms and legs and mild scratchy throat. The patient noticed these symptoms several hours after injection and was worse on day 2. There was no treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.
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| 59 | 2021-03-03 | dizziness |
her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a ...
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her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister. A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation. Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported. In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine. Information on the lot/batch number has been requested.
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| 59 | 2021-03-03 | headache, dizziness |
right ear was aching; head was ache; jaw was also aching/throbbing; swelling of bottom lip and it wa...
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right ear was aching; head was ache; jaw was also aching/throbbing; swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen; felt sick similar to a sinus infection/pressure in front of head, jaw, right ear/sinus pressure/pressure in nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure; dizzy on and off/Dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included sinus problems, allergy, allergy to cow's milk, TMJ (she had her wisdom teeth she was having issues on the right side; after they pulled it out she was fine), and wisdom teeth pulled out at the age of 57 or 58. Concomitant medication included ascorbic acid, biotin, folic acid, iron, manganese, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, retinol, riboflavin, selenium, thiamine, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM FRUITY CHEWABLES). The patient previously took keflex and was allergic to it. The patient received her first dose of COVID-19 vaccine on 19Jan2021. She was okay from Tuesday to Thursday. On Friday (22Jan2021), the patient reported to have felt sick similar to a sinus infection, there were pressure in front of head, jaw, and right ear and was dizzy on and off for a long period. She had a sinus pressure/pressure in her nose and felt like she had a bad sinus infection in whole head. She is not saying she had a sinus infection, but that's what she experienced after receiving the shot. Her right ear was aching, head was ache, and jaw was also aching/throbbing on unspecified dates. The patient mentioned that she had swelling of bottom lip and it was hot/bottom of the lip (underneath) was swollen on 07Feb2021 but it went away today (08Feb2021). It was actually her neighbor that noticed the swelling and said it was on the bottom of lip chin area, it also felt hard when touching it. She called her primary care doctor following the events. At first, she did not want to provide these to her primary care, she did not have high blood pressure, high cholesterol or anything, but she did have bad sinuses. She took an antibiotic for sinus and pressure and her doctor told her that these could be side effects of the COVID vaccine as it causes dizziness and pressure. The dizziness must have been from the pressure since it was in her ear, cheek bones, and right ear was throbbing. It took her one month to come back to her normal self. The patient is scheduled to receive the next shot on 09Feb2021 and asked if she need to get the next shot or should she wait another week. The patient recovered from events "felt sick similar to a sinus infection/pressure in front of head, jaw, and right ear/sinus pressure/pressure in her nose/bad sinus infection in whole head/bad sinuses/took an antibiotic for sinus and pressure" and dizzy on and off/dizziness on 06Feb2021; recovered from event swelling of bottom lip on 08Feb2021; while unknown outcome for the remaining events. Information on the lot/batch number has been requested.
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| 59 | 2021-03-08 | weakness |
Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021...
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Profoundly weak by Saturday the day after the injection (2/6/2021), hospitalized by Monday (2/8/2021), on a ventilator by Wednesday (2/10/2021) and died the following Monday, (2/15/2021) She was treated for HLH (hemophagocyticlymphoistiocytosis)
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| 59 | 2021-03-09 | headache, fatigue |
having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; ...
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having a small stroke; weakness in her right hand and arm; Right arm was really sore; really tired; Headache; having issues with her right hand being numb/1st 2 fingers on her right hand were numb; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 01Mar2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200, expiry date was not reported) (at 59 years of age), via an unspecified route of administration in the right arm on 20Feb2021 15:49 at a single dose for COVID-19 immunisation. The patient's medical history and family medical history were none. The concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, 1st dose, lot number: EL9263, injection in right arm on 30Jan2021 (at 59 years of age). There was no other vaccines administered on same date with the Pfizer vaccine and there was no any other vaccinations within four weeks prior to the first administration date of the vaccine. The patient stated that she is not an HCP, but she does work in a mental health. She stated that she is concerned. She got her 2nd dose of the vaccine on Saturday and was having weakness in her right hand and arm. She asked if this was expected. She added that when she got up yesterday, her right arm was really sore, she was extremely tired, and she had a headache. She went to bed early that night at around 5:30pm, and she woke up around 8 or 9pm that night and tried to pick up her phone and couldn't. She stated that the 1st 2 fingers on her right hand were numb. When she got up today it was fine. They are working from home, so she was typing some notes and then it felt like her fingers went numb, it felt like her 1st finger was like rubber. She stated that the numbness comes and goes. She mentioned that she doesn't have a headache right now, but it felt like it could come back. The events did not require emergency room or physician visit. On 01Mar2021, it was reported that the patient was having issues with her right hand being numb and the representative that she spoke with recommended she follow up with her PCP, which she did, and they diagnosed her with having a small stroke and also referred her to a neurologist as well. She said that her primary care provider she saw was a nurse practitioner. She said that she also saw a neurologist. It was not reported if the patient received treatment for 'having a small stroke' while no treatment received for all other events. The outcome of having a small stroke was unknown; 'weakness in her right hand and arm' was not recovered; while 'Right arm was really sore' and 'really tired' was recovering. The outcome of Headache and 'having issues with her right hand being numb/1st 2 fingers on her right hand were numb' was recovered on an unknown date.
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| 59 | 2021-03-10 | malaise, fever |
I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and ...
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I began to feel ill on that Wednesday morning. I had had a bilateral mastectomy in Nov of 2020, and tissue expanders are still in place. I reached a fever of 103.6 and had pain and extreme redness in my right tissue expander. I also had all axillary lymph nodes removed from that side in December 2020. On Friday I was still feeling ill and noticed redness, so I immediately contacted my doctor and was instructed to meet him at the hospital. I was admitted and placed on antibiotics and had my tissue expander removed The next morning after no improvement from antibiotic infusion. I had a wound vac placed and stayed in the hospital for one week and had my expander replaced on that following Saturday. I am not planning on taking the second shot.
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| 59 | 2021-03-10 | dizziness |
Patient had dizziness after receiving vaccine. Evaluated by clinic staff - then reporting throat ti...
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Patient had dizziness after receiving vaccine. Evaluated by clinic staff - then reporting throat tightness and reported having left shoulder pain for the prior 1.5 hours. patient was sent to the ED by EMS. The pt states that she had her first covid vaccine injection today and less than 30 minutes after her vaccine she developed acute central chest pain radiating to her left shoulder. She was given a full dose asa and 1 SL nitro by EMS. She states her chest pain was a 9/10 and it was pressure and tightness. She had associated lightheadedness. She states her pain is much worse than her typical chest pain she gets at home and takes nitro for. She states she is unsure if it is exertional, it is not worsened by deep breathing or palpation. She denies syncope, facial swelling, diaphoresis, n/v, abdominal pain, and hx of allergic reactions from vaccines.
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| 59 | 2021-03-11 | shortness of breath, pneumonia |
3/6/21 ER 59 y.o. female who presents with SHORTNESSS OF BREATH FROM NURSING HOME. EMS STATES THA...
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3/6/21 ER 59 y.o. female who presents with SHORTNESSS OF BREATH FROM NURSING HOME. EMS STATES THAT PT HAD COPIOUS ORAL SECRETIONS AND WAS IN REESPIRATORY DISTRESS UPON THEIR ARRIVAL.EMS PRE-ARRIVAL TREATMENT: IV ATTEMPTS UNSUCCESSFUL, PLACED ON BIPAP AND SATS CAME UP TO 98% Presented by EMS from facility with altered mental status confusion Desat 85 on 02 3L NC foaming at the mouth is What nursing home staff reported; EMS unable to get IV access but did apply CPAP at 10 with sat of 99%; patient will wake up with painful stimuli. Nursing Home reports patient wears BIPAP S.T. rate 20/8/10 at night and 2 hours during the Day COVID vaccination Pfizer patient received 1/7/2021 and 1/28/2021 Took insulins this morning and guaifenesin, blood sugar accu check 221 Transferred to higher level of care
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| 59 | 2021-03-16 | night sweats |
I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting t...
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I tested positive for Covid on November 11th 2020,and was asymptomatic. Within 48 hrs of getting the vaccine both my right hand and right leg started tingling and I had pins and needles sensation. I also woke up in the middle of the night with immense night sweating. My arm started becoming numb and cold. I talked to a doctor and she suggested I go to the ER right away as this could be indicative of a minor stroke. I was admitted in the hospital as they needed to run several tests. I spoke with other doctors who suggested not taking the 2nd shot as it could make matters worse. So I opted out of taking the 2nd jab. I wonder if there is any study about adverse reaction for former Covid positive people and if they are better of only taking the 1st jab. Another Covid positive friend also had a similar reaction after the 1st jab. His right side of face became numb. I am worried about lasting damage if any. Could somebody please get back with me on this.
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| 59 | 2021-03-18 | fatigue, dizziness, fever, night sweats, headache |
Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and un...
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Had Covid fairly bad I got pneumonia with it; Super tired; 103 to 104.6 fever; Glands in neck and under arm on the side where got the shot swelled up; hurt quite badly; huge swollen lymph nodes; Body ache; Could barely walk; could walk to shuffle my feet; joints stiff; Horrible headaches; Diarrhea; I was dizzy and foggy; Night I break out into a horrible sweat in night like I have to change my pajamas twice; I am like wet; Arm sore/My arm was just little bit sore; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EN6202) (at the age of 59) as a single dose, for covid-19 immunisation. Medical history included an unspecified heart condition and a flu shot un an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID) and ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE). The patient stated, "I am calling about the side effects I had from my Covid shot vaccine. I am concerned about getting the second one because my reaction was so big. I got it on Saturday, this past Saturday about 12:45 I think 12:30 and I did fine, the shot didn't hurt at all. That night I was a little bit tired but that's it. My arm was just little bit sore. The next day I got up, I still felt good I went to work for 2 hours and then about 12 o'clock it hit me all at once. This Sunday I ran anywhere from a 103 to 104.6 fever and that was me taking Tylenol and I took Tylenol every 4 hour because my fever was still high. The glands in my neck and the glands under my arm on the side where I got the shot swelled up, they are still swollen. My whole body ached. I had Covid fairly bad I got pneumonia with it all for "two weeks" (not clarified) but my fever was not as high as got with the shot, the vaccine like I could barely walk after the vaccine because my joints were so stiff only way I could walk was to shuffle my feet, it was horrible. I had a fever yesterday all day but it was only in the 102.3 and 4, it never went back to 103. Glands in my arm and my neck hurt quite badly. My arm where I got it, it wasn't swollen but I get the same reaction when I get a Flu shot (unspecified shot) so that's not a big deal. I got horrible headaches. I had diarrhea all day Sunday and yesterday and so this morning my fever is only right around 101 like 101.1, 101.2, I am still super tired and also yesterday and day before I was dizzy and foggy. I still have a slight fever today. My lymph nodes are still swollen, my neck and under my arm, my arm where I got the shot is still swollen and sore but I can tolerate that. My joints are stiff a little bit but not nearly as bad as they were, so I don't know if I should get the second shot, everyone says the second shot is worst like all those heart palpitations start with it as well." One of my other symptom is at night I break out into a horrible sweat like I have to change my pajamas twice. It was last night and the night before. I am like really wet." The outcome of the events was not reported.
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| 59 | 2021-03-22 | fever, shortness of breath, dizziness |
Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM...
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Started having a severe reaction after I received the vaccine, my symptoms started at around 6:30 PM I started to get very red and my face was swollen then I started to have a difficultly in breathing then I felt dizzy and I had a high fever and I started vomiting. and my blood pressure was very high. Then I called 911 and I was transferred to the Emergency hospital.
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| 59 | 2021-03-22 | shortness of breath, pneumonia | shortness of breath chest pain respiratory failure with hypoxia multifocal pnuemonia |
| 59 | 2021-03-28 | shortness of breath, fever, chills |
Extreme rigors, fever, shortness of breath/hypoxemia within hours of receiving vaccine according to ...
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Extreme rigors, fever, shortness of breath/hypoxemia within hours of receiving vaccine according to staff at the care home. leukopenia, pulmonary edema, death
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